MEDICINES (MARKETING AUTHORISATION) ġ S.L.458.34 1
SUBSIDIARY LEGISLATION 458.34
MEDICINES (MARKETING AUTHORISATION) 
REGULATIONS
1st May, 2004
LEGAL NOTICE 426 of 2003.
Citation.
Authorisation) Regulations.
Interpretation.
Cap. 458.
''the Authority'' means the Medicines Authority established under
article 4 of the Act;
''the Agency'' means the European Agency for the Evaluation of
Medicinal Products established by Regulation (EEC) No 2309/93;
''the Commission'' means the Commission in accordance with
Council Decision 1999/468/EC of 28 th June, 1999;
''the Community'' means the European Union, previously referred
to as the European Community and the European Economic
Community;
''imported'' means a medicine brought into Malta for the purpose
of being placed on the market;
''Licensing Authority'' means the Licensing Authority referred to
in article 3 of the Act;
''medicines'' and''''medicinal products'' means medicinals for
human use;
''Member State'' means a State which is a member of the
European Union and shall also include Iceland, Norway and
Liechtenstein;
''provisional market authorisation'' means a market authorisation
issued by the Licensing Authority for products present on the
market in Malta up till the 31st November, 2002;
''reference Member State'' means the Member State, which is
granted the market authorisation on which an application for a
market authorisation is based;
''risk to public health'' means all riska with regard to the quality,
safety and efficacy of the medicinal products;
''Superintendent'' means the Superintendent of Public Health.
(2) The provisions of these regulations shall not apply to:
( a ) any medicinal product which is prepared in a
pharmacy in accordance with a medicinal prescription
for an individual patient, commonly known as the
magistral formula;
2 ġ S.L.458.34 MEDICINES (MARKETING AUTHORISATION)
( b ) any medicinal product which is prepared in a
pharmacy in accordance with prescriptions of a
pharmacopoeia and is intended to be supplied directly
to patients served by the pharmacy in question,
commonly known as the official formula;
( c ) medicinal products intended for research and
development trials;
( d ) intermediate products intended for further processing
by an authorised manufacturer;
( e ) any radionuclides in the form of sealed sources;
( f ) whole blood, plasma or blood cells of human origin.
Application. 3. The provisions of these regulations shall apply to
industrially produced medicinal products for human use intended to
be placed on the market in Malta.
Placing on the 
market.
4. No medicinal product, radionuclide generators,
radionuclide kits, radionuclide precursor radiopharmaceutical and
industrially prepared radiopharmaceuticals, may be imported,
placed on the market or otherwise sold in Malta unless, there is in
respect of that product, a valid market authorisation, issued by the
Licensing Authority in accordance with Council regulation No.
(EEC) 2309/93 of 22 July 1993, and such importation, placing on
the market or sale is in accordance with the terms and conditions of
such market authorisation:
Provided that a market authorisation shall not be required in
the case of a radiopharmaceutical prepared at the time of its use by
a person or by an establishment duly authorised to use such
medicinal products in an approved health care establishment
exclusively from authorised radionuclide generators, radionuclide
kits or radionuclide precursors in accordance with the
manufacturer’s instructions:
Provided further that the Licensing Authority may, in
exceptional cases, subject to any condition it deems fit, allow the
use of a medicinal product which does not have a marketing
authorisation:
Provided further that products having a provisional market
authorisation shall be allowed to remain on the market until such
time as the Licensing Authority may, in respect of such products,
issue a market authorisation.
Grant or renewal of 
market 
authorisation.
