CELEX: 51987PC0697(04)
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 RADIOPHARMACEUTICALS

No C 36/30                                Official Journal of the European Communities                                         8. 2. 88
               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 radiopharmaceuticals
                                                         COM(87) 697 final
                                (Submitted by the Commission to the Council on 12 January 1988)
                                                            (88/C 36/05)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             radiopharmaceuticals in their finished form which are made
                                                                      up exclusively from authorized kits, generators or precursor
 Having regard to the Treaty establishing the European                radiopharmaceuticals in health care establishments;
 Economic Community, and in particular Article 100A
thereof,                                                              Whereas the Commission should be empowered to adopt any
                                                                      necessary changes in the requirements for the testing of
Having regard to the proposal from the Commission,                    proprietary medicinal products set out in the Annex to
                                                                      Directive 75/318/EEC of 20 May 1975 on the
In cooperation with the European Parliament,                          approximation of the laws of the Member States relating to
                                                                      analytical, pharmaco-toxicological and clinical standards
Having regard to the opinion of the Economic and Social               and protocols in respect of the testing of proprietary
 Committee,                                                           medicinal products (6), as last amended by Directive
                                                                      87/19/EEC of 22 December 1986 ( 7 ), to take account of the
Whereas disparities in the provisions currently laid down by          special nature of radiopharmaceuticals in close cooperation
law, regulation or administrative action by Member States             with the Committee for the Adaptation to Technical Progress
may hinder trade in radiopharmaceuticals within the                   of the Directives on the Removal of Technical Barriers to
Community;                                                            Trade in the Proprietary Medicinal Products Sector;
Whereas the essential aim of any rules governing the
                                                                      Whereas any rules governing radiopharmaceuticals must
production, distribution or use of medicinal products must
                                                                      take into account the provisions of Directive
be to ensure a high level of protection of public health;
                                                                      84/466/Euratom of 3 September 1984 laying down basic
                                                                      measures for the radiation protection of persons undergoing
Whereas the provisions laid down by Directive
                                                                      medical examination or treatment (8); whereas account
65/65/EEC (l),        as last       amended      by    Directive      should also be taken of Directive 80/836/Euratom (9) which
87/21/EEC ( 2 ), and Second Directive 75/319/EEC (3), as              amends the Directives laying down the basic safety standards
last amended by Directive 83/570/EEC ( 4 ), on the                    for the health protection of the general public and workers
approximation of provisions laid down by law, regulation or           against the dangers of ionizing radiation ( 9 ), as last amended
administrative action relating to proprietary medicinal               by Council Directive 84/467/Euratom of 3 September
products, although appropriate are inadequate for                     1984 ( 10 ), the objective of which is to prevent the exposure of
radiopharmaceuticals;                                                workers or patients to excessive or unnecessarily high levels
                                                                      of ionizing radiation, and in particular oi Article 5c thereof,
Whereas, in accordance with Article 5 of Directive                    which requires prior authorization for the addition of
87/22/EEC (5) on the approximation of national provisions            radioactive substances to medicinal products as well as for
relating to the placing on the market of high technology              the importation of such medicinal products,
medicinal products, particularly those derived from
biotechnology, the Commission is required to submit
proposals to harmonize, along the lines of Directive
75/319/EEC, the conditions for authorizing the
                                                                      HAS ADOPTED THIS DIRECTIVE:
manufacture       and    placing     on    the     market     of
radiopharmaceuticals before 22 December 1987;
Whereas in the case of radiopharmaceuticals authorization
                                                                                                   Article 1
should     be     required     for    industrially     prepared
radiopharmaceuticals, generators, kits and precursor
radiopharmaceuticals; whereas, however, a separate                    1.    In derogation from Article 34 of Directive
authorization       should      not     be     required      for      75/319/EEC and subject to the provisions of this Directive,
H   OJ No  22, 9. 2. 1965, p. 369/65.                                  («) OJNoL 147,9.6. 1975, p. 1.
(2) OJ No  L 15, 17. 1. 1987, p. 36.                                   (7) OJ No L 15, 17. 1. 1987, p. 31.
(3) OJ No  L 147, 9. 6. 1975, p. 13.                                   (8) OJ No L 265, 5. 10. 1984, p. 1.
(4) OJ No  L 332, 28. 11. 1983, p. 1.                                  (") OJ No L 246, 17. 9. 1980, p. 1.
(5) OJ No  L 15, 17. 1. 1987, p. 38.                                  (10) OJ No L 265, 5. 10. 1984, p. 4.
 ---pagebreak---  ^        ^                                                  Official journal of the European Communities                                           l^oC^^l
 the provisions of U i ^ e c t i v e ^ ^ ^ ^ E C a n d ^ ^ l ^ ^ E C                                                        Ar^^^
 shall apply to radiopharmaceuticals for human use^
 e^cludin^ radionuclides in the form of sealed sources.
