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There are 63 services for Product and material authorisations

Product and material authorisations

For the protection of people and nature, the handling of certain materials and the distribution of certain goods is regulated. This applies specifically to pharmaceuticals, active ingredients, and particularly hazardous substances such as radioactive material. You can find the relevant information here.

Services:

Apply for a permit to modify an installation for the generation of electricity from renewable energy sources (repowering).

If you intend to make changes to an installation that requires a permit and generates electricity from renewable energy sources, you must apply for a permit from the relevant authority.

Apply for a permit to participate in the narcotics trade

If you wish to participate in the narcotics trade, you must apply for a permit.

Apply for approval for recycling processes of plastics in contact with foodstuffs

Do you want to recycle plastics and use them to produce food contact materials such as packaging? Then you need to apply for approval for the relevant recycling process on the European Commission's online portal E-Submission Food Chain Platform.

Apply for approval for the operation of an X-ray facility or the significant modification of the operation for teleradiology

If you wish to operate a teleradiology X-ray facility or make significant changes to it, you must first apply for a permit from the competent authority.

Apply for approval of active and intelligent substances in food contact materials

Do you want to use active and intelligent substances for materials that come into contact with food? Then you need to apply for approval on the European Commission's online portal E-Submission Food Chain Platform.

Apply for approval of health claims on food

Health claims on foods usually require approval. You can apply for this approval via the E-Submission Food Chain (ESFC) platform of the European Commission .

Apply for approval of new substances for plastics in food contact materials

You want to use a new substance for the production of food contact plastics? Then you need an authorization. You can submit the application online on the portal E-Submission Food Chain Platform of the European Commission.

Apply for approval of new substances for regenerated cellulose film in contact with foodstuffs

You want to use new substances for the production of regenerated cellulose films in food contact? To do so, you need to submit an application for approval on the European Commission's online portal E-Submission Food Chain Platform.

Apply for batch release of immunomodulators as veterinary medicinal products

Would you like to market immunomodulators approved in Germany as veterinary medicinal products? Then you must apply for a batch release from the Paul Ehrlich Institute (PEI).

Apply for batch release of Sera as a veterinary medicinal product

Would you like to market sera approved in Germany as veterinary medicinal products? Then you must apply for a batch release from the Paul Ehrlich Institute (PEI).

Apply for batch release of tuberculins as veterinary medicinal products

Would you like to market tuberculins approved in Germany as veterinary medicinal products? Then you must apply for a batch release from the Paul Ehrlich Institute (PEI).

Apply for feed authorisation

With a value of around 10 billion euros, animal feed is the most important agricultural input in Germany. The demand for animal feed is about 66 million tons per year, which...

Apply for general rulings for foodstuffs

Would you like to import foodstuffs that are legally marketed or manufactured in another EU Member State but deviate from German health protection regulations? Then you can apply for a general ruling.

Apply for inclusion of a digital health application (DiGA) in the DiGA directory

If you are a manufacturer of a digital application that is to be included in the DiGA directory as a digital health application (DiGA), you must submit an application to the Federal Institute for Drugs and Medical Devices (BfArM).

Apply for inclusion of a smoke flavoring primary product in the Community list of authorized primary products.

If you want to use a new smoke flavoring in or on food, you must have it approved at the European level . If approved, the smoke flavoring will be placed on the EU Community List of Primary Products.

Apply for official test number for quality wine, sparkling wine and semi-sparkling wine for quality wine testing

If you produce or bottle quality wine, sparkling wine or semi-sparkling wine, you need an official inspection number. You can apply for this from the competent authority.

Apply for recognition as a testing, inspection or certification body (PÜZ body) for construction products

Building products, their manufacture/application Types of construction whose execution require exceptional expertise and experience of the persons entrusted with them, must...

Apply for recognition for radon measurements in the workplace

If you want to provide and evaluate devices for legally required measurements of radon activity concentration at workplaces, you must be recognized by the Federal Office for Radiation Protection (BfS).

Applying for a non-commercial firearms manufacturing permit

If you want to manufacture, process and repair weapons or ammunition without making a profit, you need a non-commercial weapons manufacturing license.