5. (1) A market authorisation may only be granted or
renewed if the general conditions applicable to authorisations and
the conditions set out under Directive 2001/83/EC on the
Community Code relating to medicinal products for human use and
subsequent amendments thereto, are fulfilled as follows:
( a ) an application for market authorisation shall be made
to the Licensing Authority which shall refer such
application to the Authority for processing;
( b ) a marketing authorisation may only be granted to an
applicant established in the Community;
MEDICINES (MARKETING AUTHORISATION) ġ S.L.458.34 3
( c ) the application shall be accompanied by the following
documents and particulars to be submitted in
accordance with Annex I of Directive 2003/63/EC:
(i) the name or corporate name and permanent
address of the applicant and, where applicable,
of the manufacture;
(ii) the name of the medicinal product;
(iii) the qualitative and quantitative particulars of all
the constituents of the medicinal product in
usual terminology, but excluding empirical
chemical formulae, with mention of the
international non-proprietary name
recommended by the World Health Organisation
(WHO) where such name exists;
(iv) a description of the manufacturing method;
(v) therapeutic indications, contra-indications and
adverse reactions;
(vi) posology, pharmaceutical forms method and
route of administration and expected shelf life;
(vii) if applicable, reasons for any precautionary and
safety measures to be taken for the storage of the
medicinal product, its administration to patients
and for the disposal of waste products, together
with an indication of any potential risks
presented by the medicinal products for the
environment;
(viii) a description of the control methods employed
by the manufacturer (qualitative and quantitative
analysis of the constituents and of the finished
product, special tests, such as sterility tests, tests
for the presence of pyrogenic substances, the
presence of heavy metals, stability tests,
biological and toxicity tests, controls carried out
at an intermediate stage of the manufacturing
process);
(ix) results of physico-chemical, biological or
microbiological tests, toxicological and
pharmacological tests and clinical trials;
(x) a summary, in accordance with regulation 8, of
the product characteristics, one or more
specimens or mock-ups of the outer packaging
and the immediate packaging of the medicinal
product with a package leaflet;
(xi) a document showing that the manufacturer is
authorised in his own country to produce
medicinal products; and
(xii) copies of any authorisation obtained in another
Member State or in a third country to place the
medicinal product on the market, together with a
list of those Member States in which an
application for authorisation submitted in
4 ġ S.L.458.34 MEDICINES (MARKETING AUTHORISATION)
accordance with the provisions of these
regulations is under examination. Copies of the
summary of the product characteristics proposed
by the applicant in accordance with regulation 8
or approved by the competent authorities of the
Member State. Copies of the package leaflet
proposed. Details of any decision to refuse
authorisation, whether in the community or in a
third country, and the reasons for such a
decision.
(2) The information under subregulation (1)( c ) shall be updated
on a regular basis.
Application for 
radionuclide 
generator.
6. In the case of an application for a market authorisation for
a radionuclide generator, the application shall also contain:
( a ) a general description of the system together with a
detailed description of the components of the system
which may affect the composition or quality of the
daughter nucleid preparation; and
( b ) qualitative and quantitative particulars of the eluate of
the sublimate.
Details to be 
provided.
7. (1) The applicant shall not be required to provide the
results of toxicological and pharmacological tests or the results of
clinical trials if he shows to the satisfaction of the Authority that:
( a ) either the medicinal product is essentially similar to
another already authorised in Malta, and that the
holder of the marketing authorisation of such similar
product has consented to the toxicological,
pharmacological and, or clinical references contained
in the file of such product being used for the purpose
of examining the application in question; or
( b ) the constituent or constituents of the medicinal product
have a well established medicinal use, with recognised
efficacy and an acceptable level of safety by means of
a detailed scientific bibliography; or
( c ) the medicinal product is marketed in Malta and is
essentially similar to another product which has been
authorised within the Community, in accordance with
the Community provisions in force, for not less than
six years, which period shall, in the case of high
technology, be extended to ten years:
Provided that where the medicinal product is intended for a
different therapeutic use from that of the other medicinal products
marketed, or is to be administered by different routes or in different
doses, the results of appropriate toxicological and pharmacological
tests and or the appropriate clinical trials must also be provided.
(2) In the case of new medicinal products which contain known
constituents not hitherto used in combination for therapeutic
purposes, the results of toxicological and pharmacological tests and
of clinical trials relating to that combination must be provided,
MEDICINES (MARKETING AUTHORISATION) ġ S.L.458.34 5
provided that it shall not be necessary to provide references relating
to each individual constituent.
Summary of 
product 
characeristics.
8. The summary of the product characteristics shall contain
the following information:
( a ) the name of the medicinal product;
( b ) the qualitative and quantitative composition in terms
of the active substance and constituents of the
excipient, knowledge of which is essential for proper
administration of the medicinal product, in such
manner that the usual common name or chemical
description shall be used;
( c ) pharmaceutical forms;
( d ) pharmacological properties and, in so far as this
information is useful for therapeutic purposes,
pharmacokinetic particulars;
( e ) clinical particulars:
(i) therapeutic indications;
(ii) contra-indications;
(iii) adverse reactions (frequency and seriousness);
(iv) special precautions for use and, in the case of
immunological medicinal products, any special
precautions to be taken by persons handling such
products and administering them to patients,
together with any precautions to be taken by the
patient;
(v) use during pregnancy and lactation,
(vi) interaction with other medicaments and other
forms of interaction;
(vii) posology and method of administration for
adults and, where necessary, for children;
(viii) overdose (symptoms, emergency procedures,
antidotes);
(ix) special warnings;
(x) effects on ability to drive and to use machines;
( f ) pharmaceutical particulars:
(i) major incompatibilities;
(ii) shelf life, when necessary after reconstruction of
the medicinal product or when the immediate
packaging is opened for the first time;
(iii) special precautions for storage;
(iv) nature and contents of the immediate packaging;
(v) special precautions for disposal of unused
medicinal products or waste materials derived
from such medicinal products, if appropriate;
( g ) name or corporate name and permanent address of the
marketing authorisation holder;
6 ġ S.L.458.34 MEDICINES (MARKETING AUTHORISATION)
( h ) for radiopharmaceuticals, full details of internal
radiation dosimetry, additional detailed instructions
for extemporaneous preparation and quality control of
such preparation and, where appropriate maximum
storage time during which any intermediate
preparation such as an eluate or the ready-to-use
pharmaceutical will conform with its specifications.
Experts to 
formulate and sign 
documents.
9. The Authority shall take all the necessary measures to
ensure that the documents and particulars listed in the preceding
regulations are drawn up and signed by experts with the necessary
technical or professional qualifications.
Duty of experts. 10. It shall be the duty of experts -
( a ) to perform tasks falling within their respective
disciplines (analysis, pharmacology and similar
experimental sciences, clinical trials) and to describe
objectively the results obtained (qualitatively and
quantitatively);
( b ) to describe their observations in accordance with
Annex I of Directive 2003/63/EC, and to state, in
particular:
(i) in the case of the analyst, whether the medicinal
product is consistent with the declared
composition, giving any substantiation of the
control methods employed by the manufacturer;
(ii) in the case of the pharmacologist or the
specialist with similar experimental competence,
the toxicity of the medicinal product and the
pharmacological properties observed;
(iii) in the case of the clinician, whether he has been
able to ascertain effects on persons treated with
the medicinal product which correspond to the
particulars given by the applicant in accordance
with the provisions of these regulations, whether
the patient tolerates the medicinal product well,
the posology the clinician advises and any
contra-indications and adverse reactions; and
( c ) where applicable, to state the grounds for using the
bibliography referred to under regulation 7(1)( b ).
Reports by experts. 11. Detailed reports by the experts shall be deemed to form
part of the particulars accompanying the application submitted by
the applicant.
Processing of 
application.
12. It shall be the duty of the Authority to ensure that an
application for a marketing authorisation is processed within a
period of two hundred and ten days from the date of its submission:
Provided that this period shall be suspended when the
processing of the application stops for any reason deemed
necessary by the Authority, which reason shall be communicated in
writing to the applicant.
MEDICINES (MARKETING AUTHORISATION) ġ S.L.458.34 7
Application 
already under 
examination in a 
Member State.
13. In those cases where an application is already under
examination in a Member State, the Authority shall suspend the
examination of the application, await an assessment by the
aforementioned State and inform that State and the applicant of its
decision to suspend.
Duties of the 
Authority on 
receiving the 
report.
