The Medicines (Medicines Act 1968 Amendment) Regulations 1977

Amendments of other provisions of Part II of the Act

4.—(1) In Part II of the Act (licences and certificates relating to medicinal products) there shall be made the further amendments provided for by paragraphs (2) to (5) below.

(2) After section 18(2) (applications for licences) there shall be inserted the following subsection—

“(3) Where documents that constitute a dossier for the purposes of Article 9 of Second Council Directive 75/319/EEC of 20 May 1975 are forwarded to the licensing authority under and in accordance with the said Article, such forwarding shall be deemed to be an application for the grant of a product licence under this Part of this Act.”.

OJ No L147,9.6.1975, p. 13.”.OJ No L147,9.6.1975, p. 13.

(3) In section 20(1)(b) (grant or refusal of licences) after the word “Act” there shall be inserted the words “and any Community obligation”.

(4) After subsection (1) of section 24 (duration of licences) there shall be inserted as subsection (1A)—

“(1A) Where any licence has been granted under this Part of this Act and the licensing authority subsequently consider that it would no longer be possible to grant that licence without contravening a Community obligation, the licence shall (notwithstanding subsection (1) above) expire on such date as may be specified in a notice served on the holder of the licence by the licensing authority.”,

and in subsection (2) of that section for the words “such licence” there shall be substituted the words “licence granted under this Part of this Act”.

(5) At the end of section 28(3) (suspension, revocation and variation of product licences) there shall be inserted after paragraph (i) (as added(1)—

“(j) that, in relation to medicinal products of any description to which the licence relates any of the provisions contained in regulations which—

(i) are made under section 85 of this Act (labelling and marking of containers and packages), and

(ii) impose requirements which give effect to Community obligations,

has to a material extent been contravened by the holder of the licence or by a person procured by him to manufacture or assemble such medicinal products.”

(1)

Paragraph (i) was added by the Medicines (Medicines Act 1968 Amendment) Regulations 1975 S.I. 1975/1169 (1975 II, p. 4033).