EU rules in the field of PPPs will no longer apply to the United Kingdom after the withdrawal date. In particular, business operators should consider that, according to Union law, third countries cannot act as rapporteur Member States, zonal rapporteur Member States or evaluating Member States for MRLs.
Business operators should also bear in mind the following:
- For new applications: until the withdrawal, the UK may hold a role (rapporteur Member States, zonal rapporteur Member States or evaluating Member States for MRLs) but it is important to closely monitor the timeline and chose another Member State if the application will not be finished before the withdrawal date.
- On-going applications: the UK may still have a role, but the advice to business operators is to monitor the timeline carefully and choose another Member State if the application will not be filed before the withdrawal date.
- It is not mandatory for applicants for authorisations for PPPs and authorisation holders to be established in the European Union.
- It is not mandatory for applicants for approval of active substances and applicants for MRLs to be established in the European Union.
- The manufacturing site(s) of active substances can take place in third countries. However, after the withdrawal date the substance will be imported from a third country and will be subject to any applicable EU law in this respect.
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