# 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 5: FIXED COMBINATION MEDICINAL PRODUCTS

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

Applications based upon Article 10 (1) (b) shall relate to new medicinal products made of at least two active substances not previously authorised as a fixed combination medicinal product.
For those applications a full dossier (Modules 1 to 5) shall be provided for the fixed combination medicinal product. Where applicable, information regarding the manufacturing sites and the adventitious agents, safety evaluation shall be provided.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/II/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-II/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.