Wednesday, November 17, 2004

Release of human and veterinary medicines regulatory information

"With the impending changes to legislation governing the release of information received by the MHRA and the VMD (Veterinary Medicines Directorate) as part of the medicines regulatory process, the regulatory agencies have met with industry representatives (ABPI (Association of the British Pharmaceutical Industry) and NOAH (National Office of Animal Health)) to consider how requests for information should be handled.

These discussions have resulted in a memorandum of understanding and a paper listing the likely decisions should requests for particular information be received.

This paper has become known as the 'Traffic Light Document' because of the coding system used to differentiate different groups of information.

This document is being published on the MHRA, VMD, ABPI and NOAH websites and we would welcome your comments....The purpose of the document is to provide guidance for those involved in making and receiving requests to release information. The changes to legislation mean that the blanket restrictions on the release of information under Section 118 of the Medicines Act and Regulation 14 of the Marketing Authorisation for Veterinary Medicinal Products Regulations 1994 will be removed.

New requests for information will be considered under the Freedom of Information Act 2000, which comes into force on 1 January 2005. For requests for information on veterinary medicines, the Environmental Information Regulations 1992, which are due to be revised early in 2005, are also relevant"

Please send comments to: (for medicinal product interests)

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