Authority for Justice and Consumer Protection

Notify a competent person according to the Medicines Act

Prerequisites

• Competent persons must have the necessary expertise and reliability.
• You need 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

Documents required

• Job references (copy)
• Training certificate (copy)
• CV
• Certificate of good conduct (copy)
• Declaration of designation form
• commitment declaration

Please note

Deadlines

You need the certification of your qualified person from the competent authority in order to obtain permission to manufacture medicinal products and to manufacture medicinal products.




Report any changes affecting the Qualified Person immediately.

Procedure

• You can notify a competent person in writing or electronically.
• Submit the competent person’s report with all required documents to the competent authority.
• The authority will examine your report and the documents submitted. If necessary, it will request further documents or information from you.
• Once all the necessary documents and information have been provided, the responsible authority will decide on your report.
• You will be informed of the decision.
• The ad can be confirmed or rejected.
• You will receive a fee statement with a request for payment.

Processing time

The processing time depends on the administrative effort and is approximately 1 to 4 weeks.

Fees

The amount of the fees depends on the administrative effort.

Legal remedies

• contradiction


• Information on how you object will be transmitted with the decision on your ad.

Legal basis

• § 14 Medicines Act (AMG)


• § 15 Medicines Act (AMG)


• § 20 Medicines Act (AMG)