Europa Point (8)(a)(ii) of the second paragraph of Article 4 of Directive 65/65 concerning proprietary medicinal products, as amended by Directive 87/21, which establishes in certain circumstances an abridged procedure for the issue of marketing authorization for proprietary medicinal products and lays down the conditions under which recourse may be had to that procedure, must, having regard both to the fundamental objective of the directive, which is to safeguard public health, and to the need to ensure that recourse to simplified procedures for marketing products similar to those already authorized does not result in damage to the interests of innovative firms, be interpreted as meaning that a national authority with competence to issue national marketing authorization cannot have discretion to issue authorization under the abridged procedure when the abovementioned conditions have not been satisfied. That means that such authorization may not be issued where the particulars and documents submitted in support of an application do not contain detailed references to published scientific literature presented in accordance with each of the requirements laid down in Parts 2 and 3 of the Annex to Directive 75/318 concerning analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products, and where those documents do not comprise experts’ reports complying with each of the requirements laid down in Articles 1 and 2 of Directive 75/319 concerning proprietary medicinal products.
Citations:
C-440/93, [1995] EUECJ C-440/93
Links:
European, Health
Updated: 03 June 2022; Ref: scu.161220
