Informationsbeauftragte Anzeige

§ 74a Medicines Act (AMG)
§ 12 (2) Drug and Active Ingredient Manufacturing Ordinance (AMWHV)

If you operate a pharmaceutical company that markets finished medicinal products, you must notify the competent authority of a person responsible for information. You must also notify any changes concerning this person immediately.

If you operate a pharmaceutical company that markets finished medicinal products, you must notify the competent authority of a person responsible for information. You must also notify any changes affecting this person immediately.

The information officer is responsible, among other things, for ensuring that medicinal products are correctly registered, properly labelled and not advertised in a misleading manner.

• Information officers must have the necessary expertise and reliability.
• Information officers require a university degree in pharmacy, chemistry, biology, human or veterinary medicine,
• Alternatively, the person responsible for information can provide evidence of completed training in the previously mentioned areas or proof of employment as a pharmaceutical representative.

Fees apply. The amount of the fees depends on the administrative effort.

• You report the person responsible for information to the responsible authority in writing or electronically. Attach all required documents to the report.
• The responsible authority will check your notification formally and for completeness.
• If necessary, you will be asked to submit further documents or information.
• The responsible authority will examine your report.
• Your ad can be approved or rejected.
• The decision will be communicated to you.
• A fee statement will then be prepared and sent to you with a request for payment.

Processing takes at least 4 weeks.

You must immediately report any changes concerning the person responsible for information.

If you do not report the person responsible for information or do not report it correctly, or do not report any changes concerning this person immediately, you are committing an administrative offence, which can be punished with a fine.

Contradiction

• A pharmaceutical company that places finished medicinal products on the market must appoint a person responsible for information. The person responsible for information must be reported to the competent supervisory authority.
• An information officer must have appropriate expertise and reliability.
• Changes concerning the person responsible for information must also be reported immediately
• Notification in writing or electronically via online service

Justice and Consumer Protection Authority