          MEDICINES                         _g CAP. 458.        1
CHAPTER 458
MEDICINES ACT
To make provision for matters connected with the manufacture, preparation and assembly,
wholesale distribution, storage, destruction, disposal, advertising and authorisation of
medicinal products and any activity connected therewith and the regulation of the sale of
medicinal products, pharmacies and related pharmaceutical activities and for any other
matters ancillary thereto or connected therewith.
21st November, 2003;
1st December, 2003
ACT III of 2003.
ARRANGEMENT OF ACT
Articles
1
Part I Preliminary 2
Part II Administration 3 - 18
  Title I Licensing Authority 3
  Title II The Medicines Authority 4 - 13
  Title III Medicines Review Board 14 - 18
Part III General Provisions 19 - 89
  Title I Marketing authorisation relating to Medical Products 19 - 36
  Title II Manufacture of Medical Products for Human Use 37 - 53
  Title III Wholesale Distribution of Medicinal Products for
Human Use 54 - 65
  Title IV Pharmacies and related Pharmaceutical Activity 66 - 89
Part IV Poisonous Substances 90 - 96
Part V Other dealings with Medicinal Products 97 - 98
Part VI Offences and Penalties 99 - 100
Part VII Enforcement 101 - 104
Part VIII Miscellaneous Provisions 105 - 109
First Schedule - Panel of experts to sit on Medicines Review
Board
Second Schedule - Proceedings of the Medicines Review Board
Third Schedule - Conditions and criteria where any person can
have or not have a direct or indirect interest in a
pharmacy
  2        CAP. 458. _h               MEDICINES
Short title and 
commencement.
1. The short title of this Act is the Medicines Act.
PART I
PRELIMINARY
Interpretation. 2. In this Act, unless the context otherwise requires -
"advertising" in relation to medicinal products includes any form
of door-to-door information, canvassing activity or inducement
designed to promote the prescription, supply, sale or consumption
of medicinal products and without prejudice to the generality of the
foregoing in particular includes:
( a ) the advertising of medicinal products to the general
public;
( b ) the advertising of medicinal products to persons
qualified to prescribe or supply them;
( c ) visits by medical or sales representatives to persons
qualified to prescribe medicinal products;
( d ) the supply of samples;
( e ) the provision of inducements to prescribe or supply
medicinal products, by way of a gift, offer or promise
of any benefit or bonus, whether in money or in kind,
except when the intrinsic value of such an inducement
is minimal;
( f ) sponsorship of promotional meetings attended by
persons qualified to prescribe or supply medicinal
products;
( g ) sponsorship of any scientific congress attended by
persons qualified to prescribe or supply medicinal
products and in particular where payment of their
travelling and accommodation expenses is offered in
connection therewith;
but shall exclude:
(i) the labelling and the accompanying package
leaflets, as may be specified in accordance with
the provisions of Part III, Title I of this Act;
(ii) correspondence, even if accompanied by
material of a non-promotional nature, which is
in reply to a specific question about a particular
medicinal product;
(iii) factual, informative, announcement or reference
material relating to pack changes, adverse-
reaction warnings as part of general drug
precautions, trade catalogues, price lists and
other material of a similar nature provided that
such material does not include any product
claim;
(iv) any statement relating to human health or
disease, provided there is no reference, whether
direct or indirect, to a medicinal product;
          MEDICINES                         _g CAP. 458.        3
"analysis" includes testing of a medicinal product or any of its
constituents, both active or inactive, in respect of their chemical,
physical, pharmaceutical, biological, toxicological or
pharmacological properties;
"assemble", in relation to a medicinal product, means to enclose
the product in a container which is labelled before the product is
sold or supplied, or, where the product is already enclosed in the
container in which it is to be sold or supplied, labelling the
container before the product is sold or supplied in it, and shall also
include the act of introducing approved information in or on the
container and "assembly" shall be construed accordingly;
Cap. 94.
"authorised officer" in relation to the Medicines Authority means
any officer or employee of the Authority or any other person
authorised by the Authority to act on its behalf and in relation to
the Licensing Authority means any officer or employee of the
Department as referred to in article 5 of the Department of Health
(Constitution) Ordinance authorised by the Licensing Authority to
act on its behalf;
"business" means any economic activity whether carried out by
the individual or by a body of persons, whether corporate or
unincorporate and includes the exercise of a profession;
"clinical trial" means any investigation in human subjects
intended to discover or verify the clinical, pharmacological or other
pharmacodynamic effects of one or more medicinal product under
investigation, or to identify any adverse reactions to one or more
medicinal product under investigation or to study absorption,
distribution, metabolism and excretion of one or more
investigational medicinal product with the object of ascertaining its
safety or efficacy; and includes clinical trials carried out in either
one site or multiple sites, whether locally or in one or more states
recognised by the Licensing Authority;
"composition" in relation to a medicinal product, means the
ingredients constituting it and the proportions, and the degrees of
strength, quality and purity, in which those ingredients are
respectively contained in it and as may be established in a
recognised pharmacopoeia;
"container" in relation to a medicinal product, means the
immediate packaging or outer packaging;
Cap. 427.
"cosmetic product" shall have the same definition as found under
the Product Safety Act;
Cap. 31.
"dental practitioner" means a person who is authorised to
exercise such profession under the Medical and Kindred
Professions Ordinance or any other law replacing the same; 
"disease" includes any injury, ailment or adverse condition,
whether of body or mind;
"dispensing" includes sale or supply of medicinal products;
Cap. 449.
Safety Act;
  4        CAP. 458. _h               MEDICINES
"good practice" in relation to manufacturing practice, laboratory
practice, distribution practice, clinical practice and dispensing
practice means the standards for the proper execution of the
relative activity as established by or under this Act; 
"herbal medicinal product" means any medicinal product
containing as active ingredients one or more herbal substances or
one or more herbal preparations or one or more herbal substances
in combination with one or more such herbal preparations;
"herbal preparations" means preparations obtained by subjecting
herbal substances to treatments such as extraction, distillation,
expression, fractionation, purification, concentration and
fermentation.  These include comminuted or powdered herbal
substances, tinctures, extracts, essential oils, expressed juices and
processed exudates;
"herbal substances" means all mainly whole, fragmented or cut
plants, plant parts, algae, funghi, lichen in an unprocessed, usually
in dried form but sometimes fresh.  Certain exudates which have
not been subjected to a specific treatment are also considered to be
herbal substances;
"homeopathic medicinal product" means any medicinal product
prepared from products, substances or compositions referred to as
homeopathic stocks in terms of a homeopathic manufacturing
procedure described by a recognised Pharmacopoeia;
"immediate packaging" means the container or other form of
packaging immediately in contact with the medicinal product;
"immunological medicinal product" means any medicinal
product consisting of vaccine, toxin, serum or allergen product
where:
( a ) vaccine, toxin and serum include - 
(i) agents used to produce active immunity;
(ii) agents used to diagnose immunity;
(iii) agents used to produce passive immunity; and
( b ) ''allergen product'' means any medicinal product which
is intended to identify or induce a specific acquired
alteration in the immunological response to an
allergising agent;
"ingredient" in relation to the manufacture or the preparation of a
substance, includes anything which is the sole active ingredient of
the substance as manufactured or prepared;
"investigational medicinal product" means a pharmaceutical
form of an active substance or placebo being tested or used as a
reference in a clinical trial, and includes products already with a
marketing authorisation but used or assembled (formulated or
packaged) in a way different from the authorised form, or when
used for an unauthorised indication, or when used to gain further
information about the authorised form;
"labelling" means any information on the immediate or outer
packaging;
          MEDICINES                         _g CAP. 458.        5
"licence" means a licence issued under the provisions of this Act;
"licensee" means any person who is the holder of a licence for a
particular activity granted under this Act;
"magistral formula" means any medicinal product prepared in a
pharmacy in accordance with a prescription for an individual
patient;
"manufacture", in relation to a medicinal product, includes any
process carried out in the course of manufacturing the product, but
does not include dissolving or dispersing the product in, or diluting
or mixing it with, some other substance used as a vehicle for the
purpose of administering it;
"medical device" means any instrument, apparatus, appliance,
material or other article, whether used alone or in combination,
including any software necessary for its proper application
intended by the manufacturer to be used for human beings for the
purpose of - 
( a ) diagnosis, prevention, monitoring, treatment or
alleviation of disease;
( b ) diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap;
( c ) investigation, replacement or modification of the
anatomy or of a physiological process; and
( d ) control of conception and which does not achieve its
principal intended action in or on the human body by
pharmacological, immunological or metabolic means,
but which may be assisted in its function by such
means;
Cap. 31.
"medical practitioner" means a person who is authorised to
exercise such profession under the Medical and Kindred
Professions Ordinance or any other law replacing same; 
"medicinal prescription" means any prescription issued by a
professional person qualified to prescribe medicinal products by or
under this Act;
"medicinal product" means any substance or combination of
substances presented for treating or preventing disease in human
beings, as well as any substance or combination of substances
which may be administered to human beings with a view to making
a medical diagnosis or to restoring, correcting or modifying
physiological functions in human beings;
"medicinal purpose" includes any one or more of the following
purposes:
( a ) the treating or preventing disease;
( b ) the diagnosing of disease or ascertaining the existence,
degree or extent of a physiological condition;
( c ) contraception;
( d ) inducing anaesthesia;
( e ) the prevention or interference with the normal
  6        CAP. 458. _h               MEDICINES
operation of a physiological function, whether
permanently or temporarily, and whether by way of
terminating, reducing or postponing or increasing or
accelerating the operation of that function or in any
other way.
"Medicines Authority" means the Authority established under
article 4;
"Medicines Review Board" means the Board established under
article 14;
"Minister" means the Minister responsible for public health;
"official formula" means any medicinal product that is prepared
in a pharmacy in accordance with instructions found in a
prescription of a recognised pharmacopoeia and which is intended
to be supplied directly to a patient being served by the said
pharmacy;
"outer packaging" means the packaging into which the
immediate packaging is placed;
"package", in relation to any medicinal product, means any box,
packet or other article in which one or more container of the
product are, or are intended to be, enclosed, and, where any such
box, packet or other article is, or is to be itself enclosed in one or
more other boxes, packets or articles, includes any of the said
boxes, packets or articles;
"package leaflet" means a leaflet containing information for the
user which accompanies the medicinal product;
"pharmacist" means a person who is authorised to exercise such
profession under the Medical and Kindred Professions Ordinance,
or any other law replacing the same;
Cap. 31.
