PRESCRIPTION AND DISPENSING REQUIREMENTS RULES

PRESCRIPTION AND DISPENSING REQUIREMENTS

SUBSIDIARY LEGISLATION 458.49

PRESCRIPTION AND DISPENSING

REQUIREMENTS RULES

1st December, 2006

LEGAL NOTICE 292 of 2006, as amended by Legal Notices 303 of 2013

and 401 of 2014.

The title of these rules is the Prescription and Dispensing

Requirements Rules.

(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,

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,

professional qualification, work address (including the

name of the relevant Member State) and contact details

(e-mail and telephone or fax, the latter both with

international prefix), 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, date of birth, age and locality of current

residence of the patient and the 'Common name' as

defined in article 2 of the Medicines Act; the brand

name if (i) the prescribed product is a biological

medicinal product, as defined in Part I, point 3.2.1.1.

of the Schedule to the Medicines (Marketing

Authorisation) Regulations, or (ii) if the person

authorised in accordance with article 81 of the

Medicines Act to issue a prescription deems it

medically necessary; in that case the prescription shall

shortly state the reasons justifying the use of the brand

name; the 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;

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

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

PRESCRIPTION AND DISPENSING REQUIREMENTS

officially signed by the prescriber, which may include

digital signatures; and

(e) if the product prescribed qualifies under the criteria for

prescribing a brand name as specified in paragraph (c),

the pharmacist dispensing the product shall dispense

the product with the brand name as prescribed.

(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 within forty-eight 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), 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.

(1) The dispensing pharmacist shall write clearly and

legibly thereon in ink or any other indelible manner the word

"di sp ensed", date of di sp ensing, th e quan tity suppl ied, the

Pharmacy Council registration number, signature and endorse the

prescription with the pharmacy stamp.

(2) For repeat prescriptions and partially dispensed

prescriptions, which are given back to the patient, the dispensing

PRESCRIPTION AND DISPENSING REQUIREMENTS

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 repeat prescription or partially

dispensed 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 rule 4(3), 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 twenty-four 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.