Information - Services - Formalities by subjects - Preparations for business start-up - Erlaubnispflichtige und überwachungspflichtige Unternehmen - Medicinal products; appointment of private experts - Dienstleistungsportal Bayern

Description

Samples left behind according to Section 65(1) sentence 2 AMG may only be examined by private experts appointed according to Section 65(4) AMG.

Responsible for the appointment are

• 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 the Upper Palatinate.

Prerequisites

Prerequisites are:

1. the expertise according to Section 15 AMG; instead of the practical activity according to Section 15 (1) and (4) AMG, a practical activity in the examination and assessment of medicinal products in drug testing laboratories or in other similar drug institutes may be substituted,
2. the reliability required to exercise the activity as an expert for the examination of official samples and
3. the availability of suitable rooms and facilities for the intended examination and assessment of medicinal products.

Procedure

The informal application with the necessary documents must be sent to the competent government.

Processing time

The order can only be placed after all necessary documents have been submitted and open questions have been clarified and, if necessary, the intended rooms and facilities have been inspected.

Required documents

• Certificate of competence according to § 15 AMG
• proof of reliability

  Certificate of good conduct of document type 0

• Evidence of the availability of suitable premises and facilities for the intended testing and evaluation of medicinal products.

Fees

• On the basis of the administrative effort and time involved and the importance of the matter for the applicant, a fee of between €5.00 and €25,000 is set for the appointment.

  The costs are to be borne by the applicant.

Legal bases

• § 65 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

Remedy

Administrative court action