http://www.legislation.gov.uk/uksi/2004/3224/regulation/4/made

The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

European Parliament

King's Printer of Acts of Parliament

2017-06-19

MEDICINES

These Regulations implement certain provisions of Directive 2004/27/EC of the European Parliament and of the Council (“the 2004 Directive”) amending Directive 2001/83/EC on the Community code for medicinal products for human use (“the 2001 Directive”), and make consequential amendments to various enactments following the adoption of Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.