European Commission issued QC Test Exemption for the EU post 29 Mar 2019.
The European Commission (EC) recently issued a letter on 21st February 2019 which outlines their recognition of the reality that some companies are facing in spite of their best efforts in achieving Brexit readiness by 29th March 2019. This letter outlines that the EC have allowed for an exemption period in certain situations where organisations are challenged, to allow Quality Control (QC) testing that is currently performed in the UK to continue to be tested in exceptional circumstances to facilitate the continued supply of medicinal products on the EU markets.
There are key criteria that must be in place and documented in order to avail of this exemption. In their letter the EC specifically state that:
“In applying these provisions, Competent Authorities may allow Marketing Authorisation Holders, for a limited period of time, as a justified case, to rely on quality control testing performed in the United Kingdom (hereafter “the exemption”), under the following conditions:
- A batch release site in the EU27 is identified by the Marketing Authorisation Holder by the withdrawal date.
- The batch release site is supervised by a Qualified Person established in the EU27 by the withdrawal date.
- The establishment designated by the Third Party conducting the quality control testing may be verified by a Competent Authority of the EU27, including on the spot checks.
- All necessary steps have been taken to prepare the transfer of the quality control testing site from the United Kingdom to the EU27. “
If you meet the criteria outlined above the EC have explained how the Marketing Authorisation Holders can apply for this exemption. This letter stipulates that the Marketing Authorisation Holder must “immediately notify the relevant national competent authority that granted the Marketing Authorisation (or EMA in case of Centrally Authorised Products). The notification must be submitted without undue delay but in no case later than on 29 March 2019.
In the notification the Marketing Authorisation Holder must:
- Specify the batch release site in the EU27.
- Confirm that the qualified person established in the EU27 is responsible for the quality control testing site in the United Kingdom.
- Confirm and set out their precise timetable for transfer of the quality control testing site (which should allow the process to be completed quickly and in principle by the end of 2019 at the latest).
- Specify the period of time and batches (packs and quantities) that are requested to be exempted. This should be strictly restricted to what is necessary.
- Commit to providing batch testing results for those batches from the existing facilities within the United Kingdom.
- Transfer samples of those tested batches together with the testing results to the batch release site in the EU27 in due time to make them available for inspection.
The full letter can be viewed using the following link:
If you missed the “Brexit Checklist” that was issued by PharmaLex last week, here is your chance to review it: https://www.pharmalex.com/brexit-checklist/
This is a high-level checklist that will guide you through your own assessment of Brexit readiness. If the answers to the questions posed in Table 1 of this checklist are found in the red boxes, we would suggest that you carefully consider the actions your organisation has taken to be compliant with EU regulations after 29 March 2019.
We, at PharmaLex, can support your organisation in many ways including the provision of regulatory support for MAH’s and the delivery of a collaborative response to any technical queries that you may have in relation to Brexit. Please connect with us to discuss +353 1 846 4742 or email us at email@example.com.