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.
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.
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.
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.
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.
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
.
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.
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.
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).
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...
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 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.
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.
Building products, their manufacture/application
Types of construction whose execution
require exceptional expertise and experience of the persons entrusted with them, must...
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 manufacture medicinal products (human or veterinary medicinal products, including clinical investigational medicinal products), test sera or test antigens, active...
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.
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.
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.
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).
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.
Permits, approvals and certificates in connection with medicinal products are issued by the State Administration Office in Halle. It is also responsible for supervising...
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.
Chemicals
Classification, labelling and packaging of chemicals
Hazardous chemicals need to comply with strict EU requirements. You may have to ensure your products follow...
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.
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).
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...
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.
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...
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 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.
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.
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.
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection 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...
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.
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 approval, testing and safety of a medicinal product for use in humans or immunological veterinary medicinal products, you can obtain information.
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).
In Germany, high-activity sealed radioactive sources are used in industry, commerce, medicine, research and agriculture. Industrial applications include, for example, the...
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.
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.
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.