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6 May 2011

DMA defines new requirements for Qualified Persons in pharmaceutical companies

The Danish Medicines Agency has updated the guidelines on requirements and expectations for the Qualified Person in a pharmaceutical company, stating that a person cannot be approved as a Qualified Person on the authorisation if on leave, because a Qualified Person is expected to be present at the company regularly.

Therefore, it is required that, e.g. during maternity leave, the company must apply to replace the Qualified Person concerned with the authorisation. When the Qualified Person concerned returns from leave, the company must reapply to have this person approved as Qualified Person on the authorisation. Please see here.

As of 27 May 2010, the Danish Medicines Agency permits Danish companies, authorised pursuant to section 39 of the Danish Medicines Act to manufacture and import medicinal products and intermediate products, to have more than one qualified person authorised and named on the section 39 authorisation. Please see here.