                                                                                        Por radiopharmaceuticals^ in addition to themformation
                                                                                        referred to in Article ^a of Uirective De^DBoBPPC^ the
 ^.     Por the purposes of this lOirective^ the following                              summary of product characteristics referred to in p o m t ^ o f
 definitions shall apply^                                                               the second paragraph of A r t i c l e ^ o f P o i r e c t i v e ^ ^ ^ ^ P P C
                                                                                        shall contain the following additional p o m t s ^ a n d ^
 — aeadiopharmaceuticaf shall mean any medicinal product
     which^ when ready for use^ contains one or more                                         ^.         full details of radiation dosimetry^
     radionuclides ^radioactive isotopes^ included for a
     medicinal purposed                                                                      ^.        additional detailed instructions for preparations
                                                                                             and where appropriated maximum storage time during
— ^enerator^ shall mean any system mcorporatm^afi^ed                                        which any intermediate preparation such as an eluate or
     parent radionuclide from which is producedadau^hter                                    the ready t o u s e pharmaceutical willconformwithits
     radionuclide which is to he removed hyelution and used                                  specificationsB
     maradiopharmaceutical^
— ^iC shall mean any industrial preparation to he
     reconstituted or combined with radionuclides in the                                                                    Ar^^^
     final radiopharmaceuticals usually prior to its
     administrations
                                                                                        Idie outer carton and the tin of medicinal products
— ^precursor radiopharmaceuticals shall mean any other                                  contamm^radionuclides shall be labelled in accordance with
     mdustriallyproducedradionuchdefortheradiolahellin^                                 the regulations forthe safe transport of radioactive materials
    of another substance pTior to administration.                                       laid down by the International Atomic Pner^y Agency,
                                                                                        ^loreover^ the labelling shall comply with the following
                                                                                        provisions^
^.      ^ o t h i n ^ m t h i s U i r e c t i v e s h a l l m a n y waydero^ate
from the Community rules for the radiation protection of                                ^      The label on the shielding shall include the particulars
persons under^oin^medicale^ammationor treatment or                                             mentioned in Article t^3 of directive ^ ^ ^ ^ P P C . In
from the Community ruleslaym^down the basic safety                                             additionmhe labelling on the shielding shall explain in
standards for the health protection of the general public and                                  full thecodm^s used on thevial and shall indicated where
workers against the dangers of loni^in^ radiation.                                             necessary^ for a^iven timeanddate^ the amount of
                                                                                               radioactivity per dose or per vial and thenumber of
                                                                                               capsules or^forhquidsmhe number of milhlitres in the
                                                                                               container.
                                                                                        ^      The vial shall             be labelled    with    the     following
                                                                                               informations
Idie authorisation referred to m Article ^ of directive
D ^ D ^ P P C s h a l l be required for generators'lots^ precursor                             — the name or codeofthe medicinal product including
radiopharmaceuticals                   and           industrially        prepared                    the name or chemical symbol of the radionuclides
radiopharmaceuticals.r^owever^authori^ation shall not be
                                                                                               — the batch identification and expiry date^
required foraradiopharmaceutical in its ready for use form^
if the radiopharmaceutical is prepared by an approved                                          — the international symbol for radioactivity^
person in an approved health care establishment exclusively
                                                                                               — the name of the manufacturers
from       authorised            generators'              l^its or      precursor
radiopharmaceuticals in accordance with the manufacturers                                      — t h e a m o u n t o f radioactivityasspecifiedunder^
instructions.                                                                                        above.
                                      Ar^^^                                                                                 Ar^^^
In addition to the requirements set out m Article ^ of                                  1.       member states shall ensure thatadetailed instruction
directive ^ ^ ^ ^ ^ P P C ^ an application for authorisation to                         leaflet         is      enclosed      with     the     pac^a^m^            of
market a generator shall also contain the following                                     radiopharmaceuticals^ generators' l^its or precursor
information and particulars^                                                            radiopharmaceuticals. The te^t of this leaflet shall be
                                                                                        established in accordance with the provisions of Article^of
— a general description of the system together with a                                   U i r e c t i v e ^ ^ t ^ ^ E E C and shall contain all the information
    detailed description of the components of the system                                referred to therein. In additionmb^ leaflet shall include any
    which may effect the composition or quality of the                                  precautions to be taleenbythe user and the patient durm^the
    daughter nucleid preparations                                                       preparation and administration of the product and special
                                                                                        precautions for the disposal of the container and its unused
— qualitative and quantitative particulars of the eluate.                               contents.
 ---pagebreak--- No C 36/32                              Official Journal of the European Communities                                     8. 2. 88
2.     Member States shall permit the use of user information                                Article 8
leaflets which have been established in more than one of the
languages of the Community provided that the information           1.     Member States shall take the necessary measures to
contained in all the language versions of the leaflet is           comply with this Directive not later than 1 January 1991.
identical.                                                         They shall forthwith inform the Commission thereof.
                                                                   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 7
                                                                   Directive.
Any amendments which are necessary in the testing                  3.     This Directive shall be progressively extended to
requirements for medicinal products set out in the Annex to        existing medicinal products covered by this Directive before
Directive 75/318/EEC to take account of the extension of           31 December 1992.
the scope of Directives 65/65/EEC and 75/319/EEC to
cover radiopharmaceuticals shall be adopted in accordance
with the procedure laid down in Article 2c of Directive                                      Article 9
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.