CELEX: 51984PC0437(01)
Language: en
Date: 1984-09-25
Title: 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

5. 11. 84        (                   Official Journal of the European Communities                           No C 293/1
                                                             II
                                                     (Preparatory Acts)
                                               COMMISSION
             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(84)     437final
                           (Submitted by the Commission to the Council on 3 October 1984)
                                                       (84/C 293/01)
THE COUNCIL OF THE EUROPEAN                                       national decisions relating to the placing on the
COMMUNITIES,                                                      market of proprietary medicinal products for human
                                                                  use; whereas pharmaceutical firms may, according
                                                                  to these provisions, request a Member State to take
Having regard to the Treaty establishing the Euro-
                                                                  due account of an authorization already issued by
pean Economic Community, and in particular
                                                                  another Member State;
Article 100 thereof,
Having regard to the proposal from the Commis-                    Whereas Council Directive 81/851 / E E C of 28 Sep-
sion,                                                             tember 1981 on the approximation of the laws of the
                                                                   Member States relating to veterinary medicinal
Having regard to the opinion of the European Par-                  products (3) makes provision for a procedure for
                                                                   coordinating national decisions relating to veteri-
liament,
                                                                   nary medicines;
Having regard to the opinion of the Economic and
Social Committee,
                                                                  Whereas, however, these procedures are not suffi-
                                                                  cient to open up to high-technology medicinal prod-
                                                                  ucts the large Community-wide single market which
Whereas 'high-technology' medicinal products                      they require;
requiring lengthy periods of costly research will con-
tinue to be developed in Europe only if they benefit
from a favourable regulatory environment, particu-
larly identical conditions governing their placing on             Whereas, in this technically advanced sector, the
the market throughout the Community;                              scientific expertise available to each of the national
                                                                  authorities is not always sufficient to resolve prob-
                                                                  lems posed by high-technology medicinal products;
Whereas Council Directive 75/319/EEC of 20 May
 1975 on the approximation of provisions laid down
by law, regulation or administrative action relating              Whereas it is consequently important to provide for
to proprietary medicinal products ('), as last                    a Community mechanism for concertation, prior to
amended by Directive 83/570/EEC (2), makes prov-                  any national decision relating to a high-technology
ision for certain procedures for coordinating                     medicinal product, with a view to arriving at uni-
                                                                   form decisions throughout the Community;
 (>) OJ No L 147, 9. 6. 1975, p. 13.
 0 OJNoL332, 28. 11. 1983, p. 1.                                   (3) OJ No L 317, 6. 11. 1981, p. 1.
 ---pagebreak--- No C 293/2                          Official Journal of the European Communities                                5. 11. 84
Whereas it is desirable to extend this Community               developed by means of the new biotechnological
concertation to immunological products and substi-             processes mentioned in part A of the Annex, the
tutes for blood constituents developed by means of             competent authorities shall be required to bring the
new biotechnological processes, and to new prod-               matter before either the Committee for Proprietary
ucts based on radioisotopes, the development of                Medicinal Products or the Committee for Veterinary
which in Europe can only take place if a sufficiently          Medicinal Products, as appropriate, for an opinion.
large and homogeneous market exists;                           This requirement shall also apply for the other
                                                               high-technology medicinal products listed in part B
                                                               of the Annex, provided that the person responsible
Whereas the necessity for the adoption of new tech-            for placing the product on the market has expressly
nical rules applying to high-technology medicinal              requested the competent authority concerned to
products or for the amendment of existing rules                refer the matter and has sent a copy of the request to
must be examined during a preliminary concertation             the Committee concerned.
between the Member States and the Commission
within the competent Committees so as not to
endanger the advance of pharmaceutical research                2. Where the Committee has, in accordance with
whilst at the same time ensuring optimal protection            the provisions of this Directive, issued an opinion
of public health within the Community,                         favourable to the placing on the market of a high-
                                                               technology medicinal product, the competent
                                                               authorities shall bring the matter before the Com-
                                                               mittee for a new opinion before deciding on the sus-
                                                               pension or withdrawal of the marketing authoriza-
                                                               tion for the medicinal product in question.
