Display the person responsible for information in accordance with the Medicinal Products Act

If you submit your application via the online service, you must submit the required evidence to the competent authority in the original or as a certified copy.

State Office for Social Affairs, Youth and Pensions

In Rhineland-Palatinate, you must submit the documents in the following form:

• Licence to practise medicine / certificate of study (official or notarized copy)
• Proof of practical experience (Signed original; Interim certificates: officially certified copy)
• Curriculum vitae (signed original)
• Certificate of good conduct (original, document type "OB" - sent directly to the authority)
• Form "Declaration of Designation" (signed original)
• Declaration of commitment (signed original)

Initial application: prior to the placing on the market of finished medicinal products.

Change/change of the person responsible for information: as soon as possible, at least 6 weeks in advance

• § 74a Arzneimittelgesetz (AMG)
• § 12 (2) Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)

If you do not instruct an information officer or if you do not provide a notification in full or on time, or if you perform an activity as an information officer without fulfilling the necessary requirements, you are acting in violation of the regulations.

The administrative offence can be punished with a fine of up to 25,000 euros.

07.08.2023