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.

Description

For the customs clearance of medicinal products for free circulation in the case of Section 73, paragraph 1, sentence 1, no. 2 and paragraph 1a, no. 2 in conjunction with paragraph 1, sentence 1, no. 2 of the Medicinal Products Act (AMG), the submission of a certificate from the authority responsible for the recipient is required, in which the medicinal products are described and it is confirmed that the conditions according to paragraph 1 or paragraph 1a are fulfilled.

The following authorities 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.

Prerequisites

A prerequisite is the marketability (marketing authorisation according to § 21 ff. AMG) of the medicinal products to be imported.

Procedure

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

Processing time

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

Required documents

  • Proof of approval
  • GMP certificates of the manufacturing plants

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

Fees

  • Costs (fees): EUR 50 to 750 (according to 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.

Remedy

Administrative court proceedings; information

Administrative court action

Status: 11.10.2021

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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Responsible for you

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.