COVID-19: Danish Medicines Agency puts inspection and control tasks on hold

26 March 2020

Due to the COVID-19 pandemic, the Danish Medicines Agency is putting all on-site inspections and laboratory controls on hold until further notice. The Danish Medicines Agency will, however, continue with office-based assessments and controls, and, if needed, also on-site inspections.

The Danish Medicines Agency will only conduct on-site inspections if there is a potential risk to patient safety. All other on-site inspections and laboratory controls are put on hold until further notice. We will, however, carry on with some inspections in the form of office-based assessments.

COVID-19 calls for pragmatic and flexible solutions

The Danish Medicines Agency has the responsibility of inspecting 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.

Under normal circumstances, the Danish Medicines Agency inspects several different areas – from laboratories and hospitals conducting clinical trials to companies manufacturing medicines and medical devices, and pharmacies dispensing and selling medicines.

This has changed with the present measures to contain the spread of coronavirus, which obviously also apply to the authorities and the pharmaceutical industry.

The Danish Medicines Agency is therefore working with the European Medicines Agency to find common control methods and guidance for the industry to be used under the current COVID-19 breakout. The common agreement is to ensure that both inspections and controls can be conducted in compliance with the preventive measures to contain the spread of the virus, while safeguarding patient safety and ensuring that critical clinical trial applications are not affected.

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