Pharmaceuticals; appointment of private experts

Private experts who wish to examine and appraise drug counter-samples must be appointed.

Description

Prerequisites

Prerequisites are:

  1. the expertise according to § 15 AMG; instead of the practical activity according to § 15 Para. 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 can take place,
  2. the reliability required to act as an expert for the examination of official samples, and
  3. the availability of suitable premises and facilities for the intended examination and assessment of medicinal products.

Procedure

The informal application with the required documents should be sent to the relevant 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

  • A fee of between €5.00 and €25,000 shall be assessed for the order on the basis of the administrative expense incurred and the time taken and the importance of the matter for the applicant.

    The costs shall be borne by the applicant.

Remedy

Administrative court proceedings; information

Administrative court action

Status:27.10.2023

Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

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