Between 18 October 2012 and 19 November 2012 the MHRA ran a public consultation on the transposition of the Falsified Medicines Directive 2011/62/EU into UK legislation. You can read the original consultation and a summary of the responses below.
European Directive 2011/62/EU of the European Parliament and of the Council ("the Falsified Medicines Directive") amends Directive 2001/83/EC on the Community code relating to medicinal products for human use to introduce measures to prevent the entry of falsified medicines into the legal supply chain. The UK Government is required to implement these changes in law by 2 January 2013.
The Falsified Medicines Directive:
- Introduces the concept brokering for finished medicinal products and provides a new definition for brokering medicinal products.
- Introduces a requirement that brokers have to register with the Competent Authority of the EEA Member State in which they are established.
- Extends the requirement for a wholesale dealer's licence for export of medicines to third countries.
- Extends existing obligations for wholesale dealers and provides new obligations, in particular reporting any suspected falsified medicines.
- Formalises current regulatory expectations for the manufacturer of the medicinal product to have audited their suppliers of active substances for compliance with the relevant Good Manufacturing Practice (“GMP”), and provides a solid legal basis in the Directive for the written confirmation of audit (the “QP Declaration”).
- Introduces a formal requirement for manufacturers of medicinal products (or a third party acting under contract) to audit their suppliers of active substances for compliance with the requirements of Good Distribution Practice (“GDP”) particular to active substances.
- Formalises the regulatory expectation that manufacturers of the medicinal product will verify the authenticity and quality of the active substances and excipients they use.
- Introduces a new obligation on product manufacturers to inform the Competent Authority and Marketing Authorisation Holder should the manufacturer obtain information that products (manufactured under the scope of the manufacturing authorisation) may be falsified, whether those products are being distributed through the legitimate supply chain, or by illegal means.
- Makes a number of significant changes to the controls on active substances and excipients intended for use in the manufacture of a medicinal product for human use, and in particular introduces two new definitions for Active substances and Excipients.
- Introduces a new requirement for manufacturers, importers and distributors of active substances to be registered with the Competent Authority of the Member State in which they are established.
- Introduces a new requirement for companies selling medicines at a distance to members of the public to be registered and a requirement for a common internet logo on their website.
The Falsified Medicines Directive substantially changes the European framework concerned with the supply of medicines, and may capture businesses that have traditionally not been directly regulated.
An example of this would be internet platforms based in the UK offering medicines for wholesale or retail supply, which may be considered to be brokering or offering “sales-at-a-distance”. We recommend that such businesses consider their activities and seek specific advice from the MHRA.
We are keen to hear the views of interested parties. The purpose of this consultation therefore is to:
- Present draft transposition regulations and explain our approach in determining them;
- Test that the transposition regulations are full, accurate and workable legislative text;
- Ensure that the draft transposition regulations do not introduce any unintended changes;
- Seek further evidence of the impact of the transposition regulations and proposed policy changes.
In addition to the consultation document, you will find a summary response sheet and a confidentiality request form.
Responses to the consultation will be published on the MHRA’s website (unless individual respondents ask us not to publish their response).
For fees relating to the registration of brokers of medicinal products and manufacturers, importers and distributors of active substances see Public consultation (MLX 377): Fees legislation for 2013.
- Public consultation (MLX 379): Summary of responses (321Kb)
- Public consultation (MLX 379): Transposition of Directive 2011/62/EU (“the Falsified Medicines Directive”) into UK legislation (188Kb)
- Public consultation (MLX 379): Impact Assessment (3053Kb)
- Public consultation (MLX 379): The Human Medicines (Amendment) Regulations 2012 (2453Kb)
- Public consultation (MLX 379): Transposition table (1792Kb)
- Public consultation (MLX 379): Confidentiality template(29Kb)
- Public consultation (MLX 379): Consultation response sheet(119Kb)