The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993
These Regulations prescribe the information, documents, samples and other material to be provided in or with an application, made after the coming into force of the Regulations, for a product licence under Part II of the Medicines Act 1968 (“the Act”) in relation to medicinal products for human use. They replace, in relation to such applications, the requirements of the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971 (S.I. 1971/973) which are amended in consequence.