New regulations on Prescription on Medicinals - published - 23/12/2006

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L.N. 292 of 2006
(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
1. (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 1st December 2006.
2. (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.
3. Every prescription shall>
(a) be easily legible and written in ink or in other indelible
(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
Title and
L.N. 19 of 1996.
Form and content of
B 4105
(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.
4. (1) It shall not be lawful for any person, not being a
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.
Dispensing of
B 4106
5. 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.
6. (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
(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.
7. 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.
Particulars to be
Applicability of
Cap. 101 and 31.
Ippubblikat mid-Dipartiment ta’ l-Informazzjoni ( — Valletta — Published by the Department of Information ( — Valletta
Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press
Prezz 12ç – Price 12c

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