The Queen v Licensing Authority of the Department of Health and Norgine Ltd, ex parte Scotia Pharmaceuticals Ltd (C-440/93)

Judgment of 5 Oct 1995

law://eu/cjeu/1993/c-440-93/para_17@2026-11-14

17The abridged procedure in no way relaxes the requirements of safety and efficacy which must be met by medicinal products but is merely intended to shorten the period for preparing an application for authorization by freeing the applicant from the obligation to carry out the tests specified in point (8) of the second paragraph of Article 4. However, that obligation is replaced by the obligation to demonstrate by detailed references to published scientific literature that the tests Usted in the Annex to Directive 75/318 were carried out previously and showed that the constituent or constituents of the medicinal product satisfied the criteria referred to in Article 4.

The Queen v Licensing Authority of the Department of Health and Norgine Ltd, ex parte Scotia Pharmaceuticals Ltd (C-440/93)

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