"pharmacy technician" means a person authorised to act as such
under the Medical Kindred and Profession Ordinance or any other
law replacing the same;
"pre-packaging" means the act by which a pharmacist divides a
medicinal product into quantities more appropriate for individual
patient use, thus changing the outer packaging of this product for
the act of dispensing;
"prescribed" means prescribed by regulations made by the
Minister under this Act; 
"qualified person" means any person who is a qualified person in
relation to a manufacturer’s licence as provided in article 38 (1)( e );
"radionuclide generator" means any system incorporating a fixed
parent radionuclide from which is produced a daughter
radionuclide which is to be removed by elution or by any other
method and used in a radiopharmaceutical;
"radionuclide kit" means any preparation to be reconstituted or
combined with radionuclides in the final radiopharmaceutical,
usually prior to its administration;
"radionuclide precursor" means any radionuclide not being a
          MEDICINES                         _g CAP. 458.        7
radiopharmaceutical, radionuclide generator or radionuclide kit
which is produced for the radio-labelling of another substance prior
to administration;
"radiopharmaceutical" means a medicinal product which, when
ready for use, contains one or more radionuclides included for a
medicinal purpose;
"recognised laboratory" means any laboratory recognised as such
by the Licensing Authority for the purposes of this Act;
"recognised pharmacopeia" means a pharmacopeia recognised by
rules for the purpose of this Act;
"responsible person" means any person who is a responsible
person in relation to a wholesale dealer's licence as provided in
article 55(1)( d );
"rules" means rules made by the Licensing Authority under the
provisions of this Act;
"substance" means any matter irrespective of origin be it human
(including human blood and human blood products), animal
(including micro-organisms, whole animals, parts of organs, animal
secretions, extracts), vegetable (including micro-organisms, plants,
parts of plants, vegetable secretions, extracts), or chemical
(including elements, naturally occurring chemical materials or
chemical products obtained by chemical change or synthesis);
Cap. 94.
"Superintendent of Public Health" has the same meaning as is
assigned to it by article 4 of the Department of Health
(Constitution) Ordinance;
Cap. 437.
"veterinary surgeon" means a person who is authorised to
exercise such profession under the Veterinary Services Act, or any
other law replacing the same;
"wholesale distribution" in relation to a medicinal product,
includes all activities consisting of procuring, holding, supplying,
distributing, exporting or importing medicinal products, other than
retail sale or for personal use.
PART II 
ADMINISTRATION
Title I - The Licensing Authority 
Functions of the 
Licensing 
Authority.
3. (1) The Superintendent of Public Health shall be the
Licensing Authority for the purposes of this Act.
(2) The Licensing Authority shall have the following functions:
( a ) to establish standards to ensure the quality, safety and
efficacy of medicinal products;
( b ) to establish standards for the operation of pharmacies;
( c ) to establish standards for the manufacture, preparation,
assembly, packing, packaging or re-packing and
labelling of medicinal products or any substance which
is used or is intended to be used in such products;
  8        CAP. 458. _h               MEDICINES
( d ) to establish standards for the operation of wholesale
distribution;
( e ) to establish standards for the testing or analysis of
medicinal products or any substance which is used or
is intended to be used therein;
( f ) to establish standards for the carrying out of clinical
trials;
( g ) to establish standards for the reporting of adverse
reactions, serious adverse reactions or suspected
unexpected adverse reactions and make provision for
the collection or submission of related information
from any person or activity regulated by or under this
Act;
( h ) to establish standards in relation to the advertising of
medicinal products;
( i ) to advise the Minister in the making of regulations in
respect of the classification of medicinal products;
( j ) to issue, renew, amend, vary, suspend or revoke
marketing authorisations for medicinal products;
( k ) to withdraw or recall medicinal products from the
market in the interest of public health ; and
( l ) to ensure compliance with international obligations
entered into by the Government of Malta in relation to
any matter regulated by or under this Act;
 ( m ) to issue, renew, amend, vary, suspend or revoke any
authorisation or licence that may be required by or
under this Act;
( n ) to carry out inspections of any activity, service or
procedures in relation to medicinal products and to do
all such things as may be necessary for the purpose of
ensuring compliance with any provisions of this Act,
or made thereunder v;
 ( o ) to authorise the advertising and promotion of
medicinal products;
( p ) to carry out any other activity as may be prescribed;
( q ) to advise the Minister on any matter connected with its
functions or any other provision of this Act.
 (3) The Licensing Authority may by rules delegate any of its
functions referred to in subarticle (2)( m ) ( n ) and ( o ) to the
Medicines Authority.
(4) The Licensing Authority shall levy such fees as may be
prescribed for the purpose of this Act:
Provided that such regulations may provide for the waiving
of such fees in such circumstances as may be prescribed.
(5) For the proper exercise of its functions, the Licensing
Authority may establish advisory committees as it may deem
necessary.
          MEDICINES                         _g CAP. 458.        9
Title II - The Medicines Authority 
Establishment of 
the Medicines 
Authority.
4. There shall be established a Medicines Authority, which
shall be headed by a Chief Executive Officer.
Legal personality 
of the Medicines 
Authority.
5. (1) The Medicines Authority shall be a body corporate
having a separate and distinct legal personality and shall be
capable, subject only to the provisions of this Act, of entering into
any contract, of acquiring, holding and disposing of any kind of
property both movable and immovable, of employing personnel for
the purposes of its operations; and of suing and being sued, and to
which any function or operation of government are or may be
assigned under this or any other law.
(2) The legal and judicial representation of the Medicines
Authority shall vest in the Chief Executive Officer:
Provided that the Medicines Authority may appoint one or
more of its officers or employees to appear in its name and on its
behalf in any judicial proceedings or in any act, contract,
instrument or other document whatsoever.
Functions of the 
Medicines 
Authority.
6. (1) The Medicines Authority shall have the following
functions:
( a ) to carry out those such functions as may be delegated
to it by the Licensing Authority in terms of article
3(3);
( b ) to assist and advise the Licensing Authority on any
matter relating to the regulation of medicinal products
and related activities;
( c ) to undertake such activities and projects as may be
necessary or expedient for the proper exercise of its
functions;
( d ) to establish such procedures as may be necessary for
obtaining and assessing information as regards the
safety, quality and efficacy of medicinal products to be
placed on the market in Malta;
( e ) to establish such procedures as may be necessary to
make such assessments of medicinal product safety,
quality and efficacy as it may deem necessary for
those products to be placed on the market in Malta;
( f ) to establish such procedures as may be necessary for
monitoring and obtaining reports on the quality, safety
or efficacy of medicinal products;
( g ) to make recommendations to the Licensing Authority
in relation to standards and licensing;
( h ) to advise the Licensing Authority on the precautions or
restrictions to which medicinal products may be
subjected for their marketing or continued use in
Malta; and
 ( i ) to furnish, whenever it so thinks fit or is so requested
by the Licensing Authority, advice or make
  10        CAP. 458. _h               MEDICINES
recommendations to the Licensing Authority in
relation to any matter connected with its functions.
(2) For the proper exercise of its functions, the Medicines
Authority may require the production of such information or
documents as may be necessary for any of its functions and may
seek expert advice from any person, who is not a member of the
Medicines Review Board, possessing the necessary qualifications
and experience in the fields listed in the First Schedule, and may
also establish such advisory committees as it may deem necessary,
either for general or specific purposes.
(3) The Medicines Authority shall levy such fees as may be
prescribed for the purposes of this Act:
Provided that such regulations may provide for the waiving
of such fees in such exceptional circumstances as may be
prescribed .
Organisation of the 
Medicines 
Authority.
7. The Authority shall establish such Directorates as may be
necessary, and shall assign to each such Directorate those functions
which it may deem expedient for the proper exercise of its
functions. 
The Chief 
Executive Officer 
of the Medicines 
Authority.
8. (1) The Chief Executive Officer shall be appointed by the
Minister from amongst persons who are suitably qualified and
experienced in the medical, pharmaceutical or medical science
sector.
(2) The Chief Executive Officer shall be responsible for the
overall management and performance of the Authority including
the management of the day-to-day operations of the Authority.
(3) A person shall not be eligible to be appointed or to hold
office as Director or Chief Executive Officer of the Authority if he:
(i) is a member of the House of Representatives; or
(ii) is a Judge or a Magistrate; or
(iii) is legally incapacitated; or
(iv) has been declared bankrupt or has made a
composition or arrangement with his creditors;
or
(v) has been convicted of fraud or any other offence
against public trust, or has otherwise been
sentenced to a term of imprisonment for a term
not less than three months; or
(vi) has a financial or other interest whether direct or
indirect, in any enterprise or activity which is
likely to affect the discharge of his functions as
a member of the Authority.
 (4) ( a ) The Chief Executive Officer of the Authority shall
hold office for a period not exceeding five years and
shall be eligible for re-appointment for further periods
each not exceeding five years.
( b ) The Chief Executive Officer of the Authority may be
relieved from office by the Minister prior to the expiry
          MEDICINES                         _g CAP. 458.        11
of his term of office where, in the opinion of the
Minister, he has been guilty of misconduct or on the
ground of inability to continue to perform the functions
of his office, whether due to infirmity of mind or of
body, or to any other cause, or of misbehaviour.
Employees of the 
Medicines 
Authority.
9. (1) Subject to the provisions of the Constitution and of any
other enactment applicable thereto, and without prejudice to the
other provisions of this Act, the appointment of officers or
employees of the Authority shall be made by the Authority. The
terms and conditions of employment shall be established by the
Authority with the concurrence of the Minister, given after
consultation with the Minister responsible for finance.
 (2)  The Prime Minister may, at the request of the Authority
after it consults with the Minister, from time to time and by
direction detail a public officer for duty with the Authority in such
a capacity and for such term and under such conditions as may be
established in relation to the officer so detailed.
(3) The Prime Minister may at any time revoke any such
direction given under subarticle (2).
(4) Where an officer is detailed for duty with the Authority
such officer shall, during the time in which such a direction is in
force, be under the administrative direction and control of the Chief
Executive Officer and shall otherwise remain and retain all rights
and duties as a public officer and for the purposes of any law
relating to government service pension, service with the Authority
shall be deemed to be service with the Government:
Provided that no account shall be taken in assessing the
pensionable emoluments of such officer for the purposes of any law
relating to government service pensions of any allowances, bonuses
or gratuities paid to such officer by the Authority in excess to what
he is entitled as a public officer:
Provided further that during the time in respect of which he
is so detailed to perform duties with the Authority the terms and
conditions of his service shall not be less favourable than those
which are attached to his appointment under the Government
during the period aforesaid. Such terms and conditions shall not be
deemed to be less favourable merely because they are not in all
respects identical with or superior to those enjoyed by the officer
concerned at the date of such offer, if such terms and conditions,
taken as a whole, in the opinion of the Prime Minister offer
substantially equivalent or greater benefits.
Accounts of the 
Medicines 
Authority.
10. (1) The Authority shall keep proper books of account in
such manner as the Minister of Finance may from time to time
direct. Such accounts shall be audited by an auditor appointed for
the purpose by the Authority and shall moreover be subject to audit
by the Auditor General.
(2) The Authority shall, not later than six weeks after the end
of each financial year, present to the Minister and the permanent
secretary the audited accounts together with a report on the
workings of the agency which report shall state the manner in
  12        CAP. 458. _h               MEDICINES
which the agency has operated to fulfil its functions and its plans in
the future.
(3) The reports referred to in subarticle (2) shall be laid on the
Table of the House of Representatives by the Minister not later than
six weeks after its receipt, or where the House is during the period
not in session not later than the second week after the House
resumes its sittings. 
Procurement by the 
Medicines 
Authority.
11. Except with the approval of the Minister, the Authority
shall not enter into any contract for the supply of goods or materials
or for the execution of work or for the rendering of services, to or
for the benefit of the Authority, which is estimated by the Authority
to involve an expenditure exceeding one hundred thousand liri or
such other amount as the Minister may from time to time direct in
writing, except after notice of the intention of the Authority to
enter into such contract has been published and competitive tenders
have been issued.
