| Summary: |
These Regulations amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 ("the principal Regulations") which specify the standard provisions of licences issued under the Medicines Act 1968. In particular, Schedule 2 to the principal Regulations specifies the standard provisions of licences granted to manufacturers of medicinal products, including the requirement in Article 46 of Directive 2001/83/EC[5], relating to medicinal products for human use, to comply with "good manufacturing practice". These Regulations substitute a new definition of "good manufacturing practice" and so implement Commission Directive 2003/94/EC, in so far as that Directive relates to the manufacture of medicinal products for human use, other than "investigational medicinal products" (products used in clinical trial).
A full regulatory impact assessment has not been produced for this instrument as it has no impact on the costs of business. A Transposition Note in relation to the implementation of Commission Directive 2003/94/EC has been placed in the libraries of both Houses of Parliament.
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