Medicinal products; application for import permit and import certificate for human and veterinary medicinal products and active substances requiring a permit

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

An import permit in accordance with Section 72 of the German Medicines Act (AMG) is required by anyone who

  • Medicinal products within the meaning of Section 2 (1) or (2) No. 1 AMG,
  • active substances which are of human, animal or microbial origin or which are produced by genetic engineering, or
  • other substances of human origin intended for the manufacture of medicinal products

from countries that are not member states of the European Union or other contracting states to the Agreement on the European Economic Area. The same applies to persons and institutions that wish to import medicinal products of human origin for direct use in humans on a professional or commercial basis.

The import permit must be applied for informally before commencing the activity. The governments of Upper Bavaria and Upper Franconia are responsible for issuing the import permit. 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.

For the import of medicinal products in the sense of § 2 Para. 1 and Para. 2 No. 1, 1a, 2, and 4 AMG as well as certain active substances requiring a license, a certificate in accordance with § 72 a Para. 1 Sentence 1 No. 1 AMG or a certificate in accordance with § 72 a Para. 1 Sentence 1 No. 2 AMG is also required.

A certificate according to § 72 a para. 1 sentence 1 no. 1 AMG is sufficient,

  • if the competent authority of the country of manufacture has confirmed in this certificate that the medicinal products or active substances are manufactured in accordance with recognized rules for the manufacture and assurance of their quality (in particular those of the European Communities, the World Health Organization or the Pharmaceutical Inspection Convention), and
  • such certificates are mutually recognized (i.e. between the Federal Republic and the respective manufacturing country).

If certificates are not mutually recognized, a certificate according to § 72 a Para. 1 Sentence 1 No. 2 AMG is required.

Such a certificate can only be issued if the competent authority or a competent authority of a member state of the European Union or of another state party to the Agreement on the European Economic Area has regularly verified in the country of manufacture that the basic rules mentioned are observed in the manufacture of the medicinal products or active substances. The costs of such an inspection of the production site for medicinal products or active pharmaceutical ingredients located abroad shall be borne by the applicant.

The governments of Upper Bavaria and Upper Franconia are responsible for issuing the certificate in accordance with Section 72 a (1) sentence 1 no. 2 AMG. 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.

Attention. The following applies to private individuals:

Medicinal products that are not authorized or registered in Germany are subject to a ban on movement according to § 73 AMG. This means that these drugs may not be brought into Germany by private individuals. It is irrelevant here whether there is a corresponding drug or even a drug with the same name available for purchase in Germany.

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.

    Dieser Assistent unterstützt Sie bei der Erstellung eines formlosen Schreibens, wenn die zuständige Stelle kein Antragsformular zur Verfügung stellt.

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:

    • Import permit for medicinal products: 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: 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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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.