Sachkundige Person nach § 14 Arzneimittelgesetz anzeigen

Arzneimittelgesetz (AMG)

• § 14 Entscheidung über die Herstellungserlaubnis
• § 15 Sachkenntnis
• § 20 Anzeigepflichten

The German Medicinal Products Act describes the requirements for various responsible persons (legal guarantors).

It stipulates that you must notify the competent authority of a qualified person for the manufacturing authorisation.

• Employment references (copy)
• Proof of training (certified copy)
• Curriculum vitae (in tabular form, relating to training and professional activity)
• Certificate of good conduct (document type O for direct transmission from authority to authority)
• Form "Declaration of nomination"
• Declaration of commitment

• Qualified persons must have the necessary expertise and reliability.
• As a qualified person in accordance with Sections 14 and 15 of the German Medicines Act (AMG ), you require a licence to practise as a pharmacist or alternatively a university degree in pharmacy, chemistry, biology, human or veterinary medicine and proof of successfully completed examinations in accordance with the catalogue of subjects listed in Section 15 AMG.

There are no costs for the advert.

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 authority.
• The authority checks the notification formally and for completeness.
• If any documents are found to be missing during the check, you will be contacted and asked to provide the missing documents.
• Once the missing documents have been submitted or the formal check has been passed, the competent authority will make a decision.
• The notification can be confirmed or rejected.
• The decision will be communicated to you as the person making the notification.
• A statement of fees will then be drawn up and sent to you with a request for payment.

Pursuant to Section 20 of the Medicinal Products Act, the holder of a manufacturing/import licence must notify the competent authority in advance of any change in connection with the qualified person, submitting the supporting documents. In the event of an unforeseen change of the qualified person in accordance with Section 14, the notification must be made immediately.

You must report any changes immediately. A fine may be imposed in the event of an offence.

• Objection
• Information on how to lodge an objection will be sent with the decision on your advert.