Applicability of the 
Code of Ethics.
12. The Chief Executive Officer and all other executive
officers and employees of the Authority shall conform with and
abide by any public service values and Code of Ethics that may be
in force from time to time in relation to public officers.
Exemption from 
tax, etc.
13. The Authority shall be exempt from any liability for the
payment of any tax on income or duty on documents for the time
being in force in Malta.
Title III - Medicines Review Board 
Establishment of 
Medicines Review 
Board.
14. (1) There shall be a Medicines Review Board which shall
be composed of three members and three substitute members
appointed by the Minister, as follows:
( a ) a person who shall be a legal practitioner having at
least seven years’ legal experience who shall act as the
chairperson; and
( b ) two other persons who possess the technical and
scientific qualifications and experience in the field of
regulation of medicinals.
(2) The Minister shall designate a public officer to act as
secretary for the Medicines Review Board.
(3) The members of the Medicines Review Board shall be
appointed by the Minister for a term of three years under such
terms and conditions as may be specified in their appointment.
Members so appointed may be re-appointed on the expiration of
their term of office.
(4) Where any member of the Medicines Review Board is
unable to act, the substitute member having the same qualifications
shall act in his stead.
 (5) A person shall not be qualified to hold office as a member
or substitute member of the Medicines Review Board if he:
(i) is a member of the House of Representatives, or
(ii) is a Judge or a Magistrate; or
          MEDICINES                         _g CAP. 458.        13
(iii) is legally incapacitated; or
(iv) has been declared bankrupt or has made a
composition or arrangement with his creditors;
or
(v) has been convicted of fraud or any other offence
against public trust, or has otherwise been
sentenced to a term of imprisonment for a term
not less than three months; or 
(vi) has a financial or other interest, whether direct
or indirect, in any enterprise or activity which is
likely to affect the discharge of his functions as
a member of the Board.
Cap. 12.
(6) The provisions of Sub-title II of Title II of Book Third of
the Code of Organization and Civil Procedure shall,  mutatis
mutandis , apply to members of the Medicines Review Board who
may be challenged or may abstain from sitting on that Board during
the hearing of an appeal.
(7) A person shall cease to be a member of the Medicines
Review Board at the expiration of his term of office, or if any
circumstances arise that, if he were not a member of the Medicines
Review Board, he would cease to be qualified for such
appointment.
(8) A member of the Medicines Review Board may be removed
from office by the Minister if, in his opinion, such member is no
longer fit to continue in office or has become incapable of properly
performing his duties as a member.
Medicines Review 
Board may appoint 
advisors.
15. (1) In the execution of its functions, the Medicines
Review Board may seek the advice of any knowledgeable person
on any matter which is the subject of an appeal being heard.
 (2) The Board may also require any government department
and, or authority to provide it with such information or advice it
may deem necessary for the proper exercise of its functions.
Functions of the 
Medicines Review 
Board.
16. (1) It shall be the function of the Medicines Review
Board:
( a ) to hear any appeal made by any person aggrieved by
any recommendation of the Medicines Authority in
relation to the safety, quality and efficacy of a
medicinal product following an application for a
marketing authorisation submitted by the appellant; 
( b ) to provide advice and make its recommendations to the
Licensing Authority regarding any appeal or request
made to it.
(2) Concurrently with the submission of its recommendations
to the Licensing Authority, the Board shall also submit a copy of
such recommendations to the appellant and to the Medicines
Authority.
(3) Any administrative and financial support required by the
Medicines Review Board for the performance of its functions shall
  14        CAP. 458. _h               MEDICINES
be provided by the Licensing Authority.
(4) Subject to the foregoing provisions the business of the
Medicines Review Board shall be conducted in accordance with the
rules contained in the Second Schedule and otherwise the Board
may regulate its own procedure.
Procedure of 
appeal.
17. (1) Where an applicant for a marketing authorisation feels
aggrieved by the findings and recommendations made by the
Medicines Authority to the Licensing Authority, he may, within
fourteen days of the receipt of a copy of such findings and
recommendations, file an appeal with the Medicines Review Board.
(2) The Licensing Authority may, if it deems it necessary,
within fourteen days of the receipt of the findings and
recommendations of the Medicines Authority on the safety, quality
and efficacy of a medicinal product, request the Medicines Review
Board to provide it with a second opinion on the case.
(3) Any appeal or request for review shall be made in writing
and shall be accompanied by the prescribed fee.
(4) The application for an appeal or request for review shall
clearly and comprehensively state the grounds for the appeal or
review and shall provide all evidence and documentation to sustain
any claim made and which may be necessary to enable the Board to
decide on the case:
Provided that the Medicines Review Board may require the
submission of such further information or documentation as it may
deem necessary:
Provided further that the Medicines Review Board shall
after obtaining all the relevant information, process the application
within a time limit specified in regulations made under this Act.
Public hearing. 18. (1) The Medicines Review Board shall appoint the matter
for public hearing within thirty days of the day of filing of the
appeal or request for review and shall decide the matter as
expeditiously as possible.
 (2) The Medicines Review Board will inform the appellant, the
Licensing Authority and the Medicines Authority of its opinion in
writing as soon as is practicable.
PART III
GENERAL PROVISIONS 
Title I - Marketing Authorisation Relating to Medicinal Products 
Applicability of 
certain provisions.
19. (1) The provisions of articles 20 to 36 shall apply to
industrially produced medicinal products for human use intended to
be placed on the market in Malta.
(2) Articles 20 to 36 shall not apply to -
( a ) any medicinal product prepared in accordance with a
magistral formula;
( b ) any medicinal product prepared in accordance with an
          MEDICINES                         _g CAP. 458.        15
official formula;
( c ) medicinal products intended for research and
development trials;
( d ) intermediate products intended for further processing
by an authorised manufacturer;
( e ) radionuclides in the form of sealed sources.
Authorisation to 
place medicinal 
products on the 
market.
20. (1) No person shall place a medicinal product on the
market in Malta unless he is in possession of a marketing
authorisation from the Licensing Authority, in accordance with the
provisions of this Act or any regulations or rules made thereunder:
Provided that the Licensing Authority may, in exceptional
cases, allow the use of a medicinal product without a marketing
authorisation subject to such conditions as it may attach to it:
Provided further that a medicinal product that is essentially
identical to a medicinal product for which a marketing
authorisation has already been granted shall only be subject to
conditions as may be determined by the Licensing Authority.
(2) Any application for the grant of a marketing authorisation
shall be made to the Licensing Authority and shall be accompanied
by the prescribed fee.
(3) The application shall contain all the information and
documents necessary for the assessment of the safety, quality and
efficacy of the medicinal product and shall be submitted in such
form and manner as the Licensing Authority may by rules require. 
(4) The Licensing Authority shall forward the application
submitted to it to the Medicines Authority as soon as possible.
(5) Where an application for the issue of a marketing
authorisation is received by the Medicines Authority, the Authority
may -
( a ) refuse to process the application if such application is
not submitted in accordance with the provisions of this
Act;
( b )  request the applicant to furnish it with such further
information relating to the application as it may
consider necessary; and where any such request has
been made, the Medicines Authority shall not be
required to determine the application until the
information as requested has been submitted to it;
( c ) assess the application in respect of medicinal product
safety, quality and efficacy in such a manner and
within such period as may be prescribed by or under
this Act; and
( d ) carry out any other activity as may be prescribed by
the Minister from time to time.
(6) The Medicines Authority shall report its findings and make
its recommendations to the Licensing Authority, and shall submit a
copy thereof to the applicant, in such a manner and within such
  16        CAP. 458. _h               MEDICINES
period as may be prescribed.
Review or appeal. 21. Where the Licensing Authority or the applicant disagree
with the findings or recommendations of the Medicines Authority,
either party may lodge an appeal to the Medicines Review Board in
the manner established under this Act. 
Granting of 
marketing 
authorisation.
22. (1) On receipt of the findings and recommendations of the
Medicines Authority, or following an appeal or a request for a
review by the Medicines Review Board, the Licensing Authority
may refuse or otherwise issue a marketing authorisation either as
recommended by the Medicines Authority or subject to any such
condition or obligation as it may deem necessary.
(2) The decision of the Licensing Authority shall be final and
together with the detailed reasons for such decision shall be
communicated to the Medicines Review Board, the Medicines
Authority and the applicant as necessary.
Notification of 
marketing 
authorisation.
23. (1) In granting or refusing a marketing authorisation, the
Licensing Authority shall also inform the Medicines Authority of
such a decision.
(2) A marketing authorisation shall specify: 
( a ) the summary of product characteristics as approved;
( b ) the approved labelling and packaging;
( c ) any conditions that may be attached to the granting of
the marketing authorisation;
( d ) the classification of the medicinal product;
( e ) the term of validity of the marketing authorisation;
( f ) any other specification that the Licensing Authority
may deem necessary.
Validity of market 
authorisation.
24. (1) Every marketing authorisation granted under this Act,
shall unless previously revoked, expire at the end of its validity. 
(2) Every marketing authorisation so granted under this Act
shall unless previously revoked, be renewable upon an application
by the holder made at least three months before the expiry of the
period of validity.
Application of 
renewal.
25. (1) Where an application for the renewal of a marketing
authorisation under this Act has been duly made, the validity of the
marketing authorisation shall be deemed to continue to have effect
until such time as the Licensing Authority has determined the
application.
(2) Notwithstanding the provisions of any other law, no court
may issue a warrant of prohibitory injunction restraining the
Licensing Authority from determinining any such application.
Notification of 
refusal.
26.  The Licensing Authority shall refer an application for
renewal of a marketing authorisation to the Medicines Authority,
and in such case the provisions of article 20(4), (5) and (6) and of
article 21 shall,  mutatis mutandis  apply. 
          MEDICINES                         _g CAP. 458.        17
Refusal to renew 
marketing 
authorisation.
27. (1) The Licensing Authority may refuse to grant or renew
the marketing authorisation on the basis of poor quality, safety and
efficacy of the medicinal product or in the interest of public health
or any other reason that would normally be a valid reason for the
suspension, revocation or refusal of a marketing authorisation:
Provided that the Licensing Authority shall notify the
Medicines Authority and the applicant of the decision giving
detailed reasons for such decision.
(2) A renewal of a marketing authorisation shall specify - 
( a ) the summary of product characteristics as approved;
( b ) the approved labelling and packaging;
( c ) any conditions that may be attached to the granting of
the marketing authorisation;
( d ) the classification of the medicinal product;
( e ) the term of validity of the marketing authorisation;
( f ) any other specification that the Licensing Authority
may deem necessary.
Suspension or 
revocation of 
marketing 
authorisation.
28. (1) The Licensing Authority shall suspend or revoke a
marketing authorisation for a medicinal product where that product
proves to be harmful in the normal conditions of use, or where its
therapeutic efficacy is lacking, or where its qualitative and
quantitative composition is not as declared. For the purpose of this
article therapeutic efficacy shall be deemed to be lacking when it is
established that therapeutic results cannot normally be obtained
with the medicinal product. 
(2) An authorisation shall also be suspended or revoked where
the particulars supporting the application as provided for in this Act
are found to be incorrect or have been amended without
authorisation or when the requisite controls required by or under
this Act have not been carried out.
