Centralised Procedure Medicinal Products: Brexit Update
How will the UK’s departure from the EU impact on medicinal products for human and veterinary health? We have written an overview that, we hope, will serve as a handy guide. The Q & A document “Questions and Answers to United Kingdom’s withdrawal from European Union with regard to Medicinal Products for Human and Veterinary use within the framework of the Centralised Procedure” was updated to Rev 03 which was published on the 19.06.2018. The following points were added to Rev. 03:
- For human medicinal products placed on the market after the 30.03.2019, the Official Control Authority Batch Release will have to be carried out by an Official Medicines Control Laboratory located in the EEA for official batch release or by an officially recognised partner for official batch release. The EDQM can provide a list of Official Medicines Control Laboratories on request at email@example.com that may be in a position to provide official batch release certificates for different products.
- For veterinary medicinal products, the MAH will need to identify a Competent Authority located in the EEA region to carry out the Official Batch Protocol Review and Evaluation or alternatively to appoint an officially recognised partner to carry out the Review and Evaluation.
- It is expected that findings of inspections to determine GMP compliance, Good Clinical Practice compliance and Pharmacovigilance compliance conducted by the UK Competent Authority before the 30.03.2019 will be implemented by the companies inspected.
- From the 30.09.2019, UK Notified Bodies will lose their status as an EU Notified Body. As a consequence of this, the Notified Bodies in the UK will no longer be able to be an applicant in an initial consultation procedure with the EMA and the EMA will no longer be able to issue a scientific opinion to them as notified bodies of a third country.
- MAH’s currently using multi-country packs that include the UK may find they need to adapt their packaging. The important consideration in this case is to ensure the product labelling and Patient Information leaflet are fully in line with the Summary of Product Characteristics authorised in the EU.
- Where a MAH relies on the service of a deputy QPPV as part of its back-up arrangements in the absence of the QPPV, the arrangements should ensure that the deputy QPPV is established and performs his/her tasks in the EEA.
- Information on how the UK’s withdrawal from the Union affects CE Certification of medical devices by UK’s Notified Bodies can be found in the “Commission notice on the withdrawal of the UK and EU rules in the field of industrial products”.
Reference: Questions and Answers to United Kingdom’s withdrawal from European Union with regard to Medicinal Products for Human and Veterinary use within the framework of the Centralised Procedure Rev 03 published 19.06.2018.
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Further Brexit Reading from Acorn Regulatory
The results of the European Parliamentary elections in the UK point to a divided country. However, the recently formed Brexit Party has secured a significant vote at the Conservative Party’s expense. Now, as the Conservative Party seeks to regroup and select a new leader, the likelihood of a ‘no deal’ exit has further increased. The seventh Acorn Regulatory Brexit whitepaper looks at the impact of a no-deal Brexit departure from the EU on a number of sectors.
Brexit will impact on many aspects of the life sciences sector. One of the areas that will be most impacted will be the role of the Qualified Person for Pharmacovigilance (the QPPV). In this article, we consider the impact that the UK’s exit from the EU will have on the role and the measures that companies will need to take once Brexit happens.
The ongoing coverage of the UK’s moves towards leaving the European Union continues. This is a difficult time for companies in the life science sector in the UK and outside of the UK as they work to ensure that patients will be able to access medicinal products and devices when the UK finally departs, as is expected on October 31st. the likelihood of departing in a no deal Brexit scenario has now exacerbated and companies are best served by preparing for such an outcome.
Brexit has been an ever-present issue for professionals in the life sciences sector since 2016. We have worked with many companies in preparing them for the changes that will come from the UK leaving the EU. Here, we have created a ‘long read’ blog looking at Brexit regulatory issues and what you need to know to ensure that you are prepared for the changes that it will bring about.