Brexit

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.

The Brexit started officially on 1/02/20 but some consequences will only enter into force after the transition period.

Parallel trade permits

As the UK is no longer a Member State, parallel trade permits for products of UK origin will no longer be valid after the transition period. Import of the concerned products will hence no longer be allowed after the transition period. For the sake of clarity, the permits will be withdrawn, with a period of grace of 6 months for sale of stocks present on the Belgian market and an extra 12 months for use of stocks.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 31/01/2020, 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.

For applications for which is was to be expected that the UK would not come to a conclusion/final decision before 1/02/20, the zonal secretariat and the Central Zone Steering Committee (CZSC) allocated in the meantime a fall-back zRMS.

 The fall)back zRMS will coordinate that the dossier and evaluations of aspects completely finalised by UK will be handed over to him.

The fall-back zRMS will be responsible for the final assessment. 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 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 of € 12 500 will be charged if it would be possible to rely (partially) on the British evaluation (RD of 13/11/11, Art. 1. §1.1°a+d). If it would not be possible to rely on the British evaluation, the original retribution as cMS falls away and a new fee of € 25.000 will need to be payed (RD of 13/11/11, Art 1. §1.1°a).

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.

If the applicant would not have received any information with respect to the fall-back zRMS, he can always contact the UK or the zonal secretariat (email to post@ctgb.nl).

Mutual recognition

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 the transition period. This will still be possible during the transition period. However, Belgium is prepared to continue making use of UK assessments, even after the transition period, 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 European Commission Q&A, all authorisations that have been granted by mutual recognition from the UK 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.