Information - Services - Formalities by subjects - Business start-up preparations - General - Drug manufacturing; application for a permit to manufacture and dispense convalescent plasma (RKP) from donors with neutralizing anti-SARS-CoV-2 antibodies for therapeutic purposes. - Dienstleistungsportal Bayern

Description

In the event of a shortage of medicinal products required for the prevention or treatment of life-threatening diseases, or in the case of a threatening communicable disease the spread of which necessitates the immediate provision of specific medicinal products considerably in excess of the usual level, the competent authorities may, on a case-by-case basis, permit medicinal products that are not authorized or registered for marketing within the scope of the Medicinal Products Act (AMG),

• be placed on the market for a limited period of time, and
• by way of derogation from Section 73(1) of the AMG, be brought into the area of application of the AMG.

This applies if the medicinal products may be lawfully placed on the market in the state from which they are brought within the scope of the AMG. The permission by the competent authority is at the same time considered as a certificate according to § 72a paragraph 1 sentence 1 number 3 AMG or according to § 72b paragraph 2 sentence 1 number 3 AMG that the import is in the public interest.

In the case of a supply shortage or a threatening transmissible disease, the competent authorities may also allow a temporary deviation from permit or approval requirements or from other prohibitions under the AMG in individual cases. A determination is made by the Federal Ministry that a supply shortage or a threatening communicable disease exists or no longer exists. The determination shall be made by notice published in the Federal Gazette. The announcement is made in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety, insofar as radioactive medicinal products and medicinal products in the manufacture of which ionizing radiation is used are concerned.

Prerequisites

A prerequisite for the granting of a permit pursuant to Section 79 (5) AMG by the competent government is a determination by the Federal Ministry of Health that COVID-19 is a threatening transmissible disease, the spread of which requires the immediate provision of specific medicinal products that significantly exceeds the usual level. This determination was again published in the Federal Gazette on July 22, 2020. This enables the competent authorities of the federal states to deviate from the requirements of the German Medicines Act for a limited period in individual cases.

For the application, the existence of a valid manufacturing authorization according to § 13 AMG for the manufacture of blood preparations by the apheresis method is required.

The other requirements can be found in the information sheet under "Further links").

Procedure

The application for permission must be made informally.

Deadlines

The application for permission must be submitted before the start of the activity.

As soon as the classification of COVID-19 of 22.07.2020 is revoked by the Federal Ministry of Health by publication in the Federal Gazette, applications can no longer be submitted.

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

• none

Legal bases

• § 79 Arzneimittelgesetz (AMG)

  Ausnahmeermächtigungen für Krisenzeiten

• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)
• Bekanntmachung nach § 79 Absatz 5 des Arzneimittelgesetzes im Bundesanzeiger

Remedy

Administrative court action

Links to more information

• Merkblatt "Voraussetzungen zur Ausstellung einer Gestattung gemäß § 79 Absatz 5 des Arzneimittelgesetzes (AMG) für die Herstellung und Abgabe von Rekonvaleszentenplasma (RKP) von Spendern mit neutralisierenden Anti-SARS-CoV-2 Antikörpern zu Therapiezwecken