CELEX: 51988PC0663(01)
Language: en
Date: 1988-11-10
Title: AMENDED 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

3. 12. 88                            Official Journal of the European Communities                           No C 308/9
                                                            II
                                                    (Preparatory Acts)
                                               COMMISSION
            Amended 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 (')
                                             COM(88) 663 final — SYN 114
            (Submitted by the Commission pursuant to the third paragraph of Article 149 of the Treaty on
                                                   11 November 1988)
                                                      (88/C 308/07)
            0) OJ No C 36, 8. 2. 1988, p. 22.
                    ORIGINAL PROPOSAL                                                AMENDED PROPOSAL
                                                    Title unchanged
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                        THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European           Visas unchanged
Economic Community, and in particular Article 100A
thereof,
Having regard to the proposal from the Commission,
In cooperation with the European Parliament,
Having regard to the opinion of the Economic and
Social Committee,
Whereas the essential aim of any rules governing the            First recital unchanged
production, distribution or use of medicinal products
must be to ensure a high level of protection of public
health;
"Whereas the directives on the approximation of the laws        Whereas the directives on the approximation of the laws
relating to proprietary medicinal products must be              relating to proprietary medicinal products must be
adapted to scientific progress and take account of the          adapted to scientific progress and take account of the
experience obtained since their adoption;                       experience obtained since their adoption so as to ensure
                                                                greater quality, safety and efficacy;
Whereas, in its conclusions of 15 May 1987 on                   Third to sixth recitals unchanged
improvement in the use of proprietary medicinal
products by the consumer (*),. the Council considered
that the system for leaflets accompanying proprietary
medicinal products, for human consumption, on the
market in the Community should be improved;
O OJ No C 178, 7. 7. 1987, p. 2.
 ---pagebreak--- N o C 308/10                                        Official Journal of the European Communities                                         3. 12. 88
                              ORIGINAL PROPOSAL                                                          AMENDED PROPOSAL
W h e r e a s the guarantees of the quality of medicinal
products manufactured within the C o m m u n i t y should be
maintained by requiring compliance with the principles
of g o o d manufacturing practice for medicinal products
irrespective of the final destination of the p r o d u c t s ;
W h e r e a s the Commission should be e m p o w e r e d to
define in detail the principles of g o o d manufacturing
practice for medicinal products in close cooperation with
the C o m m i t t e e for Adaptation to Technical Progress of
the Directives on the Removal of Technical Barriers in
the P r o p r i e t a r y Medicinal P r o d u c t s Sector;
W h e r e a s having regard to the resolution of the E u r o p e a n
Parliament of 13 J u n e 1986 on the export of p h a r m a -
ceutical p r o d u c t s to the T h i r d W o r l d , measures should
be taken to improve the provision of information for
third countries about the conditions of use of medicinal
p r o d u c t s within the M e m b e r States;
W h e r e a s the scope of Directive 6 5 / 6 5 / E E C (*), as last            W h e r e a s the scope of Directive 6 5 / 6 5 / E E C , as last
a m e n d e d by Directive 8 7 / 2 1 / E E C (2) and Second                    amended           by Directive      87/21/EEC,        and   Second
Directive 7 5 / 3 1 9 / E E C ( J ), as last a m e n d e d by Directive        Directive 7 5 / 3 1 9 / E E C , as last a m e n d e d by Directive
8 3 / 5 7 0 / E E C ( 4 ), on the approximation of provisions laid             8 3 / 5 7 0 / E E C , on the approximation of provisions laid
d o w n by law, regulation or administrative action relating                   d o w n by law, regulation or administrative action relating
to proprietary medicinal p r o d u c t s should be extended to                 to proprietary medicinal p r o d u c t s should be extended to
cover other r e a d y - m a d e medicinal p r o d u c t s which d o            cover other industrially manufactured medicinal products
n o t comply with the definition of proprietary medicinal                      hitherto excluded;
products;
W h e r e a s in the C o m m u n i t y directives relating to                  Eight recital deleted
medicinal p r o d u c t s the w o r d 'therapeutic' should be
u n d e r s t o o d as covering all the medicinal purposes for
which a medicinal p r o d u c t may be administered to
h u m a n beings or animals, which m a y be to prevent or
treat disease, t o m a k e a medical diagnosis o r to restore,
correct or modify physiological functions,
HAS ADOPTED THIS DIRECTIVE:                                                    HAS ADOPTED THIS DIRECTIVE:
                                   Article  1                                                                 Article 1
Council Directive 6 5 / 6 5 / E E C of 26 J a n u a r y 1965 on the            Unchanged
approximation of provisions laid d o w n by law, regulation
or administrative action relating to proprietary medicinal
products is hereby a m e n d e d as follows:
(')   OJ    No     22, 9. 2. 1965, p. 369/65.
