What will happen when Brexit transition period is over

As known, the transition period established following the exit of United Kingdom from the European Union will end next 1st January, and the British Regulatory Agency MHRA is getting ready to take the handling of medicinal product procedures directly in their own hands.

To this purpose, the Agency released a series of guidances in early September clarifying how medicines shall be registered when any bond with the EU is finally cut; a no-deal scenario with the European Union is at the base of the new provisions.

The MHRA guidances address several issues certainly arising when the European authorities and directives are a reference no more. The focus is on preventing a shortage of medicines in the British market, a shortage that could loom should companies arrive unprepared to the fatal moment of the final exit from the EU, especially in the critical situation generated by the continuous need to handle the COVID-19 pandemic. In order to avoid such eventuality, the Agency worked intensively to face and solve any possible scenario, under the alert scrutiny of the ABPI, the Association of British Pharmaceutical Industry.

So, what will happen after 1st January 2021?

To start with, all authorisations obtained via a European centralised procedure will automatically be converted into national procedures, making the MHRA the only authority responsible on the subject of medicines. Marketing authorisation holders, however, will be able to decide whether to give up such conversion, notifying their decision to the Authority within 21 January 2021. If they should decide to proceed, they will be bound to submit to MHRA the essential baseline data of the centralised authorisations to be converted in e-CTD format within one year.

Further guidelines will also explain how to renew marketing authorisation at the end of the transition period. In particular, MHRA specified that the renewal date of the converted authorisation will remain unchanged, and that the renewal shall be submitted in the 9 months preceding the expiry.

On the other hand, for centralised authorisations still pending on 1st January 2021, the British Agency has proposed two possible paths: either submit an “in-flight” assessment application, in parallel with the European procedure, or wait that the product is approved by EMA; then following the conversion procedure. On this regard, a table is available showing the possible solution based on the status of assessment of the application on the moment of the exit from the EU.

The guidances also address the issues regarding the authorisations under Article 29 (i.e. in case of no agreement between the Member States on decentralised and mutual recognition procedures); a national scheme to handle conditional authorisations is also expected, very similar to the one in force in the EU.

Advanced therapies and biosimilars will also be handled in the same way, but for the latter MHRA informed that – at the end of the transition period – the submission of registration application will only be possible for drugs whose reference product has been authorised for at least 8 years.

Finally, separate guidelines regulate PMFs and their relevant inspection (to be recognised until further notice), bioequivalence and therapeutic equivalence studies, parallel importation authorisations, certificates of suitability and ASMFs.

Only the procedures regarding medicinal products intended for the market of Northern Ireland will remain out of MHRA jurisdiction and be regulated separately, in virtue of the exception made in order to save the direct border with Europe.

However, it was in today’s news that Boris Johnson is on the verge of going back on the agreement, and intends to delete the provisions on the customs, reinstating the checks at the Irish borders. For the British Prime Minister, the agreement on the borders would be only an emergency plan in case of failure of the trade talks with EU. The situation of the pharmaceutical industry in relation to Brexit is therefore still open to new developments, and the sector is anxiously waiting to learn the actual consequences of the exit of the United Kingdom from the EU.

Written by: Maria Pia Felici

Foto di Pete Linforth da Pixabay