Authorisations from the European Medicines Agency
Authorisations from the European Medicines Agency will be converted into equivalent UK authorisations on 1 January 2021. Guidance on the conversion process is available from MHRA.
If you rely on an authorisation from the European Medicines
Agency as the basis for the SPC, you may be asked to provide information on the converted UK authorisation after 1 January 2021, so that this can be recorded on the register. This will not affect the validity of your SPC.
New applications for a paediatric extension
Current EU law provides for a 6-month extension to SPCs which protect medicines that have been tested for paediatric use.
From 1 January 2021, the availability of this extension will be determined based on equivalent provisions in the UK’s Human Medicines Regulations 2012.
The process of applying for an extension will remain the same. You will still be able to make the request at the same time as filing the SPC application, or at any point up to 2 years before the SPC expires.
You will need to meet the same requirements to be given the extension. The only exception is that you will no longer need to provide evidence of authorisations covering the product across the EEA…