Distribution of active ingredients and medicinal products

The Danish Medicines Agency inspects wholesale distributors of active pharmaceutical ingredients (APIs) and/or medicinal products to check that distribution is carried out in accordance with the rules of good distribution practice (GDP). The overall objective of the GDP requirements is to ensure that the properties of medicines do not deteriorate during storage and transport, and that defective medicines can be traced and recalled.  

 

Risk-based inspections
All facilities with a GDP company authorisation under Section 39 of the Danish Medicines Act shall be inspected on the basis of an assessment of where the highest risk is presumed. This is called a risk-based approach.  The Danish Medicines Agency assesses the need for inspection of the individual company primarily on the basis of the outcome of previous inspections. 

 

NOTICE
GDP – Executive Order No 1541 of 18th December 2019 on the distribution of medicinal products (retsinformation.dk)

GUIDANCE DOCUMENTS
GDP Guidance of 5th November 2013 on Good Distribution Practice of medicinal products for human use
API GDP Guidance of 19th March 2025 on principles of good distribution practice for active substances for medicinal products for human use

REGULATION FOR VETERINARY MEDICINAL PRODUCTS
Regulation (EU) 2019/6 on veterinary medicinal products
Implementing Regulation (EU) 2021/1248 on good distribution practice for veterinary medicinal products