(3) When the packaging, labelling or the package leaflet of the
medicinal product in question do not comply with the requirements
as specified by or under this Act, the Licensing Authority may
suspend the marketing authorisation by notice served on the holder
of the marketing authorisation concerned and the suspension shall
continue to have effect until the Licensing Authority is satisfied
that the requirements have been fulfilled. 
(4) If the Licensing Authority suspends or revokes a marketing
authorisation, it shall notify the holder of the marketing
authorisation and the Medicines Authority of such decision stating
in detail the reasons on which such a decision is based. 
(5) The holder of the marketing authorisation may, within
fourteen days of such notification, request the Medicines Review
Board to examine the circumstances leading to the suspension or
the revocation of the marketing authorisation, and the Medicines
Review Board shall make its recommendations on the matter to the
Licensing Authority:
  18        CAP. 458. _h               MEDICINES
Provided that the request shall not suspend the effects of
the decision of the Licensing Authority and that the Licensing
Authority shall not be bound by the recommendations made by the
Medical Review Board. 
Classification of 
medicinal 
products.
29. (1) When a marketing authorisation is granted or renewed,
the Licensing Authority shall specify the classification of the
medicinal product in accordance with the provisions of this Act,
but in general into:
( a ) a medicinal product subject to a medicinal
prescription; or 
( b ) a medicinal product not subject to a medicinal
prescription, where such medicinal product is
considered that with reasonable safety it can be sold or
supplied by or under the supervision of a pharmacist
unless otherwise provided for by this Act that a
medicinal product under subarticle (1)( b ) is classified
under subarticle (1)( a ).
 (2) The Licensing Authority may by rules determine the type,
content and presentation or otherwise of a prescription and who is
authorised to issue the said prescription that may be needed for a
medicinal product or class of medicinal products.
List of medicinal 
products having a 
marketing 
authorisation.
30. (1) The Licensing Authority shall, at least annually,
publish in the Gazette a list specifying -
( a ) the medicinal products that have a valid marketing
authorisation;
( b ) the medicinal products which may only be sold by
prescription; and 
( c ) where applicable, the type of prescription required and
the person or persons authorised to issue the said
prescription.
(2) Whenever a marketing authorisation has been issued in
relation to a medicinal product the Licensing Authority shall
publish in the Gazette the information specified in subarticle (1)( a ),
( b ) and ( c ) and such publication shall be deemed to amend the list
of medicinal products issued under subarticle (1).
(3) The Licensing Authority shall publish in the Gazette, as
soon as is practical, the list of medicinal products for which the
marketing authorisation has been suspended or revoked and such
publication shall be deemed to amend the list of medicinal products
issued under subarticle (1).
Advertising of 
medicinal 
products.
31. A medicinal product may only be advertised in accordance
with such conditions as may be established by or under this Act.
Homeopathic 
medicinal 
products.
32. The provisions of this Part shall apply to homeopathic
medicinal products for human use except for homeopathic
medicinal products which:
( a ) are administered orally and externally, subject to such
          MEDICINES                         _g CAP. 458.        19
regulations as may be made by the Minister in respect
thereof;
( b ) have no specific therapeutic indication appearing on
the labelling of the medicinal product or in any
information relating thereto; and
( c ) have a sufficient degree of dilution to guarantee the
safety of the medicinal product, in particular, the
medicinal product may not contain either more than
one part per 10,000 of the mother tincture or more than
1/100 th  of the smallest dose used in allopathy with
regard to active principles whose presence in an
allopathic medicinal product results in the obligation
to submit a medicinal prescription.
Products derived 
from human blood 
or human plasma.
33. The provisions of this Part shall apply to medicinal
products based on blood constituents which are prepared
industrially by a private or a public establishment but shall not
apply to blood, plasma or blood cells of human origin.
Radiopharmaceutic
al medicinal 
product.
34. The marketing authorisation referred to in article 20 shall
be required for generators, kits, precursor radiopharmaceuticals and
industrially prepared radiopharmaceuticals other than
radiopharmaceuticals prepared at the time of use by a person or by
an establishment authorised, under this Act, to use such medicinal
products in an approved health care establishment exclusively from
authorised generators, kits or precursor radiopharmaceuticals in
accordance with the manufacturer’s instructions. 
Immunological 
medicinal 
products.
35. (1) The provisions of this Part shall apply to
immunological medicinal products.
(2) The Licensing Authority may prescribe rules regulating the
issue or otherwise of a marketing authorisation for immunological
medicinal products.
Herbal medicinal 
products.
36. (1) The provisions of this Part shall apply to herbal
medicinal products other than herbal medicinal products prepared
in accordance with a magistral or an official formula:
(2) The Licensing Authority may prescribe rules regulating the
issue or otherwise of a marketing authorisation for herbal medicinal
products.
Title II - Manufacture of Medicinal Products for Human Use 
Manufacturer’s 
licence.
37. Without prejudice to any exemption that may be granted
under this Act, no person shall manufacture, assemble or in any
way modify any medicinal product except in accordance with a
manufacturer's licence issued in accordance with the provisions of
this Act or any regulations or rules made thereunder:
Provided that such a licence shall not be required for the
preparation, division, changes in packaging or presentation where
these processes are carried out for the purpose of dispensing or
administering as provided under this Act. 
  20        CAP. 458. _h               MEDICINES
Application for 
manufacturer’s 
licence.
38. (1) Any application for the grant of a licence to
manufacture, assemble or modify a medicinal product shall be
made to the Licensing Authority and shall contain such
information, documents, samples and other material as provided by
or under this Act: 
Provided that such application shall indicate the following: 
( a ) the name of the medicinal product and pharmaceutical
form or forms, which is to be manufactured, assembled
or in any way modified;
( b ) the place where such activity is to take place, and such
information and documentation as may be required in
order to show that such place is suitable and sufficient
for that purpose;
( c ) the equipment and control facilities as may be required
by or under this Act;
( d ) the name and address of the applicant;
( e ) the name of at least one qualified person who shall be
professionally responsible for the activity, such person
having such qualifications as may be prescribed: 
Provided that when more than one qualified person
is nominated, the application will clearly delineate the
specific responsibilities of each person;
( f ) any other information, documentation or evidence as
may be requested by the Licensing Authority in
accordance with or under this Act.
(2) The Licensing Authority shall determine the application in
the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant
information is provided.
Granting of manufacturer’s licence.
39. (1) The Licensing Authority shall, before determining an
application, inspect the premises indicated in the application and
shall not issue a licence until it is satisfied that such premises
conform with the requirements established by or under this Act: 
Provided that a licence may be made conditional to the
carrying out of such obligations as may be imposed therein. 
(2) The manufacturer's licence shall specify the premises and
the medicinal products and pharmaceutical form or forms to which
it applies. 
(3)  The licence holder shall ensure that the activity is carried
out in accordance to the provisions of this Act and any regulations
made thereunder.
Notice for further 
information.
40. Where the Licensing Authority considers that
circumstances may exist which would render necessary the
consideration of whether the licence should be varied, suspended or
revoked, the Licensing Authority may serve on the holder of a
          MEDICINES                         _g CAP. 458.        21
manufacturer's licence a notice requiring him, within such time as
may be specified in the notice, to furnish it with any information
specified in the notice.
Suspension or 
revocation of 
manufacturer’s 
licence.
41. (1) The Licensing Authority may suspend a
manufacturer’s licence under this Act for such period as it may
determine, or may revoke, or vary the provisions of, any such
licence.
(2) The powers vested in subarticle (1) shall only be
exercisable in any of the following circumstances, where: 
( a ) the matters stated in the application on which the
licence was granted were false or incomplete in a
material particular;
( b ) a material change of circumstances has occurred in
relation to any of those matters; 
( c ) any of the conditions of the licence has been
contravened; 
( d ) the requirements in relation to the licences as
established by or under this Act have not been
complied with; 
( e )  the processes of manufacture or assembly of a
medicinal product are carried out in a manner that is
not in compliance with the provisions of the marketing
authorisation of that medicinal product;
( f ) the conditions for good manufacturing practice are not
being complied with; and
( g ) in any other circumstance as is established by or under
this Act.
Inspection in 
relation to 
manufacturers, etc.
42. (1) The Licensing Authority shall carry out regular
inspections to ensure that the requirements established by or under
this Act in relation to the manufacture, assembly or modification of
a medicinal product are complied with.
(2) The Licensing Authority or any person carrying out an
inspection shall:
( a ) inspect the manufacturing establishment and any other
location he may deem necessary;
( b ) examine any relevant documents;
( c ) take any samples he may deem necessary;
( d ) draw up a report of the findings and communicate the
contents of such report to the licensee or the applicant
for a licence in relation to such inspection and to the
qualified person;
( e ) carry out any other activity he may deem appropriate
for the proper execution of his duties and
responsibilities as provided for by or under this Act.
(3) Except in urgent cases an inspection shall be carried out in
the presence of a qualified person or his representative, if any, .
  22        CAP. 458. _h               MEDICINES
Duration and 
renewal of 
manufacturer's 
licence.
43. (1) Subject to the provisions of this Act, every licence
granted under this Part shall, unless previously renewed or revoked,
expire at the end of its validity. 
(2) Any licence so granted shall, unless previously revoked, be
renewable upon an application by the licensee made at least three
months before the expiry of the validity period. 
(3) The Licensing Authority may by rules establish the period
of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the
renewal of a licence under this Part, the Licensing Authority:
( a ) may renew the licence, with or without modifications,
for such a further period as specified; or
 ( b ) if, having regard to the provisions of this Act, it
considers it necessary or expedient to do so, may
refuse to renew the licence. 
 (5) The provisions of articles 25, 39 and 40 shall apply to such
applications.
Responsibilities of 
manufacturer’s 
licence holder.
44. It shall be the duty of the holder of a manufacturer's
licence- 
( a ) to immediately inform the Licensing Authority of any
change of the qualified person; 
( b ) to provide authorised officers access to his premises at
any reasonable time;
( c ) to enable the qualified person to carry out his duties
established by or under this Act;
( d ) to maintain such records for any transaction in
medicinal products as may be established by or under
this Act and have such records available for inspection
by any authorised officer for such period of time as
may be required by or under this Act;
( e ) to have at his disposal the services of staff to satisfy
the requirements specified by or under this Act in
relation to the manufacture, assembly or modification
of medicinal products;
( f ) to apply in writing to the Licensing Authority of any
change proposed or modification required in relation
to the licence;
( g ) to comply with the regulations or Orders relating to
good practice in manufacture as may be established by
or under this Act or under any other Act;
( h ) to dispose of medicinal products as established by or
under this Act or under any other Act;
( i ) other responsibilities as may be established from time
to time by or under this Act.
Responsibilities of 
the qualified 
person.
45. (1) The responsibilities of a qualified person shall be:
( a ) to ensure that standards of good practice in
          MEDICINES                         _g CAP. 458.        23
manufacturing are complied with at all times;
( b ) to ensure that each batch of medicinal products has
been manufactured, tested and complies in all respects
with any requirement established by or under this Act;
and 
( c ) to ensure that each batch of medicinal products has
been manufactured in accordance with the
requirements of the marketing authorisation.
 (2) The qualified person shall at all times be present at the
premises when the activity is being carried out:
Provided that the qualified persons may nominate another
person similarly qualified to act as his representative.
(3) When the qualified person has nominated a representative
as aforesaid he shall immediately inform the Licensing Authority
of such nomination.
