# 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 3: Safety of the repeated administration of one dose

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

In the case of immunological veterinary medicinal products to be administered more than once, as part of the basic vaccination scheme, a study of the repeated administration of one dose shall be required to reveal any adverse effects induced by such administration. These tests shall be carried out on the most sensitive categories of the target species (such as certain breeds, age groups), using each recommended route of administration.
The animals shall be observed and examined for at least 14 days after the last administration for signs of systemic and local reactions. Other objective criteria shall be recorded, such as rectal temperature and performance measurements.

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