14. The Authority shall within ninety days of receipt of the
aforementioned assessment report, either recognise the decision
and the summary of product characteristics as approved by that
Member State or, if it deems that there is a risk to public health, it
shall inform the applicant, the Agency and the reference Member
State and other Member State concerned by the application:
Provided further, that the provision of this regulation shall
not be applicable to medicinal products present on the market in
Malta up till the 30th November, 2002.
Examination of 
application.
15. In order to examine the submitted application, the
Authority -
( a ) shall verify whether the particulars submitted by the
applicant are in terms of the provisions of these
regulations and examine whether any condition for
issuing a market authorisation are complied with;
( b ) may submit the medicinal product, its starting
materials and, if need be, its intermediate products or
other constituent materials, for testing by a State
laboratory or by a laboratory designated for that
purpose in order to ensure that the control methods
employed by the manufacturer and described in the
particulars accompanying the application are
satisfactory, in which case the period of two hundred
and ten days referred to under regulation 12 is
suspended;
( c ) may, where appropriate, require the applicant to
supplement the particulars accompanying the
application in respect of the items and, in such case,
the two hundred and ten days referred to under
regulation 12 shall be suspended until such time as the
supplementary information required has been
provided. Likewise, these time limits shall be
suspended when the applicant is given the opportunity
of an oral or written explanation.
Information to 
holder.
16. ( a ) When the marketing authorisation is issued it shall be
subject to the general conditions in the Schedule and
the holder shall be informed by the Authority of the
summary of the product characteristics as approved by
it.
( b ) The Authority shall take all necessary measures to
ensure that the information given in the summary is in
conformity with that accepted when the marketing
authorisation is issued or subsequently.
( c ) A copy of the authorisation together with the summary
of the product characteristics shall be forwarded to the
8 ġ S.L.458.34 MEDICINES (MARKETING AUTHORISATION)
Agency.
( d ) It shall be duty of the Authority to draw up an
assessment report and comments on the dossier as
regards the results of the analytical and
pharmacotoxicological tests and the clinical trials of
the medicinal product concerned. The assessment
report shall be updated whenever new information
becomes available which is of importance for the
evaluation of the quality, safety or efficacy of the
medicinal product concerned.
Exceptional 
circumstances.
17. (1) In exceptional circumstances, and following
consultation with the applicant, an authorisation may be granted
subject to certain specific obligations, including:
( a ) the carrying out of further studies following the
granting of authorisation; and
( b ) the notification of adverse reactions to the medicinal
product.
(2) Such exceptional decisions may be adopted only for
objective and verifiable reasons and shall be based on one of the
causes referred to in part 4 (G) of Annex I of Directive 2003/63 EC.
Duties of 
authorisation 
holder.
18. After an authorisation has been issued, the authorisation
holder must, in respect of the methods of manufacture and control,
take account of any scientific and technical progress and introduce
any changes which may be required to enable the medicinal product
to be manufactured and checked by means of generally accepted
scientific methods accepted by the Authority.
Validity of market 
authorisation.
19. An authorisation shall be valid for five years and shall be
renewable for five-year periods, on an application by the holder at
least three months before the expiry date, and after consideration
by the Authority of a dossier containing in particular, details of the
data on pharmacovigilance and other information relevant to the
monitoring of the medicinal product.
Civil and criminal 
liability.
20. An authorisation shall not affect the civil and criminal
liability of the manufacturer and, where applicable, of the
marketing authorisation holder.
Refusal of 
marketing 
authorisation.
21. (1) The marketing authorisation shall be refused if, after
verification of any particulars and documents submitted to it, the
Authority deems that:
( a ) the medicinal product is harmful in the normal
conditions of use, or
( b ) its therapeutic efficacy is lacking or is insufficiently
substantiated by the applicant, or
( c ) its qualitative and quantitative composition is not as
declared.
(2) Authorisation shall likewise be refused if the particulars
and documents submitted do not comply with the provisions of
these regulations.
MEDICINES (MARKETING AUTHORISATION) ġ S.L.458.34 9
Mutual 
recognition.
22. ( a )  (i) Before submitting an application for the
recognition of a marketing authorisation in
Malta, the holder of the authorisation shall
inform the Authority in a reference Member
State that an application is to be made in
accordance with this regulation and shall notify
it of any additions to the original dossier.
