- 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”.
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: