The Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992
These Regulations further amend the Medicines (Applications for Product Licences and Clinical Trial Certificates and Animal Test Certificates) Regulations 1971 and the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 by adding to the requirements as to particulars to be contained in, or to accompany, an application for the grant or renewal of a product licence, so implementing in part Council Directives—89/342/EEC relating to immunological products (OJ No. L142, 25.5.1989, p.14) (Regulations 2(a), 2(b), 3 and 4 which implement articles 1, 2 and 3 of that Directive);89/343/EEC relating to radiopharmaceuticals (OJ No. L142, 25.5.1989, p.16) (Regulations 2(c), 3 and 4 which implement in part articles 1, 2, 3 and 4 of that Directive); and89/381/EEC relating to medicinal products derived from human blood or human plasma (OJ No. L181, 28.6.1989, p.44) (Regulations 2(a), 3 and 4 which implement articles 1 and 2 of that Directive);