Product and material authorisations

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

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

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

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

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

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).

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).

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).

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.

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).

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).

If you wish to produce or distribute certain feedstuffs, you must apply for approval for the feed company concerned.

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.

Health claims on foods generally require authorization. You can apply for this authorization via the European Commission's E-Submission Food Chain (ESFC) platform.

Do 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 European Commission's E-Submission Food Chain Platform portal.

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).

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).

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.

The CE mark is an indication that a product has been tested by the manufacturer and that it meets all EU-wide requirements for safety, health protection and environmental protection.

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

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

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

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).

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.

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

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.

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.

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

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

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).

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).

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

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

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

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.

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.

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

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

Designations that can be interpreted as a health claim may be used without an approval procedure, provided that an approved health claim is attached. You can apply for an exemption from this regulation for traditional names.

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.

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.