PHARMACY LICENCE REGULATIONS

SUBSIDIARY LEGISLATION 458.16

PHARMACY LICENCE REGULATIONS

5th October, 2007

LEGAL NOTICE 279 of 2007, as amended by Legal Notices 81 of 2008,

198 of 2010, 305 of 2013 and 400 of 2014.

The title of these regulations is the Pharmacy Licence

Regulations.

In

these

regulations,

unless

the

context

otherwise

requires -

"Act" means the Medicines Act;

"Cruise Liner Sea Terminal" means the site within the

boundaries of the emphyteutical concession granted by

Parliamentary Resolution 323 of 2003;

"drug" includes any medicinal product as defined in the Act;

"licence" means a licence granted under article 66 of the Act;

"Licensing Authority" means the Superintendent of Public

Health in terms of article 3(1) of the Act;

" M a l t a I nt e r n a t i on a l A i r p or t " m e a ns t he s i t e w i t h i n t he

boundaries of the emphyteutical concession granted by

Parliamentary Resolution 298 of 2011;

"the Minister" means the Minister responsible for health;

"pharmacy" means any premises from which any medicinal

products 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 or veterinary

surgeon, or otherwise;

"relocation" means the transfer of pharmacy premises from one

place within a locality to another place within the same locality;

" Sma rt Ci ty" means the site with in the boun darie s of the

emphyteutical concession granted by Parliamentary Resolution 281

of 2007;

"special designated areas" means the sites indicated in regulation

4A;

"town" means a locality, including all hamlets and outlying

areas, having a local council or committee so designated under the

Local Government Act and qualifying as such under this Act and

"village" shall be construed to be the same;

"walking distance" means the shortest walking distance.

(1) No person shall qualify for a licence if he is a medical

practitioner, dental surgeon or veterinary surgeon.

(2) It shall not be lawful for any medical practitioner, dental

surgeon or veterinary surgeon or any other person authorised to

issue prescriptions under the 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.

(3)

It shall not be lawful for any person

(a) to carry on the business of a pharmacy on account of,

or in partnership with any medical practitioner, dental

surgeon or veterinary surgeon or any other person

authorised to issue prescriptions under the Act or any

other Act;

(b) to enter into any agreement with any medical

practitioner, dental surgeon 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.

(4) If a pharmacy is kept closed for a period of six months or

for any aggregate period of six months within one calendar year,

the licence thereof shall be considered as being no longer valid and

on completion of any such period the Licensing Authority shall

give notice accordingly to the person to whom the licence has been

issued.

(1) The number of pharmacies that may be licensed within

the boundaries of any town or village shall not be less than two, and

such pharmacies shall be situated no less than three hundred meters

walking distance from each other

Provided that such distance shall not apply in the case of

pharmacies already holding a licence on the day of coming into

force of these regulations

Provided further that no pharmacy can open within three

hundred meters walking distance from a pharmacy in a

neighbouring town or village.

(2) In every town or village the number of pharmacies shall not

exceed the ratio of one pharmacy for every two thousand five

hundred inhabitants.

(3) The number of inhabitants of a town or village shall be

taken to be the number if inhabitants of that town or village as

published by the National Office of Statistics.

The provisions of regulation 4 shall not apply to special

designated areas which for the scope of these regulations shall be

Smart City, the Malta International Airport and the Cruise Liner

Sea Terminal.

(1) A licence for a pharmacy in a town or village shall not

be granted to an applicant who already holds a licence for a

pharmacy in the same town or village.

(2) An applicant who already holds a licence in a town or

village may be granted another pharmacy licence in another town

or village provided that there are no pending applications for a

pharmacy in that locality from persons who hold no licence for a

pharmacy

Provided that the provisions of this regulation shall not

apply in respect of renewals of existing pharmacy licences but shall

be taken into account if and when a request for the transfer of such

a licence or an application for relocation is made.

(3) Any licensee may transfer an existing licence to another

person by means of an application to the Licensing Authority.

(4) Any licensee may after authorisation by the Licensing

Authority relocate the pharmacy to other suitable premises within

the same town or village provided that the conditions of regulation

6 are adhered to.

A licensee may apply for the relocation of a pharmacy as

long as the relocation is within the same town or village and the

proposed new premises

(a) offer better facilities in terms of these regulations than

the existing premises;

(b) are situated no less than three hundred meters walking

distance from any other existing pharmacy or not more

than 50 meters from the current premises

Provided that in the case of an application for a

pharmacy licence submitted before the application for

relocation of an existing pharmacy, and where, as a

result of such relocation, the distance between the

proposed new pharmacy and the relocated pharmacy is

less than 300 metres, then the requisite of 300 metres

shall not apply in determining the validity or otherwise

of the pending application.

The provisions of regulation 5 shall not apply to an

application for a licence for a hospital in-patient pharmacy

Provided that such pharmacy may be bound by the

Licensing Authority to provide service to the public on a twenty

four hour, seven days a week basis, excluding normal pharmacy

retail hours

Provided further that such provisions shall not apply to any

pharmacy which forms part of the Government health service.

Any licence granted after the coming into force of these

regulations shall have as a condition of the licence the obligation to

p a r t i c ip a t e i n an y n at i o n a l ph ar m ac e ut i c a l di s t r i bu t i o n or

dispensing system that the Minister may at any time wish to

introduce.

