CELEX: 51987PC0697(01)
Language: en
Date: 1988-01-05
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVES 65/65/EEC, 75/318/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW, REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS

No C 36/22                                Official Journal of the European Communities                                           8. 2. 88
            — Insolvente liquidatie na faillietverklaring van de kredietinstelling:
                — Law on bankruptcy of 30 September 1893 and amendments S 140, Articles 1 to 212 of Title I.
               — Competent authority: the Court.
                                                             PORTUGAL
            — Rules governing the winding-up of banking institutions:
                — Article 11 et seq. of Decree Law No 30—689 of 27 August 1940.
                — Competent authority: Minister of Finance.
            — Liquidacao na sequencia de revojacao de autorizacao:
                — Competent authority: Minister of Finance.
            — Cooperative banks:
               — Articles 75 and 77 of Decree Law No 454 / 80 of 9 October 1980 which refer to the general rules governing
                   the bankruptcy procedure.
                — Article 1245 et seq. of Chapter XV of Decree Law No 44/129 of 28 December 1961.
               — Sale of property: Article 882 et seq.
                                                         UNITED KINGDOM
            — Compulsory winding-up (Insolvency Act 1986, Section 4).
            — Creditors' voluntary winding-up.
            — Corporate voluntary arrangements (Insolvency Act 1986, Section 1).
            — Corporate arrangements and reconstructions (Companies Act 1985, Section 13).
            For Building Societies (Building Societies Act 1986, Section 10):
            — Compulsory winding-up.
            — Creditors' voluntary winding-up.
            — Dissolution by consent of an appropriate majority of the society's members.
            Competent authority: judicial authority.
            Voluntary liquidation (Insolvency Act 1986, Section 4).
            Proposal for a Council Directive amending Directives 6 5 / 6 5 / E E C , 7 5 / 3 1 8 / E E C and 7 5 / 3 1 9 / E E C
            on the approximation of provisions laid down by law, regulation or administrative action relating to
                                                   proprietary medicinal products
                                                         COM(87) 697 final
                             (Submitted by the Commission to the Council on 12 January 1988)
                                                            (88/C 36/02)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                In cooperation with the European Parliament,
                                                                        Having regard to the opinion of the Economic and Social
Having regard to the Treaty establishing the European
                                                                        Committee,
Economic Community, and in particular Article 100A
thereof,
                                                                        Whereas the essential aim of any rules governing the
                                                                        production, distribution or use of medicinal products must
Having regard to the proposal from the Commission,                      be to ensure a high level of protection of public health;
 ---pagebreak---   8,2,88                                                   Official journal of trie European Communities                                      l^oC^/23
 whereas theDirectivesontheapproximationof the laws                                     1, In Articlel,the following p o m t s ^ a n d 5 a r e inserted^
 relating to proprietary medicinal products must be adapted
 to scientificprogress and tal^e account of the experience                                  '^,   ^^v^^^^^^^^^ro^^r
 obtained since their adoptions                                                                  Any medicinal product prepared in advance which
                                                                                                 does not comply withthe definition of proprietary
 whereas,mitsconclusionsofl5May 1987 onimprovement                                               medicinal products and which is marketed in a
 in the use of proprietary medicinal products by the                                             pharmaceutical form w h i c h m a y b e u s e d without
 c o n s u m e r s theCouncil considered that thesystemfor                                       further industrial processing,
 leaflets accompanying proprietary medicmalproducts,for
 human consumption, on the market in the Community                                          5,    ^^r^^^
 should be improved^
                                                                                                I^hemedicmal purpose forwhichamedicmal product
                                                                                                is administered to human beings or animals, as
 whereas the guarantees of the quality of medicinal products                                    specified in p o m t 2 '
 manufactured within the Community should he maintained
 by requiring compliance with the principles of good
 manufacturing practice for medicinal products irrespective                            2    Article2is amended as follows
 of the final destination of the products^
                                                                                            'Idie provisions of Chapters H to V shall apply to
                                                                                            medicinal products for human use intended to be placed
whereas the Commission should be empowered to define in
                                                                                            on the market m Member states in the form of
detail the principles of good manufacturing practice for
                                                                                            proprietarymedicmalproductsorreadyDmademedicmal
medicinal products in close cooperation with the Committee
                                                                                            products to the exclusion of medicinal products which
 for Adaptation to^fechnical^rogressoftheDirectiveson the
                                                                                            are prepared extemporaneously in an individual
removal ofLechmcal earners in the proprietary Medicinal
                                                                                            pharmacy for individual patients,'
products sector,
whereas, having regard to the resolution of the European                               3    In the title,preamble and ChaptersHtoVall references
parliament of 1 3 ] u n e l 9 8 ^ on the export of pharmaceutical                           to 'proprietary medicinal product' or to 'proprietary
products to t h e f h i r d ^ o r l d , m e a s u r e s should betaken to                  product'are replaced by'medicinal product',
improve theprovision of information for thirdcountnes
about the conditions of use of medicinal products within the                           ^, In A r t i c l e d , t h e following point D,Dis inserted^
Member ^tates^
