EU and MHRA anti-counterfeiting proposals published
Two important documents outlining regulatory proposals to combat counterfeiting of medicines were published towards the end of last year.
Two important documents outlining regulatory proposals to combat counterfeiting of medicines were published towards the end of last year.
The first, published by the European Commission, is part of a three-part package of proposed changes to Directive 2001/83 - the other parts refer to pharmacovigilance and patient information. It sets out details of proposals for features to be part of the packaging of prescription medicines to counteract counterfeiting, such as the inclusion of tamper-evident features and inclusion of pack-specific identification codes.
It also proposes measures for the stricter control of the distribution of medicinal products and for the manufacture and distribution of active pharmaceutical ingredients. The proposals will now be subject to the co-decision procedure of the European Union.
The second document referred to has been published by the Medicines and Healthcare products Regulatory Agency (MHRA) and makes proposals for strengthening the UK supply chain by introducing stricter requirements to be met by applicants for wholesale dealers" licences and those nominated as responsible persons on such licences. The document also proposes controls on inter-pharmacy dealing on medicinal products. Comments are invited by MHRA by 13 March.
The willingness of both Agencies to tackle this increasingly worrying problem is to be welcomed and industry will be studying both sets of proposals closely and commenting on them. No doubt the proposals will also stimulate much wider general debate in this area. This column will follow this process as it unfolds during the coming year.