DISPENSARIES (LICENSING) g S.L.458.16 1
SUBSIDIARY LEGISLATION 458.16
DISPENSARIES (LICENSING) REGULATIONS
6th July, 1984
LEGAL NOTICE 31 of 1984, as amended by: Legal Notices 16 of 1985,
35 and 67 of 1986, 20 of 1987, 103 of 1992 and 117 of 1996.
Title.
(Licensing) Regulations.
Interpretation.
requires- 
Cap. 464.
"dispensary" means any premises from which any medicinal
substances are sold, dispensed or otherwise supplied directly to the
public by retail, irrespective of whether such sale, dispensing or
supply is carried out on the presentation of a prescription given for
the purpose by a medical practitioner, dental surgeon, dentist or
veterinary surgeon, or otherwise;
"drug" includes any medical substance;
"licence" means a licence granted under the Act;
"Superintendent" means the Superintendent of Public Health.
Licence.
Amended by:
L.N. 35 of 1986.
3. (1) No licence may be granted or renewed except in
conformity with the provisions of these regulations.
(2) A licence shall lapse on the 31st day of December of any
year in which it is granted or renewed.
(3) The Superintendent may in issuing any licence lay down
amongst the conditions the hours during which the dispensary shall
be kept open.
(4) If a dispensary is kept closed for a period of six months or
for any aggregate period of six months in a calendar year, the
licence thereof shall be considered as being no longer valid and on
the completion of any such period the Superintendent shall give
notice accordingly to the person to whom the licence has been
issued.
Disqualification 
from holding a 
licence.
4. (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 the dispensary.
Dispensing area.
preparation and compounding of medicinal substances and there
shall be provided and maintained in good working order in that
area, a supply of wholesome drinking water, water at suitably
2 g S.L.458.16 DISPENSARIES (LICENSING)
controlled temperature and a properly drained sink.
Toilets. 6. A toilet shall be provided and such toilet shall be
connected with a flushing apparatus in good working order; and in
the area of such toilet there shall be provided a supply of water,
soap, nail-brushes and hand drying facilities.
State of premises. 7. The premises shall be kept in a good state of repair and at
all times clean; and no structural alterations may be carried out
without the prior approval of the Superintendent.
Connection with 
habitation.
8. (1) No dispensary shall form part of or communicate with
with a premises used for habitation, and no dispensary shall be used
for sleeping purposes.
(2) The provisions of subregulation (1) and of regulation 6
shall not apply in respect of a dispensary existing before the
coming into force of these regulations and which cannot be made to
comply with such provisions.
Restricted use of 
premises.
9. * (1) The licensee of a dispensary shall not carry out or
cause, permit or suffer to be carried out on the premises any
activity which is not strictly that of the storage, preparation,
dispensing, sale or supply of drugs, or that of the storage and sale
of other articles as are mentioned in regulation 14(3).
(2) There shall be no communication, whether permanent or
temporary, between the premises of a dispensary and any other
premises which is used for any activity whatsoever, commercial,
professional or otherwise, except in accordance with subregulation
(1).
Management of 
dispensary.
10. (1) A dispensary shall be managed by an apothecary who
is authorised to practise his profession under the Act, and such
apothecary shall be present in the dispensary during all times the
dispensary is kept open.
(2) The licensee and the managing apothecary and, in their
absence, any person acting on their behalf to open or close the
dispensary for the daily running thereof, shall inform forthwith the
Superintendent of the absence (other than momentary) of the
managing apothecary.
(3) The managing apothecary shall give to the Superintendent
previous notice in writing of the name and address of any new
pharmacy technician who will be assisting him in the dispensary.
(4) Where any pharmacy technician ceases to be employed in
any dispensary, the managing apothecary of such dispensary shall
inform the Superintendent within forty-eight hours of such
cessation.
(5) (i) The managing apothecary, any other apothecary and
any pharmacy technician in charge of or employed at a
dispensary, as the case may be, shall wear a clean
white overall at all times during which they are present
at the dispensary.
*Not yet in force.
DISPENSARIES (LICENSING) g S.L.458.16 3
Cap. 258.