(ii) The holder of the authorisation shall submit an
application to the Authority and shall testify that
the dossier is identical to that accepted by the
reference Member State, or shall identify any
additions or amendments it may contain. In the
latter case, the holder shall certify that the
summary of the product characteristics proposed
by him in accordance with regulation 8 is
identical to that accepted by the reference
Member State in accordance with regulation 16.
(iii) The Authority shall recognise the marketing
authorisation granted by the reference Member
State within ninety days of receipt of the
application and the assessment report. It shall
inform the reference Member State which
granted the initial authorisation, the other
Member States concerned by the application, the
Agency, and the marketing authorisation holder:
Provided that this shall not apply when the
Authority has reason to believe that the
marketing authorisation of the medicinal product
may present a risk to public health. In such case
the Authority shall inform the reference Member
State, the applicant ,any other Member State
concerned with the application and the Agency,
giving reasons for its decisions and advising
what action to be taken to correct any defect in
the application.
(iv) The Authority shall endevour to reach an
agreement with all the Member States concerned
regarding the action to be adopted. If agreement
is not reached within ninety days the matter shall
then be referred to the Agency.
(v) The Authority and any other Member State
concerned shall also provide the Committee
within ninety days of receipt of the application,
with a report giving the reasons for
disagreement. This report shall be copied to the
applicant who on receipt of such report shall
forward to the Committee a copy of the
information and particulars referred to under
regulations 5, 7(1) and 8.
( b ) (i) In those cases where Malta is the Reference
Member State, the Authority may require the
applicant to provide it with all the particulars
and documents necessary to enable it to check
10 ġ S.L.458.34 MEDICINES (MARKETING AUTHORISATION)
that the dossiers filed are identical.
(ii) The Authority, upon request by the holder of the
authorisation shall prepare an assessment report
in respect of the medicinal product concerned,
or, if necessary, shall update any existing
assessment report. The Authority shall prepare
the assessment report, or update it within ninety
days of the receipt of the request.
(iii) The Authority shall then forward the assessment
report to the Member State or Member States
concerned at the same time as the application is
submitted.
Application for 
variation.
23. A market authorisation holder may apply to vary the
marketing authorisation and such application shall be submitted to
that Authority and to all other Member States which have
previously authorised the medicinal product concerned.
Referral to the 
Agency.
24. When the Licensing Authority is of the opinion that the
variation, suspension or withdrawal of the marketing authorisation
is necessary in the interest of public health it shall refer the matter
to the Agency:
Provided that when urgent action needs to be taken in the
interest of public health the Licensing Authority may suspend the
marketing and use of the medicinal product concerned and inform
the Commission and other Member States within twnty-four hours
giving reasons for its decision.
MEDICINES (MARKETING AUTHORISATION) ġ S.L.458.34 11
SCHEDULE
Regulation 16( a )
General Conditions applicable to Authorisations
1. The authorisation holder shall report to the Authority any change of name
andċor address and any change of address at which there is carried on a business to
which the authorisation relates.
2. The authorisation holder shall ensure that any product to which the
authorisation relates is manufacture only in accordance with the methods set out in,
or furnished in connection with, his application for the authorisation and that the
specification of the constituents and of the finished product are in accordance with
the information contained in, or furnished in connection with the said application,
except insofar as may otherwise be approved by the Authority.
3. The authorisation holder shall not issue, or cause another person to issue, or
consent to the issue of any advertisement or recommendation, relating to any product
to which the authorisation relates, which contains particulars as to the uses, nature or
effects of such product or warnings or precautions in use concerning such product,
unless the terms of the advertisement or recommendation, insofar as they relate to
such particulars, warnings, or precautions in use correspond to or differ only to an
extent that is not material from those specified in the authorisation.
