Here, we summarize the consequences of the Brexit – the United Kingdom’s (UK) exit of the European Union – for parallel import permits, for applications for plant protection products with the UK as Zonal Rapporteur Member State and for applications for mutual recognition.
Parallel import permits
As the UK will no longer be a Member State, parallel import permits for products of UK origin will no longer be valid. Import of the concerned products will hence no longer be allowed once the Brexit is official. For the sake of clarity, the permits will be withdrawn, with a period of grace of 6 months for sale of stocks present on the Belgian market and an extra 12 months for use of stocks.
Applications for authorisation of plant protection products with the UK as Zonal Rapporteur Member State
Until Brexit, the UK can act as (inter-)Zonal Rapporteur Member State (zRMS). In case of Art. 33 applications, if the core assessment and authorisation are issued in the UK before the date of Brexit, the Concerned Member State (cMS) has up to 120 days after reception of those documents to decide on the product authorisation on their territory. In the meantime, applicants are recommended to look for another zRMS, and no longer submit new zonal applications to the UK.
When the UK did not come to a conclusion/final decision before the date of Brexit, there are two options:
- The application was not submitted yet or the UK did not yet start the assessment: applicants are asked to indicate to the zonal secretariat which zRMS they prefer (email to email@example.com, stating ‘zonal secretariat’ in the subject), in concertation with this proposed zRMS. The zonal secretariat and the Central Zone Steering Committee (CZSC) will allocate a fall-back zRMS as soon as possible after the date of Brexit.
- The UK has started the assessment already, but did not issue the authorisation before the date of Brexit: in that case the CZSC will coordinate that the dossier and evaluations of aspects completely finalised by UK will be handed over to a fall-back zRMS. An inventory of ongoing applications has been made, and the allocation of a possible fall back zRMS for each application has been initiated. It will depend on the fall-back zRMS to what degree this evaluation will be reviewed or even adopted for the core assessment. Partly finalised 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 finalised its assessment (which should be checked by the applicant with the fall-back zRMS). Belgium will in general wait until the UK has finalised its assessment. The timing of transfer of documents will follow the same logic. The fall-back zRMS may contact the UK to make practical appointments. The fall-back zRMS will be responsible for the final assessment. 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. In Belgium, on top of the fee as cMS, a fee will be charged corresponding to the extra workload as zRMS (at 100 euro/hour).
As the Brexit will result in a higher workload for the Member States it is expected that the timelines for the assessment and authorisation of Plant Protection Products applications will be prolonged.
Mutual recognition is only possible for authorisations granted by another Member State. It is hence no longer possible to grant mutual recognition for UK authorisations after Brexit. However, Belgium is prepared to continue making use of UK assessments as long as they have been carried out according to the Uniform Principles and making use of the correct endpoints and guidance documents. This could substantially speed up the authorisation process. From a legal point of view, such an application will need to undergo the zonal procedure, and the fee as zRMS will be charged.
As explained in the Commission Q&A, all authorizations that have been granted by mutual recognition from the UK before the Brexit date remain unaffected.
Location of authorisation holders
There are no requirements regarding the address of the holders of an authorisation or permit for parallel import, like a restriction to the EU. Regulation 1107/2009 is deliberately silent on this matter. Hence, Brexit has no consequence in this matter.