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When people refer to "FDA law" they usually mean the laws and regulations administered by the United States Food and Drug Administration - a U.S. federal agency that regulates food, drugs, medical devices, cosmetics, and related products for the U.S. market. Those U.S. rules do not apply automatically in Germany. If you are located in Goslar, Germany, your primary regulatory framework will be German and European Union law. At the same time, if you manufacture, export, import or distribute products that are intended for the United States you may also need to comply with U.S. FDA requirements in addition to German and EU rules.
This guide explains the practical differences, when you might need specialized legal help, which German and EU rules are most relevant in and around Goslar, and how to take the next steps to get legal assistance.
Regulatory work in the fields of medicines, medical devices, food, cosmetics and related products is highly technical and can have serious consequences if done incorrectly. People and businesses frequently seek a lawyer in these areas for reasons such as:
- Product classification disputes - whether a product is a medicine, a medical device, a cosmetic, a food or a consumer product affects which rules apply.
- Market access for Germany, the EU and the U.S. - approvals, registrations, CE-marking, conformity assessment, clinical trial approvals, and FDA submissions have different procedures and timelines.
- Labeling and advertising compliance - German and EU rules set strict limits on claims for medicines and certain health-related claims, and U.S. FDA rules impose other requirements when selling in the U.S.
- Inspections, audits and enforcement - inspections by German authorities or by U.S. FDA inspections for facilities exporting to the U.S. can lead to corrective actions, recalls, penalties or business interruptions.
- Product safety incidents and recalls - managing a recall or field safety corrective action requires legal guidance to minimize liability and comply with notification obligations.
- Clinical trials and research - preparing applications, obtaining ethics approvals, drafting informed consent forms, and meeting reporting duties require specialized legal and regulatory understanding.
- Cross-border contracts and distribution agreements - negotiating supply, manufacturing, distribution, licensing, and indemnity provisions in an international context involves multiple legal regimes.
Engaging a lawyer with regulatory and product compliance experience helps you reduce legal and commercial risk, interact correctly with authorities, and plan efficient market-entry strategies.
Although the U.S. FDA is a U.S. agency, several German and EU laws govern the same subject areas and are directly relevant in Goslar.
- Pharmaceuticals and clinical trials - the German Arzneimittelgesetz (AMG) implements EU pharmaceutical law and governs marketing authorization, prescription rules, pharmacovigilance and clinical trials. The EU Clinical Trials Regulation also applies to clinical trial conduct in the EU.
- Medical devices - the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) are the primary rules for placing medical devices on the EU market. Compliance involves conformity assessment, technical documentation, clinical evaluation, post-market surveillance and cooperation with notified bodies. Germany has national implementing provisions where applicable.
- Food, supplements and additives - the Lebensmittel-, Bedarfsgegenstaende- und Futtermittelgesetzbuch (LFGB) is Germany's main food law, supplemented by EU food regulations covering hygiene, additives, novel foods and claims.
- Cosmetics - the EU Cosmetics Regulation sets safety, labeling and ingredient rules for cosmetics sold in the EU.
- Product safety and consumer protection - the Produktsicherheitsgesetz (ProdSG) and related EU product safety rules impose obligations on manufacturers and distributors to place safe products on the market and to report dangerous products.
- Advertising and marketing - the Heilmittelwerbegesetz (HWG) restricts advertising of medicinal products in Germany. Additional national and EU rules limit health claims for foods and dietary supplements.
- Packaging and waste - the Verpackungsgesetz governs packaging obligations and producer responsibilities in Germany.
- National authorities and local bodies - the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) handle medicines and vaccines. The Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Risk Assessment (BfR) play roles for food and consumer products. At the state level, Lower Saxony authorities and the local Gesundheitsamt in Goslar handle inspections, notifications and enforcement for public health and food safety matters.
If you sell or ship products to the United States from Goslar, you will need to consider U.S. FDA obligations in addition to the German and EU rules summarized above. Those U.S. obligations include facility registration, listings, premarket submissions and U.S. labeling rules as applicable to the product category.
Not by itself. U.S. FDA law applies to products that are imported into or offered for distribution in the United States. If you do not sell in the U.S., FDA requirements generally do not apply. If you intend to export products to the U.S., you must comply with relevant FDA requirements as well as German and EU law.
