The consequences of the Brexit are in many cases quite different in the EU countries. We are compiling some examples of such harmonised and non-harmonised consequences.
Diverse Mutual recognition situation
In Germany, applications for mutual recognition with UK as reference member state are acceptable, if the application is submitted before Brexit. Thus, a German decision of the mutual recognition (MR) evaluation is also possible after the 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 accordance with Regulation (EC) No 1107/2009, it is not required that applicants for authorisations for plant protection products, authorisation holders of PPPs and holders of a permit for parallel import must be established in the European Union. This is agreed by many Member States.
However, in Austria, 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 the Brexit. For changing the office, an application according to Article 45 of regulation 1107/2009 is necessary.
Various issues accepted by all Member states
All Member states agree that existing MR-authorisations with UK as reference member state are not affected by the withdrawal of the UK. Those authorisations remain on the market as the authorisation by an EU-MS has been granted before the withdrawal date of the UK. As of the withdrawal date, the EU Member States can no longer recognise a MR-authorisation which 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.
One important point for all applications is that UK efficacy trials will 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 the 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. Presumable this will be the case in all Member States.
As of the withdrawal date, a parallel trade permit for a PPP of which the United Kingdom was the Member State of origin issued by an EU-27 Member State prior to the withdrawal date is no longer valid. Plant protection products benefiting from such parallel trade permit can therefore no longer be placed on the market in the particular Member State.
For the a.s. procedures, the re-allocation of the RMSs (AIR III and AIR IV) is completed. For AIR V, 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 (in September 2019) and in the SCoPAFF meeting (in 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.