O     OJ     No    L 15, 17. 1. 1987, p. 36.
(3)   OJ     No    L 147, 9. 6. 1975, p. 13.
(4)   OJ     No    L 332, 28. 11. 1983, p. 1.
 ---pagebreak--- 3. 12. 88                              Official Journal of the European Communities                            No C 308/11
                      ORIGINAL PROPOSAL                                                 AMENDED PROPOSAL
1. In Article 1, the following points 4 and 5 are inserted:       1. In Article 1, the following points 4 and 5 are inserted:
   '4.    Ready-made medicinal product                            '4.     Magistral formula:
   Any medicinal product prepared in advance which                any medicinal product prepared in a pharmacy in
   does not comply with the definition of proprietary             accordance with a prescription for an individual patient.
   medicinal products and which is marketed in a
   pharmaceutical form which may be used without
   further industrial processing.
          Therapeutic                                                     Official formula:
   The medicinal purpose for which a medicinal product            any medicinal product prepared in a pharmacy in
   is administered to human beings or animals, as                 accordance with the prescriptions of a pharmacopoeia
   specified in point 2.'                                         and which is intended to be supplied directly to the
                                                                  patients served by the pharmacy in question.'
2. Article 2 is amended as follows:                               2. Article 2 is amended as follows:
   'The provisions of Chapters II to V shall apply to                 '1.     The provisions of Chapters II to V shall apply
   medicinal products for human use intended to be                    to proprietary medicinal products for human use
   placed on the market in Member States in the form of               intended to be placed on the market in Member
   proprietary medicinal products or ready-made                       States.
   medicinal products to the exclusion of medicinal
   products which are prepared extemporaneously in an
                                                                      2.     Where a Member State authorizes the placing on
   individual pharmacy for individual patients.'
                                                                      the market of industrially produced medicinal products
                                                                      which do not comply with the definition of a
                                                                      proprietary medicinal product, it shall also apply the
                                                                      provisions of Chapters II to V to them.
                                                                      3.     The provisions of Chapters II to V shall not
                                                                      apply to:
                                                                      — medicinal products prepared on the basis of a
                                                                           magistral or officinal formula,
                                                                      — medicinal products intended for         research  and
                                                                           development trials,
                                                                      — intermediate products intended for             further
                                                                           processing by an authorized manufacturer.
                                                                      4.     A Member State may, in accordance with legis-
                                                                      lation in force and to satisfy special needs, exclude
                                                                      from the provisions of Chapters II to V medicinal
                                                                      products supplied in response to a genuine unsolicited
                                                                      order, formulated in accordance with the specifications
                                                                      of an authorized health care professional for use by his
                                                                      individual patients on his direct personal responsi-
                                                                      bility.'
3. In the title, preamble and Chapters II to V all                 3. Unchanged
    references to 'proprietary medicinal product' or to
    'proprietary product' are replaced by 'medicinal
    product'.
 ---pagebreak--- No C 308/12                             Official Journal of the European Communities                                  3. 12. 88
                        ORIGINAL PROPOSAL                                                  AMENDED PROPOSAL
4. In Article 4a, the following point 6.6 is inserted:             4. In Article 4a, the following point 6.6 is inserted:
    '6.6. special precautions for disposal of unused                  '6.6. special precautions for disposal of unused
           product or waste materials, if appropriate.'                      products or waste materials derived from the
                                                                             products, if appropriate.'
5. In Article 13, the following point 9 is inserted:               5. In Article 13, the following point 9 is inserted:
    '9. special precautions for disposal of unused product            '9. special precautions for disposal of unused
         or waste materials, if any.'                                      products or waste materials derived from the
                                                                           products, if any.'
6. In Article 14, the following fifth indent is added:             6. Unchanged
    '— manufacturer's batch number.'
                           Article 2                                                          Article 2
In Council Directive 75/318/EEC of 20 May 1975 on                 Unchanged
the approximation of the laws 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
'proprietary medicinal product' or to 'proprietary
product' shall be replaced by 'medicinal product'.
                           Article 3                                                          Article 3
Council Directive 75/319/EEC of 20 May 1975 on the                Unchanged
approximation of provisions laid down by law, regulation
or administrative action relating to proprietary medicinal
products is hereby amended as follows:
  1. In Article 4, the text of paragraph (b) is amended as          1. In Article 4, the text of paragraph (b) is amended as
      follows:                                                         follows:
      '(b) may submit the medicinal product, its active                 '(b) may submit the medicinal product, its starting
           principles or other constituent materials for                     materials and if necessary intermediate products,
           testing by a State laboratory or by a laboratory                  or other constituent materials for testing by a
           designated for that purposes in order to ensure                   State laboratory or by a laboratory designated
           that the control methods employed by the                          for that purpose in order to ensure that the
           manufacturer and described in the particulars                     control methods employed by the manufacturer
           accompanying the application in accordance                        and described in the particulars accompanying
           with point 7 of Article 4 (second paragraph) of                   the application in accordance with point 7 of
           Directive 65/65/EEC are satisfactory.'                            Article 4 (second paragraph) of Directive
                                                                             65/65/EEC are satisfactory.'
