Citation, commencement and interpretation

1.-(1) These regulations may be cited as the Medicines (Medicines Act 1968 Amendment) Regulations 1977 and shall come into operation on 15th July 1977.

(2) In these regulations, unless the context otherwise requires, "the Act" means the Medicines Act 1968 and other expressions have the same meanings as in the Act.

(3) The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889 shall apply for the purposes of the interpretation of these regulations as they apply for the purposes of the interpretation of an Act of Parliament.

(4) These regulations shall not apply to Northern Ireland.

Amendment of section 7 of the Act

2.-(1) Section 7 of the Act (product licences) shall be amended in accordance with this regulation.

(2) In subsection (5) for the words "is responsible for the composition of the product" there shall be substituted the words-

"(a)is responsible for the composition of the product, or

(b)in the case of a proprietory medicinal product, is responsible for the placing of that product on the market, in the United Kingdom.".

(3) At the end of the section there shall be inserted the following subsection-

"(7) In this section-

(a)"proprietary medicinal product" means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack,

(b)for the purposes of paragraph (a) "medicinal product" does not include-

(i)vaccines, toxins or serums,

(ii)medicinal products based on human blood or blood constituents or radioactive isotopes,

(iii)homoeopathic medicinal products, or

(iv)veterinary drugs.".

(4) This regulation shall come into force on 1st September 1977.

Amendment of section 8 of the Act

3.-(1) Section 8 of the Act (manufacture and wholesale dealing) shall be amended in accordance with this regulation.

(2) For subsection (3) (wholesale dealer's licence) there shall be substituted the following subsections-

"(3) No person shall, in the course of a business carried on by him-

(a)sell, or offer for sale, any medicinal product by way of wholesale dealing, or

(b)distribute, otherwise than by way of sale, any proprietary medicinal product which has been imported, but was not consigned from a member State,

except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a "wholesale dealer's licence").

(4) In this section-

(a)"proprietary medicinal product" means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack,

(b)for the purposes of paragraph (a) "medicinal product" does not include-

(i)vaccines, toxins or serums,

(ii)medicinal products based on human blood or blood constituents or radioactive isotopes,

(iii)homoeopathic medicinal products, or

(iv)veterinary drugs.".

(3) This regulation shall come into force on 1st September 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) 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(2)-

"(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."

EXPLANATORY NOTE

These Regulations amend the Medicines Act 1968 so as to enable the implementation of certain Community obligations under two Council Directives Nos. 65/65/EEC and 75/319/EEC which relate to proprietary medicinal products.

The amendments relate to-

(a)requirements to hold licences by persons responsible for placing proprietary medicinal products on the market and by distributors of such products imported from outside the European Economic Community (regulations 2 and 3);

(b)the treatment of dossiers forwarded to the licensing authority under Article 9 of Council Directive 75/319/EEC as applications for product licences (regulation 4(2));

(c)refusal, suspension and revocation of licences (regulation 4(3) and (5); and

(d)duration of licences which are not in accordance with Community obligations (regulation 4(4)).