Inspection

Inspection

The Danish Medicines Agency inspects the development, manufacture, storing, distribution and monitoring of pharmaceuticals as well as registered medical device operators and clinical investigation of medical devices. Inspections serve the purpose of ensuring compliance with rules and practices – for the benefit of patient safety.

We inspect a range of different companies and operators – including laboratories, research teams, hospital departments and pharmacies.  

We take part in international inspection co-operation schemes aimed at harmonising inspections and reducing the inspection load.  Inspections conducted outside Denmark are coordinated by the European Medicines Agency (EMA).

The course of an inspection

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 various material to prepare our inspection.

The inspection may be conducted by one or more inspectors and could be joined by experts from the Danish Medicines Agency or another authority depending on what is 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 in relation to applicable rules. The inspectors will also make random checks to determine compliance with procedures and rules. 

Inspection types

The Danish Medicines Agency conducts inspections in connection with authorisation processes, or as part of risk-based routine programmes for monitoring authorisations and registrations. An extraordinary inspection may also be decided based on new information, reports of serious errors, whistleblower reports or fraudulent practices.

The inspection types are called:
• pre-approval inspections
• routine inspections
• inspections for cause.

The Danish Medicines Agency also performs voluntary inspections of activities beyond the scope of our inspection obligation upon request from companies in Denmark.

Inspection report

After an inspection, the Danish Medicines Agency issues an inspection report that highlights any deficiencies.

To follow up on an inspection report, the company, research team, etc. must submit a description of how they plan to solve any deficiencies. The inspector will close out the inspection once this action plan is deemed adequate.

In certain inspection areas (GMP, GDP and GLP), a certificate is subsequently issued.

In some cases, deficiencies may be so serious for patient safety or data integrity that the Danish Medicines Agency must recall the involved medicine or medical device from the market and/or suspend its marketing authorisation.

The violation of certain provisions is punishable by a fine.

Prices

Expenses related to the Danish Medicines Agency’s inspections in Denmark are included in the registration/authorisation fees/annual fees.

Reimbursement is claimed for travelling expenses for inspections conducted in non-EU countries. Voluntary inspections, as well as inspections of third-country manufacturing of active pharmaceutical ingredients (APIs), are also subject to a fee. Please also see: Fees payable for medicinal products and companies

Complaints

During our inspections, we determine compliance with applicable rules and requirements. After the inspection, we will issue an inspection report, which will include a deadline for submission of follow-up actions on any deviations. If the report contains significant errors or misunderstandings, you must submit them to the inspector within five business days.

On completion of the inspection process, we will send out a link, asking you to share your feedback in our anonymous satisfaction survey. All proposals will be used to improve our internal workflow, and we encourage you to contribute to this process.

You may object to a planned inspection, and you may complain about matters related to the conduct, report and follow-up of inspections. Please address complaints to the inspector’s immediate manager in the Control & Security of Supply Department, detailing the following.
 
•  A clear description of the specific points of complaint
•  Date(s) and relevant events
•  Documents, if any, to support the complaint

An inspection report is generally not a decision in the sense of the Danish Public Administration Act and may therefore not be appealed legally.

However, an inspection process may lead us to make a legal decision. Any such decision will include guidance on how to appeal pursuant to section 25 of the Danish Public Administration Act. It will also inform you whether you may appeal to another administrative authority; in our area, this would be the Danish Ministry of the Interior and Health.