Pharmaceuticals; application for an export certificate

A certificate in accordance with the World Health Organization certificate system must be applied for when exporting pharmaceuticals.

Description

Upon application by the pharmaceutical entrepreneur, the manufacturer, the exporter or the competent authority of the country of destination for the export of medicinal products, the competent authorities shall issue a certificate in accordance with the certificate system of the World Health Organization (WHO) pursuant to Section 73 a (2) of the German Medicines Act (AMG).

Responsibilities

The governments of Upper Bavaria and Upper Franconia are responsible for issuing the export certificate.

Locally, the Government of Upper Bavaria is responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia and the Government of Upper Franconia for the administrative districts of Middle Franconia, Upper Franconia, Lower Franconia and Upper Palatinate.

Prerequisites

If an export certificate (certificate of origin) is required by the authorities of the country of destination for the export of medicinal products, you can apply for it as a pharmaceutical entrepreneur at the responsible offices.

Deadlines

Deadlines are not to be met.

Required documents

  • The medicinal products to be exported must be described in accordance with the WHO scheme, and the requirements of the country of destination must be specified.

Fees

  • Cost per preparation: 50 € (according to cost schedule - tariff no. 7.IX.8 /tariff item 8.1)

Remedy

Administrative court proceedings; information

administrative claim

Status: 14.09.2022

Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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