  2. In Article 6, the last paragraph is replaced by the            2. In Article 6, the last paragraph is amended as
      following:                                                        follows:
      'The inclusion of a package leaflet in the packaging              'The inclusion of a package leaflet in the packaging
      of "over the counter medicinal products" shall be                 of medicinal products shall be obligatory unless all
      obligatory unless all the information required by this            the information required by this Article can be
      Article can be conveyed on the packaging itself.                  conveyed on the container and the external
                                                                        packaging.'
 ---pagebreak--- 3. 12. 88                               Official Journal of the European Communities                             No C 308/13
                        ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
     For the purposes of this Article, "over the counter
     medicinal products" are those medicinal products
    which are placed on the market with a view of their
     direct sale to the public, without the need for a
     medical prescription, for use in the relief of minor
     illnesses not requiring a medical diagnosis.
    In the case of other medicinal products, Member
     States may require that a leaflet be included with the
    packaging.
    Within two years of the date of the adoption of this
    Directive, the Commission shall present to the
    Council a report on the possibility of making more
    systematic the use, and more legible and intelligible
    the content, of package leaflets, accompanied if
    appropriate by suitable proposals.'
 3. Article 16 (1) is amended as follows:                           3. Unchanged
    '1.     Member States shall take all appropriate
    measures to ensure that the manufacture of
    medicinal products is subject to the holding of an
    authorization. This manufacturing authorization
    shall be required notwithstanding that the medicinal
    products manufactured are intended for export'.
 4. The following Article 16a is inserted:                         4. The following Article 16a is inserted:
     'Article 16a                                                       'Article 16a
    1.     At the request of the manufacturer or the auth-             At the request of the manufacturer, the exporter or
    orities of a recipient country, Member States shall                the authorities of an importing third country,
    certify that a manufacturer of medicinal products is               Member States shall certify that a manufacturer of
    in possession of the authorization referred to in                  medicinal products is in possession of the auth-
    paragraph 1 of Article 16. When issuing such                       orization referred to in Article 16 (1). When issuing
    certificates, Member States shall have regard to the               such certificates, they shall comply with the following
    prevailing administrative arrangements of the World                conditions:
    Health Organization.
                                                                       1. Member States shall have regard to the prevailing
                                                                           administrative arrangements of the World Health
                                                                           Organization.
    2.     The summary of the product characteristics                  2. For medicinal products intended for export which
    approved by the Member State in accordance with                        are already authorized on their territory, they
    Article 4b of Directive 65/65/EEC shall be annexed                     shall supply the summary of the product charac-
    to the certificate.                                                    teristics as approved in accordance with Article 4b
                                                                           of Directive 65/65/EEC.
    3.     When the manufacturer is not in possession of               3. When the manufacturer is not in possession of a
    a marketing authorization in the country of origin,                    marketing authorization, he shall provide the
    he must provide the authorities responsible for estab-                 authorities responsible for establishing the
    lishing the certificate referred to in paragraph 1 with                certificate referred to in paragraph 1 with a
    a declaration explaining why no marketing auth-                        declaration explaining why no marketing auth-
    orization has been obtained.'                                          orization is available.'
 ---pagebreak--- N o C 308/14                            Official Journal of the European Communities                                    3. 12. 88
                       ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
 5. In Article 17, the following paragraph (d) is inserted:         5. In Article 19, the following paragraph (f) is inserted:
     '(d) demonstrate that he complies with the principles              '(f) to comply with the principies and the guidelines
           of Good Manufacturing Practices for medicinal                       of good manufacturing practice for medicinal
           products laid down by Community law.'                              products laid down by Community law.'
 6. The following Article 17a is inserted:                          6. The following Article 19a is inserted:
      'Article 17a                                                       'Article 19a
    The principles of good manufacturing practices for                 The principles and guidelines of good manufacturing
    medicinal products referred to in Article 17,                      practice for medicinal products referred to in Article
    paragraph (d) shall be adopted, in the form of a                    19 (f) shall be adopted, in the form of a directive
    directive addressed to Member States, in accordance                addressed to Member States, in accordance with the
    with the procedure laid down in Article 2c of                      procedure laid down in Article 2c of Directive
    Directive 7 5 / 3 1 8 / E E C                                      75/318/EEC; detailed guidelines shall be published
                                                                       by the Commission and revised as appropriate to take
                                                                       into consideration scientific and technical progress.'
