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.
Pharmaceutical manufacturing; notification of subsequent changes and change of qualified person.
Changes in relation to a manufacturing authorization according to Section 13 of the German Medicines Act are subject to notification.
Pharmaceutical manufacturing; application for a permit for the treatment 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 is subject to authorization.
Pharmaceutical manufacturing; application for a permit for tissue collection and laboratory testing.
Tissue collection and laboratory testing are subject to licensing.
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 permit for wholesale trade in pharmaceuticals
The issuance of a wholesale permit is necessary if, for example, companies want to procure, store, dispense or export pharmaceuticals on a professional or commercial basis (exception: dispensing to consumers other than physicians, dentists, veterinarians or hospitals).
Pharmaceutical legislation; import permit and certificates for tissues and certain tissue preparations
The import of tissue / tissue preparations from a third country is subject to authorization.
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.
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