Whether companies are importing medicinal products into the UK from the EU or exporting them from the UK to the EU. knowledge of forthcoming changes is essential as the Brexit transition period comes to an end.
The impact resulting from the Brexit will depend on a number of factors, including the current location of QP batch release, QPPV services and whether products are registered via the European centralized procedure, or through MRP, DCP or national procedures.
Other topics that must be addressed may include the need to ensure that an appropriate legal entity exists in either the UK or an EEA country, ensuring that the Marketing Authorisation Holder (MAH) meets post-Brexit obligations and understands potential impacts on artwork and labeling.
For further insight/information on changing regulations, FAQs and other Brexit related news, visit brexit.freyrsolutions.com.
Brexit-related Regulatory support, including assistance with market entry/access for companies without a currently approved product in the EEA or UK, QP changes, Pharmacovigilance System Master File (PSMF) and EU QPPV requirements, etc.
Pharmacovigilance services (including safety reports)
Strategic Regulatory consulting, including Regulatory affairs & Regulatory intelligence
Registration pathways and license management services
End-to-end operational support for Marketing Authorization Applications(MAA)
Regulatory submission guidance and preparation
Dossier preparation, review and management
Support with CE marking for drug products with companion devices (e.g., injectors for pro-insulin)
Labeling, Patient Information Leaflet (PIL) and summary of product characteristics