Information - Services - Formalities by subjects - Foreign trade - Import of goods and services from EU and non-EU countries - Medicinal products; application for an import permit and an import certificate for medicinal products for human and veterinary use and active substances subject to authorisation - Dienstleistungsportal Bayern

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 which are not Member States of the European Union or other Contracting States to the Agreement on the European Economic Area into the area of application of this Act on a commercial or professional basis. The same shall apply to persons and institutions wishing to import medicinal products of human origin for direct human use 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. The Government of Upper Bavaria is locally 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 subject to authorisation, a certificate according to § 72 a Para. 1 Sentence 1 No. 1 AMG or a certificate according to § 72 a Para. 1 Sentence 1 No. 2 AMG is also required.

A certificate according to Section 72 a (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 inspected the country of manufacture to ensure that the above-mentioned basic rules are observed in the manufacture of the medicinal products or active substances. The costs of such an inspection of the manufacturing site for medicinal products or active substances located abroad shall be borne by the applicant.

The Governments of Upper Bavaria and Upper Franconia are responsible for issuing the certificate according to Section 72 a (1) sentence 1 no. 2 AMG. The Government of Upper Bavaria is locally 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 authorised or registered in Germany are subject to a ban on movement in accordance with § 73 AMG. This means that these medicines may not be brought into Germany by private individuals. It is irrelevant here whether there is a corresponding or even identically named drug available for purchase in Germany.

Prerequisites

The requirements for the granting of the import permit according to § 72 AMG as well as the certificate according to § 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 under pharmaceutical law: 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 the schedule of costs - 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 Catalogue - 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).

Legal bases

• § 72 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)

  Einfuhrerlaubnis

• § 72 a Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)

  Zertifikat bzw. Bescheinigung

• § 73 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)

  Verbringungsverbot

• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

Remedy

administrative claim

Links to more information

• Merkblatt: Voraussetzungen zur Erteilung einer Erlaubnis gemäß § 72 Abs. 1 AMG zur Einfuhr von Arzneimitteln, Wirkstoffen (menschlich, tierisch, mikrobiell, gentechnisch hergestellt) oder anderen zur Arzneimittelherstellung bestimmten Stoffen menschlicher Herkunft
• Merkblatt: Voraussetzungen zur Erteilung einer Bescheinigung gemäß § 72 a Abs. 1 Satz 1 Nr. 2 Arzneimittelgesetz (AMG) zur Einfuhr von Arzneimitteln i.S.v. § 2 Abs. 1 u. 2 Nrn. 1, 1a, 2 und 4 AMG, zur Einfuhr Wirkstoffen, die menschlicher, tierischer oder mikrobieller Herkunft sind, oder die auf gentechnischem Wege hergestellt werden und zur Einfuhr anderer zur Arzneimittelherstellung bestimmter Stoffe menschlicher Herkunft (§ 72 a Abs. 1 b AMG)