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If you operate a pharmaceutical company that places finished medicinal products on the market, you must notify the competent authority of an information officer. Any changes must also be reported immediately.
If you operate a pharmaceutical company that places finished medicinal products on the market, you must notify the competent authority of an information officer. Any changes must also be reported immediately.
The law stipulates that the competent supervisory authority must be notified of an information officer with the appropriate expertise and reliability.
The information officer is responsible, among other things, for ensuring that medicinal products are correctly registered, properly labeled and not misleadingly advertised.
- Employment references (copy)
- Proof of training (copy)
- Curriculum vitae
- Certificate of good conduct (copy)
- Form "Declaration of nomination"
- Declaration of commitment
- Information officers must have the necessary expertise and reliability.
- Information officers require a university degree in pharmacy, chemistry, biology, human or veterinary medicine and at least 2 years of professional experience
You can notify an information officer in writing or online:
- You notify the information officer by means of a written notification or using the online service.
- Upon receipt, the authority checks the notification formally and for completeness.
- If the check reveals that documents are missing, the pharmaceutical company will be contacted and asked to supply the missing documents.
- Once the missing documents have been submitted or the formal check has been passed, the authority will make a decision.
- The receipt of the notification will be confirmed to the pharmaceutical company
- Information officer notification
- A pharmaceutical company that places finished medicinal products on the market must appoint an information officer. The information officer must be notified to the competent supervisory authority.
- An information officer must have the necessary expertise and reliability.
- For the corresponding notification of responsibility, please use the online service Personnel changes according to the Medicinal Products Act or send the written notification by post.
- Competent authority: Saxony-Anhalt State Administration Office