Medicines (Marketing Authorisation) (Amendment) Regulations,

L.N. 231 of 2008

MEDICINES ACT

(CAP. 458)

Medicines (Marketing Authorisation) (Amendment) Regulations,

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

Act, the Minister for Social Policy has made the following regulations>-

The title of these regulations is the Medicines (Marketing Title.

Authorisation) (Amendment) Regulations, 2008 and they shall be read

and construed as one with the Medicines (Marketing Authorisation)

Regulations, 2007 hereinafter referred to as “the principal regulations”. L.N. 324 of 2007.

Regulation 2 of the principal regulations shall be amended as Amends

regulation 2 of

the principal

regulations.

(a)

sub-regulation (1) thereof shall be amended as follows>

(i) immediately after the definition “abuse of medicinal

products” there shall be inserted the following new definition>

“advanced therapy medicinal product” means a

product as defined in Article 2 of Regulation (EC) No

1394#2007 of the European Parliament and of the Council

of 13 November 2007 on advanced therapy medicinal

products<”<

(ii) the definition “provisional

marketing

authorisation” shall be deleted< and

(b) in paragraph (g) of sub-regulation (2) thereof, for the

words “direct personal responsibility.” there shall be substituted

the words “direct personal responsibility<” and immediately

thereafter there shall be added the following new paragraph>

“(h) any advanced therapy medicinal product, as

defined in Regulation (EC) No 1394#2007, which is prepared

on a non-routine basis according to specific quality standards,

and used in Malta in a hospital under the exclusive

professional responsibility of a medical practitioner, in order

to comply with an individual medical prescription for a

custom-made product for an individual patient. The

manufacturing of these products shall be authorised by the

Licensing Authority in Malta.”.

Sub-regulation (1) of regulation 4 of the principal regulations

shall be amended as follows>

(a) in paragraph (a) thereof, immediately after the words

“for paediatric use” there shall be added the words “and Regulation

(EC) No. 1394#2007 of the European Parliament and of the Council

of the 13 th November 2007 on advanced therapy medicinal

products”< and

(b) paragraph (g) thereof shall be deleted and paragraph (h)

shall be renumbered as paragraph (g) thereof.

Paragraph (a) of sub-regulation (1) of regulation 7 of the

principal regulations shall be amended as follows>

(a) in sub-paragraph (i) thereof, for the words from “Article

6 of Directive 2001#83#EC” to the words “in Malta or in the

Community.” there shall be substituted the words”“Regulation 4(1)

for not less than eight years in a Member State or in the Community.

A generic medicinal product authorised pursuant to this provision

shall not be placed on the market until ten years have elapsed from

the initial authorisation of the reference product>”<

(b) immediately after sub-paragraph (i) thereof, there shall

be added the following proviso>

“Provided that the said ten-year period shall be extended

to a maximum of eleven years if, during the first eight years

of those ten years, the marketing authorisation holder obtains

an authorisation for one or more therapeutic indications which,

during the scientific evaluation prior to their authorisation,

are held to bring a significant clinical benefit in comparison

with existing therapies.”< and

(c) in the second proviso to sub-paragraph (ii) thereof, in

the definition “reference medicinal product” for the words “under

regulation 4,” there shall be substituted the words “under regulation

4(1),”.

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