Now the UK has left the EU, pre-market approval is required for many regulated products. For now, the UK has decided to continue to follow the EU regulations and the EFSA guidance documents. However, applicants must submit a separate dossier to the UK Food Standards Agency (FSA)
In order to submit a dossier to the UK Food Standards Agency (FSA) the following steps should be followed:
- Applicants must register their intention to submit a dossier via the online application service. After completing the application form the applicant will be issued an application number & a link where the documents that support your dossier can be filed.
- Once you have filed your dossier, it will take the FSA 8 calendar days to perform an administrative check & 30 working days to validate the dossier.
- Once the dossier has passed validation, a scientific risk assessment will be performed by the FSA.
- The timelines for this assessment will depend on the complexity of the product, but it is estimated that this risk assessment will take approximately 1 year.
- Once the risk assessment has been performed, the evidence is presented to ministers who will decide whether the product should be authorized for use in Great Britain.
How to submit application to the UK FSA? – we have all the procedure explained in our video. Pen & Tec´s regulatory experts can help you to obtain authorisation in the UK in a cost effective and time effective way. If you need guidance or have any questions, feel free to contact us and we will be happy to help.