Product classification depends on intended purpose, composition and mode of action. German and EU law use legal definitions and tests to classify products. A lawyer or regulatory consultant can review product information, claims, formulation and intended use to advise the correct classification and the applicable regulatory pathway.
Yes. For most medical devices sold in the EU, CE-marking under the MDR is required. CE conformity includes technical documentation, clinical evaluation, quality management and, for certain device classes, assessment by a notified body.
You must comply with German and EU food law for marketing in Germany and the EU. For export to the U.S., U.S. FDA rules on facility registration, dietary supplement labeling, ingredient approvals, new dietary ingredient notifications and import controls may apply. You may also face customs requirements and U.S. testing or import holds.
Inspections can be routine or triggered by complaints or incidents. They may result in requests for corrective actions, formal warnings, product seizures or administrative fines if violations are found. A lawyer can help you prepare for inspections, respond to inspection findings and negotiate with authorities.
Recalls and safety notifications follow specific reporting and action rules depending on product type. You should immediately document the issue, notify competent authorities such as the Gesundheitsamt and relevant federal bodies, stop distribution if necessary, and inform customers and distributors. Legal counsel should be involved early to manage compliance and limit liability.
Yes. Clinical trials with medicinal products or certain devices require ethics committee approval and regulatory approvals under the AMG and EU Clinical Trials Regulation. The relevant federal agency may also need to authorize the trial. A lawyer or regulatory expert can assist with applications and documentation.
Advertising of medicinal products is tightly controlled and certain claims for foods and supplements are restricted. The HWG and EU rules limit promotional statements. Advertising that suggests medicinal properties for foods or cosmetics may trigger enforcement. Always review planned claims with counsel or a regulatory expert.
Penalties range from product detention or seizure, mandatory corrective actions, and public warnings to administrative fines and criminal proceedings in severe cases. Penalties depend on the regulatory area and severity of the breach. Civil liability and product liability claims from consumers can also arise.
Look for lawyers or law firms that advertise cross-border regulatory expertise and have experience with both EU and U.S. regulatory regimes. Key indicators include prior work on exports to the U.S., FDA submissions, international compliance projects and multidisciplinary teams that include regulatory scientists. You can ask for references and examples of similar matters.
Consult these authorities and organizations for official guidance and support when dealing with regulatory questions in Goslar:
- Federal Institute for Drugs and Medical Devices - BfArM - for medicines and certain medical device matters.
- Paul-Ehrlich-Institut - PEI - for vaccines, blood products and immunological medicines.
- Federal Office of Consumer Protection and Food Safety - BVL - and the Federal Institute for Risk Assessment - BfR - for food and consumer safety issues.
- Landesamt fuer Verbraucherschutz or the Lower Saxony state authorities that handle local enforcement and inspections.
- The local Gesundheitsamt in Goslar for public health notifications and local inspections.
- Industrie- und Handelskammer (IHK) for business-related guidance on exports, customs and market entry.
- Anwaltkammer Niedersachsen to find licensed attorneys and confirm professional standing.
- European Medicines Agency - EMA - for EU-level guidance on medicines and coordinated procedures.
For U.S. export questions you may need U.S. counsel or regulatory consultants familiar with U.S. FDA requirements, export controls and customs procedures.
If you need legal assistance in this area, use the following checklist to prepare and find the right support:
- Identify the issue clearly - product type, markets you intend to serve, current status of approvals and any enforcement or inspection notices.
- Gather documentation - product specifications, labels, claims, safety data, quality management records, distribution and sales agreements, previous correspondence with regulators.
- Choose the right specialist - seek a lawyer with experience in your product category, cross-border trade if exporting to the U.S., and familiarity with German, EU and if needed U.S. FDA law.
- Arrange an initial consultation - a preliminary meeting will help scope the legal needs, timelines and estimated costs. Ask about prior experience with similar cases.
- Plan for compliance steps - based on the lawyer's advice, implement necessary labeling changes, technical documentation, registrations or corrective actions.
- Preserve evidence and maintain records - document decisions, quality controls and communications with authorities to support compliance and defend against claims if needed.
- Consider insurance and liability mitigation - review product liability insurance and contractual protections in supply and distribution agreements.
Remember that this guide is for informational purposes and does not constitute legal advice. For tailored advice related to your specific situation in Goslar contact a qualified lawyer who can assess your facts and represent your interests before relevant authorities.
