Prescription and Dispensing Requirements Rules, 2006

L.N. 292 of 2006

MEDICINES ACT

(CAP. 458)

Prescription and Dispensing Requirements Rules, 2006

IN exercise of the powers conferred by Articles 29 (2) and 82 of

the Medicines Act, the Licensing Authority has made the following

rules>-

(1) The title of these rules is the Prescription and Dispensing

Requirements Rules, 2006.

(2) These rules shall be deemed to have come into force on

the 1 st December 2006.

(1) These rules apply to medicinal products and to products

or substances not classified as medicinal products but which have been

deemed by the Medicines Authority to require a medicinal prescription

for their use.

(2) The provisions of these rules are without prejudice to

those stipulated in the Free Medicinals (Prescription Forms) Regulations,

1996 in respect of prescription forms for free medicinals.

Every prescription shall>

(a) be easily legible and written in ink or in other indelible

manner<

(b) bear the date on which it is written, clearly indicate in a

legible manner and in block letters the full name, and contact details,

such as the telephone number, of the prescriber as well as the

registration number assigned by the relevant council, and shall be

signed accordingly in original<

(c) bear the name, age and locality of current residence of

the patient and the name, strength, dosage form, quantity and

duration of treatment of each prescribed product included in the

said prescription, together with clear instructions on how the

prescribed product is to be taken or used. Repeat prescriptions are

to be marked accordingly indicating the total period of duration of

treatment< and

(d) in the case of computer generated prescriptions, bear

the details in paragraphs (a), (b) and (c) hereof and be signed in

handwriting by the prescriber.

(1) It shall not be lawful for any person, not being a Dispensing of

prescription.

pharmacist duly licensed to practise in Malta, to dispense a prescribed

product against a prescription.

(2) It shall not be lawful for any pharmacist to dispense any

product to which these regulations apply except on a prescription issued

from persons duly authorized under article 81 of the Medicines Act,

unless the product is deemed by the Licensing Authority not to require

a prescription.

(3) Verbal instructions over the telephone shall not be

accepted and honored unless the following conditions are satisfied>

(a) that the pharmacist is satisfied that the verbal instruction

over the telephone is being requested by a person duly authorized

under article 81 of the Medicines Act, who by reason of an

emergency is unable to furnish a prescription immediately>

(b) that the prescriber undertakes to furnish the pharmacist

with a prescription complying with the provisions of rule 3 hereof

within 48 hours of the verbal instructions>

(c) that the product is dispensed in accordance with the

directions of the prescriber> and

(d) that an entry is made into any record kept under the

Medicines Act>

Provided that these conditions shall not apply to narcotic or

psychotropic substances.

(4) It shall not be lawful for any pharmacist to dispense a

product against a prescription after the expiry of six months from the

date specified in rule 3(b) hereof, unless it is a repeat prescription, in

which case it shall only be dispensed other than in accordance with the

directions contained in the repeat prescriptions.

(5) If a prescription is more than six months old, the patient

shall be referred to the prescriber for reassessment.

(6) In the case of antibiotics, the prescription shall not be

dispensed after ten days from the date of issue of the prescription.

The dispensing pharmacist shall write clearly and legibly

thereon in ink or any other indelible manner the word “dispensed”, date

of dispensing, the quantity supplied, the Pharmacy Council registration

number, signature and endorse the prescription with the pharmacy stamp.

(1) A pharmacist dispensing a prescription shall enter into any

record kept under the Medicines Act the following particulars>

(a)

the date on which the prescription is dispensed>

(b) the name, quantity and the pharmaceutical form and

strength of the product>

(c) the full name of the prescriber and his registration

number>

(d) the date of the prescription> and

(e) in the case of medicinal products dispensed in

compliance with sub-rule (3) of rule 4, the date on which the

prescription is received.

(2) The requirements of sub-rule (1) shall be satisfied in

the case of computerized records, provided that the information is also

retained in the form of a print-out for each day on which the pharmacy

is open. Such print-out shall be dated and certified by the managing

pharmacist on the day to which the print-out relates or within a period

of 24 hours thereafter.

The provisions stipulated in the Dangerous Drugs Ordinance,

and in the Medical and Kindred Professions Ordinance, in respect of

prescriptions for narcotic and psychotropic substances, shall also apply.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press