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The UK's Medicines and Healthcare Regulatory Agency (MHRA) has published the outcome of a consultation on measures to strengthen the country's drug supply chain.
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has published the outcome of a consultation on measures to strengthen the country's drug supply chain. The three-month consultation also sought opinions on the EC's proposals to amend Directive 2001/83/EC to reduce the risk of counterfeit drugs entering the supply chain.
There was broad support among respondents for measures intended to increase confidence in a Wholesale Dealer's license, as well as provisions aimed at raising the professional status of the Responsible Person by introducing a Code of Practice against which the Responsible Person can be judged. A number of comments were also received by the agency regarding provisions aimed at pharmacies.
Regarding the storage and transit of drugs, there was support for better controls over transit arrangements and audit trails; however, concerns were raised about how this could be applied to the wide range of transport suppliers currently used, and whether the introduction of proposals for licensing, auditing, and inspection would cause some suppliers to refuse to transport medicines. In reply, the MHRA said that it would consult logistic provider organizations when taking any proposals forward.
The consultation also discussed proposals regarding criminal sanctions for offenses associated with the counterfeiting of medicines. Respondents believe that current penalties are limited in scope and do not provide any deterrent, and that there is a need to introduce a specific counterfeiting offense. This is something the MHRA has said that it will explore further.
The full outcome of the consultation can be read at MHRA's website.
Stephanie Sutton is an assistant editor at Pharmaceutical Technology Europe.