These Regulations make amendments to: the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the Standard Provisions Regulations”), which amongst other matters set the standard conditions for licences to manufacture or distribute by way of wholesale dealing medicinal products in the United Kingdom and which implement in part Titles IV and VII of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use; and the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the Marketing Authorisations Regulations”), which relate to the scheme for authorising the marketing of medicinal products for human use in the United Kingdom and which implement various provisions of Directive 2001/83/EC, as amended.