Notify a competent person in accordance with the Medicinal Products Act
Description
The requirements for various responsible persons are described in the Medicinal Products Act. It stipulates that you must notify the competent authority of a competent person with appropriate qualifications and reliability for the decision on manufacturing authorization. Any changes must also be reported immediately.
- Qualified persons must have the necessary expertise and reliability.
- They require a university degree in pharmacy, chemistry, biology, human or veterinary medicine,
- Alternatively, completed training in the aforementioned areas or proof of employment as a pharmaceutical representative.
- Employment references (copy)
- Proof of training (copy)
- Curriculum vitae
- Certificate of good conduct (copy)
- Form "Declaration of nomination"
- Declaration of commitment
Please submit certified copies.
The certificate of good conduct must be suitable for submission to an authority (document type O). It must not be older than 3 months.
Fictitious approval: To be notified immediately upon change.
Processing Time: 3 Months
You can file a lawsuit.
Saxony-Anhalt State Administration Office
Forms available:
Written form required: Yes
Informal application possible: Yes
Personal appearance necessary: No
Online services available: Yes
You can notify a qualified person in writing or online.
- You notify the competent person by means of a written application or using the online service.
- The notification is then received by the competent authority.
- The competent authority checks the notification formally and for completeness.
- If any documents are found to be missing during the check, you will be notified.
- Once the missing documents have been submitted or the formal check has been passed, the competent authority will make a decision.
- The competent authority can confirm or reject your notification.
- The authority will inform the pharmaceutical company of its decision.
The pharmaceutical company will receive a notification of costs.
A fine may be imposed in the event of a violation.
Ministry of Justice and Consumer Protection of the Free and Hanseatic City of Hamburg
Ministry of Labor, Social Affairs, Health and Equality of the State of Saxony-Anhalt
06.05.2022
16.11.2023
Saxony-Anhalt State Administration Office
The text was automatically translated based on the German content.
