Pharmacy Licence Regulations, 2007

L.N. 279 of 2007

MEDICINES ACT

(CAP. 458)

Pharmacy Licence Regulations, 2007

IN exercise of the powers conferred by article 66 of the Medicines

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>-

The title of these regulations is the Pharmacy Licence

Regulations, 2007.

In these regulations, unless the context otherwise requires -

“the Act” means the Medicines Act<

“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<

“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<

“town” means a locality, including all hamlets and outlying

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

Local Councils 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 Disqualification

from holding a

practitioner, dental surgeon or veterinary surgeon.

licence.

(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 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.

(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 Medicines 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 Restrictions on the

granting of a

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

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 in accordance with the requirements

of the Local Councils Act.

(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 of

these regulations 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<

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

distance from any premises in respect of which an application for

a licence is pending.

The provisions of regulation 5 of these regulations shall not Hospital

pharmacies.

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 National

pharmaceutical

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

participate in any national pharmaceutical distribution 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 Standards

to a 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 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 the licensee of a pharmacy 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 and sale of other

articles as allowed by these regulations.

(4) Without prejudice to sub-regulation (2) of this regulation,

there shall be no communication between the premises of a pharmacy

and any other premises which is used for any activity whatsoever,

commercial, professional or otherwise, except in accordance with sub-

regulation (3) of this regulation>

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.

The pharmacy shall be provided with reference sources and Equipment, stock

and appearance.

equipment and other utensils as the managing pharmacist may require

for the practice of good pharmacy within the premises.

(1) It shall be the duty of the managing pharmacist to keep Registers and report

of sales and stock of

separate written or electronic records into which shall be entered>

drugs.

(a) the sale of every medicinal product which requires a

prescription as established by article 30 of the Medicines Act<

(b) the sale of every poisonous substance as provided in

article 93 of the Medicines Act<

(c) every purchase and sale of drugs listed in the Second

Schedule to the Drugs (Control) Regulations, 1985<

L.N. 22 of 1985.

(d) every purchase and sale of drugs as required by rules or

regulations made under the Dangerous Drugs Ordinance.

(2) All the pages of each register referred to in sub-regulation

(1) shall be numbered consecutively.

(3) In the case of an electronic record security mechanisms

approved by the Licensing Authority shall be in place to prevent the

tampering of data and an audit trail of entries and deletions.

(4) All records shall be open for inspection by the Licensing

Authority or any officer acting on its behalf.

(1) The managing pharmacist shall supply the Licensing Duties of managing

pharmacist.

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 to be employed

within the pharmacy which falls under his responsibility.

(2) The managing pharmacist shall keep written records of

any pharmacist or pharmacy technician engaged to work in the 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 the

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 pharmacist shall 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 sub-regulation (1) of this regulation

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.

The Dispensaries Licensing Regulations, 1984 are hereby

repealed.