4. The authorisation holder shall inform the Authority of any material change
that has been made; or is proposed to be made in the particulars contained in or
furnished in connection with the application, in relation to any product to which the
authorisation relates, that is to say:
4.1 in the composition of the product, or of any of its constituents,
4.2 in the specification of the product or of any of its constituents,
4.3 in the methods of manufacture of the product or of any of its
constituents,
4.4 in the methods and procedures described in the application for
ensuring compliance with such specification,
4.5 in the arrangements described in the application for storage of the
product,
4.6 in the recommended uses, routes of administration or dosage
schedules, or
4.7 in the method of retail sale, supply or sales promotion.
5. The authorisation holder shall notify the Authority of any change proposed
to be made in the labelling or package leaflet relating to any medicinal product to
which the authorisation relates. Any such change not connected with the summary of
product characteristics, which have not been opposed by the Authority within ninety
days following the said notification shall be deemed to be approved by the Authority
and may be put into effect by the authorisation holder.
6. The authorisation holder shall inform the Authority of any additional
information received by him which may alter the validity of data provided in support
of the application, or may further the understanding of the substance and its effects
or may alter the directions for use of the medicinal product which is the subject of
the authorisation.
7. The authorisation holder shall kept a record of reports of adverse effects
associated with the use of the product to which the authorisation relates. The record
12 ġ S.L.458.34 MEDICINES (MARKETING AUTHORISATION)
shall be available for inspection by a person authorised by the Authority who may
take copies thereof. The authorisation holder shall furnish to the Authority a copy of
any such report of which he has a record or of which he is aware.
8. The authorisation holder shall keep available for inspection by a person
authorised by the Authority durable records of his arrangements -
8.1 for obtaining materials for the purpose of the manufacture by him or
on his behalf of any product to which the authorisation relates, and
8.2 for procuring the manufacture, importation, storage, sale or supply of
any such product, and
8.3 for the tests to be carried out on any such product or on the materials
used for its manufacture,
and shall permit the person so authorised to take copies of, or to make extracts from,
such records. The records shall be retained for a period of five years from the date on
which the relevant batch of the product was released for sale or was imported by or
on behalf of the authorised holder.
9. The authorisation holder shall keep such documents as will facilitate the
withdrawal or recall from sale or supply of any product to which the authorisation
relates.
10. The authorisation holder, on being informed by the Authority that any
product to which the authorisation relates has been found -
10.1 to be harmful under normal conditions of use, or
10.2 to be lacking in therapeutic efficacy, or
10.3 not to be in accordance with the information contained in or furnished
in connection with the application for such authorisation, or furnished
in compliance with any of the condition set out in this Schedule, as
regards the qualitative or quantitative composition of the product, or
10.4 not to be in accordance with any conditions, other than those set out in
this schedule, which are specified in the authorisation,
shall, if so directed by the Authority withhold from sale all batches of the product or
such batch as may be specified by the Authority, and so far as may reasonably be
practicable, immediately recall all supplies of the product or of such batch of the
product as has already been issued.
11. The authorisation holder shall comply with the condition set where the
controls on the product to which the authorisation relates, or on any of its
constituents, in the course of its manufacture as indicated in or in connection with
his application for the authorisation or in compliance with the conditions set out in
this Schedule, have not been carried out.
12. The authorisation holder shall notify the Authority of any decision to
withdraw from sale or supply any product to which the authorisation relates and
shall state the reason for the decision.
13. The authorisation holder shall on request by the Authority -
13.1 furnish from such batch or batches as may be specified a sample of
any product to which the authorisation relates for the purpose of test,
examination or analysis, or
13.2 furnish full particulars of the tests which have been applied to such
batch or batches of such product as may be specified and the result of
such tests.
MEDICINES (MARKETING AUTHORISATION) ġ S.L.458.34 13
14. The authorisation holder shall, if requested by the Authority, withhold from
sale any batch or batches in respect of which a sample is, or particulars are,
requested to be furnished until a certificate authorising the sale of the batch or
batches has been issued to him by the Authority.
15. The authorisation holder shall ensure that -
15.1 the product to which the authorisation relates is not sold unless it has
been manufactured in the premises in respect of which any
undertaking has been given;
15.2 such product has been manufactured in such premises and in such
circumstances as to comply with any conditions specified in such
undertaking.
16. The authorisation holder shall in the event of the authorisation being
revoked surrender it to the Authority.
