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Commission Directive 91/412/EEC of 23 July 1991 laying down… Article 2

Article 2

For the purposes of this Directive, the definition of medicinal products set out in Article 1 (2) of Council Directive 65/65/EEC (6), and the definition of veterinary medicinal products set out in Article 1 (2) of Directive 81/851/EEC, shall apply. In addition, - "manufacturer" shall mean any holder of the authorization referred to in Article 24 of Directive 81/851/EEC, - "qualified person" shall mean the person referred to in Article 29 of Directive 81/851/EEC, (1) OJ No L 317, 6.11.1981, p. 1. (2) OJ No L 373, 31.12.1990, p. 15. (3) OJ No L 373, 31.12.1990, p. 26. (4) OJ No L 317, 6.11.1981, p. 16. (5) OJ No L 15, 17.1.1987, p. 34. (6) OJ No 22, 9.2.1965, p. 369/65. - "pharmaceutical quality assurance" shall mean the sum total of the organized arrangements made with the object of ensuring that veterinary medicinal products are of the quality required for their intended use, - "good manufacturing practice" shall mean the part of quality assurance with ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.

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Other provisions in Commission Directive 91/412/EEC of 23 July 1991 laying down…

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 2 of Commission Directive 91/412/EEC of 23 July 1991 laying down… (LawPlayer, data as of 2026-07-04)

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