 7. In the second paragraph of Article 26, the following            7. In Article 26:
    subparagraph (d) is inserted:
                                                                             the first paragraph is amended as follows:
    '(d) report periodically to the competent authorities
           on whether the manufacturer complies with the                     'The competent authority of the Member State
           principles of good manufacturing practices for                    concerned shall ensure by means of repeated
           medicinal products laid down by Community                         inspections that the legal requirements relating to
           law.'                                                             proprietary medicinal products are complied
                                                                            with.'
                                                                       — the following third paragraph is inserted:
                                                                            'The officials      representing the competent
                                                                            authority shall report after each of the inspections
                                                                            mentioned in the first paragraph on whether the
                                                                            manufacturer complies with the principles and
                                                                            guidelines of good manufacturing practice laid
                                                                            down by Community law. The manufacturer
                                                                            shall be informed of the content of such reports
                                                                            and shall be able to demand a second inspection.'
    In Article 30, the following second paragraph is                   In Article 30, the following second paragraph is
    inserted :                                                         inserted :
    'Upon request, Member States shall forthwith                       'Upon reasoned request, Member States shall
    communicate the reports referred to in subparagraph                forthwith communicate the reports referred to in the
    (d) of the second paragraph of Article 26 to the                   third paragraph of Article 26 to the competent auth-
    competent authorities of another Member State. If,                 orities of another Member State. If, after considering
    after considering the reports, the Member State                    the reports, the Member State receiving the reports
    receiving the reports considers that it cannot accept              considers that it cannot accept the conclusions
    the conclusions reached by the competent authority                 reached by the competent authority of the Member
    of the Member State in which the report was estab-                 State in which the report was established, it shall
    lished, it shall inform the competent authority                    inform the competent authority concerned of its
    concerned of its reasons and may request that a                    reasons and may request further information. In the
    further inspection of the manufacturing estab-                     case of prolonged disagreement between Member
    lishment be carried out. If the Member States                      States, the Member State(s) shall inform the
    concerned are unable to reach agreement, they shall                Commission.'
    forthwith inform the Commission.'
 ---pagebreak--- 3. 12. 88                              Official Journal of the European Communities                            No C 308/15
                       ORIGINAL PROPOSAL                                                 AMENDED PROPOSAL
 9. The following paragraphs 2 and 3 are added to                  9. The following paragraphs 2, 3 and 4 are added to
    Article 33:                                                       Article 33:
    '2.    The person responsible for the marketing of a              '2.   The person responsible for the marketing of a
    medicinal product shall be obliged to notify the                  medicinal product shall be obliged to notify the
    Member States forthwith of any action taken by him                concerned Member States forthwith of any action
    to suspend the marketing of a product or to                       taken by him to suspend the marketing of a
    withdraw a product from the market, together with                 medicinal product or to withdraw it from the market
    the reasons for such action. Member States shall                  together with the reasons for such action. Member
    ensure that this information is brought to the                    States shall ensure that this information is brought to
    attention of the Committee forthwith.                             the attention of the committee forthwith.
    3.    Member States shall ensure that appropriate                 3.    Unchanged
    information about actions taken pursuant to para-
    graphs 1 and 2 which may effect the protection of
    public health in third countries is forthwith brought
    to the attention of the World Health Organization
    with a copy to the Committee.'
                                                                      4.    The Commission shall publish an annual list of
                                                                      medicinal products prohibited in the Community or
                                                                      subject to special restrictions in more than three
                                                                      Member States.'
10. The first paragraph of Article 34 is hereby amended           10. The first paragraph of Article 34 is hereby amended
    as follows:                                                       as follows:
    'This Directive shall apply to medicinal products for             'This Directive shall apply to medicinal products for
    human use in the form of proprietary medicinal                    human use within the limits mentioned in Article 2 of
    products or ready-made medicinal products to the                  Directive 65/65/EEC, as amended.'
    exclusion of medicinal products which are prepared
    extemporaneously in an individual pharmacy for
    individual patients.'
11. With the exception of the first paragraph of Article          11. Deleted
     34, all references to 'proprietary medicinal product'
     or to 'proprietary product' shall be replaced by
     'medicinal product'.
                          Article 4                                                         Article 4
1.    Member States shall take the measures necessary to          Unchanged
comply with this Directive not later than 1 January 1991.
They shall forthwith inform the Commission thereof.
2.    Requests for marketing authorization lodged after
the time limit referred to in the first paragraph must
comply with the provisions of this Directive.
3.    Articles 1, 2 and 3 of this Directive, where relevant,
shall be progressively extended to existing medicinal
products before 31 December 1992.
                          Article 5                                                         Article 5
This Directive is addressed to the Member States.                 Unchanged