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When people speak of "FDA law" they usually mean regulatory rules administered by the United States Food and Drug Administration. Those US rules do not apply directly in Poland. If you operate in Nowa Deba, Poland, the relevant framework is a mix of European Union law and Polish national law that covers medicines, medical devices, food, cosmetics and related products. Key authorities in Poland manage registration, safety monitoring, inspections and enforcement. If you plan to place products on the Polish market or export products to the US, you should understand both sets of rules - EU/Poland for local sale and FDA requirements for US import or distribution.
Regulatory matters in the areas of drugs, medical devices, food and cosmetics can be technical and carry significant legal risk. You may need a lawyer when you face any of these situations:
- Product classification uncertainty - whether an item is a medicine, medical device, cosmetic, food supplement or something else.
- Product registration or marketing authorization - preparing and submitting dossiers, responding to authority questions, or following EMA or national procedures.
- Clinical trials - preparing submissions, drafting informed consent, negotiating investigator and sponsor agreements, and handling ethics committee interactions.
- Advertising and promotion - ensuring claims comply with Polish and EU rules and avoiding misleading advertising enforcement.
- Inspections and compliance audits - responding to sanitary or pharmaceutical inspections, negotiating corrective action plans, and defending against enforcement measures.
- Recalls, safety incidents and pharmacovigilance - managing incident response, notifying authorities, and minimizing liability.
- Imports, exports and customs - handling certificates, CE marking, authorized representatives and customs paperwork for non-EU manufacturers.
- Contracts, distribution and liability - drafting distribution agreements, supply contracts, warranties and product liability risk allocation.
Key legal sources and concepts to know in Poland and the EU - applicable in Nowa Deba - include the following:
- EU regulations and directives - many rules are set at EU level and apply directly or via national law. Examples include the Medical Devices Regulation, the Clinical Trials Regulation and food safety legislation.
- Polish Pharmaceutical Law - national legislation that governs medicinal products, pharmacies and aspects of production and distribution.
- Medical devices framework - the EU Medical Devices Regulation (MDR) and related national rules regulate placing devices on the market, CE marking, clinical evaluation and vigilance.
- Food law and safety - the EU General Food Law and national sanitary regulations cover food safety, labeling, supplements and hygiene requirements.
- Cosmetics regulation - sets safety assessment, labeling and notification requirements for cosmetic products placed on the EU market.
- Good Manufacturing Practice - manufacturers of medicines and certain other products must meet GMP standards and hold appropriate certifications.
- Pharmacovigilance and vigilance systems - obligations to report adverse events and to maintain safety monitoring systems.
- Advertising and promotion rules - strict limits on promotional claims for medicines and regulated wording for medical devices, foodstuffs and supplements.
- Local enforcement - state sanitary inspectors, regional offices and specialized national agencies conduct inspections, issue orders, impose fines and manage recalls. Administrative and criminal penalties are possible for serious breaches.
Practically, businesses in Nowa Deba will deal with municipal and county authorities for local permits and inspections, provincial offices for regional issues, and national authorities for marketing authorizations and registrations.
No - US FDA approval or clearance does not automatically grant the right to place a product on the Polish or EU market. FDA decisions are relevant when exporting to the US, and they may inform product safety assessments, but you must meet EU and Polish regulatory requirements - which can differ in dossier structure, labeling, clinical evidence and conformity procedures.
Registration depends on the product type. For medicinal products you usually submit an application to the national competent authority or use an EU centralised procedure if eligible. For medical devices the process depends on device classification - higher risk devices require notified body involvement and a conformity assessment. A regulatory lawyer or consultant can help determine the correct pathway, compile technical files or dossiers, and submit applications.
Classification is a legal determination based on intended use, mode of action and composition. Small differences in labeling or claims can change the regulatory category. Getting legal and technical advice early reduces the risk of choosing the wrong regulatory route and facing enforcement or rework later.
Yes - consumer-facing information normally must be in Polish. Requirements include ingredient lists, safety warnings, intended use, dosage instructions for medicines, CE marking details for devices, and other information depending on the product category. Labeling rules also cover font size, presentation and required statements.
Often yes. Non-EU manufacturers of medical devices must appoint an EU authorised representative. For certain products and procedures a local or EU-based responsible person is required to act as liaison with authorities. Your lawyer will advise on contractual terms and responsibilities for authorised representatives.
Treat inspections seriously. Ask for identification and the scope of the inspection, cooperate but avoid volunteering speculative explanations, and preserve records. Notify legal counsel quickly if potential violations are involved. A lawyer can help manage the inspection, prepare responses, and engage with authorities on corrective actions.
Penalties vary - administrative fines, product seizures, suspension of distribution, forced recalls, or orders to cease operations. In severe cases there can be criminal liability for negligence or endangering public health. Penalties depend on the nature and gravity of the breach and whether it was deliberate or due to negligence.
Both manufacturers and health professionals have reporting obligations for adverse events. For medicines this falls under pharmacovigilance rules; for devices there are vigilance obligations. Reports must be made within statutory timelines to national authorities and, in some cases, to EU systems. Maintain a documented procedure and contact a lawyer to ensure timing and content meet legal standards.
Yes, foreign clinical data can be accepted, but it must meet applicable ethical and methodological standards and may need supplemental local data. Authorities will review whether the study population, informed consent, and trial conduct comply with EU requirements. A legal and regulatory review helps ensure foreign data will be accepted.
Look for lawyers or firms with experience in EU and Polish regulatory law for medicines, devices, food or cosmetics. Ask for client references, examples of similar work, language capabilities, and familiarity with national authorities. Confirm their professional registration in Poland. Discuss fee models - fixed fees for defined tasks, hourly rates, or retainer arrangements - and get the engagement terms in writing.
These are types of organizations and authorities to consult or contact when you need accurate regulatory information in Poland:
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products - national body for medicines and device registration.
- Chief Sanitary Inspectorate and local State Sanitary Inspection offices - for food safety, hygiene and sanitary matters in your region.
- Główny Inspektorat Farmaceutyczny - the Polish pharmaceutical inspectorate that supervises pharmacies, distribution and enforcement in the pharmaceutical sector.
- European Medicines Agency - for EU-level approvals, guidance and centralized procedures.
- National and regional ethics committees - for clinical trial approvals and oversight.
- Polish Bar Association and local lawyer directories - to find qualified attorneys authorised to practice in Poland.
- Trade associations and chambers of commerce - for industry guidance and best practice documents.
- Local municipal and county offices - for permits, waste handling, building and local compliance requirements in Nowa Deba.
If you need legal assistance with regulatory matters in Nowa Deba, follow these practical steps:
- Collect and organise all product documentation - technical specifications, ingredient lists, manufacturing details, clinical data, quality certificates and existing labels.
- Identify the likely product classification and the primary legal risks - registration needs, labelling, claims, and supply chain responsibilities.
- Contact a lawyer or law firm with regulatory experience in Poland - ask about prior cases like yours, fees and the expected timeline.
- Prepare for an initial meeting - provide a concise summary of the product, intended markets, current approvals and the specific question you need solved.
- Set clear objectives and a scope of work - for example, product classification opinion, dossier preparation, response to an inspection, or representation before an authority.
- Maintain records of all authority correspondence, quality systems and corrective actions - these are crucial if an inspection or enforcement action occurs.
- Plan for translations and local representation if you are a non-Polish speaker or a non-EU company.
Disclaimer - This guide provides general information about regulatory frameworks and practical steps. It does not constitute legal advice. For tailored advice and representation contact a qualified lawyer licensed in Poland who specialises in regulatory and administrative law for medicines, medical devices, food or cosmetics.