Suspension of 
activity of a 
qualified person.
46. The Licensing Authority, may if it has reasonable
suspicion to believe that any qualified person is acting in
contravention of any of the provisions of this Act, suspend the
activity of such qualified person by notice in writing specifying the
reasons for such suspension until such person has complied with
any requirement of the Licensing Authority to remedy the non-
compliance.
Change in 
conditions of 
manufacturer’s 
licence.
47. The Licensing Authority may upon an application made by
the holder of licence in request thereof, vary the conditions of the
licence if it is satisfied that such variation will not adversely affect
standards of good practice in manufacture as may be prescribed.
Obligations of 
Licensing 
Authority.
48. The Licensing Authority may vary, suspend, revoke or
refuse to renew a manufacturer's licence, or it may refer the matter
to the Medicines Authority, and in such case the provisions of
article 20(4), (5) and (6) and of article 21 shall,  mutatis mutandis
apply.
Manufacture of 
homeopathic 
medicinal 
products.
49. Without prejudice to article 32, the provisions of articles
37 to 48 shall apply to the manufacture and assembly of
homeopathic medicinal products other than the products listed in
article 32( a ) ( b ) and ( c ).
Manufacture of 
medicinal products 
derived from 
human blood and 
human plasma, etc.
50. Without prejudice to article 33, the provisions of articles
37 to 48 and any regulations made thereunder shall apply to the
manufacture and assembly of medicinal products derived from
human blood and human plasma other than the products listed in
article 32( a ) ( b ) and ( c ).
Manufacture of 
radio-
pharmaceuticals.
51. Without prejudice to article 34, the provisions of articles
37 to 48 and any regulations made thereunder shall apply to the
manufacture and assembly of radiopharmaceutical medicinal
products other than the products listed in article 32( a ) ( b ) and ( c ).
Immunological 
medicinal product.
52. Without prejudice to article 35, the provisions of articles
37 to 48 and any regulations made thereunder shall apply to the
manufacture and assembly of immunological medicinal products
other than the products listed in article 32( a ) ( b ) and ( c ).
  24        CAP. 458. _h               MEDICINES
Herbal medicinal 
products.
53. Without prejudice to article 36, the provisions of articles
37 to 48 and any regulations made thereunder shall apply to the
manufacture and assembly of herbal medicinal products other than
the products listed in article 32( a ) ( b ) and ( c ).
Title III - Wholesale Distribution of Medicinal Products 
for Human Use
Wholesale dealing. 54. (1) Without prejudice to any exemptions that may be
granted by or under this Act, no person shall engage in the
wholesale distribution of any medicinal product unless he is the
holder of a wholesale dealer's licence issued in accordance with the
provisions of this Act. and unless the medicinal product has been
granted a marketing authorisation by the Licensing Authority.
(2) The wholesale distribution of a medicinal product by way
of wholesale dealing shall only be carried out from the place
specified in, and in accordance with the conditions of, the licence.
Application for a 
wholesale dealer’s 
licence.
55. (1) Any application for the grant of a wholesaler's licence
shall be made to the Licensing Authority and shall contain such
information, documents, and other material as provided by or under
this Act: 
Provided that such application shall indicate the following: 
( a ) the name and address of the applicant;
( b ) the address of the premises that are to be used for the
purpose of wholesale distribution;
( c ) the equipment and control facilities as may be required
by or under this Act;
( d ) information, documentation or evidence to prove that
the premises is suitable and adequate, and that there
are suitable facilities, installations and equipment so
as to ensure proper conservation and distribution of
medicinal products;
( e ) the name of at least one responsible or qualified person
who shall be professionally responsible for the
activity, such person having such qualifications as may
be prescribed:
Provided that when more than one qualified or
responsible person is nominated, the application will
clearly delineate the specific responsibilities of each
person;
 ( f ) any other information, documentation or evidence as
may be requested by the Licensing Authority in
accordance with or under this Act.
(2) The Licensing Authority shall determine the application in
the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant
information is provided.
          MEDICINES                         _g CAP. 458.        25
Granting of a 
wholesale dealer’s 
licence.
56. (1) The Licensing Authority shall, before determining an
application, inspect the premises indicated in the application and
shall not issue a licence until it is satisfied that such premises
conform with the requirements established by or under this Act: 
Provided that a licence may be made conditional to the
carrying out of such obligations as may be imposed therein. 
(2) The wholesale dealer’s licence shall specify the premises
and the activities to which it applies. 
(3)  The licence holder shall ensure that the activity is carried
out in accordance to the provisions of this Act and any regulations
made thereunder.
Notice for further 
information.
57. Where the Licensing Authority considers that
circumstances may exist which would render necessary the
consideration of whether the licence should be varied, suspended or
revoked, the Licensing Authority may serve on the holder of a
wholesale dealer’s licence a notice requiring him, within such time
as may be specified in the notice, to furnish it with any information
specified in the notice.
Duration and 
renewal of 
wholesale dealer’s 
licence.
58. (1) Subject to the provisions of this Act, every licence
granted under this Part shall, unless previously renewed or revoked,
expire at the end of its validity. 
(2) Any licence so granted shall, unless previously revoked, be
renewable upon an application by the licensee made at least three
months before the expiry of the validity period. 
(3) The Licensing Authority may by rules establish the period
of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the
renewal of a licence under this Part, the Licensing Authority:
( a ) may renew the licence, with or without modifications,
for such a further period as specified; or
 ( b ) if, having regard to the provisions of this Act, it
considers it necessary or expedient to do so, may
refuse to renew the licence. 
 (5) The provisions of articles 25, 39 and 40 shall apply to such
applications.
Obligations of 
holder of 
wholesale dealer’s 
licence.
59. It shall be the duty of the holder of a wholesale dealer's
licence - 
( a ) to immediately inform the Licensing Authority of any
change of the qualified or responsible person;
( b ) to provide authorised officers access to his premises at
any reasonable time;
( c ) to enable the Licensing Authority to carry out its
duties established by or under this Act;
( d ) to maintain such records for any transaction in
medicinal products as may be established by or under
this Act and have such records available for inspection
  26        CAP. 458. _h               MEDICINES
by any authorised officer for such period of time as
may be required by or under this Act.
Responsibilities of 
the responsible 
person. 
60. (1) The responsible person shall ensure that standards of
good practice in wholesale distribution as may be prescribed are
complied with at all times.
(2) The qualified or responsible person shall at all times be
present at the premises when the licenced activity is being carried
out:
Provided that the qualified or responsible person may
nominate another person to act as his representative.
(3) When the qualified or responsible person has nominated a
representative as aforesaid he shall immediately inform the
Licensing Authority of such nomination.
Suspension or 
revocation of 
wholesale dealer’s 
licence.
61. The Licensing Authority may suspend a wholesale dealers'
licence granted under this Act for such period as it may determine,
or may revoke, or vary the provisions of, any such licence in any of
the following cases: 
 ( a ) where the matters stated in the application on which
the licence was issued were false or incomplete in a
material particular;
( b ) where a material change of circumstances has occurred
in relation to any of those matters;
( c ) where any of the conditions of the licence has been
contravened;
( d ) where the requirements in relation to the licence as
established by or under this Act have not been
complied with; 
( e ) where conditions of good practice in wholesale
distribution are not being complied with; and
( f ) in any other circumstance as may be established by or
under this Act.
Change in 
conditions of a 
wholesale dealer’s 
licence.
62. The Licensing Authority may, upon an application made by
the holder of a licence in respect thereof, vary the conditions of the
licence, if it is satisfied that such variation will not adversely affect
the standards of good practice in wholesale distribution. 
Obligations of 
Licensing 
Authority.
63. The Licensing Authority may vary, suspend, revoke or
refuse to renew a wholesale dealer’s licence, or it may refer the
matter to the Medicines Authority, and in such case the provisions
of article 20(4), (5) and (6) and of article 21 shall,  mutatis mutandis
apply.
Inspecting in 
relation to 
wholesale.
64. (1) The Licensing Authority shall ensure that the
requirements established by or under this Act in relation to the
wholesale dealing of a medicinal product are complied with.
(2) The Licensing Authority shall:
( a ) inspect the wholesale dealing establishment and any
other location it may deem necessary;
          MEDICINES                         _g CAP. 458.        27
( b ) examine any documents relating to the inspection;
( c ) take any samples it may deem necessary;
( d ) draw up a report of the findings, which shall be
communicated to the licensee or the applicant for a
licence in relation to such inspection and to the
responsible person;
( e ) carry out any other activity it may deem appropriate
for the proper execution of its duties and
responsibilities as provided for by or under this Act.
Special provisions.
Licensing Authority may by rules establish additional requirements
for the wholesale distribution of:
( a ) narcotic or psychotropic substances;
( b ) medicinal products derived from blood;
( c ) immunological medicinal products;
( d ) radiopharmaceuticals;
( e ) such other medicinal products or class or classes of
medicinal products as the Minister may prescribe.
Title IV - Pharmacies and Related Pharmaceutical Activity
Licence to open a 
pharmacy.
66. (1) It shall not be lawful for any person to open or keep a
pharmacy unless he is in possession of a pharmacy licence issued in
accordance with the provisions of this Act or any regulations made
thereunder.
(2) Licences are to be issued in accordance with geo-
demographic criteria as may be established by regulations made
under this Act.
(3) Regulations under this article shall not be made unless the
Minister shall have first published a draft thereof in the
Government Gazette allowing any person a period of at least four
weeks to make representations to the Minister.
(4) The Minister shall request the Licensing Authority to report
on any representation made to him after hearing such person or
taking such expert advice as it considers expedient, together with
any views it may have and the Minister may, upon receipt of the
report by the Licensing Authority proceed to revise the draft
regulations and to promulgate such regulations in accordance with
such revision.
(5) Without prejudice to any exemption that may be granted by
or under this Act, no person shall sell by retail any medicinal
product expect in accordance with a pharmacy licence issued in
accordance with the provisions of this Act or any regulations or
rules made thereunder. 
(6) The licensee shall be responsible for complying with the
conditions of the licence as may be established by or under this
Act.
  28        CAP. 458. _h               MEDICINES
Application for a 
pharmacy licence. 
67. (1) Any application for the grant of a pharmacy licence
shall be made to the Licensing Authority and shall contain such
information, documents, samples and other material as provided by
or under this Act: 
Provided that such application shall indicate the following: 
( a ) the name and address of the applicant;
( b ) the address of the premises that are to be used for the
purpose of the retail sale of the medicinal products;
( c ) the equipment and control facilities as may be required
by or under this Act;
( d ) information, documentation or evidence to prove that
the premises is suitable and adequate, and that there
are suitable facilities, installations, and equipment so
as to ensure proper conservation and dispensing of
medicinal products;
( e ) the name of a managing pharmacist who shall be
professionally responsible for all activities; 
( f ) any other information, documentation or evidence as
may be requested by the Licensing Authority in
accordance with or under this Act. 
(2) The Licensing Authority shall determine the application in
the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant
information is provided.
  Grant of a 
pharmacy licence.
68. (1) The Licensing Authority shall, before determining an
application, inspect the premises indicated in the application and
shall not issue a licence until it is satisfied that such premises
conform with the requirements established by or under this Act: 
Provided that a licence may be made conditional to the
carrying out of such obligations as may be imposed therein. 
