Explanatory note

These Regulations further amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the Principal Regulations”). They implement part of paragraph 3 of Article 4 of each of Council Directives 89/342/EEC relating to immunological products (OJ No.L142, 25.5.1989, p.14) and 89/381/EEC relating to medicinal products derived from human blood or human plasma (OJ No.L181, 28.6.1989, p.44). The remaining parts of Article 4 of each of the above Directives have been implemented by regulations 3 and 4 of the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992 (S.I.1992 No.2846) (“the Standard Provisions Amendment Regulations”). Article 1 of each of the above Directives has been implemented by regulations 2 and 3 of the Medicines Act 1968 (Amendment) Regulations 1992 (S.I.1992 No.604), regulations 2(a) and (b) of the Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992 (S.I. 1992 No.755) (the “Applications Amendment Regulations”), and regulations 2(2) and (3) of the Standard Provisions Amendment Regulations.Article 2 of each of the above Directives, and Article 3 of Directive 89/342/EEC, have been implemented by regulations 3 and 4 of the Applications Amendment Regulations.

These Regulations provide that the requirement in the Principal Regulations to submit samples of certain medicinal products to the licensing authority (Schedule 5, Part I, paragraphs 3 to 5 of the Principal Regulations) shall not apply in respect of blood products and certain immunological medicinal products for human use where such samples have previously been examined by the competent authority of another member State and declared to be in accordance with the specifications in a marketing authorisation which complies with EC directives concerning the approximation of provisions relating to medicinal products.