C-268/93
ECLI:EU:C:1994:43
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OPINION OF MR DARMON — CASE C-268/93
OPINION OF MR ADVOCATE GENERAL DARMON delivered on 8 February 1994 "
Mr President, 3. Under Article 9, the directive was to be Members of the Court, brought into force by the Member States not later than 1 January 1989, and the Commis sion was to be informed thereof forthwith.
1. In this action, the Court of Justice is asked to declare that, by failing to give notice to the Commission of the laws, regulations 4. Since it had received no notification of and administrative provisions needed to give any measures adopted by the Kingdom of effect to Council Directive 88/320/EEC of 9 Spain to implement the directive, the Com June 1988 on the inspection and verification mission initiated the procedure under Arti of Good Laboratory Practice (GLP), 1 the cle 169 of the Treaty on 4 April 1990 against Kingdom of Spain has failed to fulfil its obli that State. Next, as the letter before action gations under the EEC Treaty. went unanswered, the Commission sent a reasoned opinion on 10 February 1992.
2. The matters covered by the directive are 5. The Kingdom of Spain contends that the 'the inspection and verification of the organi action should be dismissed, and observes that zational processes and the conditions under 'transposition of Directive 88/320/EEC is which laboratory studies are planned, per linked to the transposition of Directive formed, recorded and reported for the non 3 87/18/EEC because the latter constitutes a clinical testing, carried out in accordance measure preliminary to the former in so far with the rules and regulations, of all chemi as the inspection and verification made com cals (e. g. cosmetics, industrial chemicals, pulsory by Directive 88/320/EEC are based medicinal products, food additives, animal on the principles laid down by Direc feed additives, pesticides) in order to assess 4 tive 87/18/EEC'. the effect of such products on man, animals 2 and the environment'.
3 — Council Directive of 18 December 1986 on the harmoniza tion of laws, regulations and administrative provisions relat ing to the application of the principles of good laboratory * Original language: French. practice and the verification of their application for tests on 1 — OJ 1988 L 145, p. 35. chemical substances (OJ 1987 L 15, p . 29). 2 — Article 1 of the directive. 4 — Defence, p . 2 of the French translation.
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COMMISSION v SPAIN
6. The latter directive has just been trans edges that the Directorate-General for Phar posed into national law, and it should be macy of the Ministry of Health and for Con possible to adopt the royal decree transpos sumers is currently malting preparations for ing Directive 88/320 and notify it to the the adoption of a draft decree. Commission 'very shortly'.
9. The Court has consistently held that: 7. Directive 87/18/EEC was to be trans posed by 30 June 1988 and an action was brought against the Kingdom of Spain under Article 169 for failure to comply with that time-limit. 5According to the Commission, '... a Member State may not plead provisions, that directive gave rise to adequate imple practices or circumstances existing in its menting measures adopted by Royal internal legal [or financial] system in order to Decree 822/1993 of 28 May 1993. Following justify a failure to comply with obligations the applicant's withdrawal, the case was and time-limits resulting from Community removed from the register by order of the law ...' 7 President of the Court of 22 September 1993.
10. I would add, for the sake of complete 8. However, it has by no means been shown ness, that a Member State may not justify its that Directive 88/320/EEC, the only one in failure to transpose one directive by its delay question here, has been transposed. On the in adopting measures to implement an earlier contrary, the Kingdom of Spain acknowl directive.
11. It follows that the Commission's claim that the Kingdom of Spain has failed to fulfil its obligations is proved . I propose , therefore, that the Court so declare and order the defendant State to pay the costs.
5 — Case C-294/93. 7 — Judgment in Case C-290/89 Commission v Belgium [1991] 6 — Rejoinder, p. 2 of the French translation. ECR I-2851, paragraph 9.
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