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DIRECTIVE 87/21/EEC |
Council Directive 87/21/EEC of
Official Journal L 015 ,
Finnish special edition....: Chapter 13 Volume 16 p. 93
Swedish special edition...: Chapter 13 Volume 16 p. 93
COUNCIL DIRECTIVE
of
THE COUNCIL OF THE EUROPEAN
COMMUNITIES,
Having regard to the Treaty establishing the
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas point 8 of the second paragraph of Article 4 of Council Directive
65/65/EEC (4), as last amended by Directive 83/570/EEC (5), provides that
various types of proof of the safety and efficacy of a proprietary medicinal
product may be put forward in an application for marketing authorization
depending upon the objective situation of the proprietary medicinal product in
question;
Whereas experience has shown that it is advisable to stipulate more precisely
the cases in which the results of pharmacological and toxicological tests or
clinical trials do not have to be provided with a view to obtaining
authorization for a proprietary medicinal product which is essentially similar
to an authorized product, while ensuring that innovative firms are not placed
at a disadvantage;
Whereas additional details were provided in respect of the application of the
abovementioned provision by Council Directive 75/318/EEC of 20 May 1975 on 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 (6), as last amended by Directive
87/19/EEC (7);
Whereas, however, there are reasons of public policy for not conducting
repetitive tests on humans or animals without over-riding cause;
Whereas it is also advisable to make the packaging of certain proprietary
medicinal products, particularly sought after by drug addicts, less distinctive
by removing the obligation to place a special mark on the outer packaging and
the container of proprietary medicinal products classified as narcotics;
Whereas the Hellenic Republic, the Kingdom of Spain and the Portuguese Republic
should have additional time to transpose this Directive so that they may as a
priority complete the review of old proprietary medicinal products as provided
for in Article 39 of the Council Directive 75/319/EEC of 20 May 1975 on the
approximation of provisions laid down by law, regulation or administrative
action relating to proprietary medicinal products (8) as last amended by
Directive 83/570/EEC,
HAS ADOPTED THIS DIRECTIVE:
Article
1
Directive 65/65/EEC is hereby amended as follows:
1. Point 8 of the second paragraph of Article 4 shall be replaced by the
following text:
'8. Results of:
-
physico-chemical,
biological or microbiological tests,
-
pharmacological
and toxicological tests,
-
clinical trials.
However, and without prejudice to the law
relating to the protection of industrial and commercial property:
(a)
The
applicant shall not be required to provide the results of pharmacological and
toxicological tests or the results of clinical trials if he can demonstrate:
either that the proprietary medicinal product
is essentially similar to a product authorized in the country concerned by the
application and that the person responsible for the marketing of the original
proprietary medicinal product has consented to the pharmacological,
toxicological or clinical references contained in the file on the original proprietary
medicinal product being used for the purpose of examining the application in
question;
or by detailed references to published
scientific literature presented in accordance with the second paragraph of
Article 1 of Directive 75/318/EEC that the constituent or constituents of the
proprietary medicinal product have a well established medicinal use, with
recognized efficacy and an acceptable level of safety;
or that the proprietary medicinal product is
essentially similar to a product which has been authorized within the
Community, in accordance with Community provisions in force, for not less than
six years and is marketed in the Member State for which the application is
made; this period shall be extended to 10 years in the case of high-technology
medicinal products within the meaning of Part A in the Annex to Directive
87/22/EEC (1) or of a medicinal product within the meaning of Part B in the
Annex to that Directive for which the procedure laid down in Article 2 thereof
has been followed; furthermore, a Member State may also extend this period to
10 years by a single Decision covering all the products marketed on its
territory where it considers this necessary in the interest of public health.
Member States are at liberty not to apply the abovementioned six-year period
beyond the date of expiry of a patent protecting the original product.
However, where the proprietary medicinal product is intended for a different
therapeutic use from that of the other proprietary medicinal products marketed
or is to be administered by different routes or in different doses, the results
of appropriate pharmacological and toxicological tests and/or of appropriate
clinical trials must be provided.
(b) In
the case of new proprietary medicinal products containing known constituents
not hitherto used in combination for therapeutic purposes, the results of
pharmacological and toxicological tests and of clinical trials relating to that
combination must be provided, but it shall not be necessary to provide
references relating to each individual constituent. (1) OJ No L 15, 17. 1.
1987, p. 38.';
2. Article 16 is hereby repealed.
Article
2
Member States shall take the measures necessary to comply with this Directive
no later than
However, with regard to the
Article
3
This Directive is addressed to the Member States.
Done at
For the Council
The President
G. SHAW
(1) OJ No C 293, 5. 11. 1984, p. 8.
(2) OJ No C 36, 17. 2. 1986, p. 152.
(3) OJ No C 160, 1. 7. 1985, p. 18.
(4) OJ No 22, 9. 2. 1965, p. 369/65.
(5) OJ No L 332, 28. 11. 1983, p. 1.
(6) OJ No L 147, 9. 6. 1975, p. 1.
(7) See page 31 of this Official Journal.
(8) OJ No L 147, 9. 6. 1975, p. 13.
End of the document