Information - Services - Formalities by subjects - Business start-up preparations - Companies subject to licensing and monitoring requirements - Medicinal products; application for a permit to manufacture medicinal products for human use and active substances requiring a permit - Dienstleistungsportal Bayern

Description

A manufacturing authorization pursuant to Section 13 of the German Medicines Act (AMG) is required by anyone who

• Medicinal products as defined in Section 2 (1) or (2) No. 1 AMG,
• test sera,
• test antigens,
• active substances which are of human, animal or microbial origin or are produced by genetic engineering, as well as other substances of human origin intended for the production of medicinal products

is manufactured commercially or professionally for the purpose of supply to others.

Manufacturing is the extraction, production, preparation, processing, decanting, including filling, packaging, labeling and release of medicinal products.

The manufacturing authorization must be applied for informally before commencing the activity.

The governments of Upper Bavaria and Upper Franconia are responsible for the supervision of manufacturers of human and veterinary medicinal products, active substances and substances of human origin for the manufacture of medicinal products who require a permit in accordance with Section 13 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.

Prerequisites

The requirements can be found in the information sheet.

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

• A fee of between €500 and €50,000 is set on the basis of the administrative effort and time involved and the importance of the matter for the applicant (according to Schedule of Costs - Tariff No. 7.IX.8/Tariff item 1.1.1.1). This also includes expenses for necessary site inspections by our pharmaceutical officials (according to the schedule of costs - tariff no. 7.IX.8/tariff item 1.2).

Legal bases

• §§ 13 ff. Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)

  Herstellung von Arzneimitteln

• 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 Herstellungserlaubnis gemäß § 13 Abs. 1 i.V.m. §14 Arzneimittelgesetz AMG