(2) The pharmacy licence shall specify the premises and the
activities to which it applies: 
Provided that the Licensing Authority may, upon
application, grant an additional licence for the use of identified
premises to be used as a store for the purpose of the pharmacy after
it is satisfied that such premises comply with any requirements
established by or under this Act.
Notice for further 
information.
69. Where the Licensing Authority considers that
circumstances may exist which would render necessary the
consideration of whether the licence should be varied, suspended or
revoked, the Licensing Authority may serve on the holder of a
pharmacy licence a notice requiring him, within such time as may
be specified in the notice, to furnish it with any information
specified in the notice.
Duration and 
renewal of 
pharmacy licence.
70. (1) Subject to the provisions of this Act, every licence
granted under this Part shall, unless previously renewed or revoked,
expire at the end of its validity. 
          MEDICINES                         _g CAP. 458.        29
(2) Any licence so granted shall, unless previously revoked, be
renewable upon an application by the licensee made at least three
months before the expiry of the validity period. 
(3) The Licensing Authority may by rules establish the period
of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the
renewal of a licence under this Part, the Licensing Authority:
( a ) shall renew the licence, with or without modifications,
for such a further period as specified; or
( b ) if, having regard to the provisions of this Act, it
considers it necessary or expedient to do so, may
refuse to renew the licence. 
 (5) The provisions of articles 25 and 39 shall apply to such
applications.
 Transfer of a 
pharmacy licence.
71. No person may transfer a licence unless authorised by the
Licensing Authority which authorisation shall not be issued unless
the Licensing Authority is satisfied that the new licensee complies
with any requirement established by or under this Act, and on
payment of the prescribed fee.
Suspension or 
revocation of 
pharmacy licence.
72. The Licensing Authority may suspend a pharmacy licence
granted under this Act for such period as it may determine or may
revoke, or vary the provisions of any such licence in any of the
following circumstances:
( a ) where any matter stated in the application on which
the licence was issued is false or incomplete 
( b ) where a material change of circumstances has occurred
in relation to any of those matters;
( c ) where the provisions of the licence have been
contravened by the licensee; or
( d ) in any other circumstance as may be established by or
under this Act:
Provided that the Licensing Authority shall notify the
licensee of the decision giving detailed reasons for such decision.
Temporary closure 
of pharmacy.
73. (1) The licensee of a pharmacy shall not close a pharmacy,
temporarily or otherwise, unless he has given at least twenty-four
hours notice to, and such closure has been authorised by, the
Licensing Authority:
Provided that the temporary closure shall not be construed
to include the closure of a pharmacy resulting from the unforeseen
or unexpected absence of a pharmacist,  force majeure  resulting in
the inability to open the premises, or closure outside the business
hours established for pharmacies by rules made the Licensing
Authority.
(2) Subject to the provisions of subarticle (1), the licence in
relation to a pharmacy which has remained closed for a period of
five consecutive working days without the authorisation of the
  30        CAP. 458. _h               MEDICINES
Licensing Authority shall be deemed to have been automatically
revoked.
(3) The Licensing Authority may, on receipt of a notice as is
referred to in subarticle (1), or where it has come to its knowledge
that a pharmacy has been closed, seal all the medicinal products,
wherever kept by the licensee in terms of the provisions of this Act,
and take charge of any register required to be kept by the licensee
under this or any other law.
Obligations of the 
holder of a 
pharmacy licence.
74. It shall be the duty of the holder of a pharmacy licence - 
( a ) to inform the Licensing Authority of any change of the
managing pharmacist, prior to such change; 
( b ) to provide authorised officers access to his premises at
any reasonable time;
( c ) to enable the Licensing Authority to carry out its
duties established by or under this Act;
( d ) to maintain such records for any transaction in
medicinal products as may be established by or under
this Act and have such records available for inspection
by any authorised officer for such period of time as
may be required by or under this Act;
( e ) to comply with regulations or Orders relating to good
practice in retail sale of medicinal products as may be
established by or under this Act;
( f ) to dispose of medicinal products as established by or
under this Act or any other law;
( g ) other responsibilities as may be established from time
to time by or under this Act.
Managing 
pharmacist.
75. (1) Every pharmacy shall be managed by a pharmacist
hereinafter referred to as the "managing pharmacist".
(2) The managing pharmacist shall:
( a ) act as the managing pharmacist of a licensed pharmacy
including any other premises used as a store by the
said pharmacy in terms of article 68(2); 
( b ) ensure that he or another pharmacist sells or supervises
the sale of medicinal products present in the pharmacy
and keep records of the pharmacist who was present at
all times while the pharmacy was open;
( c ) keep any documents, information or evidence in the
manner as may be required to be kept by or under this
Act;
( d ) carry out such obligations pertaining to a managing
pharmacist as may be established by or under this Act;
( e ) nominate a substitute managing pharmacist when he
cannot carry out his duties for a period of five or more
consecutive days and shall notify the Licensing
Authority of this substitution:
          MEDICINES                         _g CAP. 458.        31
Provided that in exceptional cases the licensee may
nominate a replacement and notify the Licensing
Authority;
( f ) comply with regulations or rules relating to good
practice in the dispensing of medicinal products as
may be established by or under this Act;
( g ) dispose of medicinal products as established by or
under this Act or any other law.
(3) No pharmacist may, without the authority in writing of the
Licensing Authority, act as a managing pharmacist of two or more
pharmacies:
Provided that the Licensing Authority shall not give such
authority unless it is satisfied that such pharmacist can reasonably
carry out the duties of a managing pharmacist for more than one
pharmacy.
(4) No pharmacist shall take up or abandon his duties as a
managing pharmacist of any pharmacy without giving prior notice
in writing to that effect to the Licensing Authority.
Duties of 
pharmacist.
76. (1) Unless otherwise provided by or under this Act, a
medicinal product shall only be prepared or dispensed from a
pharmacy and by a pharmasist:
Provided that a pharmacist may permit medicinal products
to be prepared or dispensed by a pharmacy technician under his
personal supervision as regulated by or under this Act.
(2) In carrying out his functions in the preparation and
dispensing of medicinal products from a pharmacy, a pharmacist
shall act in accordance with such standards as may be established
by or under this Act or any other Act.
Interest in a 
pharmacy.
77. The conditions and criteria where any person can have or
not have a direct or indirect interest in a pharmacy are to be defined
in the Third Schedule to this Act.
Licensee may 
employ one or 
more pharmacists.
78. The licensee shall employ a pharmacist to carry out the
responsibilities of a managing pharmacist and shall provide all the
support and in no way interfere with the managing pharmacist’s or
a pharmacist's professional responsibilities in the performance of
his duties as defined in by or under this Act or under any other law. 
Medicinal products 
to be sold from a 
pharmacy.
79. (1) A pharmacy shall only dispense in medicinal products
and trade in products or groups or classes of products that may
from time to time be established by rules made by the Licensing
Authority. 
(2) Unless otherwise provided by or under this Act, a medicinal
product shall only be sold from a pharmacy:
Provided that the Licensing Authority may, in special
circumstances relating to the provision of services to the public, by
rules prescribe that a medicinal product or class or classes of
medicinal products therein specified may be sold from a premises
other than a pharmacy such premises not being a general retail
  32        CAP. 458. _h               MEDICINES
outlet:
Provided further that the Licensing Authority may with
same circumstances by rules prescribe that a medicinal product of
class or classes of medicinal products therein specified may be
sold, prepared or provided to a patient by a person, other than a
pharmacist, who is suitably qualified for such purpose:
Provided also that such rules shall provide for the
circumstances under which such a sale, preparation or provision
may occur and impose such restrictions as may be provided.
(3) The Licensing Authority may by rules establish a list of
medicinal products that as a minimum must be available at a
pharmacy at all times:
Provided that this requirement may be temporarily waived
in relation to a particular medicinal product or class of medicinal
product in exceptional circumstances, if the Licensing Authority is
satisfied that the unavailability of such a medicinal product or class
of medicinal product from a pharmacy is beyond the control of the
managing pharmacist.
Dispensing of a 
medicinal product.
80. (1) A pharmacist shall prepare or dispense any medicinal
product required by any person presenting a prescription unless he
has a justified reason of concern that the prescription is false, that
the person is misusing the prescribed medicinal product, or that the
medicinal product is not available or if he has professional reasons
for not preparing or dispensing the prescription.
(2) Upon presentation of a prescription for a medicinal product,
unless the prescriber specifically requests a particular branded
product by writing "branded" or "®" on the prescription, a
pharmacist can dispense the medicinal product prescribed or an
equivalent medicinal product having the same chemical entity,
dose, dosage form, formulation and dosage frequency as the
medicinal product indicated on the prescription.
(3) When, in dispensing any medicinal product, a pharmacist
discovers that there are reasons why the medicinal product should
not be dispensed to the patient or that the dosage regimen indicated
on the prescription goes beyond what can be considered a safe
therapeutic dose, the pharmacist is bound to draw the attention
thereto of the person prescribing the same and may require such
person to write out in ink or in other indelible manner on the
prescription a statement assuming responsibility for the
prescription.
(4) The pharmacist shall assume full responsibility for the
dispensing of medicinal products which do not need a prescription
for dispensing to patients.
Dispensing against 
prescription.
81. (1) It shall not be lawful for any pharmacist to dispense
any medicinal product except on the prescription of a medical or
dental practitioner, veterinary surgeon or other person authorized to
prescribe under this or any other Act, unless the medicinal product
is deemed not to require a medicinal prescription by the Licensing
Authority.
          MEDICINES                         _g CAP. 458.        33
(2) The provisions of subarticle (1) shall also apply to products
or substances not classified as medicinal products but which have
been deemed to require a medicinal prescription for their use by the
relevant competent authority.
Presentation of a 
prescription.
82. The Licensing Authority may by rules prescribe the format,
content and presentation of a prescription required by or under this
Act.
Labelling of 
dispensed 
products.
83. The pharmacist shall label each medicinal product or
magistral formula or official formula dispensed in accordance with
such regulations or rules made under this Act.
Disposal of 
expired, 
deteriorated or 
imperfect products.
84. It shall not be lawful for any managing pharmacist to sell,
allow the sale, dispensing or supply in any other way of - 
( a ) any imperfect, deteriorated or harmful substance;
( b ) any medicinal product bearing an expiry date which
has expired;
Cap. 449.
Safety Act, or any regulations made thereunder: 
Provided that such imperfect, deteriorated or expired
substances or medicinal products shall only be kept in such place
and in such a manner as the Licensing Authority may from time to
time by rules establish.
Storage of 
medicinal products 
in pharmacy.
85. (1) It shall not be lawful for any managing pharmacist to
keep anywhere within the pharmacy any medicinal product in any
container or under such conditions which are not suitable to the
nature thereof and which are not such as to protect it from
alteration, deterioration or contamination.
(2) It shall not be lawful for any managing pharmacist to permit
any medicinal product under his charge to be kept or stored outside
the pharmacy under his management, and it shall be his duty to
ensure that the pharmacy has the facilities to ensure that medicinal
products are stored in accordance with storage recommendations:
Provided that in the case where the Licensing Authority has
granted a licence for the keeping or storage of medicinal products
in any premises other than the pharmacy, the responsibilities of the
managing pharmacist shall also apply to such premises.
