The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005
These Regulations further amend the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the principal Regulations”). The principal Regulations implement certain provisions of Directive 2001/83/EC of the European Parliament and of the Council on the community code for medicinal products for human use (“the 2001 Directive”). In particular, the principal Regulations implement the provisions of the 2001 Directive which relate to marketing authorisations. Schedule 1 of the principal Regulations, which this instrument amends, exercises the derogation in article 5 of the 2001 Directive.