All survey results will be kept strictly confidential.

PharmaLex is carrying out a survey to identify what activities pharmaceutical organizations have completed in preparation for Brexit given the challenges of a potential ‘no-deal’ and uncertainty around a negotiated outcome. The survey provides an opportunity for industry to have a say on how prepared their organization is with the UK leaving the EU.
SUPPLY CHAIN
With regard to the supply of medicines and medical devices:

Question Title

* 1. Have you mapped your supply chain to determine Brexit exposure, including route to market?

Question Title

* 2. Have you considered implications of the UK land bridge and/or Northern Ireland protocol for supply to and from Ireland, if applicable?

Question Title

* 3. Have you taken the necessary steps to ensure sufficient stock levels and continuity of supply both in the period leading up to 31 December 2020 and post the transition period?

Question Title

* 4. Have you reviewed stocks at wholesale level and ensured arrangements are in place to allow for timely replenishment of such stocks, including custom requirements where applicable and allowing for potential delays during transportation?

CUSTOMS

Question Title

* 5. Have you registered with Revenue for an EORI number?

Question Title

* 6. Do you understand what is needed to fulfil customs declaration requirements?

Question Title

* 7. Have you considered a customs agent/broker or in-house management to complete declarations?

Question Title

* 8. Have you considered what authorisations or simplifications about customs procedures might be relevant?

Question Title

* 9. Have you determined whether you have to comply with UK customs requirements?

Question Title

* 10. Have you identified classification codes for devices/products/ingredients?

Question Title

* 11. For suppliers sourcing devices from the UK, are you prepared for the additional responsibilities you will have as an importer when sourcing products from the UK post-Brexit?

EU MEDICINES REGULATORY COMPLIANCE
To ensure all activities are being undertaken to meet EU regulatory requirements by 31 December 2020:

Question Title

* 12. Have you transferred the UK MAH to one based in the EU/EEA?

Question Title

* 13. Have you relocated the batch release site in the UK to the EU/EEA?

Question Title

* 14. Have you relocated the QC testing sites in the UK to the EU/EEA?

Question Title

* 15. Have you transferred the UK RMS to an EU/EEA based RMS?

Question Title

* 16. Is your nominated QPPV based in an EU/EEA Member State?

Question Title

* 17. For clinical trials, have you transferred any UK based sponsors or legal representatives and the site of batch release to the EU/EEA?

Question Title

* 18. Are you aware that GMP certificates issued by the MHRA and VMD will be considered as part of a risk based approach to confirm the Union GMP compliance in regulatory submissions?

Question Title

* 19. Have you considered regulatory approval timelines to ensure regulatory compliance before the 31 December 2020?

UK MEDICINES REGULATORY COMPLIANCE
UK regulatory requirements have yet to be confirmed and previous guidelines covering the UK position in the event of a no-deal Brexit have been withdrawn, however post 31 December 2020:

Question Title

* 20. Have you considered UK based MAH for UK products currently registered with EU based MAH?

Question Title

* 21. Do you have a temporary UK based contact person ready for EU based MAH?

Question Title

* 22. Is your nominated QPPV based in the UK already or will you need to identify a new QPPV before the end of any arranged interim period?

Question Title

* 23. Are you prepared to submit baseline dossiers for Centralised products subject to ‘grandfathering’?

Question Title

* 24. Have you considered regulatory approval timelines to ensure regulatory compliance during any MHRA issued interim period? (i.e. approvals may take longer due to a high volume of submissions to the MHRA)

MEDICAL DEVICES
To ensure all activities are being undertaken to meet EU regulatory requirements by 31 December 2020:

Question Title

* 25. For devices certified by UK notified bodies – have you confirmed with the manufacturer that they will transfer to an EU-27 notified body by 31 December 2020 and that there is a plan for continued certification of the devices?

Question Title

* 26. For devices manufactured in the UK or with UK Authorised Representative – have you ensured an authorised representative has been designated in an EU-27 Member State?

Question Title

* 27. For clinical investigations – have you transferred any of the UK based sponsors or legal representatives to the EU/EEA?

Question Title

* 28. Would you like to receive our White Paper which will include an analysis of the results of this survey? If so, please provide us with your email address below.

T