New HMA/EMA draft guidance document open for public consultation
8/25/2011 2:04:00 PM
The Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) have been working together with a view towards achieving greater transparency of their operations and better addressing the increasing requests for information they hold from members of the civil society.
This draft guidance document entitled "Heads of Medicines Agencies/European Medicines Agency guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing-authorisation dossier - release of information after granting of a marketing authorisation" is presented as a consensus document agreed by the entire Network of Competent Authorities, laying down practical orientations for national and European authorities in regard to requests for access to information contained in marketing authorisation (MA) dossiers. Notwithstanding this guidance document, it should be noted that National Competent Authorities and EMA ultimately are required to follow national or European legislation in terms of access to documents.
HMA have agreed in their meeting in Visegrad 28 April 2011 to start a public consultation on this document to hear the view of concerned stakeholders (including industry, healthcare professionals and patient organisations) before a final version of the guidance document will be agreed upon.
The document is available for consultation on the following webpage:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/06/WC500106995.pdf
Comments related to this document should be sent before 1st September 2011 to the following mailbox:
HMA-EMATransparencyConsultation@ema.europa.eu
With Kind Regards,
Alessandro Camera | Medical Information Sector European Medicines Agency | 7 Westferry Circus | Canary Wharf | London E14 4HB | United Kingdom Tel. +44 (0)20 7418 8724 | Fax +44 (0)20 7523 7129 | alessandro.camera@ema.europa.eu |
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