Vaselife et Chrystal V. College voor de toelating van gewasbeschermingsmiddelen en biociden

C-445/18
July 9, 2018
Final judgment
European Union, Luxembourg

Economic stakeholders
Vaselife International BV, Chrysal International BV
College voor de toelating van gewasbeschermingsmiddelen en biociden
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EU court
Other
Interpretation of Article 52 of Regulation (EC) No 1107/2009
European Court of Justine of Luxembourg, European Union
No description

November 14, 2019
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The Court of Justice of the European Union has received a reference for a preliminary ruling from the Dutch Court of Appeal for Administrative Proceedings in Economic Matters on the arrangements for maintaining a parallel trade permit for a plant protection product under Article 52 of Regulation 1107/2009 when the authorisation of the reference product is amended.

This application was made in the context of a litigation between a reference permit holder, Vaselife International Bv, and a parallel trade permit holder, Chrysal International Bv, against the Dutch national agency competent for the authorisation of pesticides, mainly concerning the refusal of this authority to renew the parallel trade permit granted in the past to Vaselife.

The Court ruled that :
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 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.

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.

2. 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.