1994 No. 103

MEDICINES

The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994

Made

Laid before Parliament

Coming into force

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred upon them by sections 47(1) and 129(5) of the Medicines Act 19681 or, as the case may be, those conferred by the said provisions and now vested in them2 and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations3, hereby make the following Regulations:

Citation, commencement and interpretation1

1

These Regulations may be cited as the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994, and shall come into force on 14th February 1994.

2

In these Regulations, “the principal Regulations” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 19714.

Amendment of regulation 2 of the principal Regulations2

In regulation 2 of the principal Regulations (interpretation), in paragraph (1)—

a

after the definition of “blood product” there shall be inserted the following definition—

“certificate of registration” means a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

b

in the definition of “product to which Chapters II to V of the 1965 Directive apply”6 for “and Article 1 of Council Directive 89/381/EEC6” there shall be substituted “, Article 1 of Council Directive 89/381/EEC6 and Article 9(1) of Council Directive 92/73/EEC”7.

Amendment of Schedule 2 to the principal Regulations3

1

Schedule 2 to the principal Regulations (standard provisions for manufacturer’s licences and manufacturer’s licences of right) shall be amended in accordance with the following paragraph.

2

In paragraph 16—

a

after paragraph (a) of sub-paragraph (3) there shall be inserted the following paragraph:

aa

where there is in relation to the product which has been manufactured or assembled, a certificate of registration, to ensure that each batch of the product has been manufactured or assembled and checked in compliance with that certificate and the provisions of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19948;

b

in paragraph (b) of sub-paragraph (3), after “(a)” there shall be inserted “or (as the case may be) (aa)”;

c

in sub-paragraph (5) the words “or to medicinal products that are homoeopathic products” shall be omitted.

Amendment of Schedule 3 to the principal Regulations4

1

Schedule 3 to the principal Regulations (standard provisions for wholesale dealer’s licences including wholesale dealer’s licences of right) shall be amended in accordance with the following paragraphs.

2

In paragraph (6), in sub-paragraph (1) after the words “product licence” in both places in which they appear there shall be inserted “or certificate of registration”.

3

In paragraph 8—

a

at the end of paragraph (a) of sub-paragraph (3) there shall be inserted “or”;

b

after paragraph (a) of sub-paragraph (3) there shall be inserted the following paragraph:

aa

where there is in relation to the imported proprietary product, a certificate of registration, to ensure that each batch of product has been tested in accordance with the manufacturing and control file submitted with the application for that certificate;

c

in paragraph (b) of sub-paragraph (3), after “(a)” there shall be inserted “or (as the case may be) (aa)”.

Signed by authority of the Secretary of State for Health

Tom SackvilleParliamentary Under-Secretary of StateDepartment of Health
John RedwoodSecretary of State for Wales
Fraser of CaimyllieMinister of State The Scottish Office

In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 20th December 1993.

Gillian ShephardMinister of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 17th December 1993.

F. A. ElliottPermanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 20th December 1993.

W. J. HodgesPermanent Secretary

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the principal Regulations”) by implementing in part Council Directive 92/73/EEC (OJNo. L297, 13.10.1992, p. 8) (“the Directive”) which widens the scope of Directives 65/65/EEC (OJ No.22, 9.2.1965, p. 369/65) and 75/319/EEC (OJNo. L147, 9.6.1975, p. 13). The latter two Directives relate to the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products; the Directive lays down additional provisions on homoeopathic medicinal products.

Regulation 2 amends the definition of “product to which Chapters II to V of the 1965 Directive apply” and inserts a definition of “certificate of registration”.

Regulation 3 implements Article 3 of the Directive by amending Schedule 2 to the principal Regulations to require the holder of a manufacturer’s licence relating to homoeopathic medicinal products for human use to have a qualified person available to carry out the functions specified in paragraph 16(3) of Schedule 2, including, where appropriate, that of ensuring compliance in specified respects with the certificate of registration and the provisions of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994.

Regulation 4 amends Schedule 3 to the principal Regulations by making similar provision in respect of wholesale dealer’s licences which relate to products imported otherwise than from member States of the European Community and also so as to provide that wholesale dealers may deal only in products which have a certificate of registration, subject to certain exceptions.

Other parts of the Directive are implemented by the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S. I. 1994/105), the Medicines (Labelling and Leaflets) Amendment Regulations 1994 (S. I.1994/104) and the Medicines Act 1968 (Amendment) Regulations 1994 (S. I.1994/101).