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First, a key clarification: the United States Food and Drug Administration - commonly called the FDA - is a United States federal agency. Its laws and regulations apply within the United States and to products imported into the United States. FDA rules do not directly govern products sold only in Poland or the European Union. If you are in Mława and dealing with products that will stay in Poland or the EU, your matters will primarily be governed by EU and Polish law and by Polish regulatory authorities.
That said, FDA rules become relevant in two common situations for people and companies in Mława: when you plan to export food, medicines, medical devices, cosmetics, or other regulated products to the United States; or when you cooperate with US partners, clinical trial sponsors, or distributors who require FDA compliance. In those cases you will need to meet both US FDA requirements and applicable EU and Polish requirements.
Regulatory matters for medicines, medical devices, food, cosmetics, and related products are complex and technical. You may need legal help in many situations, including:
- Product classification and regulatory strategy when you are unsure whether a product is a medicine, device, food, cosmetic, biocide, or another category.
- Market access and registration, including preparing and submitting applications for marketing authorizations, registrations, or notifications before Polish or EU authorities and, if exporting to the US, supporting FDA submissions.
- Compliance with manufacturing standards such as Good Manufacturing Practice - GMP - and quality system requirements for medical devices and pharmaceuticals.
- Labeling and advertising reviews to ensure claims are lawful under Polish, EU, and, when relevant, FDA requirements.
- Preparing for and responding to inspections by regulatory authorities, including handling inspection findings and corrective action plans.
- Product recalls, withdrawals, and crisis management when safety issues occur.
- Contracts and distribution agreements with local or international partners, including clauses on regulatory compliance, liability, indemnity, and recall coordination.
- Clinical trials and research compliance, including informed consent, approvals, data protection under GDPR, and safety reporting to Polish and EU authorities and, if required, to US partners or the FDA.
- Enforcement actions, criminal or administrative investigations, penalties, or disputes with regulators or competitors.
- Cross-border trade issues such as customs, import-export rules, and requirements to comply simultaneously with EU and US rules.
In Poland and the EU the regulatory framework for health, food, cosmetics, and related products combines EU regulations and directives with Polish national laws. Important points to understand:
- EU law often applies directly in Poland. Key EU-level instruments include the Medical Device Regulation - MDR 2017/745 - and the In Vitro Diagnostic Regulation - IVDR 2017/746 - for devices; Regulation (EC) No 726/2004 and related legislation for centrally authorized medicines; General Food Law Regulation (EC) No 178/2002 for food safety; and EU cosmetic regulation for cosmetics.
- Polish national laws implement EU rules and set local administrative procedures. The main Polish acts you may encounter include the Pharmaceutical Law - Ustawa Prawo farmaceutyczne - and Polish laws on food safety and nutrition, medical devices, and veterinary medicines.
- Key Polish authorities include the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products - Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych - often abbreviated URPLWMiPB; the Chief Pharmaceutical Inspectorate - Główny Inspektorat Farmaceutyczny - GIF; the Main Sanitary Inspectorate - Główny Inspektorat Sanitarny - GIS; and regional and local sanitary and veterinary inspections.
- For food safety, EU institutions such as the European Food Safety Authority - EFSA - set scientific opinions at EU level, while national sanitary inspections and the State Veterinary Inspection handle implementation in Poland.
- If exporting to the US, you must also meet FDA requirements such as product registration, facility registration, labeling rules, and FDA inspections for imported products. This requires coordination between your Polish/EU obligations and US obligations.
FDA law is the set of US federal statutes, regulations, and guidance enforced by the US Food and Drug Administration. It does not directly apply in Poland. However, FDA rules apply to products imported into the United States and to activities occurring within the US. If you intend to export products from Mława to the US or work with US partners, you will need to comply with FDA requirements in addition to EU and Polish law.
That depends on the product. For medicinal products and many biologicals you will work with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and possibly the European Medicines Agency for centralized procedures. For medical devices you will follow MDR and work with designated notified bodies plus national authorities. For food and cosmetics you will interact with sanitary inspections and customs, and follow applicable EU regulations. A specialist lawyer or regulatory consultant can map the correct pathway for your product.
Typically you will need both Polish or EU counsel and US counsel. Polish counsel can help ensure compliant manufacture, labeling, and documentation under EU law, and prepare you for US-related documentation and contracts. US FDA-specialist counsel can advise on specific FDA submission requirements, facility registration, import procedures, and representation before the FDA. For smaller matters, a Polish lawyer with cross-border experience may be sufficient, but for complex FDA interactions US counsel is recommended.
