C-283/97
ECLI:EU:C:1998:324
- Súd
- Súdny dvor Európskej únie
- IČS
- 61997CC0283
- Zdroj
- eur-lex.europa.eu ↗
OPINION OF MR SAGGIO — CASE C-283/97
OPINION OF ADVOCATE GENERAL SAGGIO delivered on 25 June 1998 *
1. O n 1 August 1997, the Commission of the law and had no information to show that the European Communities brought an action Kingdom of Belgium had fulfilled its obliga- under Article 169 of the EC Treaty for a dec- tion to comply with the provisions of the laration that, by failing to adopt the laws, Directive, on 10 February 1994, under the regulations and administrative provisions nec- procedure provided for by Article 169 of the essary to comply with Council Directive Treaty, the Commission called upon that State 92/73/EEC of 22 September 1992 widening to submit its observations within a period of the scope of Directives 65/65/EEC and two months. 75/319/EEC on the approximation of provi- sions laid down by law, regulation or admin- istrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products (hereinafter 'the Directive'), ! the Kingdom of Belgium has failed to fulfil its obligations under the EC Treaty and the Directive. 4. By letter of 12 June 1995 from the Belgian permanent representation to the European Union, the Belgian authorities informed the Commission that measures to transpose the Directive were being prepared.
2. Under the first subparagraph of Article 10(1) of the Directive, Member States were to take the measures necessary to comply with the Directive by 31 December 1993 and forth- with to inform the Commission thereof. 5. As it had received no further information on the adoption of such measures, the Com- mission, by letter of 4 March 1997, sent a rea- soned opinion to the Kingdom of Belgium, in which it expressed the view that, by failing to adopt the laws, regulations and administrative provisions necessary to comply with the Directive, the Kingdom of Belgium had failed 3. Since it had not received any communica- to fulfil its obligations under the Directive. tion from the Belgian Government relating to The Commission also called on the Kingdom the transposition of the Directive into Belgian of Belgium, pursuant to the second paragraph of Article 169 of the Treaty, to take the mea- sures necessary to comply with that reasoned * Original language: Italian. opinion within two months of its notifica- 1 — OJ 1992 L 297, p. 8. tion.
I - 6082
COMMISSION v BELGIUM
6. O n 29 April 1997 the Belgian authorities a draft Royal Decree concerning the registra- sent the Commission the draft Royal Decree tion of medicines and containing provisions which contained provisions implementing the implementing the Directive was sent to the Directive. Conseil d'État in May 1997 and was thus awaiting the opinion of that body.
7. In its application the Commission points out that since, according to settled case-law, 9. In the light of the evidence put forward by the Member States to whom a directive is the parties I consider that the application addressed are obliged to bring their domestic brought by the Commission is well founded. legislation into line with the provisions of The Kingdom of Belgium has not imple- that directive within the period prescribed mented the provisions of the Directive within therein and may not plead provisions, prac- the period prescribed by Article 10 thereof. tices or circumstances existing in their internal legal systems in order to justify a failure to comply with the obligations and time-limits laid down in Community directives, the defen- dant State has failed to fulfil its obligations Moreover, it must be borne in mind that, under the Directive inasmuch as on expiry of according to consistent case-law, the fact that the period prescribed by the Directive it had the procedure for transposing the Directive not adopted any measures to implement the was in progress, as argued by the defendant provisions thereof. government, does not mean that the applica- tion is unfounded or devoid of purpose since 'the question whether a Member State has failed to fulfil its obligations must be deter- mined by reference to the situation prevailing 8. In its defence the Kingdom of Belgium in the Member State at the end of the period does not dispute that it had failed to adopt laid down in the reasoned opinion, and sub- the domestic provisions necessary to imple- sequent changes cannot be taken into ment the Directive. It merely points out that account'. 2
10. I n the light of the foregoing observations, I p r o p o s e t h a t the C o u r t s h o u l d :
(1) declare that, b y failing t o a d o p t t h e laws, regulations and administrative p r o v i - sions necessary t o c o m p l y w i t h C o u n c i l Directive 9 2 / 7 3 / E E C of 22 S e p t e m b e r
2 — Sec, most recently, Joined Cues C-232/95 and C-233/95 Commission v Greeca [1998] ECR I-3343.
I - 6083
OPINION OF MR SAGGIO — CASE C-283/97
1992 widening 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 medicinal products and laying down additional provisions on homeopathic medicinal products the Kingdom of Belgium has failed to fulfil its obligations under the Directive;
(2) order the Kingdom of Belgium to pay the costs.
I - 6084