Premises, etc., in 
accordance with 
requirements and 
standards.
86. Premises, facilities, records and equipment used for the
storage, preparation and dispensing of medicinal products are to be
kept in accordance with the requirements and standards established
by or under this Act.
Pharmacist to be 
guided by set 
standards.
87. The preparation of magistral and official formulas, and the
pre-packing, reconstitution, dispensing and administration of
medicinal products and any other activity related to medicinal
products and their use shall be in accordance with such standards as
may be established under this Act.
Inspections of 
pharmacies.
88. (1) The Licensing Authority shall have the right to inspect
pharmacies and any premises licensed for use as stores under
article 68(2) whenever it deems necessary.
  34        CAP. 458. _h               MEDICINES
(2) Any inspection as aforesaid shall be carried out in the
presence of the managing pharmacist or of the pharmacist for the
time being in charge of the pharmacy.
(3) At the time of the inspection, the inspecting officer shall
draw up a list of deficiencies that may have been identified at the
time of the inspection and shall sign this list, and such list shall be
countersigned by the managing pharmacist or by the pharmacist for
the time being in charge of the pharmacy: 
Provided that the inspecting officer shall draw up a report
of the inspection within seven working days of the inspection and
shall forward a copy of such report to the Licensing Authority, the
licensee and the managing pharmacist:
Provided also that the managing pharmacist or pharmacist
for the time being in charge of the pharmacy may make comments
or otherwise make reservations in respect of the contents of the said
list.
(4) ( a ) If in the course of the inspection, any article is found to
be in breach of the provisions of this Act or any
regulation made thereunder, the inspecting officer shall
forthwith seize the said article.
( b ) The wrapper or receptacle containing the article so
seized shall be sealed and the signature of the
inspecting officer and the managing pharmacist shall
be appended to the seal:
Provided that if the managing pharmacist so
requests, the article in question shall be divided, by the
inspecting officer, in two equal parts, sealed and signed
in the manner as aforesaid, and one part be given to the
managing pharmacist:
Provided further that the inspecting officer shall
send the seized article, sealed and signed in the manner
aforesaid to the Licensing Authority together with the
inspection report as described in subarticle (3). 
(5) If the managing pharmacist or the pharmacist for the time
being in charge of the pharmacy refuses to countersign the list
referred to in subarticle (3), the inspecting officer shall record such
fact on the said list together with the reason given, if any, for such
refusal.
Opening of 
pharmacies.
89. The Licensing Authority may by notice in the Gazette
establish the business hours of pharmacies and may also require
pharmacies in specified localities or districts to open for the
serving of customers on such days and for such times as may be
specified in such notice. 
PART IV
POISONOUS SUBSTANCES
Definition of 
poisons.
90. For the purposes of the provisions contained in this Part,
"poison" means -
          MEDICINES                         _g CAP. 458.        35
( a ) all those substances which, taken even in a very small
dose, may cause the death or serious injury to any
person,
( b ) all those substances which the Minister may, on the
advice of the Licensing Authority, prescribe,
but does not include any similar substance which is used, or is
intended to be used, for day to day domestic purposes, which latter
substance, however shall be deemed to be a poison for the purpose
of article 94.
Keeping, etc., of 
poisons.
91. It shall not be lawful for any person to keep for sale,
manufacture, sell or otherwise distribute or deal in any poison
without a licence from the Licensing Authority .
Licence for sale of 
poisons.
92. (1) The licence mentioned in article 91 shall only be
granted to manufacturers of, and dealers in chemical products,
colorists and such other persons as require to make use of poisons
in the exercise of their trade or profession.
(2) Such licence shall show the name and surname of the
licensee, his trade or profession, and the place in which he intends
to carry on such trade or profession and any other information as
may be established from time to time by rules made by the
Licensing Authority. 
Keeping of 
poisonous 
substances in a safe 
place.
93. Every person granted a licence under article 91 shall keep
all poisonous substances in a separate and safe place the key
whereof shall be always kept by the licence holder.
Sale of poisonous 
substances.
94. (1) No person granted a licence under article 91 shall sell
or deliver any poisonous substance, either by wholesale or retail, to
any person not being a pharmacist, except on production of a
prescription or for purposes of disinfection or industry or for any
other purpose as may be authorised by the Licensing Authority.
(2) Every person granted a licence under article 91 shall keep,
maintain, update, store and make available to the Licensing
Authority or any authorised person any information as may from
time to time be required by the Licensing Authority and in any such
manner as may be form time to time be required by the Licensing
Authority.
(3) Poisonous substances shall be labelled in such a manner the
Licensing Authority may from time to time by rules establish. 
Power of 
inspection.
95. The Licensing Authority or any authorised officer, may in
the interest of public health, pay surprise visits to the business
premises of manufacturers of and dealers in chemical products and
of the other persons referred to in article 91.
Poisoned grain, 
seed etc., 
Cap. 430.
96. Without prejudice to the provisions of the Pesticides
Control Act, it is prohibited to sow, cast, put or place, or cause to
be sown, cast, put or placed in or upon any land or other exposed
place any grain, seed, meal, or flesh which has been so dipped or
steeped in poison, or has been so mixed with poison or other
ingredient or preparation as to be rendered poisonous and
calculated to destroy life. 
  36        CAP. 458. _h               MEDICINES
PART V
OTHER DEALINGS WITH MEDICINAL PRODUCTS
Special restrictions 
on persons to be 
supplied with 
medicinal 
products. 
97. The Licensing Authority may by rules provide, either in
respect of medicinal products generally or in respect of medicinal
products of a description or falling within a class specified in the
rules that, subject to such exceptions as may be so specified, no
person -
( a ) being the holder of a marketing authorisation, or
( b ) in the course of business carried by him and
consisting, in whole or in part, of manufacturing
medicinal products or of selling medicinal products by
way of wholesale dealing,
shall sell or supply any medicinal product to which the rules apply
to any person who does not fall within a class specified in those
rules.
Adulteration of 
medicinal 
products.
98. No person shall -
( a ) add any substance to, or abstract any substance from, a
medicinal product so as to affect injuriously the
composition of the product, with the intent that the
product shall be sold or supplied in that state; or
( b ) sell or supply, or offer or expose for sale or supply, or
have in his possession for the purpose of sale or
supply, any medicinal product whose composition has
been injuriously affected by the addition or abstraction
of any substance.
PART VI
OFFENCES AND PENALTIES
Offences and 
penalties.
99. (1) Without prejudice to any other liability under any
other law, any person who fails to comply with any of the
provisions of this Act or any regulations or rules made thereunder
shall be guilty of an offence and shall, on conviction, be liable, in
the case of an offence against:
( a ) the provisions of articles 20, 24, 28, 37, 39, 41 and 43,
to a fine ( multa  ) of not less than ten thousand liri and
not exceeding fifty thousand liri or to imprisonment
for a term not exceeding two years, or both such fine
and imprisonment;
( b ) the provisions of articles 54, 56, 58 and 61, to a fine
( multa ) of not less than five thousand liri and not
exceeding thirty thousand liri or to imprisonment for a
term not exceeding six months, or both such fine and
imprisonment;
( c ) the provisions of articles 44, 45, 66(1), 71, 75(3),
75(4), 76(1), 81(1), 91 and 98, to a fine ( multa ) of not
less than two thousand liri and not exceeding twenty
thousand liri or to imprisonment for a term not
exceeding three months, or to both such fine and
          MEDICINES                         _g CAP. 458.        37
imprisonment;
( d ) the provisions of articles 59, 60, 65, 74( b ), 75(1),
75(2), 84, 93, 94(1) and 96, to a fine ( multa ) of not less
than five hundred liri and not exceeding ten thousand
liri;
( e ) the provisions of articles 31, 66(2), 78, 85(1), 85(2)
and 94(2), to a fine ( multa ) of not less than two
hundred liri and not exceeding five thousand liri; 
( f ) the provisions of articles 29, 73(1) and 94(3), to a fine
( multa ) of not less than one hundred liri and not
exceeding one thousand liri.
(2) Without prejudice to the powers of the Licensing Authority
under this Act, where any person who has committed an offence is
the holder of a licence or an authorisation under this Act, and the
conviction is the third or subsequent conviction, the Court shall, at
the request of the prosecution, order the revocation or suspension
of the aforesaid licence or authorisation.
Special procedure.
of offences, where the Licensing Authority believes that a person
has committed an offence against this Act or any regulations or
rules made thereunder, the Authority shall give notice in writing to
such person describing the offence of which the person is accused,
indicating the steps to be taken to remedy the offence and the
penalty which he is required to pay in respect of that offence.
(2) The Minister shall prescribe the penalties that may be
demanded by the Licensing Authority in relation to any specified
offence:
Provided that such penalty shall not exceed an amount of
ten thousand liri.
(3) Where a notice under this article has been given, the person
named in the notice may, within twenty-one days of the service of
the notice, accept responsibility for the offence specified in the
notice and within the same period pay the penalty indicated in the
notice, and comply with the relative provision of this Act, or of the
regulations or rules made thereunder and no further proceedings
may be taken under this Act in respect of such offence. 
Cap. 9.
(4) Where the person to whom notice is given under subarticle
(1) has not paid the penalty within the twenty-one day period
referred to in subarticle (3) and has not, within the time specified,
complied with the requirements of this Act, criminal proceedings
may be taken against him in accordance with the provisions of the
Criminal Code, of this Act and of any other law applicable of the
offence.
PART VII
ENFORCEMENT
Right of entry.
prejudice to the other provisions of this Act, any person duly
authorised in writing by the Licensing Authority shall, on
  38        CAP. 458. _h               MEDICINES
production of his authorisation or credentials, have a right at any
reasonable time to enter any premises:
( a ) for the purpose of ascertaining whether there is or has
been, or there is likely to be any contravention of any
provisions of this Act or of any regulations or rules
made thereunder;
( b ) generally for the purposes of the exercise by the
Licensing Authority of its function under this Act or
under any regulations or rules made thereunder.
For the purposes of this Part, premises shall include any
building, structure, any other place whatsoever or any means of
transport.
(2) Any authorised officer shall, on the production of his
authorisation, have a right at any reasonable time to board any ship
or aircraft for the purpose of ascertaining whether there is in the
ship or aircraft any substance or article imported in contravention
of any provisions of this Act or of any regulations or rules made
thereunder or whether the said craft is carrying out any activity in
contravention to any of the said provisions.
Power to inspect, 
take samples and 
seize goods and 
documents.
102. (1) For the purpose of ascertaining whether there is or has
been or there is likely to be a contravention of this Act or of any
regulations or rules made thereunder, an authorised officer shall
have a right to inspect:
( a ) any substance or article appearing to him to be a
medicinal product;
( b ) any article used or intended to be used to contain any
medicinal product or to be a label or leaflet used or
intended to be used in connection with a medicinal
product; or
( c ) any plant or equipment appearing to him to be used or
intended to be used in connection with the
manufacture or assembly of medicinal products, and
any process of manufacture or assembly of any
medicinal products and the means employed, at any
stage in the process of manufacture or assembly, for
testing the materials after they have been subjected to
those processes.
 (2) An authorised officer may, for the purpose specified in the
preceding subarticle, take a sample of any:
( a ) substance or medicinal product sold or supplied or
intended to be sold or supplied; or
( b ) substance or article used or intended to be used in the
manufacture of a medicinal product.
