The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1993

Amendment of Schedule 1 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971

2.—(1) Part I of Schedule 1 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971(1) (standard provisions for product licences including product licences of right) shall be amended in accordance with the following paragraphs of this regulation.

(2) After paragraph 1 there shall be inserted the following paragraphs—

“1A. Where the licence relates to a medicinal product for human use, the licence holder shall not recommend the use of the medicinal product to which the licence relates for any indication other than the indications specified in the licence.

1B. Where the licence relates to a medicinal product for human use, the licence holder may sell or supply the medicinal product to which the licence relates only in the same strength and pharmaceutical form, and to the same specification in terms of active constituents and of the finished product, as specified in the licence.

1C. Where the licence relates to a medicinal product for human use, the licence holder may sell or supply the medicinal product to which the licence relates only where that product has been manufactured by the manufacturers specified, at the sites of manufacture specified, and by the method specified, in the licence.”.

(3) At the beginning of paragraphs 2(1) and (2) and 3, there shall be inserted the words “Where the licence relates to a medicinal product which is not for human use,”.

(4) After paragraph 14 there shall be inserted the following paragraphs—

“15. Where the licence relates to a medicinal product for human use, the holder of that licence shall, in relation to that medicinal product, in order that the licensing authority may monitor the continuing assessment of the benefits and risks of that product—

(a) provide the licensing authority forthwith with any new information not in his original application, and

(b) inform the licensing authority forthwith of any change to the information contained in any documents, samples and other material submitted with his application for grant of the licence.

16. In relation to a medicinal product for human use which the licensing authority have specified, on granting the licence, to be one to which Part 4G of the Annex to Council Directive 75/318/EEC(2) as amended applies, and for which the licensing authority have accordingly identified a programme of studies for, and have specified a period for, the purposes of this provision,—

(a) the licence holder shall, within that period, carry out and complete that programme and provide the licensing authority with details of the results of that programme, and

(b) any leaflet, data sheet or other medical information relating to that product shall draw the attention of persons qualified to prescribe or supply that product to the fact that the particulars available concerning the product are as yet inadequate in certain specified respects.”.

(1)

S.I. 1971/972; relevant amending instruments are S.I. 1974/1523, 1977/1039 and 1983/1730.

(2)

OJ No. L147, 9.6.1975, p.1. The Directive has been amended by Council Directive 89/341/EEC (OJ No. L142, 25.5.1989, p.11), and the annex to the Directive has been substituted by Commission Directive 91/507/EEC(OJ No. L270, 26.9.1991, p.32).