Keywords
Summary

Keywords

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1. Preliminary rulings ° Jurisdiction of the Court ° Interpretation of Community law ° Amendment of the national legislation in point before the national court after the reference ° No effect

(EEC Treaty, Art. 177)

2. Approximation of laws ° Proprietary medicinal products ° Authorization to place on the market ° Suspension or revocation of authorization ° Grounds laid down by Community law ° Exclusive nature ° Power of national authorities to provide for authorizations to lapse ° None

(Council Directive 65/65, Art. 21)

Summary

1. Article 177 of the Treaty confers jurisdiction on the Court to interpret Community law and therefore changes in the national legislation in point before the national court after the order making the reference cannot influence that interpretation.

2. Article 21 of Directive 65/65 relating to proprietary medicinal products must be interpreted as meaning that the suspension or revocation of an authorization to market medicinal products may be decided only on the grounds laid down by that directive or other applicable provisions of Community law.

The provisions of the aforesaid directive, as amended, also preclude national authorities not only from introducing grounds for suspension or revocation other than those laid down by Community law but also from providing for the lapse of authorizations to market medicinal products, the effects of such lapse being the same as those of revocation since in both cases an existing authorization is terminated.