Public consultation (MLX 350): Amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements

The attached consultation sought views on proposals to amend the Medicines for Human Use (Marketing Authorisations, Etc.) Regulations 1994 in order to ensure UK legislation is fully in line with existing EU law covering the circumstances when marketing authorisation holders should report new information which might influence the evaluation of the benefits and risks for a medicine to the MHRA.

In March 2008, the MHRA announced the outcome of an investigation into GlaxoSmithKline (GSK) and their failure promptly to supply important information relating to the safety of Seroxat in children. At that time, Ministers committed the UK to playing an active part in the review of pharmacovigilance legislation at a European level. In addition, a commitment was made to strengthen UK legislation to make clear the requirements on marketing authorisation holders to supply information impacting on risks and benefits, with a time frame for doing so. The commitment was to change the regulations by the end of 2008 and this consultation sought stakeholder views on the proposed changes.

The deadline for responses was 15 August 2008 and 31 responses were received by the deadline.

Summary of responses
A summary report on the issues raised by consultees in response to this consultation is available to download below.

Government response to consultation
The government response to the consultation is available to download below

Draft Statutory instrument (SI)
The regulations in the draft SI that can be downloaded below would amend the Medicines for Human Use (Marketing Authorisation Etc.) Regulations (the 1994 Regulations) in connection with transposition of Directive 2001/83 of the European Parliament and Council on the Community Code relating to medicinal products for human use. They clarify certain aspects of the information-reporting obligations in Schedule 3 to the 1994 Regulations. Subject to the parliamentary process the SI will come into force by the end of 2008.

The following table indicates how organisations responded to the consultation and these replies are published in full.

Ref	Organisation
1	Mr Matthew Holford (918Kb)
2	Constella on behalf of Geistlich Sons Ltd (27Kb)
3	Orbis Consumer Products Ltd and Kappin Ltd (51Kb)
4	Alliance Pharmaceuticals Ltd (53Kb)
5	Flynn Pharma Ltd (95Kb)
6	NRIM Ltd (51Kb)
7	Chanelle Medical Ltd (51Kb)
8	Asked for name not to be published (359Kb)
9	IBA S.A. (53Kb)
10	Navamedic ASA (51Kb)
11	CHEPHASAAR GmbH (53Kb)
12	Reckitt Benckiser Healthcare (UK) Ltd (51Kb)
13	Faculty of Pharmaceutical medicine (16Kb)
14	Merck Sharp and Dohme (MSD) (286Kb)
15	Castagnola Ltd (59Kb)
16	Eisai Europe Ltd (46Kb)
17	Pharmaceutical Society of Northern Ireland (85Kb)
18	Viridian Pharma Ltd (54Kb)
19	UK Clinical Pharmacy Association (16Kb)
20	Wyeth (15Kb)
21	Novartis Pharma UK (243Kb)
22	Fresenius medical Care Deutschland GmbH (16Kb)
23	Nicobrand Ltd (69Kb)
24	Royal College of General Practitioners (RCGP) (32Kb)
25	British Association of Research Quality Assurance (BARQA) (11Kb)
26	Association of the British Pharmaceutical Industry (ABPI) (24Kb)
27	Braun Melsungen AG (109Kb)
28	Guild of Healthcare Pharmacists (52Kb)
29	Pfizer Drug Safety (114Kb)
30	BioIndustry Association (BIA) (92Kb)
31	Mind (11Kb)