Information - Services - Formalities by subjects - Preparations for business start-up - Erlaubnispflichtige und überwachungspflichtige Unternehmen - Medicinal products; application for a customs certificate - Dienstleistungsportal Bayern

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.

• Prefillable Form, Bavaria-wide: Antrag auf Erteilung einer Zollbescheinigung nach § 73 Absatz 6 AMG zur Vorlage bei der Zolldienststelle

  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

• 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.

Legal bases

• § 73 Abs. 1 Satz 1 Nr. 2 sowie Abs. 1a Nr. 2 in Verbindung mit Abs. 1 Satz 1 Nr. 2 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

Remedy

Administrative court action