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.
Memorandum of understanding and the 'Traffic Light Document'.pdf
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.
The new legislation provides both a right to request information and a series of exemptions where information may not be released to protect, for example, commercial or personal confidentiality.
Requests for information will undergo a 'public interest' test to consider whether it would be in the public's interest for the information to be released or withheld.
The Traffic Light Document identifies the likely response to a request for a particular type of information.
However, it should not be regarded as definitive as the public interest test will be applied on a case by case basis.
The MHRA, VMD, ABPI and NOAH will review the value of this document in the light of the requests for information received during the first six months of 2005. In the meantime, any comments you may have on the document is welcome, and will inform this review. Please send comments to:
martin.bagwell@mhra.gsi.gov.uk (for medicinal product interests)
http://www.mhra.gov.uk