Directive 2001/82/EC of the European Parliament and of the CouncilShow full title

[F1 6. Special requirements for live vaccines U.K.

6.1. Spread of the vaccine strain U.K.

Spread of the vaccine strain from vaccinated to unvaccinated target animals shall be investigated, using the recommended route of administration most likely to result in the spread. Moreover, it may be necessary to investigate the spread to non-target animal species which could be highly susceptible to a live vaccine strain.

6.2. Dissemination in the vaccinated animal U.K.

Faeces, urine, milk, eggs, oral, nasal and other secretions shall be tested for the presence of the organism as appropriate. Moreover, studies may be required of the dissemination of the vaccine strain in the body, with particular attention being paid to the predilection sites for replication of the organism. In the case of live vaccines for zoonoses within the meaning of Directive 2003/99/EC of the European Parliament and of the Council (1) to be used for food producing animals, these studies must shall take particularly into account the persistence of the organism at the injection site.

6.3. Reversion to virulence of attenuated vaccines U.K.

Reversion to virulence shall be investigated with the master seed. If the master seed is not available in sufficient quantity the lowest passage seed used for the production shall be examined. Use of another passage option shall be justified. The initial vaccination shall be carried out using the route of administration most likely to lead to reversion to virulence. Serial passages shall be made in target animals through five groups of animals, unless there is justification to make more passages or the organism disappears from the test animals sooner. Where the organism fails to replicate adequately, as many passages as possible shall be carried out in the target species.

6.4. Biological properties of the vaccine strain U.K.

Other tests may be necessary to determine as precisely as possible the intrinsic biological properties of the vaccine strain (e.g. neurotropism).

6.5. Recombination or genomic reassortment of strains U.K.

The probability of recombination or genomic reassortment with field or other strains shall be discussed.]

Textual Amendments

F1 Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).

(1)

[F1 OJ L 325, 12.12.2003, p. 31 .]

Textual Amendments

F1 Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).