On 29 March 2017 The United Kingdom notified its intention to withdraw from the European Union. Thus, unless there is a new withdrawal agreement between the UK and the EU, the United Kingdom will become a third country.
In this scenario pharmaceutical companies will have to deal with the legal repercussions of the Brexit when the United Kingdom becomes a third country.
With a “no deal” Brexit, starting from 30 March 2019 the United Kingdom is no longer eligible for the participation in the VHP procedure.
Moreover, according to the recently press release of the Italian Competent Authority (AIFA), pharmaceutical companies are invited to submit the request for substantial amendments by 29 March 2019 regarding the following issues:
- Change of the Legal Representative: according to the European Directive 2001/20/EC, the Sponsor or its Legal Representative has to be established in an EU Member State. Thus, if the legal representative is based in the UK, a new Legal Representative must be communicated to AIFA and to the concerned ethics committee through the OsSC as a substantial amendment by 29 March, 2019. If the Sponsor is not able to fulfil such requests through the new OsSC by 29 March 2019 the notification should be performed via OsSC’s forum.
- Change of the Qualified Person and of the batch release certification site: according to the European Directive 2001/20/EC, the Qualified Person and the site responsible for the batch release must be placed in an EU Member State. The Sponsor, if the site is located in the United Kingdom, has to transfer it in one of the other EU Member States and this change will have to be communicated to AIFA and the Coordinating Ethics Committee by submitting through by 29 March 2019. Also, the transfer or change of the Qualified Person should be communicated. If the Sponsor is not able to fulfil such requests through the OsSC, these changes can be notified to AIFA and the Coordinating Ethics Committee in paper format by 29 March 2019.
- Investigational medicinal product supplying, manufacturing/import authorization: after 30 March 2019 the medicinal products import into the EU will need a manufacturing/import authorization and a declaration of a Qualified Person residing in an EU Member State.
Regulatory Pharma Net team is available to support companies to comply with these requirements and our experts are available to support companies with the submission to AIFA and the concerned Ethics Committee of these substantial amendments.