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PHSS Impact Statement - FMD

09 July 2018   (0 Comments)
Posted by: Tamsin Marshall
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Impact Statement - Falsified Medicines Directive July 2018

As we should all know the implementation of the falsified medicines directive 2011/62/EU (FMD) is fast approaching and comes into force in February 2019. All certified prescription medicines placed on the market in EU /EEA on or after the implementation date will be required to bear two safety features. These two features consist of the unique identifier (UI) in the form of a 2D data matrix and an anti-tamper device (ATD).

The impact and changes required have been covered in several papers, journals and presentations. There are some exemptions for certain medicinal products and these are described in the Commission Delegated Regulation (EU) 2016/161 – Annex 1 and will not form part of this discussion.

Hopefully most ‘actors’ in this scenario will already have considered the impact to their commercial supplies and have well developed plans in place to meet the requirements, or at least will have pondered over the challenges ahead. It may not be quite so apparent however that there is a wider consideration for their current and future clinical trial supplies – why? Clinical Trial Materials are exempt, aren’t they?

This is true, except the Directive states that the FMD verification process must have been completed at the point the medicine is released to the patient or their representative. Wholesalers will be authorised to decommission products for a range of healthcare professionals, public service bodies and other organisations that use or supply medicines as an occasional part of their work [Article 23], with exemption for community and hospital pharmacies. Under article 23 comparators and any non-investigational medicinal products (NIMPs), which may be part of the clinical trial design, and where safety features apply, will require decommissioning under the requirements of FMD. Where wholesale supply is relatively simple, then this challenge may be relatively straight forward to manage, however, where comparator supplies of NIMPs are being sourced from several locations e.g. retail and / or hospital pharmacies these supply chains and decommissioning options may become a significant problem.

Quality Agreements will need to define the responsibility for this decommissioning activity under Article 23. Such decommissioning activity will require careful scheduling, planning, line clearance segregation etc. and will undoubtedly incur additional cost.

The clinical trial design will need to ensure that the sourcing, selection and control of the drug products has adequately reviewed the decommissioning requirements and these responsibilities are included in a Quality Agreement. Crucially, the impact of this additional accountability and responsibility needs to be understood and communicated by all parties involved to ensure completion of the legal duties and responsibilities of the Qualified Person are not inhibited at the point of final disposition. 

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