(3) For the purposes of subarticle (1), an authorised person
shall have the right:
( a ) to inspect any records, in whatever form they are held,
related to the manufacture, assembly, sale or supply of
a medicinal product and, where such records are kept
          MEDICINES                         _g CAP. 458.        39
in electronic form:
(i) may have access to, and inspect and check the
operation of any computer, any associated
apparatus or material which is or has been in use
in connection with the records; and
(ii) may require any person having charge of, or
otherwise connected with the operation of, the
computer, apparatus or material to afford him
such assistance as he may reasonably require;
( b ) to take copies of any entry in any book or document
produced in pursuance of the preceding paragraph and
where the records are kept electronically, by means of
a computer or otherwise, require the records to be
produced in an intelligible form which may be taken
away.
(4) Any authorised officer shall have a right to seize, remove
and detain any substance or article which he has reasonable cause
to believe to be a substance or article in relation to which, or by
means of which, an offence under this Act is being or has been
committed, and any document which he has reasonable cause to
believe to be a document which may be required as evidence in
proceedings under this Act.
(5) For the purpose of subarticle (4), any authorised person
may, so far as is reasonably necessary in order to secure
compliance with the provisions of this Act and any regulations or
rules made thereunder, require any person to break open any
container, package or machine, or to permit him to do so:
Provided that where a person seizes any substance or
article, including any document, for the purposes specified in
subarticle (4), he shall inform the person from whom it is seized
and give him a receipt thereof.
(6) Without prejudice to the preceding provisions of this
article, any authorised person shall have the same rights conferred
by those provisions in relation to things belonging to, or any
business carried on by, an applicant for an authorisation or
certificate under Part III of this Act, and may exercise such rights
for the purpose of verifying any statements or information
contained in the application for the authorisation or certificate; and,
where by virtue of the provisions of this subarticle a person
exercises any such right as is specified in subarticle (4), he shall be
subject to the duty imposed by subarticle (5).
(7) Notwithstanding anything in the preceding provisions of
this article, where a person claiming to exercise a right by virtue of
the provisions of this article is required to produce his authorisation
or credentials, the right shall only be exercisable by him on the
production of the authorisation or credentials.
Application of 
sampling 
procedure to 
substance or article 
seized.
103. (1) The provisions of this article shall apply where an
authorised officer seizes a substance or article, other than a
document, in the exercise of such a right as is specified in article
102(4) and (6).
  40        CAP. 458. _h               MEDICINES
(2) If any person who in accordance with article 102(5) is
entitled to be informed of the seizure so requests, either at the time
of the seizure or at any subsequent time, not being later than
twenty-one days after he is informed of the seizure, then subject to
the following provisions of this article, the authorised officer shall
either:
( a ) set aside a sample of the substance or article seized; or
( b ) treat that substance or article as a sample,
whichever he considers more appropriate having regard to the
nature of that substance or article.
(3) An authorised officer shall not be required by virtue of
subarticle (2) to set aside a sample, or to treat a substance or article
as a sample, if the nature of the substance or article is such that it is
not reasonably practicable to do either of those things.
(4) Where in accordance with subarticle (2) an authorised
officer sets aside a sample, or treat a substance or article as a
sample, he shall divide it into three parts, each part to be marked
and sealed or fastened up in such manner as its nature will permit,
and shall supply one excerpt of it to the person who made the
request under subarticle (2).
Supplementary 
provisions as to 
right of entry.
104. (1) Any person entering any property or any other
premises, ship, aircraft, stall or place in accordance with the
provisions of article 101, may be accompanied by such other
person or take such equipment as may appear to him to be
necessary; and on leaving any such property shall, if the property is
unoccupied or the occupier or any other person who is in charge of
a ship, aircraft, vehicle, stall or place, is temporarily absent, leave
it as effectively secured.
(2) The authorised officer shall also have such other powers as
may be prescribed by regulations made by the Minister for the
proper execution of his functions.
PART VIII
MISCELLANEOUS PROVISIONS
Recognition of 
equivalent 
standards.
105. For the purposes of this Act, the Minister may, on the
advice of the Licensing Authority, by regulations prescribe that a
provision or provisions in relation to the marketing authorisation of
a medicinal product shall be deemed to be satisfied, if the standards
of manufacture, medicinal product quality, safety or efficacy, or the
provisions in relation to the granting of a marketing authorisation
of a country designated in such regulations, are satisfied.
Power of Minister 
to make 
regulations.
106. The Minister may, after consultation with the Licensing
Authority, amend the schedules to this Act, prescribe by
regulations anything that may be prescribed under this Act and
make provision on any matter relating to medicinal products,
poisons and pharmacies in order to give fuller effect to the
provisions of this Act, and, in particular, but without prejudice to
the generality of the aforesaid, shall by such regulations regulate or
otherwise provide for:
          MEDICINES                         _g CAP. 458.        41
( a ) the grant of marketing authorisations;
( b ) the manufacture of medicinal products and raw
materials used in such manufacture;
( c ) the wholesale distribution of medicinal products;
( d ) the sale and supply of medicinal products;
( e ) the licensing of pharmacies;
( f ) the reporting of adverse drug reactions;
( g ) advertising in respect of medicinal products, and the
presentation and information contained in the advert:
Provided that the advertising of certain medicinal
products or classes of medicinal products may, by such
regulations, be prohibited;
( h ) the conduct of clinical trials;
( i ) the classification of medicinal products;
( j ) the testing of medicinal products;
( k ) the regulation of homeopathic medicinal products;
radiopharmaceuticals and medicinal products derived
from human blood and human plasma; immunological
products, and herbal products;
( l ) the roles and responsibilities of a licence or
authorisation holder;
( m ) the roles and responsibilities of the managing
pharmacist, responsible person and qualified person;
( n ) standards of good practice in the manufacture,
wholesale, distribution and dispensing of medicinal
products:
Provided that in the case of dispensing the Minister
may take the opinion of the Pharmacy Board;
( o ) the recognition of equivalent standards for medicinal
product quality and efficacy in relation to such
countries as may be prescribed;
( p ) the recognition of equivalent standards for good
practice in manufacture in relation to such countries as
may be prescribed;
( q ) the fees that may be levied by the Licensing Authority
and the Medicines Authority;
( r ) exceptions to any provision in the interest of public
health.
Transitory 
provision.
107. Any medicinal products on the market on the date of the
coming into force of article 20 shall only be subject to the
provisions of that article at such time and subject to such
conditions as may by rules be established by the Licensing
Authority. 
  42        CAP. 458. _h               MEDICINES
Amendment of 
Medical and 
Kindred 
Professions 
Ordinance.
Cap. 31.
108. Omitted under the Statute Law Revision Act, 1980.
Saving.
Cap. 31.
109. (1) Any regulations made under the provisions of the
articles, of the Medical and Kindred Professions Ordinance, which
have been repealed by article 108, shall, until provision is made
under or by virtue of this Act, continue in force and have effect as
if made under this Act.
(2)  Any licence, permission or other authorisation granted
under any provision of the repealed articles as aforesaid, shall
continue in force thereafter as if it were a licence, permission or
authorisation granted under a corresponding provision or authority
granted under this Act and shall be treated and dealt with
accordingly.
(3) Any action taken or proceedings commenced against or in
relation to any person under the repealed articles as aforesaid shall
continue to have effect as if it were action or proceedings taken or
commenced under a corresponding provision of this Act.
FIRST SCHEDULE
Areas of competency
Anaesthesiology
Analytical Chemistry
Anatomy
Biochemistry
Biotechnology Products
Blood Products
Cardiology
Cosmiceuticals
Dentistry 
Dermatology
Diabetes 
Endocrinology 
ENT Medicine
Epidemiology
Family Medicine
Gastroenterology  
Genetics
Geriatrics 
Haematology
          MEDICINES                         _g CAP. 458.        43
Herbals
Homeopathics
Immunology 
Intensive care
Internal Medicine  
Medical Devices
Medical Statistics
Microbiology (such as Virology, Bacteriology)
Molecular Biology
Neurology
Nephrology
Nutraceuticals
Nutrition
Obstetrics & Gynaecology
Oncology
Ophthalmology 
Orthopaedics
Paediatrics 
Pathology
Pharmaceutical Chemistry
Pharmaceutical Technology
Pharmacognosy 
Pharmacology 
Physiology
Psychiatry
Radiology 
Radiopharmaceuticals
Respiratory Medicine 
Rheumatology
Surgery 
Toxicology
Transfusion Medicine
Urology
Vaccines
  44        CAP. 458. _h               MEDICINES
SECOND SCHEDULE
Proceedings of the Medicines Review Board
1. All members of the Medicines Review Board shall be
present for a hearing of an appeal or the development of a second
opinion.
2. All members of the Board shall have a vote and the opinion
of the Board shall reflect the opinion of the majority of members:
Provided that a dissenting member may also request that
his opinion be attached to the Board's opinion report as a minority
report.
3. The appellant shall appear before the Board either in
person or through an agent on the day and at the time fixed for the
hearing, make his submissions and produce such evidence as the
Board may allow:
Provided that the Board may postpone the hearing of the
appeal if it is satisfied that the appellant was prevented from
appearing before it owing to illness or absence from Malta or other
similar reasonable cause.
4. The Board shall give the Medicines Authority an
opportunity to make its submissions in justification of its opinion/s,
and bring such evidence as the Board may consider necessary.
5. The Board shall have the power to summon witnesses and
to administer the oath to any person appearing before it.
6. The Board shall have power to confirm or issue a different
opinion to that appealed against, as it may deem appropriate.
7. The opinion of the Board shall be final albeit not binding to
the decision of the Licensing Authority and no appeal shall lie
therefrom except on a question of law only. 
8. Subject to the foregoing provisions and to the provisions of
this Act, the Board shall regulate its own procedure.
 
          MEDICINES                         _g CAP. 458.        45
THIRD SCHEDULE
Conditions and criteria where any person can have or not have a 
direct or indirect interest in a pharmacy
(1) No person shall qualify for a licence if he is a medical
practitioner, dental surgeon, dentist or veterinary surgeon or if he is
the husband or wife of any such medical practitioner, dental
surgeon, dentist or veterinary surgeon.
(2) No licence shall be granted or renewed if a medical
practitioner, dental surgeon, dentist or veterinary surgeon has any
direct or indirect interest in a pharmacy.
(3) It shall not be lawful for any medical practitioner, dental
surgeon, dentist or veterinary surgeon or any other person
authorised to issue prescriptions under the Medicines Act or any
other Act, to enter into any agreement with any pharmacist or any
other person for any share in the profits of a pharmacy, or to have
any direct or indirect interest of whatever nature in any pharmacy.
(4) It shall not be lawful for any pharmacist:
( a ) to carry on the business of a pharmacy on account of,
or in partnership with any medical practitioner, dental
surgeon, dentist or veterinary surgeon or any other
person authorised to issue prescriptions under the
Medicines Act or any other Act;
( b ) to enter into any agreement with any medical
practitioner, dental surgeon, dentist or veterinary
surgeon or any other person authorised to issue
prescriptions as aforesaid, for any share in the profits
of a pharmacy;
( c ) to lend his name in order that the business may be
carried out by some other person.
