Citation and commencement

1.—(1) This Order may be cited as the Medicines (Exemption from Licences) (Special and Transitional Cases) Amendment Order 1989.

(2) Except as provided in article 4, this Order shall come into force on 1st August 1989.

Amendment of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971

2.—(1) The Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(3)(c) shall be amended in accordance with the following provisions of this article.

(2) In article 2 of that Order (exemption from product licences for certain special manufactured products):—

(a)in paragraph (1) for the words “and manufacture” there shall be substituted the words “, manufacture or assembly”;

(b)in paragraph (2)(ii) the words “or assembles” shall be added after the word “manufactures”;

(c)In paragraph (2)(iii) and (iv) the words “or assembly” shall be added after the word “manufacture”;

(d)in paragraph 2(v)—

(i)the words “or assembled” shall be added after the word “manufactured”; and

(ii)the words “or assembly” shall be added after the word “manufacture”.

(3) Article 3 of that Order (exemption from manufacturer’s licences for products manufactured in certain circumstances) shall be revoked.

Consequential amendments

3.  The Medicines (Chloroform Prohibition) Order 1979(4) shall be amended by omitting—

(a)the final “, or” in article 3(1)(c)(iii);

(b)article 3(1)(c)(iv) (exceptions to Prohibition Order).

Deferred commencement where directions currently in force

4.  For the purposes of any case where a direction issued pursuant to article 3 of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 is in force on 31st July 1989, the revocation made by article 2 and the amendments made by article 3 shall come into force on 1st February 1990.

Explanatory Note

(This note is not part of the Order)

This Order amends the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 (“the 1971 Order”) by—

(a)extending the product licence exemption in article 2 to the holder of a manufacturer’s licence which relates only to the assembly of special manufactured products (article 2(1) and (2)); and

(b)revoking article 3 which exempted manufacturers in certain circumstances from the requirement imposed by section 8(2) of the Medicines Act 1968, to hold a manufacturer’s licence (article 2(1) and (3)).

Article 3 of this Order provides for the consequential deletion of references to article 3 of the 1971 Order in article 3(1)(c)(iv) of the Medicines (Chloroform Prohibition) Order 1979 (prohibition except in prescribed circumstances of the sale or supply of any medicinal product consisting of or containing chloroform, not being a veterinary drug).

Articles 1(2) and 4 of this Order provide, in the case of a direction issued pursuant to article 3 of the 1971 Order which is in force on 31st July 1989, that the revocation made by article 2 and the amendments made by article 3 shall not have effect until the 1st February 1990.

Reference should also be made to the Medicines (Data Sheet and Labelling) Amendment Regulations 1989 (S.I. 1989/1183) for further amendments consequential upon the revocation of article 3 of the 1971 Order.