                                                                                           'D,^ special precautions for disposal of unused product
whereas the scope of Directive ^ 5 / ^ 5 / E E C ^ , as last                                       or waste materials, if appropriate,'
amended by Directive 87/21/EECO^,and second Directive
75/319/EEC^,                  as last amended by Directive                             5, In Article 13,the following p o m t 9 i s inserted^
8 3 / 5 7 0 / E E C p E o n t h e a p p r o x i m a t i o n o f provisions laid
down by law, regulation or administrative action relating to                               '9, special precautions for disposal ofunused product or
proprietary medicinal products, should be extended to cover                                     waste materials, if any,'
other ready-made medicinal products which do not comply
with the definition of proprietary medicinal products^
                                                                                       D, In Article 1^, the following fifth indent is added^
whereas, in the Community Directives relating to medicinal                                 '— manufacturer's batch number,'
products, the word'therapeutic'shouldbeunderstoodas
covering all the medicinal purposes for whichamedicmal
product may be administered to human beings or animals,
which may be to prevent or treat disease,to mal^eamedical                                                               Ar^^2
diagnosis or to restore, correct or modify physiological
functions,
                                                                                      In Council Directive 75/318/EEC of 20 May 1975on the
                                                                                      approximation of thelaws of Member states relating to
                                                                                      analytical, pharmaco^toxicological and clinical standards
                                                                                      and protocols in respect of the testing of proprietary
                                                                                      medicinal products,all references to'propnetary medicinal
                                                                                      product' or to 'proprietary product' are replaced by
                                                                                      'medicinal product'.
Council Directive ^ 5 / ^ 5 / E E C of 2^ January 19^5 on the
approximation ofprovisions laid down by law,regulation or
administrative action relating to proprietary medicinal
products is hereby amended as follows^                                                                                  Ar^^^
 ^oi^Der^,77n^7,D^                                                                    Council Directive 75/319/EEC of 20 M a y l 9 7 ^ on the
 ^01^DLt^r71                    r^7,D^                                                approximation ofprovisions laid down by law, regulation or
 ^ o i ^ M c n ^ , ^ t ^ , D r^                                                       administrative action relating to proprietary medicinal
 aoi^DL^^^                  m ^^,D i                                                  products is hereby amended as follows^
 ---pagebreak--- No C 36/24                               Official Journal of the European Communities                                         8. 2. 88
 1. In Article 4, the text of paragraph (b) is amended as                2.     The summary of the product characteristics
     follows:                                                            approved by the Member State in accordance with
                                                                        Article 4b of Directive 6 5 / 6 5 / E E C shall be annexed to
     '(b) may submit the medicinal product, its active                  the certificate.
           principles or other constituent materials for                 3.     When the manufacturer is not in possession of
           testing by a State laboratory or by a laboratory              a marketing authorization in the country of origin,
           designated for that purpose in order to ensure               he must provide the authorities responsible for
           that the control methods employed by the                     establishing the certificate referred to in paragraph 1
           manufacturer and described in the particulars                with a declaration explaining why no marketing
           accompanying the application in accordance with               authorization has been obtained.'
           point 7 of Article 4 (second paragraph) of
           Directive 65/65/EEC are satisfactory.'
                                                                     5. In Article 17, the following paragraph (d) is inserted:
                                                                        '(d) demostrate that he complies with the principles of
 2. In Article 6, the last paragraph is replaced by the                        Good Manufacturing Practices for medicinal
     following:                                                                products laid down by Community law.'
    'The inclusion of a package leaflet in the packaging             6. The following Article 17a is inserted:
    of "over the counter medicinal products" shall be
                                                                         'Article 17a
    obligatory unless all the information required by this
    Article can be conveyed on the packaging itself.                    The principles of good manufacturing practices
                                                                        for medicinal products referred to in Article 17,
    For the purposes of this Article, "over the counter                 paragraph (d) shall be adopted, in the form of a
    medicinal products" are those medicinal products                    directive addressed to Member States, in accordance
    which are placed on the market with a view to their                 with the procedure laid down in Article 2c of Directive
    direct sale to the public, without the need for a medical           75/318/EEC'
    prescription, for use in the relief of minor illnesses not
    requiring a medical diagnosis.                                   7. In the second paragraph of Article 26, the following
                                                                        subparagraph (d) is inserted:
    In the case of other medicinal products, Member States              '(d) report periodically to the competent authorities
    may require that a leaflet be included with the                            on whether the manufacturer complies with the
    packaging.                                                                 principles of good manufacturing practices for
                                                                               medicinal products laid down by Community
    Within two years of the date of the adoption of this                       law.'
    Directive, the Commission shall present to the Council
    a report on the possibility of making more systematic            8. In Article 30, the following second paragraph is
    the use, and more legible and intelligible the content, of          inserted:
    package leaflets, accompanied if appropriate by
                                                                        'Upon request, Member States shall forthwith
    suitable proposals.'
