The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005
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 certain transitional provisions. They also create offences in relation to the failure by certain persons to comply with obligations of the 2001 Directive or 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 (“Regulation 726/2004”) and make consequential amendments to various enactments following the implementation of the 2004 Directive and the adoption of Regulation 726/2004.