Judgment_paragraph 191 · Pharmaceutical Works Polpharma S.A. v European Medicines Agency (T-611/18)

191Point 8(b) of the second paragraph of Article 4 of Directive 65/65, in the version resulting from Council Directive 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36), provided that, ‘in the case of new proprietary medicinal products containing known constituents not hitherto used in combination for therapeutic purposes, the results of pharmacological and toxicological tests and of clinical trials relating to that combination [had to] be provided, but it [was not] necessary to provide references relating to each individual constituent’.

Pharmaceutical Works Polpharma S.A. v European Medicines Agency (T-611/18)

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