27/28 April 2023
The Danish Medicines Agency DMA has revised its guidance on the requirements and expectations for the Qualified Person (QP) in a pharmaceutical company: Requirements and expectations for the qualified person in a pharmaceutical company. In places, these deviate from the requirements of Directive 2001/83/EC, especially with regard to educational background and experience. The concept of delegated QPs is also special.
For example, the subjects of study specified in the Directive can be deviated from. These depend on the medicinal products that are to be certified and released. If an applicant has not studied all of the specified subjects during his or her studies, the person concerned must demonstrate how the knowledge in the subject in question was acquired subsequently or why the subject in question is not considered relevant for the clearance in question.
Unlike many other EU Member States, practical experience is not limited to quality control. In Denmark, a minimum of two years' experience in manufacturing, quality assurance or quality control in a pharmaceutical company is required. For this purpose, the QP must have sufficient knowledge of the quality system, including validation documentation, and be familiar with all production and quality control facilities. The authority expects the QP to spend at least ten hours per week in the company.
The Danish Medicines Agency expects an acting QP to attend a course, seminar, conference or similar focusing on GMP at least once a year.
If this is not possible, the QP is expected to meet with other persons working with QA or QC to exchange experiences. This can take the form of arranged theme meetings, experience exchange groups or similar private meetings.
A special feature in Denmark is the "Delegated Qualified Person". This is a person appointed by the company who can carry out releases on behalf of the actually authorised QP. Such a delegated QP does not have to be approved in advance by the Danish Medicines Agency. However, the QP appointed in the MIA remains responsible for ensuring that the delegated QP has the required competences and must be able to vouch for the authorised QP, perform spot checks and countersign all releases.