Start with documented quality systems and procedures, complete records of manufacturing and testing, validated processes, up-to-date training records, and a clear corrective action plan for any historical issues. Conduct internal audits, ensure traceability records are available, and appoint knowledgeable staff to interact with inspectors. A lawyer can help prepare responses to inspection findings and coordinate communications with authorities.
Act quickly. Isolate affected batches, preserve records, notify distributors and customers as required by law, and inform the relevant authority in Poland and the EU. Prepare a public communication plan, and if exporting to the US, notify your US importer or representative and consider FDA reporting obligations. Legal counsel can help manage regulatory notifications, liability exposure, and communications to limit legal risk.
GDPR is the EU data protection regulation that applies in Poland. It governs personal data processing, including health data used in clinical trials and pharmacovigilance. You must ensure lawful bases for processing, informed consent, secure data handling, and appropriate data transfer safeguards when sharing data with non-EU parties such as US partners. A lawyer with privacy expertise can help align regulatory submissions and trial procedures with GDPR.
No. Labeling and advertising claims must comply with Polish and EU rules. Claims allowed under FDA guidance may be different from those permitted in the EU. Before marketing a product in Poland, have a lawyer or regulatory expert review labels, leaflet content, and promotional materials to ensure compliance with local rules.
Enforcement can include administrative fines, product seizures, mandatory recalls, suspension of manufacturing or distribution, criminal liability for serious violations, and reputational harm. The precise penalties depend on the breach, the product category, and whether there is a safety risk. Early legal advice can reduce exposure and improve outcomes with regulators.
Look for lawyers or law firms that list regulatory, life sciences, pharmaceutical, medical device, food law, or international trade expertise. Check whether they have experience with EU regulation and with US FDA matters if you plan to export. You can contact regional bar associations or national legal organizations to find qualified lawyers, and ask for references, client examples, and language capabilities.
Bring clear information about your product, manufacturing processes, current registrations or certifications, labeling and promotional materials, contracts with suppliers and distributors, quality manuals, test data, and any correspondence with regulators. Also prepare a statement of your goals and timeline, and be ready to discuss markets you target, including whether the US is a market of interest.
When dealing with regulatory matters in Mława or Poland consider these institutions and resources for authoritative guidance and support:
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products - Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (URPLWMiPB)
- Chief Pharmaceutical Inspectorate - Główny Inspektorat Farmaceutyczny - GIF
- Main Sanitary Inspectorate - Główny Inspektorat Sanitarny - GIS and local powiat sanitary stations such as the Powiatowa Stacja Sanitarno-Epidemiologiczna
- European Medicines Agency - EMA for medicines and centralized procedures across the EU
- European Food Safety Authority - EFSA for scientific opinions on food safety
- European Commission Directorate-General for Health and Food Safety - DG SANTE for EU policy and regulation
- Polish Bar organizations such as Naczelna Rada Adwokacka and Krajowa Izba Radców Prawnych for lists of licensed lawyers and legal advisors
- Trade associations and industry groups in pharmaceuticals, medical devices, and food sectors for industry guidance and practical templates
If you need legal assistance in Mława for matters that touch on FDA requirements or on Polish and EU regulation, follow these practical steps:
- Clarify your objective - Are you exporting to the US, selling in Poland, registering a medicine or device, or responding to an inspection or safety issue? A clear goal helps a lawyer design the right strategy.
- Gather documentation - Prepare product specifications, certificates, batch records, labels, contracts, and any regulatory correspondence. These documents will accelerate an effective initial review.
- Choose the right counsel - For domestic Polish or EU regulatory issues hire a lawyer with experience in life sciences and regulatory law. If you plan to export to the United States, add a US FDA-experienced attorney or a Polish firm with strong US ties.
- Ask key questions when hiring a lawyer - Ask about regulatory experience in your product area, examples of similar matters, team language skills, estimated timelines, and fee arrangements. Ask whether they collaborate with consultants for technical or scientific support.
- Prepare for costs and timelines - Regulatory processes can take months or years depending on the product and route. Ask for a phased plan and budget estimates so you can prioritize action items.
- Maintain open communications - Keep good records of all interactions and make sure you have a single point of contact for communications with your legal team and with regulators or foreign partners.
Finally, remember this guide is informational and not a substitute for professional legal advice. For tailored guidance about your specific product or situation contact a qualified regulatory lawyer who can assess facts and represent your interests before Polish, EU, and US authorities.
