Business start-up preparations - General
Inform you generally around the topic business startup.
Here you will find information about formalities related to this subject:
Medicinal products; notification of a clinical trial
Clinical trials under the German Medicines Act are subject to notification.
Pharmaceuticals; application for recognition as a central procurement office.
Pharmaceutical entrepreneurs and wholesalers may exceptionally supply medicinal products, the supply of which is reserved for pharmacies, to central purchasing bodies for medicinal products recognized by the competent authority.
Manufacture of medicinal products; notification of subsequent changes and change of qualified person
Changes with regard to a manufacturing authorisation pursuant to Section 13 of the German Medicines Act are subject to notification.
Manufacture of medicinal products; application for a licence for the working or processing, preservation, testing, storage or placing on the market of tissues or tissue preparations
The processing, preservation, testing, storage or placing on the market of tissues or tissue preparations shall be subject to authorisation.
Manufacture of medicinal products; application for a permit for the collection of tissues and laboratory testing
The collection of tissues and the laboratory tests are subject to authorisation.
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.
A permit in accordance with Section 79 (5) of the German Medicines Act is required by anyone who intends to produce convalescent plasma (RKP) from donors with neutralizing anti-SARS-CoV-2 antibodies for therapeutic purposes or to supply it to others without a corresponding permit or authorization.
Pharmaceutical law; application for a licence for the wholesale trade in medicinal products
The granting of a wholesale permit is required if, for example, companies wish to procure, store, supply or export medicinal products on a professional or commercial basis. The supply of medicinal products to consumers other than doctors, dentists, veterinarians or hospitals is excluded.
Pharmaceutical legislation; import authorisation and certificates for tissues and certain tissue preparations
The importation of tissues / tissue preparations from a third country is subject to authorisation.
Service portal Bavaria; information portal and communication platform for entrepreneurs
Via the Bavarian Services Portal, entrepreneurs from Germany and abroad can obtain information on all the formalities and procedures required for their activities and on the competent bodies and the Single Point of Contact. The portal also publishes information on the recognition of professional qualifications abroad.
Point of Single Contact
Service providers from Germany, the EU and equivalent states (Iceland, Liechtenstein, Norway) may complete procedures and formalities within the scope of the Services Directive (Directive 2006/123/EC of the european parliament and of the council on services in the internal market), which are necessary for the start up and exercise of the service, via the Points of Single Contact. This means the Point of Single Contact informs about the required formalities and acts as an intermediary in the procedure, at the service provider's request.
European Maritime and Fisheries Fund; application for funding.
The Free State of Bavaria supports investments in commercial pond management and fishing from its own funds and the European Maritime and Fisheries Fund (EMFF 2014 - 2021).
The application period ended on 31.12.2021. Until the end of 2023, the applications received until then will be approved or settled.
A successor program is expected to start in the second half of 2022.
Business start-up; consulting and promotion
In the Free State of Bavaria, the prospects of being successfully self-employed are particularly favorable. In order to make Bavaria the frontrunner in terms of start-ups, the Bavarian state government has launched the initiative Gründerland Bayern.
Founder country Bavaria; Internet portal for existence founders and existence founders
The website provides information about the Bavarian State Government's "Gründerland Bayern" initiative. The portal offers tips for the path to self-employment and provides information on all important topics related to founding a company.
Publications on economic, energy policy and state development; ordering and retrieval
The Bavarian State Ministry of Economic Affairs, Regional Development and Energy provides comprehensive information on a wide range of topics.
More information about this subject: