Proposal for a Council Regulation (EC) amending Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin
C 131/14 EN Official Journal of the European Communities 12. 5. 1999 Article 10 Waiver of immunity illegal economic or Director of the Office for his opinion. financial activity shall be transmitted to the Any request from a national police or judicial authority regarding the waiver of immunity from jurisdiction of an official or servant of [insti- tution] concerning an internal case of irregularities, fraud or any other Article 11 Effective date This Decision shall take effect on 1 June 1999. Done at Brussels,. For [institution] Proposal for a Council Regulation (EC) amending Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1999/C 131/05) COM(1999) 130 final. - 1999/0072(CNS) (Submitted by the Commission on 18 March 1999) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission, Having regardt to the opinion of the European Parliament, Having regard to the opinion of Committee, the Economic and Social Whereas, since the adoption of Council Regulation (EEC) No 2377/90 (1), as last amended by Commission Regulation (EC) 2728/98 (2) the regulatory environment of veterinary medicinal products has been radically altered, in particular as a result of the entry into force of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (3) and of the amendments to Council Directive made 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (5) and to Council Directive 81/852/EEC of 28 Sepember 1981 on the approximation of the Member States relating to analytical, pharmacotoxicological by Directive 93/40/EEC (4) the laws of (1) OJ L 224, 18. 8. 1990, p. 1. (2) OJ L 343, 18. 12. 1998, p. 8. (3) OJ L 214, 24. 8. 1993, p. 1. (4) OJ L 317, 6. 11. 1981, p. 16. (5) OJ L 214, 24. 8. 1993, p. 31. and clinical standards and protocols of the testing of veterinary medicinal products (6); Whereas the Committee for Veterinary Medicinal Products is the henceforth responsible to the European Agency for Evaluation of Medicinal Products and it falls to that Agency, through that Committee, to issue an opinion on the maximum residue limits of veterinary medicinal products which are acceptable in foodstuffs of animal origin in accordance with Regulation (EEC) No 2377/90; Whereas Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (7) as amended by Regulation (EC) No 2743/98 (8) establishes the fees payable to the Agency for examining applications for the establishment, amendment, and extension of maximum residue limits; Whereas it is necessary, consequently, to amend Regulation (EEC) No 2377/90 by conferring on the Agency the task of dealing with applications for the establishment, amendment and extension of maximum residue limits and by aligning the decisionmaking process with respect to the authorisation and supervision of medicinal products for veterinary use with that introduced by Regulation (EEC) No 2309/93; Whereas the Agreement on the application of sanitary and phytosanitary measures which emerged from the multilateral negotiations of the Uruguay Round, approved on behalf of the European Community by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the its European Community, regards matters within as (6) OJ L 317, 6. 11. 1981, p. 1. (7) OJ L 35, 15. 2. 1995, p. 1. (8) OJ L 345, 19. 12. 1998, p. 3. 12. 5. 1999 EN Official Journal of the European Communities C 131/15 competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) (9), creates transparency obligations as regards health measures; whereas Regulation therefore be adapted in order to (EEC) No 2377/90 must enable the Community to fulfil its obligations under that Agreement, HAS ADOPTED THIS REGULATION: Article 1 Regulation (EEC) No 2377/90 is hereby amended as follows: 1. Articles 6 and 7 are replaced by the following: Article 6 1. In order to obtain the inclusion in Annex I, II or III of a pharmacologically active substance which is intended for use in veterinary medicinal products for administration to food-producing animals, an application to establish a maximum residue to the European Agency for the Evaluation of Medicinal Products set up by Council Regulation (EEC) No 2309/93, hereinafter referred to as the Agencyö. submitted shall be limit application shall This information and particulars referred to in Annex V and shall conform with the principles laid down in Directive 81/852/EEC. contain the The application shall aslo be accompanied by the fee 2. payable to the Agency. Article 7 1. The Committee for Veterinary Medicinal Products referred to in Article 27 of Regulation (EEC) No 2309/93, shall be responsible for formulating the Agency’s opinion on the classification of substances in Annexes I, II, III or IV of this Regulation. Articles 52 and 53 of Regulation (EEC) No 2309/93 2. are applicable for the purposes of this Regulation. The Agency shall ensure that the Committee’s opinion 3. is delivered within a period of 120 days following the reception of a valid application. the information submitted by the applicant If is not sufficient to enable such an opinion to be prepared, the Committee may ask the applicant to supply additional information within a specific time limit. The deadline for the opinion shall tha additional information has been received. then be deferred until 4. The Agency shall forward the opinion to the applicant. Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he wishes to appeal. In that case he shall forward the detailed grounds for his appeal to the Agency within 60 days of receipt of the opinion. Within 60 days of the receipt of the grounds for appeal, the Committee shall consider whether its opinion the conclusion should be revised and the reasons for (9) OJ L 336, 23. 12. 1994, p. 1. reached on the appeal shall be annexed to the report referred to in paragraph 5. The Agency shall forward the definitive opinion of the 5. Committee within 30 days of its adoption both to the Commission and to the applicant. The opinion shall be accompanied by a report describing the safety evaluation of the substance by the Committee, which shall give the grounds for its conclusions. The Commission shall prepare draft measures taking 6. the account of Community legislation and shall procedure provided for in Article 8. The Standing Committee for Veterinary Medicinal Products referred to in Article 8 shall adapt its rules of procedure in order to take account of the tasks conferred upon it by this Regulation. í start 2. Article 8(1) is replaced by the following: The words Committee for the Adaption to Technical 1. Progress of the Directives on Veterinary Medicinal Productsö are for Veterinary Medicinal Productsö. í replaced by Standing Committee 3. In Article 8(2) the words Committee for the Adaption to Technical Progress of the Directives on Veterinary Medicinal Productsí for by Veterinary Medicinal Productsí. Standing Committee replaced are 4. In Article 9(2) the first sentence is replaced by the following: the Committee The Commission shall as soon as possible examine the grounds given by the Member State concerned and, after consulting for Veterinary Medicinal then deliver its opinion forthwith and it shall Products, take appropriate measures; the person responsible for marketing may be requested to provide the Committee with oral or written explanationsí. 5. In Article 10, the words Committee for the Adaptation to Technical Progress of the Directives on Veterinary Medicinal Productsí for by Veterinary Medicinal Productsí. Standing Committee replaced are 6. Article 12 is replaced by the following text: Article 12 the Commission shall publish a summary of As soon as possible after the amendment of Annexes I, II, III the or IV, assessment of the safety of the substances concerned that have been examined by the Committe for Veterinary Medicinal any proprietary data shall be respected. The Agency shall provide the competent authorities and the Commission with appropriate methods of analysis for tracing residues. í confidential nature of Products. The Article 2 This Regulation shall enter into force on. 1999. This Regulation shall be binding in its entirety and directly applicable in all Member States