(ii) The managing apothecary shall wear on the overall at
all times during which he is present at the dispensary
under his management, an identity card issued by the
Superintendent for the purpose, containing a recent
colour photograph of the said apothecary, his name,
surname, qualifications the number of the identity card
issued under the Identity Card Act, the designation
‘managing apothecary’ and the name of the dispensary.
(iii) An apothecary shall send to the Superintendent two
recent passport size colour photographs at the time he
gives the notice of assumption of the management of a
dispensary.
(iv) The provisions of paragraph (iii) shall apply also to
managing apothecaries already acting in that capacity
at the time of coming into force of these regulations:
Provided that such managing apothecaries shall
submit the photographs within one week from the day
of the coming into force of these regulations:
Provided further that the provisions of paragraph
(ii) of this sub-regulation shall, in their respect, apply
on the lapse of two months after the coming into force
of these Regulations.
(6) The provisions of subregulation (5)(ii), (iii) and (iv) shall,
when so required by the Superintendent, apply  mutatis mutandis  to
any other apothecary and to any pharmacy technician employed at
any dispensary.
Order to close.
attendance, and the Superintendent is satisfied that circumstances
exist which give rise to the suspicion that a breach of the provisions
of the Act or of any regulations made thereunder, or of any
legislation relating to drugs, may occur, the Superintendent may
order that the dispensary shall be closed forthwith and be kept
closed until such time as he is satisfied that no such breach exists.
Conduct of 
employees.
12. (1) Without prejudice to the provisions of the Act
applicable to the practice of the profession of apothecary and of
pharmacy technician, no person may be employed in a dispensary if
he is found guilty in any court in Malta or abroad of an offence of
theft or abuse of drugs.
(2) Prior to the grant or renewal of a licence, the owner or other
person running the business of a dispensary, shall furnish the
Superintendent with a list of persons employed by him at the
dispensary. The Superintendent may at any time require any such
employee to produce to him a certificate of conduct from the
Commissioner of Police, and it shall be the duty of such employee
to comply with that request without delay.
Sale of medicines.
apothecary:
Provided that a pharmacy technician may, subject to the
provisions of the Act, sell those medical substances which do not
4 g S.L.458.16 DISPENSARIES (LICENSING)
require a prescription.
Equipment, stock 
and appearance.
14 . (1) Every dispensary shall be provided with metric
weights and measures and such other utensils and equipment as
may be required in accordance with good pharmacy practice.
(2) There shall also be provided in every dispensary such
medical substances as may from time to time be required in
accordance with the provisions of the Act; and every dispensary
shall comply with every other condition that may from time to time
be imposed by the Superintendent regarding the stocking and sale
of drugs.
(3) The licensee shall ensure that the appearance of the
premises and the dressing of the shop windows reflect the
professional character of the dispensary and make it clear to the
public that the practice of pharmacy is the main purpose of the
establishment, and that the wording of the signboard conforms to
the dignity of the profession:
Provided that besides medicinal preparations there may be
sold in a dispensary medical appliances pertaining to the medical
and kindred professions, cosmetics, toilet requisites, perfumery,
photographic and optical goods, baby food and other articles which
in the opinion of the Pharmacy Council do not lower the prestige of
the profession.
Labelling.  15. (1) All medicinals shall be properly labelled.
(2) For the purpose of this regulation proper labelling shall
include the expiry date where in accordance with good pharmacy
practice such date is indicated.
Safe keeping of 
drugs.
16. (1) The licensee of a dispensary shall ensure that facilities
are available in the premises for the safe keeping of drugs in such
manner as shall avoid the possibility of misuse of stock.
S.L. 31.18
Cap. 101.
(2) All drugs listed under the Second Schedule to the Drugs
(Control) Regulations, or falling under the Dangerous Drugs
Ordinance, and all poisons shall be kept under lock and key, which
key shall be kept by the managing apothecary.
(3) No person other than the managing apothecary shall have a
duplicate of the said key or have access to such key without the
permission of the Superintendent.
(4) The Superintendent may require that other medical
substances or categories of medical substances besides those
mentioned in subregulation (2) shall be kept locked as aforesaid.
Deteriorated drugs, 
and drugs with an 
expiry date.