HAS ADOPTED THIS DIRECTIVE:
                         Article 1                             3. Questions relating to medicinal products for
                                                               human use, including the medicinal products
                                                               referred to in the second paragraph of Article 34 of
 1. The Member States shall intensify coordination
                                                               Directive 75/319/EEC, shall be brought before the
in respect of national measures relating to the plac-
                                                               Committee for Proprietary Medicinal Products set
ing on the market of medicinal products within the
                                                               up by that Directive.
 meaning of Article 1 of Council Directive 6 5 / 6 5 /
 EEC of 26 January 1965 on the approximation of
 provisions laid down by law, regulation or adminis-           Questions relating to veterinary medicinal products,
trative action relating to proprietary medicinal prod-         including those referred to in the second and third
 ucts (') in order to create a regulatory environment          indents of Article 2 (2) of Directive 81/851/EEC
 favourable to the development of pharmaceutical               shall be brought before the Committee for Veteri-
 research in Europe, particularly in the field of bio-         nary Medicinal Products set up by that Directive.
 technology.
 2. Before taking a decision on the authorization,
 suspension or withdrawal from the market of a                                          Article 3
 'high-technology' medicinal product, the authorities
 of the Member States shall, in accordance with the             1. The representative of the Member State which
 provisions of Articles 2 to 5, refer the matter for an         initiated the procedure referred to in Article 2 shall
 opinion to the Committees mentioned in Article 12              act as rapporteur throughout the procedure. In this
 of Directive 75/319/EEC and Article 22 of Direc-               capacity, he shall ensure that there is close liais.on
 tive 81/851/EEC.                                               between the Committee in question and the com-
                                                                petent authorities concerned and shall provide all
                                                                information relevant to the evaluation of the medi-
  3. The provisions of paragraph 2 shall apply to the           cinal product. The information thus disclosed shall
  medicinal products listed in the Annex.                       be strictly confidential.
                                                                2. When placing the matter before the Committee,
                                                                the Member State concerned must forward to it at
                          Article 2                             least:
                                                                — a summary of the product characteristics, as
  1. As soon as they receive an application for mar-                 described in Article 4a of Directive 6 5 / 6 5 / E E C ,
  keting authorization relating to a medicinal product               or an equivalent document provided by the
                                                                     applicant if a medicinal product referred to in
                                                                     the second paragraph of Directive 75/319/EEC
 (>) OJ No 22, 9. 6. 1965, p. 369/65.                                 or a veterinary medicinal product is involved,
 ---pagebreak--- 5. 11.84                               Official Journal of the European Communities                          No C 293/3
— a summary of the documents contained in the                     waiting for the opinion of the Committee provided
     file on the marketing authorization for the medi-            that they forthwith inform the Committee thereof,
     cinal product in question.                                   indicating the reasons for the suspension and justi-
                                                                  fying the urgency of this measure.
3. Where they exist, evaluation reports and drug-
monitoring reports relating to the same medicinal                 3. The opinion of the Committee, which shall be
product shall be forwarded to the Committee by the                adopted by an absolute majority of the members
authorities of the Member States which drew them                  present, shall concern the conditions under which
up.                                                               the marketing authorization should be granted or
                                                                  the reasons for which that authorization may be
4. The person responsible for placing the medi-                   refused, suspended or withdrawn.
cinal product in question on the market shall
immediately be informed of the referral to the Com-               4. The Committee shall      forthwith inform the Mem-
mittee. He may, at his own request, provide the                   ber State concerned and      the person responsible for
Committee with oral or written explanations and                   placing the product on      the market of its opinion
forward to it any documents that he judges to be rel-             and, if necessary, of        any dissenting opinions
 evant.                                                           expressed.
