Updated 26 February 2013
In the following you will find details on the Danish Health and Medicines Authority's requirements and expectations for the Qualified Person of a pharmaceutical company authorised to manufacture and import medicinal products and intermediate products (section 39 authorisation).
An authorisation to manufacture and import medicinal products and intermediate products can only be granted if the services of at least one Qualified Person are available.
Companies must choose whether they want to have one Qualified Person named on the authorisation (1), or if they want to have several Qualified Persons named on the section 39 authorisation (2).
The following rules apply to the two schemes:
One Qualified Person named on the section 39 authorisation.
On this scheme, the company's section 39 authorised Qualified Person assumes the ultimate responsibility for all manufactured medicine batches - even if these have in effect been released by delegated Qualified Persons. The section 39 authorised Qualfied Person must co-sign the release of all manufactured batches.
Several Qualified Persons indicated on the section 39 authorisation.
In this scheme, only the Qualified Persons named on the section 39 authorisation may release the manufactured batches. Part of the release (such as the review of batch documentation) can be delegated to other adequately qualified employees, but the final certification in the batch release register must be made by a Qualified Person named on the section 39 authorisation. The manufactured batch must remain in the custody of the company until released.
Further information about the two schemes and questions and answers to scheme 2 are available in the box to the right.
These guidelines apply to both Qualified Persons authorised by the Danish Health and Medicines Authority and who are named on the company authorisation and to delegates that have not been pre-approved by the Danish Health and Medicines Authority.
Requirements for the educational qualifications of the Qualified Person:
The Danish Health and Medicines Authority requires a Qualified Person to have completed a university degree with a duration of at least four years (cf. EU Directives 2001/83/EC and 2001/82/EC). The degree has to be in one of the following scientific disciplines: Pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology. This requirement cannot be waived.
Article 49(2)/Article 53(2) provide that the Qualified Person must have received training in a number of basic subjects. These basic subjects comprise:
- experimental physics (only listed in EU Directive 2001/82/EC)
- general and inorganic chemistry
- organic chemistry
- analytical chemistry
- pharmaceutical chemistry, including analysis of medicinal products
- basic and applied biochemistry (medical)
- pharmaceutical technology
However, the requirement that the qualified person must have received training in all of the above-mentioned basic subjects can be waived. The specific subjects required will depend on the medicinal products to be released. If education did not comprise all of the above-mentioned subjects, it must be specified how the person has gained subsequent knowledge within the subject or why the subject is considered irrelevant for the concerned release activities.
The Qualified Person must have adequate experience from production, QA or QC:
- If the candidate has completed a 4-year university degree, he/she must have a minimum of two years' experience from production, QA or QC in order to be approved as a Qualified Person.
- If the candidate has completed a 5-year university degree, he/she must have a minimum of one years' experience from production, QA or QC in order to be approved as a Qualified Person.
- If the candidate has completed a 6-year university degree, he/she must have a minimum of six months' experience from production, QA or QC in order to be approved as a Qualified Person.
- It is essential that the candidate has specific experience in the products to be released. If the position requires releasing medicinal products produced under sterile conditions, the Qualified Person must have specific knowledge of this area.
The Danish Health and Medicines Authority does not waive any of the above-mentioned qualification and practical experience requirements for the Qualified Person, not even on the basis of:
- geographical location of activities
- release for export purposes only
- production of medicinal products with low potency (e.g. homeopathic products)
- a quantitatively small production.
Requirements for the Qualified Person's relation to the company:
- The Qualified Person must be permanently employed by the company or must have entered into a contract with the company.
- The Qualified Person must have sufficient knowledge of the quality system, including validation documentation.
- The Qualified Person must work at the company regularly and must be familiar with all facilities used for production and quality control. In this respect, the Danish Health and Medicines Authority expects the Qualified Person to spend at least ten hours a week in the company. If the company is small or only produces in small campaigns, the presence of the Qualified Person can be reduced.
NB! Because of the requirement for presence of a person, a person on leave cannot be approved as Qualified Person on the authorisation because we expect the person to be at the company regularly. During, e.g. maternity leave, it is therefore required that the company applies to replace the Qualified Person concerned on 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.
Continued training of the Qualified Person:
The Danish Health and Medicines Authority expects an acting Qualified Person to, at least once a year, participate in a course, seminar, conference or similar focusing on GMP. This could either be related to general GMP compliance or be specific to the products released (cf. EU Guide to GMP, annex 16, 8.3).
If course participation is deselected for one year, we expect the Qualified Person to instead meet with other people working with QA or QC to exchange experiences. This could be in the form of arranged theme meetings, experience exchange groups or similar private meetings. These meeting activities should be briefly described in a CV, so that the Qualified Person is able to document his/her participation to the Danish Health and Medicines Authority.
When a new Qualified Person is applied for, the following documents should be enclosed with the application:
- The candidate's resume, including diploma(s) and a list of completed courses and a list of relevant practical experience, courses etc.
- If the candidate is newly employed, a training schedule must be enclosed.
- For consultants, the contract concluded between the company and Qualified Person must be enclosed.The extent of time the consultant must be present at the company must have been decided so as to comply with the EU Guide to GMP, Annex 16, 4.3
For further information please see the Guidelines on applications for authorisation to manufacture and import medicines and intermediates.
These guidelines do not apply to Qualified Persons working in a pharmaceutical company holding an authorisation for wholesale distribution.