Medicinal products; application for import permit and import certificate for medicinal products for human use and active substances subject to authorization

You need an import permit and additionally a certificate if you want to import certain medicinal products from countries that are not member states of the European Union or other contracting states of the Agreement on the European Economic Area.

Description

Prerequisites

The requirements for the issuance of the import permit according to Section 72 AMG as well as the certificate according to Section 72 a Para. 1 Sentence 1 No. 2 AMG can be found in the leaflets under "Forms".

Deadlines

Deadlines are not to be met.

Forms

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

  • Prefillable Form, Bavaria-wide: Formloser Antrag (mit Unterschrift)
    Please note

    This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

Fees

  • The following fees are set on the basis of the administrative effort and time involved and the importance of the matter for the applicant:

    • Pharmaceutical import permit: 200 to 20,000 € (according to the schedule of costs - tariff no. 7.IX.8/ tariff item 6.1)
    • Certificate according to § 72 a or b AMG: 500 to 50.000 € (according to cost schedule - tariff no. 7.IX.8/ tariff item 6.2)
    • Certificate according to § 72 a No. 1e AMG in connection with Annex II Directive (EU) No. 2015/566: 100 € (according to Costs List - Tariff No. 7.IX.8/Tariff item 6.3)

    This also includes expenses for necessary on-site inspections by our pharmaceutical officials (according to cost schedule - tariff no. 7.IX.8/ tariff item 6.9).

Remedy

Administrative court proceedings; information

administrative claim

Status:27.02.2023

Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

Contains machine translated content. Show the original content

  • 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
Bild zur Leistungsbeschreibung

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.