Manufacture of active ingredients and medicinal products
Inspection of API and medicinal product manufacturers subject to Good Manufacturing Practice (GMP)
GMP are the requirements and guidelines that ensure that medicines are produced in a uniform and controlled manner. The aim is to ensure that medicines are always safe, effective and of high quality. When the Danish Medicines Agency inspects companies working under GMP, the inspection is conducted on the basis of Danish and European legislation. The purpose of the inspections is to help make medicines as safe as possible for the citizens.
Mutual recognition from other countries
The Danish Medicines Agency, together with the rest of the EU, has concluded agreements with several 3rd countries on mutual recognition of each other’s inspections. This is called the MRA, which stands for Mutual Recognition Agreement. There are agreements in place with countries such as Australia, Canada, Japan, New Zealand, Switzerland and the United States. In the agreements reached, Member States’ inspectorates have a harmonised approach to inspecting manufacturers. This means that countries recognise assessments from other Member States and thus do not need to repeat inspections.
Risk-based inspections
All facilities with a GMP 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 based on the complexity of the company’s manufacturing processes and products, the criticality of the company’s activities and the outcome of previous inspections.
NOTICE
API – Executive Order No 1609 of 5th December 2025 on the manufacture, import and distribution of active pharmaceutical ingredients
GMP – Executive Order No 1358 of 18th December 2012 on the manufacture and importation of medicinal products and intermediate products
GDP – Executive Order No 1541 of 18th December 2019 on the distribution of medicinal products (retsinformation.dk)
GUIDANCE DOCUMENTS
More detailed guidance can be found in EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
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