08 May 2014,
Updated 09 May 2014
We have updated our guidelines on requirements and expectations for the qualified person (QP) in a pharmaceutical company.
The requirements for the QP have not been changed compared to the previous guidelines. The new guidelines have mainly been updated to include the requirements for the duration of the QP's education as specified in the applicable directives. In addition, a number of other updates and specifications have been made:
- The guidelines are now available in a PDF file like the other guidelines applicable to section 39 authorisations.
- Specification of the directives' requirements that a university course of three and a half years may be approved if it is followed by at least one year of additional training. The composition and duration of the education have been further specified according to the requirements stipulated by the directives.
- The guidelines now specify that the Danish Health and Medicines Authority does not pre-approve QPs, but only assesses whether a QP can be authorised once an application for a specific person and on behalf of a specific company has been received by the Danish Health and Medicines Authority.
- It now appears from the guidelines that the authorisation of a QP only applies to the specific company. The authorisation cannot be transferred to other companies, and it is not possible to obtain a general authorisation or certification of a QP in Denmark from the Danish Health and Medicines Authority.
- A brief section on delegated qualified persons and countersigning has been added.
- Other minor corrections and specifications have been made, e.g. shorter headings and more detailed descriptions.
You can find the guidelines (PDF file) on our website under Applications for authorisation to manufacture and import medicines and intermediates