Legislation on GMP and GDP

Danish Executive Orders and EU Regulation

Information about GMP and GDP is available in the executive orders and regulations below:

GMP – executive order no. 1358 of 18 December 2012 on manufacture and import of medicinal products and intermediary products (Danish title: 'Bekendtgørelse nr. 1358 af 18. december 2012 om fremstilling og indførsel af lægemidler og mellemprodukter')

GDP – Danish executive order no. 1541 of 18 December 2019 on distribution of medicinal products (Danish title: 'Bekendtgørelse nr. 1541 af 18. december 2019 om distribution af lægemidler')

Regulation (EU) 2019/6 on veterinary medicinal products

Companies authorised to manufacture and distribute medicinal products by the Danish Medicines Agency must comply with both GMP and GDP.

Guidelines and EU Implementing regulation

Detailed distribution guidelines are available in:

Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (eur-lex.europa.eu)

Implementing regulation (EU) 2021/1248 on good distribution practice for veterinary medicinal products

Detailed guidelines on the GMP rules are available in:

The Rules Governing Medicinal Products in the European Union, Volume 4. Guide to Good Manufacturing Practice for Medicinal Products