CELEX: 51986PC0117(03)
Language: en
Date: 1986-03-05
Title: AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 81/852/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ANALYTICAL, PHARMACO-TOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF VETERINARY MEDICINAL PRODUCTS

22.5.86                                   Official Journal of the European Communities                              No C 122/7
               Amendment to the proposal for a Council Directive amending Directive 81/852/EEC on the
               approximation of the laws of the Member States relating to analytical, pharmacotoxicological
                 and clinical standards and protocols in respect of the testing of veterinary medicinal products
                                                        COM(86) 117 final
               (Submitted by the Commission to the Council pursuant to the second paragraph of Article 149 of
                                                 the EEC Treaty on 14 March 1986)
                                                          (86/C 112/10)
On 25 September 1984, the Commission presented the                   "— experimental studies validating the manufacturing
above proposal to the Council. For the reasons outlined                   process, where a non-standard method of manu-
in the explanatory memorandum, the original proposal is                   facture is used or where it is critical for the
hereby amended as follows:                                                product."
1. In Article 1, the following point 2 is inserted:                         (c) In Part 1 C (2), subparagraph (b) is replaced
                                                                                by the following:
    '2. Part 1 of the Annex, "Analytical (physico-                              "(b) the description of the substance, set
        chemical, biological or microbiological) tests of                             down in a form similar to that used in a
        veterinary medicinal products", is amended as                                 descriptive item in the European Phar-
        follows:                                                                      macopoeia, shall be accompanied by any
        (a) In Part 1 A the following section 4 is inserted:                          necessary       explanatory        evidence,
                                                                                      especially concerning the molecular
             "4. An explanation should be provided with                               structure where appropriate; it must be
                  regard to the choice of composition,                                accompanied       by     an    appropriate
                  constituents and container, supported by                            description of the method of synthetic
                  data on development pharmaceutics. The                              preparation. Where substances can only
                  overage, with justification thereof, should                         be described by their method of
                  be stated."                                                         preparation, the description should be
        (b) In Part 1 B the following fifth indent is                                 sufficiently detailed to characterize a
             inserted:                                                                substance which is constant both in its
                                                                                      composition and in its effects;".'
0) OJ No C 293, 5. 11. 1984, p. 6.                                   2. In Article 1, the existing point 2 becomes point 3.
               Amendment to the proposal for a Council recommendation concerning tests relating to the
                                    placing on the market of proprietary medicinal products
                                                        COM(86) 117 final
                (Submitted by the Commission to the Council pursuant to the second paragraph of Article 149 of
                                                 the EEC Treaty on 14 March 1986)
                                                           (86/C 112/11)
                On 25 September 1984 the Commission presented the above proposal to the Council. For the
                reasons outlined in the explanatory memorandum, the original proposal is hereby amended as
                follows:
               The following Annex XIII 'Anti-anginal drugs' and Annex XrV 'Corticosteroids intended for
                use on the skin' are added.
                0) OJ No C 293, 5. 11. 1984, p. 8.