                                                                        communicate the reports referred to in subparagraph
                                                                        (d) of the second paragraph of Article 26 to the
                                                                        competent authorities of another Member State. If,
 3. Article 16 (1) is amended as follows:                               after considering the reports, the Member State
                                                                        receiving the reports considers that it cannot accept
    '1.     Member States shall take all appropriate                    the conclusions reached by the competent authority of
    measures to ensure that the manufacture of medicinal                the Member State in which the report was established, it
    products is subject to the holding of an authorization.             shall inform the competent authority concerned of its
    This manufacturing authorization shall be required                  reasons and may request that a further inspection of the
    notwithstanding that the medicinal products                         manufacturing establishment be carried out. If
    manufactured are intended for export.'                              the Member States concerned are unable to reach
                                                                        agreement, they shall forthwith inform the
                                                                        Commission.'
4. The following Article 16a is inserted:
                                                                     9. The following paragraphs 2 and 3 are added to
    'Article 16a                                                        Article 33:
                                                                        '2.     The person responsible for the marketing of a
    1.     At the request of the manufacturer or the                    medicinal product shall be obliged to notify the
    authorities of a recipient country, Member States shall             Member States forthwith of any action taken by him to
    certify that a manufacturer of medicinal products is in             suspend the marketing of a product or to withdraw a
    possession of the authorization referred to in Article              product from the market, together with the reasons for
    16 (1). When issuing such certificates, Member States               such action. Member States shall ensure that this
    shall have regard to the prevailing administrative                  information is brought to the attention of the
    arrangements of the World Health Organization.                      Committee forthwith.
 ---pagebreak---  8. 2. 88                                  Official Journal of the European Communities                                No C 36/25
       3.    Member States shall ensure that appropriate                                          Article 4
      information about actions taken pursuant to
      paragraphs 1 and 2 which may effect the protection of            1.    Member States shall take the measures necessary to
      public health in third countries is forthwith brought to        comply with this Directive not later than 1 January 1991.
      the attention of the World Health Organization with a           They shall forthwith inform the Commission thereof.
      copy to the Committee.'
 10. The first paragraph of Article 34 is hereby amended as           2.     Requests for marketing authorization lodged after the
      follows:                                                        time limit referred to in paragraph 1 must comply with the
                                                                      provisions of this Directive.
      'This Directive shall apply to medicinal products for
      human use in the form of proprietary medicinal
                                                                      3.     Articles 1, 2 and 3 of this Directive, where relevant,
      products or ready-made medicinal products to the
                                                                      shall be progressively extended to existing medicinal
      exclusion of medicinal products which are prepared
                                                                      products before 31 December 1992.
      extemporaneously in an individual pharmacy for
      individual patients.'
 11. With the exception of the first paragraph of Article 34,
      all references to 'proprietary medicinal product' or to                                     Article 5
      'proprietary product' are replaced by 'medicinal
      product'.                                                       This Directive is addressed to the Member States.
               Proposal for a Council Directive extending the scope of Directives 65/65/EEC and 75/319/EEC on
               the approximation of provisions laid down by law, regulation or administrative action relating to
               proprietary medicinal products and laying down additional provisions for immunological medicinal
                                 products consisting of vaccines, toxins or serums and allergens
                                                         COM(87) 697 final
                               (Submitted by the Commission to the Council on 12 January 1988)
                                                            (88/C 36/03)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             Whereas the provisions laid down by Directive
                                                                     65/65/EEC (*),        as    last    amended    by   Directive
                                                                      87/21/EEC ( 2 ), and Second Directive 75/319/EEC ( 3 ), as
Having regard to the Treaty establishing the European
                                                                     last amended by Directive 83/570/EEC (4) on the
Economic Community, and in particular Article 100A
                                                                     approximation of provisions laid down by law, regulation or
thereof,
                                                                     administrative action relating to proprietary medicinal
                                                                     products, although appropriate, are inadequate for
Having regard to the proposal from the Commission,                   immunological medicinal products consisting of vaccines,
                                                                     toxins or serums and allergens;
In cooperation with the European Parliament,                         Whereas, in accordance with Article 5 of Directive
                                                                      87/22/EEC (5) on the approximation of national provisions
Having regard to the opinion of the Economic and Social              relating to the placing on the market of high technology
Committee,                                                           medicinal products, particularly those derived from
                                                                     biotechnology, the Commission is required to submit
                                                                     proposals to harmonize, along the lines of Directive
Whereas disparities in the provisions laid down by law,              75/319/EEC, the conditions for authorizing the
regulation or administrative action by Member States may             manufacture and placing on the market of immunological
hinder trade in immunological products within the                    medicinal products before 22 December 1987;
Community;
                                                                     (M   OJ No 22, 9. 2. 1965, p. 369/65.
                                                                      (2) OJ No L 15, 17. 1. 1987, p. 36.
Whereas the essential aim of any rules governing the                 (3)  OJ No L 147, 9. 6. 1975, p. 13.
production, distribution or use of medicinal products must           (4)  OJ No L 332, 28. 11. 1983, p. 1.
be to ensure a high level of protection of public health;            (5)  OJ No L 15, 17. 1. 1987, p. 38.