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 in Product and material authorisations

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Application 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 European level. If approved, the smoke flavoring will be placed on the EU Community list of primary products.
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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.
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Apply for approval for recycling processes for plastics in food contact
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.
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Apply for approval for the operation of an X-ray facility or the significant modification of the operation for teleradiology
Would you like to operate a teleradiology X-ray facility or make significant changes to it? Then you must first apply for a permit from the competent authority.
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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 authorization on the European Commission's online portal E-Submission Food Chain Platform.
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Apply for approval of new substances for cellophane films in food contact
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.
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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.
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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).
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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).
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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).
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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.
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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).
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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.
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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).
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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.
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Applying for approval of health claims on foods
Health claims on foods generally require authorization. You can apply for this authorization via the European Commission's E-Submission Food Chain (ESFC) platform.
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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).
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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).
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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.
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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.
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Applying for the quality inspection of vine planting stock
In accordance with the Seed Marketing Act and the Vine Planting Material Ordinance, you must have a quality inspection carried out on vines that have graftable scions and blind rootstocks as a basis.
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Certify explosion-proof devices
Conformity assessment procedures must always be carried out for products in potentially explosive atmospheres.
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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.
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Display a plant that requires approval for the first time due to a change in the law
If you are constructing or have erected a plant requiring a permit and this installation has not yet been approved or notified, you must report this to the competent authority in due time.
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Feed control
Animal feed is the most important agricultural input in Germany with a value of approx. 17.68 billion euros (2012). The annual consumption of animal feed is approx. 79.4 million...
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Harvest authorization register
The Harvesting Authorization Register (EZR) is an official public register. It shows the harvesting possibilities for forest reproductive material (e.g. for harvesting seeds or...
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Communicate formulations of tattooing products
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.
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Foods 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).
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Have additives in plant protection products approved
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.
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Have unauthorized plant protection products for use on infested objects approved for export
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.
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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.
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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.
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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.
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Notification of food supplements for sale in Germany
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).
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Notification of ingredients and further information on tobacco products, e-cigarettes and smokeless tobacco products Receipt
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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).
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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).
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Obtain approval for the use of plant protection products on public land
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.
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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.
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Report high-activity radiation sources to the HRQ register
You must report the disposal, acquisition, other whereabouts and leak tests of highly radioactive sources to the HRQ register. In Germany, highly radioactive sources are used in...
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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.
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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.
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Request information on medicinal products for human use that are authorized or registered in Germany and on immunological medicinal products for use in animals
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.
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Request risk assessment for new substances in food contact materials that are not subject to EU-wide harmonized material-specific regulation
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).
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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 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.
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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.
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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.
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