Applying for a permit to manufacture medicinal products

If you wish to manufacture medicinal products (human or veterinary medicinal products, including clinical investigational medicinal products), test sera or test antigens, active...

Applying for approval for a significant change to an installation requiring approval

If you intend to make significant changes to an installation that requires a permit, you must apply for a permit from the responsible authority.

Applying for approval for accident-relevant changes to an installation requiring approval

If you intend to make changes to an installation that requires approval that are relevant to an incident, you must first apply for approval from the responsible authority.

Applying for approval for the construction and operation or modification of an installation that is relevant to an incident and does not require approval

If you wish to construct and operate or modify an installation that does not require a permit and is an operating area or part of an operating area and this could have an impact relevant to incidents, you must apply for a permit.

Applying for approval of exemptions and issuing general rulings for tobacco and related products

If you want to produce or place on the market tobacco and related products that do not meet the requirements applicable in Germany, you can apply for an exemption or a general ruling under certain conditions.

Applying for approval of novel tobacco products

Novel tobacco products, for example heated tobacco products, may only be placed on the market if they have been approved. You can apply for approval from the Federal Office of Consumer Protection and Food Safety (BVL).

Applying for approval to conduct clinical trials of medical devices

If you want to conduct clinical trials as a manufacturer of medical devices, you may have to apply for approval from the Federal Institute for Drugs and Medical Devices (BfArM).

Applying for approval to operate or significantly change the operation of a technical X-ray facility

If you wish to operate technical X-ray equipment or make significant changes to it, you must first apply for a permit from the responsible radiation protection authority.

Applying for authorisation of medicinal products

Permits, approvals and certificates in connection with medicinal products are issued by the State Administration Office in Halle. It is also responsible for supervising...

Applying for batch release of vaccines as veterinary medicinal products

Would you like to market vaccines authorized in Germany as veterinary medicinal products? Then you must apply for a batch release from the Paul Ehrlich Institute.

Certification, labels (EMAS, energy labels, Eco-design, EU eco-label)

Before you can begin selling a product in an EU country, it must comply with the rules that apply in that country and throughout the EU.

Certify explosion-proof equipment

In principle, conformity assessment procedures must be carried out for products in potentially explosive atmospheres.

Change authorization for participation in narcotics traffic

If you wish to change, extend or renew your permit to participate in the narcotics trade, you must submit a change application.

Classification, labelling and packaging for hazardous chemicals

Chemicals Classification, labelling and packaging of chemicals Hazardous chemicals need to comply with strict EU requirements. You may have to ensure your products follow...

Display an installation requiring approval for the first time due to a change in the law

If you are erecting or have erected an installation that requires a permit and this installation has not yet been approved or registered, you must report this to the competent authority by the deadline.

Display handling and traffic with explosive substances

You must notify the competent authority of the commercial handling of explosive and pyrotechnic substances. You can find out more here.

Foodstuffs for special medical purposes, infant formulae and certain follow-on formulae for sale in Germany

If you wish to market food for certain consumer groups requiring special protection, such as sick people or infants, in Germany, you must notify the Federal Office of Consumer Protection and Food Safety (BVL).

Identifying applicable standards, technical specifications and getting products certified

Product information of the Federal Institute for Materials Research and Testing (BAM) Below you will find a list of the product regulations of the Federal Institute for...

Independently classify water-polluting chemical substances

If you or your company operate a facility in which chemical substances hazardous to water are handled, you must independently classify the substances used into a water hazard class (WGK) and notify the Federal Environment Agency.

Lists of drift-reducing seeders: Appliance testing and registration application

Seed treated with certain pesticides may only be sown with drift-reducing sowing equipment listed by the Julius Kühn Institute (JKI). You must have your equipment or conversion kits tested by the JKI if they are to be included in the lists.

Making notifications regarding medicinal products with standard authorization

Do you want to use a standard authorization for a medicinal product? You must report this, as well as changes and termination of use.

