WRITTEN QUESTION No. 1549/97 by Niels KOFOED to the Commission. Public services and procurement in Objective 5B areas
C 45/48 EN Official Journal of the European Communities 10. 2. 98 (98/C 45/58) WRITTEN QUESTION E-1542/97 by Hiltrud Breyer (V) to the Commission (5 May 1997) Subject: Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen The flea-repellant Tiguvon (Fenthion) manufactured by Bayer Leverkusen can be administered in different forms. Tiguvon 10 is intended for cats over 2 kg in weight. The use of Tiguvon 20 is recommended for dogs weighing between 3 and 10 kg, while dogs with a body weight of more than 10 kg should be treated with Tiguvon 20 G. People who have repeatedly treated their pets with Tiguvon (Fenthion) have suffered serious phosphate ester poisoning. As it was unable to answer my Question E-1470/96 (1) on the same subject, I would ask the Commission to answer the following question as a matter of urgency: In the Commissionís opinion, does Tiguvon comply with the EU authorizing directives? (1) OJ C 345, 15. 11. 1996, p. 76. Answer given by Mr Bangemann on behalf of the Commission (27 June 1997) Tiguvon (Fenthion) is a veterinary medicinal product. It has been authorised by the Member States according to the provisions of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (1) and Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmatoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products. These directives lay down the procedure to authorise a veterinary medicinal product under the decentralised procedure. In order to obtain a marketing authorisation according to the above mentioned directives an applicant has to produce the results of all physico-chemical, biological, microbiological, toxicological, pharmacological and clinical tests carried out on the product. Detailed studies on toxicology have to refer to potential risks from the exposure of human beings to the veterinary medical product as a result of the administration to the animal. All information which is relevant to the evaluation of the veterinary medicinal product has to be included in the dossier for the application for marketing authorisation, whether favourable or unfavourable to the product. In particular, all relevant detail must be given of any incomplete or abandoned test or trial relating to the product. Moreover, after marketing authorisation, any information not in the original application, pertinent to the assessment of benefit and risk, shall be submitted forthwith to the authorities. As a result of its evaluation of the relevant documentation the national authority will only grant a marketing authorisation, if it is assured that instructions for correct usage and a warning are included in all packets of products which present a potential risk through administration to the animal. In the case of Tiguvon the (human) user is advised to avoid close contact and not to touch the animal at the application site. (1) OJ L 317, 6. 11. 1981, as amended by Council Directives 90/676/EEC OJ L 373, 31. 12. 1990, and 93/40/EEC OJ L 214, 24. 8. 1993. (98/C 45/59) WRITTEN QUESTION E-1549/97 by Niels Kofoed (ELDR) to the Commission (5 May 1997) Subject: Public services and procurement in Objective 5B areas Will the Commission consider investigating the possibility of changing the contract directives in force in such a way that services › e. g. transport › and goods can be procured without further weakening provincial areas and