# C_2018373EN.01000601.xml

| 15.10.2018 | EN | Official Journal of the European Union | C 373/6 |
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15.10.2018

EN

Official Journal of the European Union

C 373/6

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Request for a preliminary ruling from the College van Beroep voor het Bedrijfsleven (Netherlands) lodged on 9 July 2018 — Vaselife International BV, Chrysal International BV v College voor de toelating van gewasbeschermingsmiddelen en biociden

(Case C-445/18)

(2018/C 373/06)

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

Questions referred

| 1. | Is the competent authority, the College voor de toelating van gewasbeschermingsmiddelen en biociden (Netherlands Board for the Authorisation of Plant Protection Products and Biocides; ‘the Ctgb’), authorised, after having taken a decision to re-register the reference product, whether or not of its own motion, to change the period of validity of a parallel trade permit as referred to in Article 52 of Regulation (EC) No 1107/2009, (1) where that permit was granted before the re-registration decision, in accordance with the — later — date of the period of validity applying to the decision to re-register the reference product? |
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1.

Is the competent authority, the College voor de toelating van gewasbeschermingsmiddelen en biociden (Netherlands Board for the Authorisation of Plant Protection Products and Biocides; ‘the Ctgb’), authorised, after having taken a decision to re-register the reference product, whether or not of its own motion, to change the period of validity of a parallel trade permit as referred to in Article 52 of Regulation (EC) No 1107/2009, (1) where that permit was granted before the re-registration decision, in accordance with the — later — date of the period of validity applying to the decision to re-register the reference product?

| 2. | If Question 1 is answered in the affirmative, is the change to the period of validity of a parallel trade permit an automatic consequence of a decision to re-register the reference product resulting from Regulation (EC) No 1107/2009 itself? Is the entry of the new date of the period of validity of the parallel permit into the database of the competent authority thus a purely administrative act, or does it require a decision taken by that authority of its own motion or in response to a request? |
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2.

If Question 1 is answered in the affirmative, is the change to the period of validity of a parallel trade permit an automatic consequence of a decision to re-register the reference product resulting from Regulation (EC) No 1107/2009 itself? Is the entry of the new date of the period of validity of the parallel permit into the database of the competent authority thus a purely administrative act, or does it require a decision taken by that authority of its own motion or in response to a request?

| 3. | If the answer to Question 2 is that a decision must be taken, does Article 52 of Regulation (EC) No 1107/2009, and, in particular, the third paragraph of that article, apply to that decision? |
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3.

If the answer to Question 2 is that a decision must be taken, does Article 52 of Regulation (EC) No 1107/2009, and, in particular, the third paragraph of that article, apply to that decision?

| 4. | If Question 3 is answered in the negative, which provision(s) is/are then applicable? |
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4.

If Question 3 is answered in the negative, which provision(s) is/are then applicable?

| 5. | Can a plant protection product already be considered not to be identical within the meaning of Article 52 of Regulation (EC) No 1107/2009 if the reference product does not (any longer) originate from the same undertaking? The Court of Justice is requested, in answering that question, also to consider whether the notion of an associated undertaking or of an undertaking operating under licence can also include an undertaking which produces the product according to the same recipe, with the consent of the right-holder. Is it relevant here whether the production process according to which the reference product and the parallel product which is to be introduced are manufactured is carried out by the same undertaking as far as the active substances are concerned? |
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5.

Can a plant protection product already be considered not to be identical within the meaning of Article 52 of Regulation (EC) No 1107/2009 if the reference product does not (any longer) originate from the same undertaking? The Court of Justice is requested, in answering that question, also to consider whether the notion of an associated undertaking or of an undertaking operating under licence can also include an undertaking which produces the product according to the same recipe, with the consent of the right-holder. Is it relevant here whether the production process according to which the reference product and the parallel product which is to be introduced are manufactured is carried out by the same undertaking as far as the active substances are concerned?

| 6. | Is the mere changing of the location for the production of the reference product relevant to the assessment of whether the product is identical? |
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6.

Is the mere changing of the location for the production of the reference product relevant to the assessment of whether the product is identical?

| 7. | If Questions 5 and/or 6 are/is answered in the affirmative, can the conclusion to be drawn therefrom (‘not identical’) be undermined by the fact that the competent authority has already established that, as regards its composition, the product has not undergone any change or has undergone only a slight change? |
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7.

If Questions 5 and/or 6 are/is answered in the affirmative, can the conclusion to be drawn therefrom (‘not identical’) be undermined by the fact that the competent authority has already established that, as regards its composition, the product has not undergone any change or has undergone only a slight change?

| 8. | On whom and to what extent does the burden of proof lie to show that Article 52(3) of Regulation (EC) No 1107/2009 has been satisfied if the holders of the authorisation for the parallel product and for the reference product have a difference of opinion in that regard? |
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8.

On whom and to what extent does the burden of proof lie to show that Article 52(3) of Regulation (EC) No 1107/2009 has been satisfied if the holders of the authorisation for the parallel product and for the reference product have a difference of opinion in that regard?

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(1)  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 (OJ 2009 L 309, p. 1).

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