Division 4
United Kingdom
The manufacturing process shall comply with the requirements of Commission Directive 91/412/EECf1 laying down the principles and guidelines for veterinary medicinal products and with the principles and guidelines on Good Manufacturing Practice (GMP), published by the Commission in The rules governing medicinal products in the European Union, Volume 4.
Annotations
Footnotes
Notes on Annex II
Footnotes
- f1
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This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.