# The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1993, Note: Explanatory note


(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 imposing additional requirements to be incorporated into standard provisions for product licences relating to medicinal products.
Regulation 2(2) inserts paragraphs 1A, 1B and 1C into Part I of Schedule 1 to the principal Regulations (standard provisions for product licences including product licences of right). These provide that a medicinal product for human use shall only be recommended for use for specified indications, that it shall be in the same pharmaceutical strength and form and of the same specification specified in the licence and that it shall be manufactured by the manufacturers and at the sites and by the methods specified in the licence.
Regulation 2(3) amends paragraphs 2 and 3 of Part I of Schedule 1 to the principal Regulations so that those paragraphs apply only to medicinal products which are not for human use. In relation to medicinal products for human use, the similar provisions of new paragraph 15 apply (inserted by regulation 2(4)). This paragraph implements part of the third indent in the Introduction to the Annex to Council Directive 75/318/EEC (OJNo. L147, 9.6.1975, p.1) (“the Directive”), as substituted by Commission Directive 91/507/EEC (OJ No. L270, 26.9.1991, p.32), requiring the licence holder to provide the licensing authority with details of any changes to the information in the documentation accompanying his application for the grant of a licence, together with any new information.
Regulation 2(4) also inserts paragraph 16 into Part I of Schedule 1 to the principal Regulations, to implement paragraphs (a) and (c) of Part 4G of the new Annex to the Directive. This paragraph imposes special requirements for medicinal products for human use in respect of which comprehensive information could not have been provided on the application for the grant of the licence because, for example, the indications for the product are encountered so rarely that comprehensive information cannot be obtained.
The Medicines (Applications for Grant of Product Licences–Products for Human Use) Regulations 1993 (S.I. 1993/2538) also implement requirements of the new Annex to the Directive as well as those of other Directives.

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Source: https://www.legislation.gov.uk/uksi/1993/2539/note (the official version)
Page: https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-no-2-regulations-1993/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.