Medicinal products; notification of the information officer
Pharmaceutical entrepreneurs who place finished medicinal products on the market must notify the competent authority of an information officer. Any change must be notified immediately.
Description
Any person who, as a pharmaceutical entrepreneur, places finished medicinal products on the market shall appoint a person with the necessary expertise and the reliability required for the performance of his duties to responsibly perform the task of providing scientific information on the medicinal products.
The information officer is responsible in particular for ensuring that
- the prohibition of Section 8 (1) No. 2 of the German Medicines Act (AMG) (publication of misleading information) is observed, and
- the labeling, package insert, expert information and advertising comply with the contents of the marketing authorization or registration or, if the drug is exempt from the marketing authorization or registration, with the contents of the ordinances on the exemption from the marketing authorization or registration pursuant to Section 36 or Section 39 (3) of the AMG.
The information officer may at the same time be the step-by-step plan officer pursuant to Section 63a AMG.
Prerequisites
The information officer must demonstrate the necessary expertise and the reliability required to perform the activity in order to responsibly perform the task of providing scientific information on the medicinal products
Information officers need a university degree in the field of pharmacy, chemistry, biology, human or veterinary medicine or a completed training in the previously mentioned fields.
Procedure
The notification of the information officer can be made informally in writing or online (see under "Online procedure"). It is to be sent with the necessary documents to prove the expertise to:
- the Government of Upper Bavaria for the administrative districts of Upper Bavaria, Lower Bavaria and Swabia,
- the Government of Upper Franconia for the administrative districts of Upper, Middle and Lower Franconia and Upper Palatinate.
After receipt, the authority checks the notification for completeness as well as for content and expertise. Missing documents will be requested. If all required proofs and documents are available, the notification is confirmed.
Special notes
The pharmaceutical entrepreneur shall notify the competent authority of the information officer and any change in advance. In case of an unforeseen change of the information officer, the notification shall be made without delay.
Deadlines
The pharmaceutical entrepreneur shall notify the competent authority of the information officer and any change in advance. In case of an unforeseen change of the information officer, the notification has to be made immediately.
A confirmation of the notification can only be issued after all required documents are available and open questions have been clarified.
Processing time
The processing time depends on the completeness and scope of the submitted documents. It can therefore vary individually.
Required documents
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Appointment of the information officer
Specification of name and contact details (telephone/fax number; e-mail address) is required. The designation must be dated and signed by both parties.
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Proof of expertise through
- signed curriculum vitae,
- certified certificates of education/studies,
- relevant qualified references
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personal reliability
- Official certificate of good conduct of document type O (original, not older than 3 months).
Please indicate the person applying for the certificate, the company name and location, and the file number.
Forms
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Status:13.07.2023
Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Form, Bavaria-wide
- Form, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited
If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.