Overview of changes requiring an inspection in the GMP area

23 January 2018

Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

When a manufacturing authorisation has been granted, the manufacturer must not change the terms that appear from the authorisation without our approval. Such a situation could arise if the company wants to include the manufacture of new types of formulations, or if it wants to relocate or change its name. Any such changes must be applied for and the new terms must be approved on the company's manufacturing authorisation, before the changes can be implemented.

The company can moreover effect changes that do not require the manufacturing authorisation to be changed, but still require notification to the Danish Medicines Agency and perhaps even an inspection.

Here you will find an overview of the type of changes in the GMP area that we assess to necessitate the submission of information to the Danish Medicines Agency and perhaps inspection before the change can be implemented. Please be aware that it is not an exhaustive list and that some changes on the list may require the manufacturing authorisation to be changed, e.g. if a new production room is placed at a new geographical location, thus to be authorised as a new site on the authorisation.

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Overview of changes requiring an inspection in the GMP area

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