Rules applicable to active substances (APIs)

Updated 27 May 2016

Active substances (APIs) that are used in the manufacture of human and veterinary medicines must be manufactured in compliance with the GMP rules.

This requirement applies to both manufacturers and importers of medicines from third countries (i.e. countries outside EU/EEA). API manufacturers as well as any intermediaries which portion, repackage, etc. must comply with the GMP rules.

The rules applicable to manufacture, import and distribution of active substances intended for the manufacture of human medicines are established in:

Danish API order no. 1360 of 18 December 2012 'Bekendtgørelse nr. 1360 af 18. december 2012 om fremstilling, indførsel og distribution af aktive stoffer til fremstilling af lægemidler'.

Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use

Please note that the Danish API order and the GDP guidelines only cover active substances intended for the manufacture of human medicine. Active substances intended for the manufacture of veterinary medicines are exempted from the API order and the guidelines.

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