# 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 5: Identification and assay of excipient components

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

Insofar as is necessary, the excipient(s) shall be subject at least to identification tests.
An upper and lower limit test shall be obligatory in respect of preserving agents. An upper limit test for any other excipient components liable to give rise to an adverse reaction shall be obligatory.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-2/division-E/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.