# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 3.3.2.4: Excipients

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

For excipient(s) used in cell or tissue-based medicinal products (e.g. the components of the transport medium), the requirements for novel excipients, as laid down in Part I of this Annex, shall apply, unless data exists on the interactions between the cells or tissues and the excipients.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/3/division/3.3/division/3.3.2/division/3.3.2.4 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-3/division-3.3/division-3.3.2/division-3.3.2.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.