Action required before end of January 2021.
Since 1 February 2020, when the United Kingdom withdrew from the European Union (EU), the UK has become a ‘third country’ as far as the EU is concerned. A withdrawal agreement has provided direction for the transition period, ending 31 December 2020 (European Commission, Notice to Stakeholders, 13 March 2020). At the end of the transition period, the EU rules for medicinal products will no longer apply to the UK.
What about the impact on Marketing Authorisations?
The UK leaving the EU has, of course, an impact on Marketing Authorisation Holders (MAHs). One example being that according to Article 2 of Regulation (EC) No 726/2004, the MAH must be established in the EU. Not a major impact on multinational companies, but what about a Small to Medium Enterprise (SME)? At the end of the transition period, an MAH from the UK must have the marketing authorisation transferred to an MAH in the EU with an impact, for example, on labelling and packaging.
What about access to EU databases?
On 16 October 2020 the European Commission published Commission Decision C(2020)7126, granting the United Kingdom (in respect of Northern Ireland) access to databases established under EU law. Besides information about agriculture, energy or tax, the decision also outlines database access for the pharmaceutical sector.
So, what will change?
Under section “Medicinal Product”, the European Commission outlines access to Eudralink (full access), EudraNet (partial access) but also Extended EudraVigilance, Article 57 (XEVMPD) with read only access for medicinal products authorised in Northern Ireland.
Moreover, on 1 December 2020 the EMA posted an updated guidance document EMA/520875/2020 on the impact of Brexit, especially with regards to Article 57 and the steps required by MAHs. MAHs will be able to amend EVMPD data from 15 December 2020 with review and updates of records to be finalised by end of 2020. Even with the extended deadline of 31 January 2021, the time for MAHs to act will be very short.
So what action is required by MAHs?
Maintenance of records for medicinal products outside the EEA in Article 57 database is voluntary. MAHs with medicinal product records currently referencing ‘United Kingdom (GB)’ as the ‘Authorisation Country Code’ should review their product data in the Article 57 database and, for products that will continue to be authorised by the UK with respect to Northern Ireland after 31 December 2020, change the country of authorisation to ‘United Kingdom (Northern Ireland)’ with the assigned country code ‘XI’.
The authorised medicinal product (AMP) records should be updated by submitting an extended EudraVigilance Medicinal Product Report Message (XEVPRM) with operation type ‘Update’ for the relevant EV Codes. It is worth reminding MAHs that it is their responsibility to ensure that their records in the Article 57 database are accurate.
With the UK leaving the EU, many MAHs will be required to update their medicinal product information, whether via XEVPRM messages or Variations. With an impact on product licenses, labelling and packaging, stakeholders are advised to take all necessary steps to account for the UK being outside of the EU regulatory system for medicinal products at the end of the transition period.
If you require further information, please do not hesitate to get in touch.