Pharmaceuticals; application for a customs certificate

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

Description

Prerequisites

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

Procedure

The application with the required documents should be sent to the relevant government.

Processing time

The customs certificate can only be issued after all required documents have been submitted and 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): 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.

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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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, 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.