Guidelines

The authorisation and supervision of medicinal products for human use including GMP (Good Manufacturing Practice) guidelines.  

On 22 November 2002, the European Commission,DG Enterprises released updated versions of Chapter 1 "Marketing Authorisation", Chapter 2 "Mutual Recognition" and Chapter 3 "Community Referral" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation following the adoption of the Community Code relating to medicinal products for human use (2001/83/EC of the European Parliament and of the Council) in force since 18 December 2001.