Consequences for plant protection products
On Januyary 31st 2020 the United Kingdom (UK) left the European Union. What does this mean for applications and authorisations for plant protection products? Various plant protection products derive their authorisations from assessments preformed by another EU member state. What are the consequences if this assessment is (or was) performed by the UK’s Competent Authority (CA)?
Consequences for various authorisations
The EU updates frequently a document on the consequences of Brexit for authorisations of plant protection products. The consequences for the various authorisations are listed below.
Brexit: what happens when the UK was a zonal RMS
For applications where the United Kingdom (UK) was the zonal rapporteur, the directors of the Central Zone Member States agreed that a fall-back zRMS will be designated.
Now the Brexit is a fact, the UK can no longer act as a Zonal Rapporteur Member State (zRMS; also Interzonal Rapporteur Member State is meant). In case of Art. 33 applications, if the core assessment and authorisation are issued in the UK before the date of Brexit, the Commission has ruled that the Concerned Member State (CMS) has up to 120 days after the date of Brexit to decide on the product authorisation on their territory. When the UK did not come to a conclusion/final decision before the Brexit date, there are two options:
- The application was not submitted yet or the UK did not start the assessment: Applicants are asked to indicate by e-mail to the zonal secretariat which zRMS they prefer. The zonal secretariat and the Central Zone Steering Committee (CZSC) will allocate a fall-back zRMS directly after the Brexit.
- The UK has started the assessment already, but did not issue the authorization before the date of Brexit. In that case the CZSC will coordinate that the dossier and evaluations of aspects completely finalized by UK will be handed over to a fall-back zRMS. It will depend on the fall-back zRMS to what degree this evaluation will be reviewed or even adopted for the core assessment. Partly finalized aspects will not be handed over by UK, meaning that these aspects will be completely evaluated by the fall-back zRMS or that the fall-back zRMS could wait until UK has finalized its assessment (which should be checked by the applicant with the fall-back zRMS). In case transfer of documents is needed this happens directly after the Brexit. The fall-back zRMS may individually contact the UK to make practical appointments. The fall-back zRMS is responsible for the decision.
The applicant will need to submit a new application to the fall-back zRMS, and fees will be charged depending on the MS and the status of the dossier.
As the Brexit will result in a higher workload for the Member States it is expected that the timelines for Plant Protection Products applications will be prolonged.
Mutual recognition based on an authorisation in the UK
From January 31st 2020 the EU will no longer recognise decisions previously taken by the UK as a basis for mutual recognition. In view of the period for registering and invoicing such an application (approximately 3 weeks) and an assessment period of 120 days as stipulated by the Regulation, it is no longer possible to submit new applications for mutual recognition. We therefor advise applicants, if possible, to base applications for mutual recognition on authorisation in another EU country.
The Ctgb has 45 working days to complete an application for parallel trade. The parallel trade permit is valid for 10 years. After that, a new permit must be applied for. However, this will no longer be possible on the basis of the UK authorisation.