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Pharmaceuticals; application for the appointment of private experts

Private experts who wish to examine and assess counter-samples of medicinal products must be appointed.

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Regierung von Oberbayern - Sachgebiet 55.2 - Rechtsfragen Gesundheit, Verbraucherschutz und Pharmazie

Regierung von Oberbayern

Street address

Maximilianstraße 39
80538 München

Hinweis: Wir empfehlen eine vorherige Terminvereinbarung bei persönlichen Vorsprachen

Postal address

80534 München

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Procedure details

Samples that are left behind in accordance with Section 65 para. 1 sentence 2 AMG can only be examined by private experts who have been appointed in accordance with Section 65 para. 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 are

  1. expertise in accordance with Section 15 AMG; practical experience in the testing and assessment of medicinal products in medicinal product testing centers or other similar medicinal product institutes may replace practical experience in accordance with Section 15 (1) and (4) AMG,
  2. the reliability required to work as an expert for the examination of official samples and
  3. the availability of suitable premises and facilities for the intended testing and assessment of medicinal products.

  • 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.

The informal application with the required documents must be sent to the responsible government.

A fee of between €5.00 and €25,000 is set for the appointment on the basis of the administrative work and time involved and the importance of the matter for the applicant.

The costs are to be borne by the applicant.

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

Administrative court action
Status: 17.04.2025
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
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