Changes requiring an inspection - GDP

Companies that distribute (wholesale) medicines must be authorised by the Danish Medicines Agency to do so as stipulated in section 39 of the Danish Medicines Act. The companies must comply with the rules on good distribution practice (GDP) and will be inspected regularly by our inspectors.

Once a manufacturing authorisation or a wholesale distribution authorisation has been granted, the company may not change the conditions on which the authorisation was based without first obtaining approval from the Danish Medicines Agency. Further guidance on changes that require the submission of an application and prior authorisation of the new conditions on the company’s authorisation before implementation is provided here: Company authorisations and registrations. 

In addition, some changes do not require an update to the company’s authorisation, but must still be notified to the Danish Medicines Agency and may even be subject to inspection.

The list below gives an overview of the types of changes we consider must be notified to us and may even require our inspection before implementation. Please note that the list is not exhaustive. Some of the listed changes may therefore also require that the authorisation be changed. This could be the case if new premises are placed at a new geographical site thus to be authorised as a new site on the authorisation.

Overview of changes requiring an inspection in the GDP area