RP/MLG Update

2014 saw a busy schedule of meetings for the BAPW's two regular committees, the Responsible Persons’ (RP) Committee and Members Liaison Group (MLG); the latter even venturing out around the country at Manchester United’s Old Trafford Stadium in March, Bayer’s Newbury offices in May and Lexon’s Leeds Service Centre in September.

Common themes discussed across the two groups included the BAPW’s collaboration on Responsible Person’s Training, which is being developed by Cogent, an independent standards body and the MHRA. The approved syllabus is currently close to being agreed at which point the BAPW will look to run training courses based on this curriculum, building upon its Gold Standard of Good Distribution Practice.

Regulatory topics debated included the Falsified Medicines Directive (FMD) and its implication for the medicines supply chain, particularly once the Delegated Acts are published (now expected Q4 2015) which will give the industry three years to implement the measures. Important issues within FMD remain to be agreed, most notably over the location of the final point of verification, the list of medicines on the white and black lists that determine which products should carry the necessary safety features and confirmation of the 2D matrix.

An additional European Union led topic much discussed at MGL and RP meetings was that of medical devices, in which the EU is seeking to regulate more closely following the PIP breast implant scandal in 2010. Significant concerns remain over the current draft of the legislation which requires wholesalers to open every medical device to verify its functionality. December’s RP meeting heard from Tracy Murray, Head of EU Regulatory Affairs, Compliance and Enforcement at the MHRA who reassured the group that the British Government recognises this intolerable business burden and will work at the EU level to persuade others over the concern.

Other ongoing BAPW work that was deliberated included wholesaler stock communication codes which will see the number of codes dramatically reduced and simplified to make it easier for pharmacists to understand why it is not possible to obtain certain medicines. The BAPW is currently in negotiations with PMR providers to roll out the new codes during 2015. 

More specifically to the RP Committee, its members enjoyed updates from MHRA and Home Office representatives at each meeting on topics such as storage and transportation temperatures, controlled drug transportation and licensing. For the MLG, topics of concern included generic medicine supply, best practice for managing shortages and early in 2014, the relative merits of the new PPRS agreement.

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