Product and material authorisations

Notification of activities involving medicinal products

If you work in connection with medicinal products, you must first report this to the State Office for Occupational Safety, Consumer Protection and Health (LAVG), and in some cases also to the Federal Institute for Drugs and Medical Devices (BfArM).

Certify explosion-proof devices

Conformity assessment procedures must always be carried out for products in potentially explosive atmospheres.

Applying plant protection products to control forest insects from the air

In principle, the application of plant protection products with aircraft is prohibited in the state of Brandenburg. For an application, a permit procedure must be carried out.

Operation of an X-ray facility or significant change in operation Authorization

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.

Operation of an X-ray facility or significant change to the operation of an X-ray facility

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.

Modification of an installation requiring approval in accordance with BImSchG Approval for significant modification

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

Modification of an installation requiring approval under the Federal Immission Control Act (BImSchG) Approval as part of the repowering of an installation for the generation of electricity from renewable energies

If you intend to make changes to a system that requires approval and generates electricity from renewable energies, you must apply for approval from the responsible authority.

Modification of a plant subject to approval in accordance with BImSchG Approval for accident-relevant modification

Do you intend to make changes to an installation requiring a permit that are relevant to an incident? Then you must first apply for a permit from the responsible authority.

Incident-relevant construction and operation or incident-relevant modification of an installation not requiring a permit Permit

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

Incident-relevant construction and operation or incident-relevant modification of an installation not subject to licensing Acceptance

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.

Notification of an installation requiring approval for the first time due to a change in the law Acceptance

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.

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).

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.

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.

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

You must send a notification of the transfer, receipt, other presence or leakage tests of high-activity sealed radioactive sources to the HRQ register.

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.

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.

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.

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).

Notify the authorities of the distribution of daily meal plans for weight-management diets for sale in Germany

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

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 from the Federal Institute for Materials Research and Testing (BAM) A list of the product rules issued by the Federal Institute for Materials Research and...

Identifying applicable standards, technical specifications and getting products certified

Product information from the Federal Institute for Materials Research and Testing (BAM) A list of the product rules issued by the Federal Institute for Materials Research and...

Mutual recognition of products not subject to Union specifications

Product information from the Federal Institute for Materials Research and Testing (BAM) A list of the product rules issued by the Federal Institute for Materials Research and...

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...

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.

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.

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.

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).

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.

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.

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.

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).

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

Are you a manufacturer or supplier looking to have a seeder or conversion kit added to the Julius Kühn Institute’s (JKI) list of drift-reducing seeders? If so, you must have these devices tested by the JKI.

Notify the authorities of the distribution of dietary 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).

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.

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.

Supply of foods for special medical purposes, infant formula, and certain follow-on formulas for sale in Germany with

Would you like to market food products in Germany for specific consumer groups that require special protection, such as people with medical conditions or infants? If so, you must report this to the Federal Office of Consumer Protection and Food Safety (BVL).

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.

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 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 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 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 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.

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).

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.

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.