A licence for a pharmacy shall only be granted if the

pharmacy complies with the following standards

(a) easy access to the public;

(b) the external appearance reflects the professional

character of the pharmacy and make it clear to the

public that the practice of pharmacy is the main

PHARMACY LICENCE

purpose of the establishment;

(c) the premises are compatible with the workload carried

out within it whilst ensuring efficient and effective

communication between the pharmacy staff and

members of the public;

(d) the walls, floors, ceiling, windows and all other parts

of the premises are kept clean in such manner that any

surfaces present shall be impervious and may be easily

wiped clean;

(e) the premises have a clear area set aside for the

preparation and compounding of medicinal products

and diagnostic testing;

(f)

the pharmacy premises are kept in an orderly,

organised condition;

(g) the premises provide an environment, in respect of

space, temperature, lighting, humidity, noise levels

and other factors, which is in conformity with

occupational health and safety requirements, thereby

providing a safe environment for staff and members of

the public visiting the premises;

(h) all products present on the premises are protected from

the adverse effects of extremes of temperature,

sunlight and excess humidity in a manner that there

shall be always followed the maximum or minimum

temperature and humidity and any other condition

specified on the packaging by the manufacturer;

(i)

all openings to the outside of the premises are securely

locked when the pharmacy is closed;

(j)

the toilet facilities are kept clean and in good working

order. Facilities must include hot and cold water, soap

and nail brushes and a hand drying facility. The toilet

area must not be used as a source of water for

dispensing or as a storage area;

(k) all pharmaceutical and non-pharmaceutical waste and

expired and deteriorated products are to be segregated

from pharmacy stock and placed in a designated

quarantine area. The safe disposal of pharmaceutical

and non-pharmaceutical waste is to be made according

to regulations under this Act or any other law.

(1) The premises shall be kept in a good state of repair at

all times and no structural alterations shall be carried out without

the prior approval of the Licensing Authority.

(2) No pharmacy shall form part or communicate with premises

used for habitation and no pharmacy shall be used for sleeping

purposes

Provided that the provisions of this sub-regulation shall not

apply in respect of a pharmacy existing before the coming into

force of these regulations and which cannot be structurally altered

as to comply with such provisions.

(3) It shall not be lawful for a licencee to carry out or cause to

permit, or suffer to be carried out on the premises any activity

which is not strictly that of storage, preparation, dispensing, sale or

supply of medicinal products or that of storage or sale of other

articles and all other activities related to pharmaceutical and other

healthcare services as allowed by these regulations.

(4) Without prejudice to sub-regulation (2), there shall be no

communication between the premises of a pharmacy and any other

premises which is used for any commercial activity whatsoever,

except in accordance with sub-regulation (3).

The pharmacy shall be provided with reference sources and

equipment and other utensils as the managing pharmacist may

require for the practice of good pharmacy within the premises.

(1) Without prejudice to the professional responsibility of

a pharmacist to maintain records as deemed fit and necessary for

good patient care, al l medicinal products di spensed against

prescriptions shall not need to be registered and documented,

except for those referred to in sub-regulation (4).

(2) Pharmacists shall retain all prescriptions dispensed for a

period of three months from date of dispensing; such prescriptions

shall be retained in a manner that, in case of need, reference to a

particular prescription can be made. At the end of the three month

period, the said prescriptions may be disposed of in a manner that

safeguards the patient’s confidentiality.

(3) The dispensing pharmacist shall record on the prescription

the date upon which the prescription was dispensed, his/her

signature and Pharmacy Council registration number.

(4) It shall be the duty of the managing pharmacist to keep

separate written records or electronic records into which shall be

entered -

(a) the sale of every medicinal product dispensed against a

repeat prescription;

(b) the sale of every medicinal product dispensed against a

partially dispensed prescription.

The require m ents of s ub- regu lat ions (1 ) and (2) sh all be

applicable when the prescription is fully dispensed.

(5) The provisions of this regulation shall not apply for

narcotic drugs and psychotropic substances whose purchase and

sale shall continue to be registered in line with the requirements of

the Dangerous Drugs Ordinance and any subsidiary legislation

made thereunder.

(1) The managing pharmacist shall supply the Licensing

Authority with a list of pharmacists working in the pharmacy and

of pharmacy technicians working under the supervision of a

pharmacist within the pharmacy. He shall also inform the Licensing

Authority when any such pharmacist or pharmacy technician ceases

t o be em pl oyed w it hin t he p harm a cy w hi ch fal ls und er hi s

responsibility.

(2) The managing pharmacist shall keep written records of any

phar macis t or pha rm acy tec hnici an engage d to work in t he

pharmacy on a locum basis and such records shall be signed by the

managing pharmacist and countersigned by the locum pharmacist

or pharmacy technician as the case may be and shall be available at

all times for inspection by the Licensing Authority or his delegate.

(3) The managing pharmacist or any pharmacist employed

within a pharmacy shall be obliged to wear a white coat while

attending to his professional duties and shall have an identity tag

issued by t he Pharmacy Council attached to his coat clearly

showing his name, designation and Pharmacy Council registration

number.

(4) The name and Pharmacy Council registration number of the

managing pharmaci st shal l be kept affixed in the pharmacy

premises in such a way as to be visible at all times during which the

pharmacy is open.

(1) Each pharmacy shall be kept open on such days and on

such times as the Licensing Authority may from time to time order

in accordance with the provisions of article 88 of the Act.

(2) The managing pharmacist of the pharmacy which is not

required to be kept open in terms of subregulation (1) shall affix to

the door of the pharmacy under his management, a notice clearly

visible from the street indicating the name and address of the

pharmacy or pharmacies required to be kept open in that particular

district.

The provisions of these regulations shall so far as

applicable, apply also to stores used in connection with any

pharmacy.