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Medicinal products; application for a customs certificate

A customs certificate is required if, for example, companies wish to import medicinal products from third countries into the area of application of the Medicinal Products Act.

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Regierung von Oberbayern
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Regierung von Oberfranken
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Procedure details

For the customs clearance of medicinal products for free circulation in the case of Section 73 para. 1 sentence 1 no. 2 and para. 1a no. 2 in conjunction with para. 1 sentence 1 no. 2 of the German Medicines Act (AMG), a certificate from the competent authority responsible for the recipient is required, in which the medicinal products are designated and it is confirmed that the requirements under para. 1 or para. 1a are fulfilled.

The following are responsible for the certificate

  • 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.

The prerequisite for this is the marketability of the medicinal products to be imported (marketing authorization in accordance with Section 21 et seq. of the German Medicinal Products Act).

  • Proof of approval
  • GMP certificates of the manufacturing plants

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

Costs (fees): 50 to 750 EUR (according to the schedule of costs - tariff no. 7.IX.8/ tariff item 7)

Expenses (e.g. postal delivery charges) are individual.

The costs (fees and expenses) are to be borne by the applicant.

The customs certificate can only be issued once all the necessary documents have been submitted and any outstanding questions have been clarified.

Administrative court action
Status: 17.04.2025
Editorial responsibility Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
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