Mutual recognition of products not subject to Union specifications

Product information of the Federal Institute for Materials Research and Testing (BAM) Below you will find a list of the product regulations of the Federal Institute for...

Notification of food supplements for sale in Germany

If you wish to market food supplements in Germany, you must notify the Federal Office of Consumer Protection and Food Safety (BVL).

Notify cosmetic products (possibly with nanomaterials) before placing them on the market

Cosmetic products that you wish to make available on the European market for the first time must be notified to the European Commission in advance via the Cosmetic Products Notification Portal (CPNP).

Notify daily rations for weight control nutrition for sale or use in Germany

If you wish to market daily rations for weight control nutrition in Germany, you must notify the Federal Office of Consumer Protection and Food Safety (BVL).

Obtain approval for the use of plant protection products on public land

Plant protection products can be applied in public areas, such as parks or cemeteries, by competent persons if they have been approved for this purpose by the Federal Office of Consumer Protection and Food Safety.

Obtain authorisation for export of unauthorised plant protection products for use on infested plants

You can use unauthorised plant protection products under certain conditions on plants, seeds or other infested objects if they are intended exclusively for export from Germany. You need a permit for this.

Obtaining approval for additives in plant protection products

As a manufacturer, you must have new additives in plant protection products tested and approved by the Federal Office of Consumer Protection and Food Safety.

Obtaining CE marking

CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.

Product rules and requirements

Product information of the Federal Institute for Materials Research and Testing (BAM) Below you will find a list of the product regulations of the Federal Institute for...

Registration and deregistration of medicinal products with the Federal Institute for Drugs and Medical Devices

If you want to offer a medicinal product or if you withdraw it from the market, you must report this.

Report suspected adverse reactions and damage to health caused by medicinal products, vaccines or tissue preparations

By reporting suspected cases of side effects or vaccination complications to the authorities, you help to make medicines and vaccines safer.

Report the construction and operation or modification of an installation not requiring a permit that is relevant to a major accident

If you are planning an incident-relevant construction and operation or an incident-relevant change to an installation that does not require a permit and is an operating area or part of an operating area, you must register this.

Report the dispensing of a narcotic via the electronic receipt procedure or the form server receipt procedure

If you dispense narcotics, you must report this electronically to the Federal Institute for Drugs and Medical Devices (BfArM). To create electronic dispensing slips via the form server slip procedure, you must apply for access data from the BfArM.

Request consultation procedure for novel foods

Would you like to launch a food on the German market and are unsure whether it is to be classified as a novel food? Then you can apply to the Federal Office of Consumer Protection and Food Safety (BVL) for a consultation procedure.

Request information on medicinal products for human use authorised or registered in Germany and on immunological medicinal products for use in animals.

If you would like information on the approval, testing and safety of a medicinal product for use in humans or immunological veterinary medicinal products, you can obtain information.

Request risk assessment for new substances in food contact materials that are not subject to EU-wide harmonized material-specific regulation.

If no EU-wide harmonized material-specific regulations exist for a food contact material, you can submit a request for risk assessment to the Federal Office of Consumer Protection and Food Safety (BVL).

Sending notifications of high-activity sealed radioactive sources to the HRQ register

In Germany, high-activity sealed radioactive sources are used in industry, commerce, medicine, research and agriculture. Industrial applications include, for example, the...

Share recipes of tattooing products

As a manufacturer or importer of tattooing products, you must notify the Federal Office of Consumer Protection and Food Safety (BVL) of the formulations. This also applies to certain comparable substances and preparations.

Submit an application for the use of a term as a common traditional name as an exception to the application of Article 1(3) of Regulation (EC) No 1924/2006

Designations that can be construed as health claims may be used without an approval procedure, provided that an approved health claim is attached. You can apply for an exception to this rule for traditional names.

Submit educational material for medicinal products for approval

If you, as the marketing authorization holder of medicinal products, are obliged to create additional educational material for your product, you must submit this for national approval.

View assessment reports for authorized medicinal products

On the portal for medicinal product information of the federal and state governments, you can view public assessment reports with information on the approval decision for medicinal products as a supplement to the information for healthcare professionals and package leaflets.