WRITTEN QUESTION No. 2431/97 by Edouard des PLACES to the Commission. Authorization to place plant protection products on the market (SUPPLEMENTARY ANSWER)
Date: 1997-07-08
Institutions: DES PLACES, European Parliament
Subjects: import, marketing, patents licence, pharmaceutical legislation, pharmaceutical product, plant health product, public health













EUR-Lex - 91997E2431(01) - EN






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91997E2431(01)

WRITTEN QUESTION No. 2431/97 by Edouard des PLACES to the Commission. Authorization to place plant protection products on the market (SUPPLEMENTARY ANSWER)  


Official Journal C 134 , 30/04/1998 P. 0008 





WRITTEN QUESTION P-2431/97 by Edouard des Places (I-EDN) to the Commission (8 July 1997)Subject: Authorization to place plant protection products on the marketIn the light of the judgment of the Court of Justice of 12 November 1996 in Case C-201/94 on pharmaceutical products, where the competent authority of a Member State possesses evidence that a proprietary plant protection product with an authorization to market in another Member State and a proprietary plant protection product for which it has already issued a marketing authorization are manufactured by the same company or by its licensees, and that those two products, though not absolutely identical, have at least been manufactured according to the same formula and using the same active ingredient and that, furthermore, they have the same physical and chemical effects, must that authority, unless considerations such as the effective protection of human life and health militate against it, grant that marketing authorization to the imported plant protection product?Supplementary answer given by Mr Fischler on behalf of the Commission (7 November 1997)Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ((OJ L 230, 19.8.1991. )) requires Member States to prescribe that plant protection products may not be placed on the market and used in their territory unless they have authorized the product.In the case of parallel imports of plant protection products, the Commission sees no reason why a solution should not be applied similar to that adopted by the Court of Justice in its judgement of 12 November 1996 in Case C-201/94 Smith & Nephew Pharmaceuticals. This would mean that if a Member State has evidence that a proprietary plant health product authorised for marketing in another Member State and a proprietary plant health product for which it has already granted a marketing authorisation are manufactured by the same company or its licensees, and that these two products, though not absolutely identical, have been manufactured to the same formula using the same active ingredient, that Member State must allow the imported proprietary plant health product to benefit from its marketing authorisation, unless any differences between the two products in question alter the effects of the product in terms of the requirements referred to in Article 4(1)(b) of Directive 91/414/EEC (such as effectiveness, phytotoxicity, effects on health and the environment).A similar question has been raised in a case currently pending before the Court of Justice (Case C-100/96 The Queen v. Ministry of Agriculture, Fisheries and Food ex parte British Agrochemicals Association Ltd ((OJ C 145, 18.5.1996. ))). The Advocate General gave his conclusions in this case on 2 October 1997. No date has yet been fixed for the Court's judgment.