Medicines (Marketing Authorisation) (Amendment) Regulations,

L.N. 465 of 2004

MEDICINES ACT, 2003

(ACT III OF 2003)

Medicines (Marketing Authorisation) (Amendment) Regulations,

IN exercise of the powers conferred by article 106 of the Medicines

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>-

(a) The title of these regulations is Medicines (Marketing Title and scope

Authorisation) (Amendment) Regulations, 2004 and they shall be read

and construed as one with the Medicines (Marketing Authorisation)

Regulations, 2004, hereinafter referred to as “the principal regulations”. L.N. 387 of 2004.

(b) The scope of these regulations is to transpose Directive

93#41#EEC.

Immediately after regulation 25 of the principal regulations Adds regulations

26 to the principal

there shall be added the following new regulation>

regulations.

“Applictions

“26. Applications for marketing authorisations which

made

have been referred to the Committee for Proprietary Medicinal

before 1 st

January,

Products before the 1 st January, 1995 in accordance with

1995. Article 2 of Directive 87#22#EEC and in respect of which the

Committee concerned has not given an opinion by the 1 st

January, 1995, shall be considered in accordance with

regulation (EEC) No 2309#93,”.

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