Medical Device Regulation – Article 117 Action Required
With the on going Brexit negotiations many pharmaceutical companies are bound by regulatory legislation to seek alternative Manufacturing Authorisation Holder (MAH) locations to ensure continuity of product supply within the EU.
The responsibilities of the MAH can be overwhelming and, as an MAH, it is very important to understand that the MAH retains responsibility for all MAH activities even if they have been delegated via a contractual agreement. In this article you will find some points for consideration that relate to the fulfillment of the different legal obligations of the MAH.
As MAH, each of the following points must be given due consideration to assess the robustness of your Brexit readiness strategy:
Control of Clinical Trials / Studies (pre and post marketing)
- Over 1500 clinical trials are currently ongoing that have a UK sponsor and 50% of those will continue past 2019. Current guidance covers acceptance of data generated to 30th March 2019.
The source of comparator for bioequivalence studies must be EU/EEA for clinical trial applications granted after 30th March 2019.
Oversight of Manufacturing from API to QP Disposition to market
- Transfer of batch control and batch release functions must reside within the EU/EEA. It is crucial that manufacturing and importation licence arrangements are assessed timely to ensure timely submission of MAH variations.
- Appropriate QP agreements must be in place when there are multiple QPs in the chain.
- Retesting of commercial product on importation from UK will be required.
- API from the UK will be considered 3rd country importation.
- For medical devices the location of the Authorized Representative must reside within the EU/EEA.
Control of Labeling and Packaging
- Dual labeling of UK/EU packs may no longer exist thus eliminating the cost savings and convenience in utilizing multi-market packaging.
- The local representative named on labeling and Patient Information Leaflets (PILs) must reside within the EU/EEA.
Complaints, Quality Defects and Pharmacovigilance
- The person or entity responsible for product complaints, quality defects and recall must all reside within the EU/EEA.
- Pharmacovigilance and QPPV will also be required to reside within the EU/EEA.
Supply and Distribution
- Wholesale Distribution Authorization (WDA) Holders and Responsible Persons (RPs) will need to be located within the EU/EEA. This may require restructuring of the supply chains to ensure that there are appropriately licensed partners within the EU/EEA.
- Safety features may be placed on product manufactured within the UK but the importer in the EU/EEA is responsible for correct labeling and the EU MAH will be responsible for uploading data to the respective database.
Medical Information, Marketing and Promotion
- Procedures are required to be in place to manage the development, update, approval and distribution of medicinal samples.
- Training for sales reps regarding product information, complaint and adverse reactions and report handling may differ so needs to be taken into account.
EMA has revised their Q & A document relating to the UK withdrawal: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf
PharmaLex are ready to help you prepare. Have you considered all scenarios? Are your contingency plans in place?
Please contact us to discuss.
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