CELEX: 51986PC0117(01)
Language: en
Date: 1986-03-05
Title: AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF NATIONAL MEASURES RELATING TO THE PLACING ON THE MARKET OF HIGH TECHNOLOGY MEDICINAL PRODUCTS, PARTICULARLY THOSE DERIVED FROM BIOTECHNOLOGY

No C 122/6                                Official Journal of the European Communities                                     22.5.86
                                                     COMMISSION
               Amendment to the proposal for a Council Directive on the approximation of national measures
               relating to the placing on the market of high-technology medicinal products, particularly those
                                                    derived from biotechnology (')
                                                          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 122/08)
               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 is inserted before the first recital:
                     'Whereas the primary purpose of any rules concerning the production and distribution of
                     proprietary medicinal products must be to safeguard public health;'.
               (') OJ No C 293, 5. 11.1984, p. 1.
               Amendment to the proposal for a Council Directive amending Directive 75/318/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 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 122/09)
On 25 September 1984 the Commission presented the                                "— experimental studies validating the manu-
above proposal to the Council. For the reasons outlined                                facturing process, where a non-standard
in the explanatory memorandum, the original proposal is                                method of manufacture is used or where
hereby amended as follows:                                                             it is critical for the product."
                                                                             (c) In Part 1 C (2), subparagraph (b) is replaced
1. In Article 1, the following point 2 is inserted:                              by the following:
    '2. Part 1 of the Annex, "Physico-Chemical,                                  "(b) the description of the substance, set
        Biological or Microbiological Tests of Proprietary                              down in a form similar to that used in a
        Medicinal Products", is amended as follows:                                     descriptive item in the European Phar-
                                                                                        macopoeia, shall be accompanied by any
        (a) In Part 1 A the following section 4 is inserted:                            necessary         explanatory      evidence,
            "4. An explanation should be provided with                                  especially concerning the molecular
                  regard to the choice of composition,                                  structure where appropriate; it must be
                  constituents and container, supported by                              accompanied         by    an    appropriate
                  data on development pharmaceutics. The                                description of the method of synthetic
                  overage, with justification thereof, should                           preparation. Where substances can only
                  be stated."                                                           be described by their method of
                                                                                        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;".'
(') OJ No C 293, 5. 11. 1984, p. 4.                                   2. In Article 1, the existing point 2 becomes point 3.