CELEX: 51987PC0697(02)
Language: en
Date: 1988-01-04
Title: 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

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.
 ---pagebreak---  No C 36/26                               Official Journal of the European Communities                                        8. 2. 88
 Whereas, before an authorization to market an                       biological activity or to protein content and 'qualitative and
 immunological product can be granted, the manufacturer              quantitative composition' shall include the composition of
 must demonstrate his ability to attain batch-to-batch               the product expressed in terms of biological activity.or of
 consistency;                                                        protein content.
 Whereas the Commission should be empowered to adopt any             3.     Whenever the name of an immunological medicinal
 necessary changes in the requirements for the testing of            product is expressed, the common or scientific name of the
 proprietary medicinal products set out in the Annex to              active constituents shall also be included.
 Directive 75/318/EEC of 20 May 1975 o n . 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 proprietary
 medicinal products (*), as last amended by Directive                                            Article 3
 87/ 19/EEC of 22 December 1986 ( 2 ), to take account of the
 special nature of immunological medicinal products in close
 cooperation with the Committee for the Adaptation to                In addition to the information referred to in Article 4a of
 Technical Progress of the Directives on the Removal of              Directive 65/65/EEC, the summary of product
 Technical Barriers to Trade in the Proprietary Medicinal            characteristics referred to in point 9 of the second paragraph
 Products Sector,                                                    of Article 4 of Directive 65/65/EEC shall contain the
                                                                     following information in respect of immunological
                                                                     products:
HAS ADOPTED THIS DIRECTIVE:                                              '— under point 5.4, information about any special
                                                                             precautions to be taken by persons handling the
                                                                             immunological medicinal product and persons
                                                                             administering it to patients, together with any
                          Article 1                                          precautions to be taken by the patient.'
 1.    In derogation from Article 34 of Directive
75/319/EEC, and subject to the provisions of this Directive,
Directives 65/65/EEC and 75/319/EEC shall apply to
immunological medicinal products consisting of vaccines,                                        Article 4
toxins and serums and allergen products for human use.
                                                                     1.     Member States shall ensure that the manufacturing
2.     For the purposes of this Directive, the following             processes used in the manufacture of immunological
definitions shall apply:                                             products are properly validated and attain batch-to-batch
                                                                     consistency. To this end the competent authority may submit
— 'immunological medicinal product' shall mean a product             samples from up to five in total of the bulk and /or finished
    of biological origin which is intended to effect the            product batches for testing by a State laboratory or a
    immune system and which is used in the diagnosis,                laboratory designated for that purpose, either during the
    prevention or treatment of disease. Included are vaccines,       examination of the application pursuant to Article 4 of
    toxins and serums and allergens,                                 Directive 75/319/EEC, or after a marketing authorization
                                                                     has been granted.
— 'allergen product' shall mean any product which is
    intended to identify or induce a specific acquired
    alteration in the immunological response to an allergising       2.     For the purpose of implementing Article 8 of Directive
    agent,                                                           65/65/EEC and Article 27 of Directive 75/319/EEC,
                                                                    Member States may require persons responsible for
— vaccins, toxins and sera shall have the meaning assigned           marketing immunological products to submit to a competent
    to them in the Annex to Directive 75/319/EEC.                    authority copies of all the control reports signed by the
                                                                     qualified person in accordance with Article 22 of Directive
                                                                    75/319/EEC.
                          Article 2
                                                                     3.     Where it considers it necessary in the interests of public
1.     The quantitative particulars of an immunological             health, a Member State may require persons responsible for
medicinal product shall be expressed by mass or by                  marketing the live vaccines, vaccines used in the primary
international units or by units of biological activity or by         immunization of infants, or vaccines used in public health
protein content as appropriate to the product concerned.            immunization programmes, which are listed in the Annex to
                                                                    this Directive, to submit to a competent authority samples
2.     In Directives 65/65/EEC and 75/319/EEC, the                  from each batch of the bulk and/or finished product for
expressions 'qualitative and quantitative particulars of the        examination by a State laboratory or a laboratory designated
constituents' shall also include particulars relating to            for that purpose before release onto the market, unless the
                                                                    competent authority of another Member State has previously
(») OJ No L 147, 9. 6. 1975, p. 1.                                  examined the batch in question and declared it to be in
(2) OJNoL 15, 17. 1. 1987, p. 31.                                   conformity with the approved specification. Member States
 ---pagebreak--- 8. 2. 88                                 Official Journal of the European Communities                                 No C 36/27
shall ensure that any such examination is completed within                                         Article 6
60 days of the receipt of the samples. The Annex to this
Directive containing the list of vaccines which may be                 1.    Member States shall take the necessary measures to
submitted for examination prior to release may be amended             comply with this Directive not later than 1 January 1991.
in accordance with the procedure laid down in Article 2c of           They shall forthwith inform the Commission thereof.
Directive 75/318/EEC.
                                                                      2.     Requests for marketing authorization for products
                                                                      covered by this Directive lodged after the time limit referred
                                                                      to in paragraph 1 must comply with the provisions of this
                            Article 5                                 Directive.
                                                                       3.      This Directive shall be progressively extended to
Any amendments which are necessary in the testing                     the existing immunological medicinal products before
requirements for medicinal products set out in the Annex to            31 December 1992.
Directive 75/318/EEC, to take account of the extension of
the scope of Directives 65/65/EEC and 75/319/EEC to
cover immunological medicinal products, shall be adopted in
accordance with the procedure laid down in Article 2c of                                           Article 7
Directive 75/318/EEC. Any such amendments shall come
into effect on the same date as this Directive.                        This Directive is addressed to the Member States.
                                                               ANNEX
                                      LIST OF VACCINES REFERRED TO IN ARTICLE 4 (3)
              Vaccines for human use, presented or used for the prophylaxis of the following diseases:
                  Cholera
                  Diphtheria
                  Hepatitis
                  Influenza
                  Measles
                  Mumps
                  Pertussis
                  Polio
                  Rabies
                  Rubella
                  Tetanus
                  Tuberculosis
                  Typhoid
                  Yellow Fever