Prescription and Dispensing Requirements

L.N. 401 of 2014

MEDICINES ACT

(CAP. 458)

Prescription and Dispensing Requirements

(Amendment) Rules, 2014

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister for Energy and Health, after consultation

with the Licensing Authority, has made the following regulations:-

The title of these regulations is the Prescription and Citation.

Dispensing Requirements (Amendment) Rules, 2014, and these rules

shall be read and construed as one with the Prescription and S.L. 458.49

Dispensing Requirements Rules, hereinafter referred to as "the

principal rules".

Rule 3 of the principal rules shall be amended as follows

Amends rule 3

of the principal

rules.

(a)

in paragraph (b) thereof, for the words "the full

name, and contact details" there shall be substituted the words

"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)";

(b)

paragraph (c) thereof shall be substituted by the

following

"(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;";

(c)

in paragraph (d) thereof, for the words "which may

include digital signatures." there shall be substituted the words

"which may include digital signatures; and";

(d)

immediately after paragraph (d) thereof, there shall

be added the following new paragraph

"(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.".

€0.18