The FAMHP has thoroughly prepared for Brexit in recent months and is ready to help and support the pharmaceutical industry and the medical devices industry before and after Brexit. The priority remains to prevent products becoming unavailable to patients.
In recent months, the FAMHP has worked hard to be able to address all possible scenarios after Brexit. New or unpredictable difficulties may also arise. Therefore we are staying on top of the situation so that we can act quickly and appropriately if necessary.
Medicines
The FAMHP has mapped out the medicines for which there may be a problem of availability after Brexit. Most of the attention here was paid to medicines for which there is no therapeutic alternative on the Belgian market. A first analysis revealed that only a limited number of products will be affected. For these products, the FAMHP has consulted license holders to see which additional measures are planned. Ultimately, there will be a solution for nearly all medicines.
In consultation with the member states of the European Union (EU), the European Medicines Agency (EMA) has redistributed the licenses for marketing on the European level and for which the United Kingdom (UK) had a role of reporter or co-reporter. To date, Belgium has taken over the role of reporter for eight licenses and the role of co-reporter for nine licenses.
For medicines with national licenses for which the UK was the reference member state in the mutual recognition procedure, the license holders are asked to transfer the role of reference member state to another member state. Together with work groups of the Heads of Medicines Agencies (HMA), the FAMHP has also taken various initiatives (new templates, surveys, software provision, publication of FAQs …) to make this possible.
The following rules apply to all medicines (for human and veterinary use) and regardless of the licensing procedure:
Is the address of the marketing license holder, the manufacturer responsible forbatch release (lot certification), the manufacturer responsible for quality control, responsible for pharmacovigilance (QPPV) or the pharmacovigilance master file (PSMF) in the UK? Then the license holder must transfer it to another member state within the European Union. The license holders know that they must take care of this as quickly as possible. Together with the EMA and the HMA, various FAQs have been set up that make it clear what must be submitted to whom and how that has to happen. For the practical implications of Brexit, we refer you to the website of the EMA for questions and answers for centrally licensed medicines.
The coordination groups for medicines for human and veterinary use respectively (CMDh and CMDv) of the HMA have made a specific Brexit page available.
The transfer of the site for quality control appears to be the most problematic transfer. Therefore, on 25 February 2019, the European Commission provided for a derogation option whereby the quality control after Brexit can be temporarily performed in the UK if a number of strict conditions are met.
Brexit will also require additional inspections within the framework of clinical trials, manufacturing licenses and pharmacovigilance. The FAMHP is doing everything it can to have the necessary personnel available on time to be able to perform these activities in an efficient manner.
Medical Devices
For medical devices (including medical devices for in-vitro diagnostics and active implantable medical devices), the EU will also consider the UK as a “third country” after Brexit.
This means that British companies must mandate an authorized party within the EU27 to sell medical devices on the European market. Third countries using an authorized representative within the UK must designate an authored representative within the EU27. In addition, medical devices that require a CE certificate for sale must have a CE certificate issued by an institution registered in one of the European member states. The four British-registered institutions: BSI (0086), Lloyd’s Register Quality Assurance Ltd (0088), SGS UK (0120) and UL International (0843)) may no longer issue EU certificates for the European market after Brexit. CE certificates issued by these institutions in the past will no longer be valid. The registered institutions and affected manufacturers are working at this time on making their CE certificates compliant. If the UK leaves the EU without a withdrawal agreement, manufacturers who do not receive a (new) certificate from a registered institution from the EU27 will no longer be able to legally sell their products in the EU.
You can find more information about medical devices for manufacturers, distributors and hospitals on the specific web pages.
Brexit Impact Scan for companies
In addition to the specific measures for the pharmaceutical industry and for medical devices, Brexit also has a general impact on companies. The Brexit Impact Scan by the Federal Ministry of Economy will tell you what you need to look for and what you can do to prepare your company for Brexit. Using a number of questions, the scan will determine the general impact of Brexit on your company. The questions are about import, export, intellectual property, use of digital services, transport and suppliers.