The Danish Medicines Agency inspects the development, manufacture, distribution, dispensing and monitoring of medicines and medical devices. The inspections aim to ensure that companies, research teams and the like comply with the rules and implement best practices – for the benefit of patient safety.
The Danish Medicines Agency inspects several different areas – from laboratories and hospitals conducting clinical trials to companies manufacturing medicines and medical devices, and finally the pharmacies, which dispense and sell medicines.
The inspection process
We usually give notice of our inspections 14 days or more prior to our visit, but in certain cases we also show up unannounced. When we give notice of an inspection, we usually also request material to prepare our inspection.
An inspection could be carried out by one or several inspectors who may be accompanied by experts from the Danish Medicines Agency’s depending on the area to be inspected.
An inspection could last a few hours or several days – depending on the area’s complexity and risks. During an inspection, the inspectors from the Danish Medicines Agency will normally review the quality system, procedures and workflows against the rules in the area. The inspectors will also make random checks to review compliance with procedures and rules.
In some cases, the Danish Medicines Agency must perform inspections in connection with an authorisation procedure. In other cases, we perform inspections based on an assessment of the activities’ risks for patients and consumers. The inspection could also be prompted by a particular concern – for example if serious errors or fraudulent practices have been reported.
The inspection report
After an inspection, the Danish Medicines Agency issues an inspection report that highlights any deficiencies. The deficiencies could be so detrimental to patient safety that the Danish Medicines Agency moves for the imposition of a fine, requests the recall of medicines from the market or suspends an authorisation.
To follow up on an inspection report, those inspected must submit a description of how they plan to solve any deficiencies. The inspector concludes the inspection once this action plan is deemed to be adequate.
In certain inspection areas, a certificate is subsequently issued.
Background information and the Danish Medicines Agency’s legal basis can be found under the individual inspection area’s (GXP) standard and company type (laboratories, clinical trials, distribution, manufacture, monitoring of medicines, pharmacies, retail, IT systems and medical devices).