Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
Table Eudralex | ||
Annex 1 |
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Annex 2 |
Manufacture of Biological Medicinal Products for Human Use(30 KB) | |
Annex 3 |
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Annex 4 |
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Annex 5 |
Manufacture of Immunological Veterinary Medicinal Products(43 KB) | |
Annex 6 |
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Annex 7 |
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Annex 8 |
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Annex 9 |
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Annex 10 |
Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation(17 KB) | |
Annex 11 |
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Annex 12 |
Use of Ionising Radiation in the Manufacture of Medicinal Products(50 KB) | |
Annex 13 |
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Annex 14 |
Manufacture of Products derived from Human Blood or Human Plasma(50 KB) - May 2011 | |
Annex 15 |
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Annex 16 |
Certification by a Qualified person and Batch Release(41 KB) Deutsch (de) ελληνικά (el) español (es) français (fr) italiano (it) Nederlands (nl) | |
Annex 17 |
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Annex 19 |