To start the year, MHRA has published a statement on 3rd January in case of a no deal scenario between UK and EU.
For the switch of Centralised registered products in the EU to national MA in UK, the MHRA expects an eCTD baseline to be submitted.
This baseline needs to be submitted before any variation can be processed by MHRA.
If you need any support or have any further question, please contact us at eCTD@asphalion.com
For more information, see below.
For medicines, the key arrangements include:
- automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process known as ‘grandfathering’
- targeted assessment of new applications for products containing new active substances or biosimilars which have been submitted to the EMA and received a Committee for Medicinal Products for Human Use (CHMP) positive opinion
- a full accelerated assessment for new active substances
- free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises (SMEs)
- a period until the end of 2021 to amend packaging and leaflets for a product already on the market
- allowing the parallel import of medicinal products that hold a marketing authorisation from an EU or EEA country
- continuing to recognise prescriptions issued in EU or EEA countries.
A high-level overview of the process for converting CPs to UK MAs is that:
- MAHs will have one year from EU Exit to provide MHRA with baseline data for CAPs that are converted into UK MAs.
- In order to process any variations, MHRA will require the baseline data to have been submitted or,
- MHRA will accept a ‘basic’ baseline data set initially which will enable variations and other post-authorisation submissions to be processed. The full baseline data requirements will still need to be met within one year of EU Exit.
- Further guidance will be published in due course.
For further inquiries on the requirements for conversion email firstname.lastname@example.org