 5. In order to speed up the examination of scien-                5. The Member State concerned shall reach a deci-
tific and technical questions, the Committee, in                  sion on the action it intends to take following the
 agreement with the Commission, may assign certain                Committee's opinion not later than 30 days after
 preparatory tasks to an ad hoc group of experts or to            receipt of the information provided for in para-
 highly qualified outside consultants. The members                graph 4. It shall forthwith inform the Committee of
 of the Committee, the experts and the outside con-                its decision.
 sultants shall be obliged, even after their duties have
 ceased, not to disclose information which, by its                                         Article 5
 nature, is covered by the obligation of professional
 secrecy.
                                                                   Subject to the application of other Community
                                                                   provisions, the Member States shall communicate to
                                                                  the Commission and delay the adoption of draft
                                                                   technical regulations relating to the production,
                             Article 4
                                                                   marketing or use of the medicinal products referred
                                                                   to in Article 1 of this Directive, in accordance with
 1. When the questions referred to it relate to an                 the provisions of Articles 8 and 9 of Council Direc-
 application for marketing authorization, the Com-                 tive 83/189/EEC of 28 March 1983 laying down a
 mittee shall issue its opinion 30 days before the                 procedure for the provision of information in the
 expiry of the time limits provided for in Article 7 of            field of technical standards and regulations (').
 Directive 6 5 / 6 5 / E E C and Article 4 (c) of Directive
 75/319/EEC, or in Articles 8 and 9 (3) of Directive
 81/851/EEC, as appropriate. To this end, the Mem-                                         Article 6
 ber State which referred the matter shall inform the
 Committee without delay of any extension and of                    Member States shall take the measures necessary to
 the beginning and end of any suspension of the time                comply with this Directive no later than 1 July
 limits concerned.                                                  1985. They shall forthwith inform the Commission
                                                                    thereof.
 2. When a proposal to suspend or withdraw a mar-
 keting authorization is referred to it, the Committee                                     Article 7
 shall fix an appropriate time limit for issuing its rea-
 soned opinion, having regard to the requirements
                                                                    This Directive is addressed to the Member States.
  for the protection of public health. However, in
  cases of urgency, the Member States may suspend
  the marketing authorization in question without                    (') OJNoL109, 24. 4. 1983, p. 8.
 ---pagebreak---  No C 293/4                         Official Journal of the European Communities                            5. 11. 84
                                                          ANNEX
                              LIST OF HIGH-TECHNOLOGY' MEDICINAL PRODUCTS
              A. Medicinal products developed by means of new biotechnological processes
                  which make use of genetic recombination, hybridoma technology, aneuploid cell strains and
                  enzyme bioreactors.
                  For example:
                  — new vaccines, particularly synthetic vaccines,
                  — new antibiotics,
                  — interferons,
                  — immunotoxins,
                  — hormones, particularly peptide hormones (human insulin; growth hormone),
                  — monoclonal antibodies and DNA hybridization probes used in vivo,
                  — enzymes such as urokinase,
                  — blood proteins or substitutes thereof: alpha I, antitrypsin, human seralbumin, factor
                      VIII, etc.
              B.  Other high-technology medicinal products
                  — Medicinal products administered by means of new delivery systems which constitute a
                      major innovation: transcutaneous systems, encapsulation in liposomes or polymers,
                      drug targeting systems, etc.
                  — Medicinal products containing a new substance claimed to be of major therapeutic
                      interest.
                  — New medicinal products based on radioisotopes.
                  — Medicinal products the manufacture of which is based upon an advanced technique
                      such as two-dimensional electrophoresis under gravity or microgravity.
             Proposal for a Council Directive amending Directive 75/318/EEC on 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
                                                   COM(84)     437final
                          (Submitted by the Commission to the Council on 3 October 1984)
                                                     (84/C 293/02)
THE COUNCIL OF THE EUROPEAN                                     Having regard to the opinion of the Economic and
COMMUNITIES,                                                    Social Committee;
Having regard to the Treaty establishing the Euro-
pean Economic Community, and in particular
Article 100 thereof;
Having regard to the proposal from the Commis-
sion;                                                           Whereas the testing of proprietary medicinal prod-
                                                                ucts must regularly be adapted to scientific and
Having regard to the opinion of the European Par-               technical progress in order to ensure optimum pro-
liament;                                                        tection of public health in the Community;