Chapter II MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS

United Kingdom

1. 1General provisions
2. 2Dossier requirements
3. 3Clinical trials
4. 4Labelling and package leaflet
5. 5Specific requirements for generic, hybrid and combination veterinary medicinal products and for applications based on informed consent and bibliographic data
6. 6Marketing authorisations for limited market and in exceptional circumstances
7. 7Examination of applications and basis for granting marketing authorisations
8. 8Protection of technical documentation