Our Markets – United Kingdom

Mutual recognition

In Germany, applications for mutual recognition with the UK as reference member state are acceptable, if the application was submitted before Brexit. Thus, a German decision of the mutual recognition (MR) evaluation is also possible after Brexit.

In contrast, Austria, Belgium and the Netherlands do not accept applications for MR any more, as the time from application to expected Brexit is less than 120 days.

Location of authorisation holders

According to the EU Commission and in line with Regulation (EC) No 1107/2009, many EU Member States do not require applicants for authorisations for plant protection products (PPP), authorisation holders of PPPs and holders of a permit for parallel import to be established in the European Union. In Austria, however, the authorisation holder must have a registered office within the EU. Authorisation holders with an office only in the UK will lose their Austrian authorisations after Brexit. For changing the office, an application according to Article 45 of regulation 1107/2009 is necessary.

UK as a Reference Member State

All Member states agree that existing MR-authorisations with the UK as reference member state are not affected by the withdrawal of the UK. Those authorisations remain on the market, since the authorisation by an EU-MS was granted before the UK withdrawal date. As of the withdrawal date, the EU Member States can no longer recognise a MR-authorisation that was issued by the United Kingdom.

On-going evaluations with the UK as zRMS (zonal Rapporteur Member State) or EMS (Evaluating Member State) cannot be finalised under the UK lead. In this case the file would need to be handed over to another Member State taking up the role of the zRMS or EMS.

Efficacy Trials

One important point for all applications is that UK efficacy trials continue to be accepted in the EU, as the EPPO zones are not affected by Brexit.

If there are still PPP applications that have not yet been submitted, or the UK has not yet started the assessment, the applicants are asked to indicate by e-mail to the zonal secretariat which replacement zRMS they prefer. According to the Central Zone steering committee meeting in September 2019, fall-back zRMS are assigned to applications that are under evaluation by zRMS UK in case these applications cannot be finalised before Brexit. The zonal secretariat and the Central Zone Steering Committee appoint a replacement zRMS immediately after Brexit ("fall-back zRMS").

The Netherlands expects that the processing time for applications for plant protection products will increase, as Brexit leads to a greater workload for the Member States. This will be presumably the case in all Member States.

Parallel trade permit

For all PPPs with the UK as the Member State of origin, a parallel trade permit is no longer valid if issued prior to the UK withdrawal. Plant protection products benefiting from such parallel trade permit can therefore no longer be placed on the market in the particular Member State.

Active substance procedures

For the a.s. procedures, the re-allocation of the RMSs (AIR III and AIR IV) is completed. For AIR V, the UK is no longer considered as RMS.
Also for the confirmatory data, a list for the re-allocation of RMSs as a consequence of Brexit was considered and discussed in the Post Approval Issues Working Group (September 2019) and in the SCoPAFF meeting (October 2019).

According to the EU Commission, the new RMS (who takes over files from the UK) is entitled to recover costs of work carried out.