# 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 2

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

1. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘ medicinal product ’ and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.
3 . Notwithstanding paragraph 1 of this Article and Article 3(4), Title IV of this Directive shall apply to the manufacture of medicinal products intended only for export and to intermediate products, active substances and excipients.
4 . Paragraph 1 shall be without prejudice to Articles 52b and 85a.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.