17. (1) No deteriorated drug shall be kept at any dispensary.
(2) No drug which bears an expiry date shall - 
( a ) be sold, dispensed or otherwise supplied after the
expiry date has expired, or 
( b ) be retained on the premises of any dispensary, even
though not for sale, dispensation or other supply, for a
period in excess of one month after the expiry of such
DISPENSARIES (LICENSING) g S.L.458.16 5
date.
(3) When any drug with an expiry date is sold, dispensed or
otherwise supplied in a container or wrapper which is different
from that in which it was originally packed, it shall be the
responsibility of the managing apothecary to ensure that the expiry
date is reproduced legibly on any such new packing.
Keeping of 
registers and report 
of sales and stock 
of drugs.
18. (1) There shall be provided in the dispensary a recent copy
of the British Pharmacopoea or the International Pharmacopoea.
(2) There shall also be provided the following separate
registers and book:
( a ) a main register in which shall be entered the sale of
every medical substance which requires a prescription
as provided in the Act;
( b ) a poisons register in which shall be entered the sale of
every poisonous substance as provided in the Act;
S.L. 31.18
( c ) a register or registers in which shall be entered every
purchase and sale of drugs listed in the Second
Schedule to the Drugs (Control) Regulations;
Cap. 101.
( d ) registers in which shall be entered every purchase and
sale of drugs as required by rules or regulations made
under the Dangerous Drugs Ordinance; and
( e ) a book in which shall be transcribed the  procès verbal
of the inspection of the dispensary in accordance with
the provisions of the Act.
(3) All the pages of each register and book referred to in
subregulation (2) shall be numbered consecutively and shall be
stamped by a medical officer of health, and shall be open for
inspection by a medical officer authorised by the Superintendent or
by an authorised apothecary.
S.L. 31.18
Cap. 101.
(4) Prior to each renewal of the licence, the managing
apothecary shall draw up a report in duplicate on all transactions in
respect of drugs listed in the Second Schedule to the Drugs
(Control) Regulations, as also under the Dangerous Drugs
Ordinance; such report shall include, amongst other relevant data,
in respect of each such drug, the total amount purchased, its form
and dosage, each date of purchase, the total sales and an account of
the stock taking carried out at the end of the year. A copy of such
report shall be sent to the Superintendent and another copy shall be
retained by the licensee.
(5) A report in duplicate as is referred to in subregulation (4)
shall also be drawn up by the said apothecary before he
relinquishes the management of the dispensary under his care.
Opening times.
at such times as the Superintendent may from time to time order in
accordance with the provisions of the Act.
(2) The apothecary in charge of a dispensary which is not
required to be kept open in terms of subregulation (1) shall affix to
the door of the dispensary under his management a notice clearly
6 g S.L.458.16 DISPENSARIES (LICENSING)
visible from the street showing the name and address of the
dispensary or dispensaries required to be kept open in that
particular district.
(3) A notice showing the name and address of the managing
apothecary shall be kept affixed on the door of the dispensary in
such a way as to be visible from the street and at all times during
which the dispensary is closed.
Unacceptable 
prescriptions.
Amended by:
L.N. 67 of 1986.
20. (1) It shall not be lawful to dispense any medical
preparation on the prescription of a person who is authorised under
the Act to practise the medical profession only as a house
physician/surgeon in a government hospital or clinic, or in any
other branch of the health service provided by Government, unless
such prescription bears an indication of being issued from a
government hospital or clinic or in any other branch of the health
service provided by Government.
(2) It shall not be lawful to dispense any medical preparation
on the prescription of a person who, though licensed to practice the
medical or dental profession, is disallowed by an agreement with
Government from engaging in the private practice of his profession
until he has served in a government hospital or clinic, or in any
other branch of the health service provided by Government, for
such period as may be specified in that agreement, unless such
prescription bears an indication of being issued from a government
hospital or clinic or in any other branch of the health service
provided by Government.
(3) The Superintendent shall from time to time furnish to the
managing apothecary of every licensed dispensary the names and
addresses of the medical and dental persons referred to in this
regulation.
Stores. 21. The provisions of these regulations shall,  mutatis
mutandis , apply also to stores used in connection with any
dispensary.
