Case C-445/18: Judgment of the Court (First Chamber) of 14 November 2019 (request for a preliminary ruling from the College van Beroep voor het bedrijfsleven — Netherlands) — Vaselife International BV, Chrysal International BV v College voor de toelating van gewasbeschermingsmiddelen en biociden (Reference for a preliminary ruling — Regulation (EC) No 1107/2009 — Placing of plant protection products on the market — Parallel trade — Modification of the period of validity of the parallel trade permit — Identity of the plant protection product and the reference product — Conditions)
Date: 2019-11-14
Institutions: Court of Justice
Subjects: market approval, plant health control, plant health product, proof








C_2020010EN.01001501.xml










13.1.2020   


EN


Official Journal of the European Union


C 10/15






Judgment of the Court (First Chamber) of 14 November 2019 (request for a preliminary ruling from the College van Beroep voor het bedrijfsleven — Netherlands) — Vaselife International BV, Chrysal International BV v College voor de toelating van gewasbeschermingsmiddelen en biociden
(Case C-445/18) (1)

(Reference for a preliminary ruling - Regulation (EC) No 1107/2009 - Placing of plant protection products on the market - Parallel trade - Modification of the period of validity of the parallel trade permit - Identity of the plant protection product and the reference product - Conditions)
(2020/C 10/17)
Language of the case: Dutch

Referring court

College van Beroep voor het bedrijfsleven

Parties to the main proceedings


Appellants: Vaselife International BV, Chrysal International BV

Respondent: College voor de toelating van gewasbeschermingsmiddelen en biociden

Operative part of the judgment







1.


European Union law and, in particular, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC must be interpreted as not precluding a national procedure under which the competent authority is empowered to take the initiative of its own motion to adapt the period of validity of a parallel trade permit to the period of validity of the renewed authorisation of the reference product.










2.


Regulation No 1107/2009 and, in particular, Article 52 thereof, must be interpreted as meaning that the adaptation of the period of validity of a parallel trade permit does not automatically follow from the decision to renew the authorisation of the reference product, but requires that a decision be taken in this respect.
Regulation No 1107/2009 must be interpreted as meaning that, when it comes to the adaptation of the period of validity of a parallel trade permit to the period of validity of the renewed authorisation of the reference product, the conditions for obtaining that permit laid down in Article 52(1) to (3) of Regulation No 1107/2009 must be satisfied and it is for the competent authority of the Member State concerned to determine whether that is indeed the case.
Article 52(3)(a) of Regulation No 1107/2009 must be interpreted as including a situation in which the plant protection product authorised by the Member State of origin is manufactured by company A, while the reference plant protection product is manufactured, using the same process but in a different location from the former, by company B with the consent of company A, provided that that arrangement is a long-term arrangement similar to a licensing arrangement.










3.


Article 52(2) to (4) of Regulation No 1107/2009 must be interpreted as meaning that it is for the holder of the parallel trade permit to submit a new complete application, providing the information referred to in Article 52(4) of that regulation, in order to demonstrate that the products concerned are still ‘identical’ within the meaning of paragraph 3 of that article, without prejudice to the competent authority being able to request the Member State of origin of the imported product to provide the information necessary for assessing whether those products are identical. In the event of a challenge to the decision granting the parallel trade permit, the national rules of the Member State concerned are to apply as regards the burden of proof, provided that those rules respect the principle of equivalence and do not make it excessively difficult or impossible in practice to exercise the rights conferred by the EU legal order.






(1)  OJ C 373, 15.10.2018.