Pharmacy Licence (Amendment) Regulations, 2013

L.N. 305 of 2013

MEDICINES ACT

(CAP. 458)

Pharmacy Licence (Amendment) Regulations, 2013

IN exercise of the powers conferred by article 66 of the

Medicines Act, the Minister for Health, after consultation with the

Licensing Authority, has made the following regulations:-

(1)

The title of these regulations is the Pharmacy Citation and

Licence (Amendment) Regulations, 2013, and these regulations shall commencement.

be read and construed as one with the Pharmacy Licence Regulations, S.L. 458.16

hereinafter referred to as "the principal regulations".

(2) These regulations shall be come into force on the 1st of

January, 2014.

Regulation 12 of the principal regulations shall be Substitutes

regulation 12 of

substituted by the following

the principal

regulations.

" Registers and

(1) Without prejudice to the

report of sales

professional responsibility of a pharmacist to

and stock of

maintain records as deemed fit and necessary

drugs.

for good patient care, all medicinal products

dispensed 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 requirements of sub-regulations (1)

and (2) shall 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.".

€0.18