# The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992, 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”). They implement in part Commission Directive 91/356/EEC (OJ No. L193, 17.7.91, p.30) (“the Directive”) which lays down the requirements of good manufacturing practice to be adopted by manufacturers of medicinal products for human use within the European Community and by importers of medicinal products for human use into the Community. Good manufacturing practice is defined in regulation 2(4) (articles 2 and 4 of the Directive) and manufacturers are required to comply with its principles and guidelines (regulation 5(2)).
In particular these Regulations require the holder of a manufacturer’s licence to—
establish and implement an effective pharmaceutical quality assurance system (regulation 5(3), article 6 of the Directive);
provide and maintain an independent quality control department under the authority of the person nominated as being responsible for overall quality control (regulation 5(5), article 11(1) of the Directive);
make arrangements with a person approved by the licensing authority in respect of the carrying out of tests if the licence holder does not provide and maintain his own staff, premises and plant (regulation 5(5), article 11(2) of the Directive);
retain records and samples of starting materials and finished products for the periods defined in the Regulations (regulation 5(6) and (7), article 11(4) of the Directive); and
maintain an effective system whereby complaints are reviewed and products may be recalled (regulation 5(9), article 13 of the Directive).
Similar obligations are imposed on the holder of a wholesale dealer’s licence who is authorised to import medicinal products from outside the European Community into the United Kingdom (regulation 6(2), articles 4 and 13 of the Directive) insofar as the requirements of good manufacturing practice can be applied to him.
These Regulations also amend the Principal Regulations by imposing additional requirements to be incorporated into standard provisions for product licences and manufacturer’s licences relating to certain immunological products, radiopharmaceuti cals and products derived from human blood or human plasma, in each case being a product for human use. The Regulations implement in part Council Directives—
89/342/EEC relating to immunological products (OJ No. L142, 25.5.1989, p.14) (regulations 2(2), 3, 4, 5(10) and 7 which implement articles 1 and 4 of that Directive);
89/343/EEC relating to radiopharmaceuticals (OJ No. L142 25.5.1989, p.16) (regulation 5(10) which implements part of article 1 of that Directive); and
89/381/EEC relating to medicinal products derived from human blood or human plasma (OJ No. L181, 28.6.1989, p.44) (regulations 2(3), 3, 4 and 5(10) which implement articles 1 and 4 of that Directive).
These Directives each extend the scope of Council Directives 65/65/EEC (OJ No. 22, 9.2.1965, p.369/65) and 75/319/EEC (OJ No. L147, 9.6.1975, p.13) on the approxima tion of provisions relating to medicinal products.

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Source: https://www.legislation.gov.uk/uksi/1992/2846/note (the official version)
Page: https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1992/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.