In its judgement of 10 December 2002, the Court of First Instance annulled the decision of 1st March 2000, that had refused to vary the name and package layout of a centrally authorised medicine.
The reason for the annulment is that the decision was not sufficiently motivated. On the merits, the Court states that the letter and spirit of Regulation 2309/93 suggests that a Community marketing authorisation will contain as a general rule only one name.
That name can be varied by adding another name only where the marketing authorisation holder demonstrates that this is rendered necessary by exceptional circumstances which may adversely affect public health and where the Commission has ascertained that the variation applied for satisfies the criteria of the quality, safety and efficacy of the medicinal product.
