Public Consultation (MLX 374): Transposition of Pharmacovigilance Directive 2010/84/EU

Consultation MLX374 seeks your views on the draft regulations transposing the EU Directive 2010/84/EU on Pharmacovigilance. This Directive must be transposed to UK law by 21 July 2012. This is accompanied by EU Regulation 1235/2010/EU on Pharmacovigilance, to be transposed by 2 July 2012.

The revised legislation has several key aims:

• providing for clear roles and responsibilities for key responsible parties and clear obligations against which they perform their roles
• rationalising EU decision-making on drug safety issues in order to deliver measures that are equally and fully implemented for all relevant products and across the community with a view to preventing unnecessary patient exposure to risks
• strengthening medicines safety transparency and communication to increase the understanding and trust of patients and health professionals in the safety of medicines and improve the penetration of key warnings
• strengthening companies' pharmacovigilance systems, allowing companies to improve their systems constantly while reducing administrative burden
• ensuring the proactive and proportionate collection of high-quality data relevant to the safety of medicines through risk management systems and structured data collection in the form of post authorisation safety studies, together with rationalised single case and periodic reporting of suspected ADRs
• involving stakeholders in pharmacovigilance including through direct patient reporting of suspected ADRs and inclusion of patients and heath-care professionals in decision-making
• simplification of the current community pharmacovigilance procedures with consequent efficiency gains for both the pharmaceutical industry and medicines regulators.

The text that we are consulting upon is a revised Part 11 of the draft consolidated medicines regulations, which are currently also being consulted upon by the MHRA. The parallel consultation (MLX 375) can be found on the MHRA website, and closes on 17 January 2012. In some cases the new Directive and Regulation will affect parts of the consolidation text outside of Part 11 – these are described in the consultation document below, and amendments will be made to align the two texts post-consultation.

The formal consultation on draft Part 11 regulations and proposals for policy changes is attached below. We would encourage responses from all interested parties. The consultation is open for 12 weeks, and comments are invited by 28 February 2012.

Please respond using the response form provided at Annex [F] (46Kb) below.  This can be submitted by post or email using the addresses below.

Email: mlx374@mhra.gsi.gov.uk

Postal address for responses:
Elizabeth Evans
MHRA
Area 5-M
5th Floor
151 Buckingham Palace Road
LONDON
SW1W 9SZ

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