The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992
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)).