Keywords

Summary



Keywords

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1. Actions against Member States for failure to fulfil obligations ° Commission' s right of action ° Time-limit for exercising that right ° Absence ° Discretion to choose when to initiate proceedings

(EEC Treaty, Art. 169)

2. Free movement of goods ° Quantitative restrictions ° Measures having equivalent effect ° National rules restricting to two a year the expiry dates which may be indicated on the packaging of medicinal products and certain medical instruments ° Not permissible ° Justification ° Protection of public health ° Absence

(EEC Treaty, Art. 30)

3. Approximation of laws ° Information procedure in the field of technical rules and regulations ° Obligation for Member States to communicate to the Commission any draft technical regulation ° Failure to notify the extension of an existing regulation to a new product ° Failure to fulfil obligations

(Council Directive 83/189, Arts 1(5) and 8(1))

Summary

1. In proceedings under Article 169 of the Treaty, it is for the Commission to judge at what time it will bring an action for failure to fulfil obligations; the considerations which determine its choice of time cannot affect the admissibility of the action.

That being so, the fact that no action was taken by the Commission further to the reasoned opinion, either immediately or shortly afterwards, and that the subject of the failure to fulfil obligations was not formally raised at a bilateral meeting held during the interval between the reasoned opinion and the initiation of proceedings, cannot confer on the Member State concerned a legitimate expectation that the procedure was at an end.

Furthermore, the right to choose the time for bringing an action is not affected by the fact that negotiations are in progress within the Council to harmonize national rules in the field in question; in any event such negotiations do not exempt the Member States from compliance with the applicable Community provisions so long as the provisions under discussion have not entered into force.

2. A Member State which restricts to two a year (30 June and 31 December) the expiry dates which may be shown on the packaging of medicinal products and non-reusable sterile medical instruments has failed to fulfil its obligations under Article 30 of the Treaty.

Without prejudice to the question of the costs which may be involved in altering the packaging of products exported to that State, such a measure relating to the conditions to be satisfied by products is likely to affect intra-Community trade in so far as it may reduce the period of marketing of imported products. For that reason, it constitutes a measure having equivalent effect to a quantitative restriction, notwithstanding the fact that it may correspond to a national practice, since it constitutes, per se, the expression of an obligation which requires importers to alter expiry dates.

Such a barrier cannot be justified on grounds of protecting public health, since, on the one hand, the mere advancing of an expiry date thus imposed does not constitute, per se, a measure capable of achieving that objective, and on the other, although the standardization of expiry dates makes it easier to sort products, the resulting economic advantages for traders do not constitute a ground of justification recognized in Community law.

3. A Member State fails to fulfil its obligations, under Articles 1(5) and 8(1) of Directive 83/189 laying down a procedure for the provision of information in the field of technical standards and regulations, to communicate to the Commission forthwith any draft technical specifications, the observance of which is compulsory in the case of the marketing or use of a product in a major part of its territory, where it fails to notify to the Commission a draft regulation extending to non-reusable sterile medical instruments the requirements relating to labelling of medicinal products, so that such instruments may henceforth be marketed or used in that Member State only if certain obligations are fulfilled the application of which was formerly confined to medicinal products.