# 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 1: Safety of the administration of one dose

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

The immunological veterinary medicinal product shall be administered at the recommended dose and by each recommended route of administration to animals of each species and category in which it is intended for use, including animals of the minimum age of administration. The animals shall be observed and examined for signs of systemic and local reactions. Where appropriate, these studies shall include detailed post-mortem macroscopic and microscopic examinations of the injection site. Other objective criteria shall be recorded, such as rectal temperature and performance measurements.
The animals shall be observed and examined until reactions may no longer be expected, but in all cases, the observation and examination period shall be at least 14 days after administration.
This study may be part of the repeated dose study required under point 3 or omitted if the results of the overdose study required under point 2 have revealed no signs of systemic or local reactions.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-3/division-B/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.