# 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 B: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

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

The applicant shall propose a summary of the product characteristics, in accordance with Article 14.
A proposed labelling text for the immediate and outer packaging shall be provided in accordance with Title V of this Directive, together with a package leaflet where one is required pursuant to Article 61. In addition the applicant shall provide one or more specimens or mock-ups of the final presentation(s) of the veterinary medicinal product in at least one of the official languages of the European Union; the mock-up may be provided in black and white and electronically where prior agreement from the competent authority has been obtained.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/1/division/B (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-1/division-B
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.