The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

Explanatory Note

(This note is not part of the Regulations)

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”), make changes to certain existing provisions which implement Directive 2001/83/EC and make consequential amendments to various enactments.

These Regulations implement the requirements of the 2004 Directive insofar as they relate to the manufacture, assembly, importation and wholesale distribution of medicinal products to which those Directives apply (“relevant medicinal products”), and, as respects relevant medicinal products, replace the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, which implemented the requirements of the 2001 Directive as respects those matters.

Regulation 1 concerns citation, commencement and interpretation.

Regulation 2 imposes certain requirements on the holder of a manufacturer's licence granted pursuant to section 20 of the Medicines Act 1968 (“the Act”) in connection with the manufacture and assembly of relevant medicinal products.

Regulation 3 imposes certain requirements on the holder of such a licence in connection with the import of relevant medicinal products from outside the European Economic Area.

Regulation 4 makes provision as to qualified persons who are responsible under the terms of the Directives for carrying out certain functions in relation to the manufacture, assembly and import from outside the European Economic Area of relevant medicinal products.

Regulation 5 provides that it is an offence to supply starting materials for use in the manufacture of a relevant medicinal product (other that a relevant medicinal product to which section 1 of the Medicines for Human Use (Marketing Authorisations Etc. Regulations 1994 applies) where the starting materials have not been manufactured in accordance with the principles of good manufacturing practice.

Regulation 6 and Schedules 1 and 2 set out certain additional obligations which the licensing authority may impose on manufacturer's licence holders as “standard provisions” of their licences. Section 47 of the Act provides, save where the exceptions set out in that section of the Act apply, that “standard provisions” shall have effect as provisions of the licences granted pursuant to section 20 of the Act.

Regulation 7 and Schedule 3 provide that the licensing authority may impose additional standard provisions on the holders of manufacturer's licences which relate to vaccines, toxins and sera.

Regulations 8 – 10 impose certain requirements on the holder of a wholesale dealer's licence granted pursuant to section 20 of the Act.

Regulation 11 and Schedule 4 set out certain further obligations which the licensing authority may impose on wholesale dealer's licence holders as “standard provisions” of their licences.

Regulation 12 provides that certain parts of these Regulations shall have effect as though they were made in exercise of the new regulation making powers which are inserted into section 8 of the Act by regulation 14 and Schedule 5.

Regulations 13 and 14 and Schedule 5 make provision for revocations, and for consequential amendments to the Act and other enactments.

Regulation 15 and Schedule 6 make certain transitional provisions.

Regulatory Impact Assessments in relation to these Regulations, and a Transposition Note in relation to the implementation of the 2004 Directive, have been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.