On 17 December 2009, the MHRA (Medicines and Healthcare Products Regulatory Agency, London) published a consultation procedure on the measures for strengthening the supply chains for medicinal products and for reducing the risks of counterfeit medicines under the reference MLX 365.
This is the second survey on this topic, with a first consultation (MLX 357) having already been published under the same title around December 2008 and having yielded a great number of responses (among others from the pharm. industry), which can be found here:
The MHRA has taken account of the suggestions that have been submitted after this first request of December 2008 and has now made a number of proposals for the implementation through the MLX 365 release of December 2009. These proposals have now been presented to all interested parties before the final implementation will take place.
The proposals in question give concrete advice on how the supply chain of medicinal products in the United Kingdom (UK) can be strengthened. It is the aim of this public consultation to achieve a clearly better control of the distribution of medicinal products through the lawful supply chain and to offer better protection against the risks presented by counterfeit medicines reaching patients in the UK. Furthermore, where necessary, suitable measures shall be facilitated in order to preserve the public from harm.
The MHRA itself states that the present regulatory situation does no longer fulfil the public's expectations. In some areas of the supply chain, the standards will have to be raised in order to bring all interested parties to the standard of the best.
Key topics of the MLX 365 consultations are considerations and proposals regarding wholesalers (including "Responsible Persons, RPs") and public pharmacies.
But the storage and transport of medicinal products are also addressed (sections 37-40). In point 37 the MHRA sees it as the best approach that persons who source out transport and storage activities shall be required by law to assure themselves that their contract partners are trustworthy. On this point, the MHRA will issue new regulations and a detailed guideline with the MHRA's expectations.
Responses on the MLX 365 consultation can be submitted to the MHRA until 12 March 2010. Most of the proposals are planned to be decided upon by April 2010.
With this consultation procedure, the MHRA also intends to implement the proposals from the MHRA Anti-Counterfeiting Strategy 2007 - 2010.
Two MHRA representatives will also lecture at the University of Würzburg's conference "Strategies against Counterfeit Medicines" on 26-28 April 2010:
1. Nimo Ahmed, Enforcement & Intelligence Group, MHRA, presents the MHRA's current political, strategic and operational measures.
2. Andrew John Charvill, Analytical Assessor, Medicines Testing Scheme, MHRA, shows how his laboratory supports the MHRA's measures in its fight against counterfeit medicines and which new analytical methods are used for this task.
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)