# 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, Article 46a

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

1. For the purposes of this Directive, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials.
2 . The Commission is empowered to adopt delegated acts in accordance with Article 121a to amend paragraph 1 to take account of scientific and technical progress.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/46a (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-46a
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.