# Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Division 6: Documentation for applications in exceptional circumstances

Extent: E+W+S+N.I.

A marketing authorisation may be granted subject to certain specific obligations requiring the applicant to introduce specific procedures, in particular concerning the safety and efficacy of the veterinary medicinal product, when, as provided for in Article 26(3) of this Directive, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use.
The identification of essential requirements for all applications mentioned in this section should be subject to guidelines which shall be adopted by the Agency.

---
Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/6 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-III/division-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.