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“FDA” is the common name for the United States Food and Drug Administration. Poland is regulated by its own national and European Union systems rather than by the U.S. FDA. If you are in Pułtusk and working with products such as medicines, medical devices, food, dietary supplements, cosmetics, or biocidal products, the rules you must follow come from EU regulations and Polish law enforced by national and regional Polish authorities. This guide explains the practical legal landscape you are likely to encounter in Pułtusk, why you might need a lawyer, which local authorities and laws are relevant, and how to take the next steps if you need professional help.
This guide provides general information only and is not legal advice. For advice about your specific situation consult a qualified Polish regulatory lawyer or legal advisor.
Regulatory matters for health-related products involve technical requirements, strict procedures and significant penalties for non-compliance. A lawyer with experience in regulatory and administrative law can help in many common situations, including:
- Product classification - determining whether your product is a medicine, medical device, cosmetic, food supplement, biocide or something else, because classification determines which rules apply.
- Market authorisation and registration - preparing and submitting applications for marketing authorisation, registration dossiers, or notifications, and responding to questions from authorities.
- Clinical trials and investigations - advising on approvals, informed consent, ethics committee procedures, and contractual arrangements for sponsors and investigators.
- Quality systems and inspections - helping you prepare for Good Manufacturing Practice, Good Distribution Practice, pharmacovigilance or post-market surveillance inspections and handling inspectorate communications.
- Advertising, labelling and product information - ensuring labelling, package leaflets and promotional materials meet Polish and EU requirements including required Polish language text.
- Import, export and customs - advising on import procedures, documentation, customs classification and cross-border distribution within the EU.
- Recalls, safety incidents and enforcement - managing product recalls, incident reporting, liaising with authorities, and defending against administrative fines or criminal charges.
- Contracts and distribution - drafting or negotiating distribution, manufacturing, or clinical trial agreements with appropriate regulatory clauses and indemnities.
Key regulatory sources and themes you need to know about when dealing with health and safety products in Pułtusk include:
- EU-level rules - Many product categories are governed primarily by EU regulations and directives. Important examples are the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. These set harmonised rules for conformity assessment, CE marking, clinical evaluation and post-market surveillance.
- Polish national law - Poland implements and supplements EU law through national statutes and administrative procedures. For medicines and related products the main national framework is the Polish Pharmaceutical Law - Prawo farmaceutyczne - together with implementing regulations. Food safety and nutrition are governed by Polish food safety legislation implementing EU food law.
- National authorities - Applications, registrations and enforcement in Poland involve authorities such as the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Chief Pharmaceutical Inspectorate, and the Chief Sanitary Inspectorate. These authorities oversee approvals, inspections and enforcement at national and regional levels.
- Regional and local inspectorates - At the local level, county and regional sanitary and pharmaceutical inspectorates and public health offices manage inspections, licensing of pharmacies and local enforcement. In Pułtusk you will interact with the sanitary-epidemiological station and regional inspectorates that cover Pułtusk County and the Masovian Voivodeship.
- Language and documentation - Administrative filings, applications, safety reports and product information for the Polish market typically must be submitted in Polish. Labels and patient leaflets must usually include Polish language content.
- Quality and safety obligations - Obligations such as Good Manufacturing Practice, Good Distribution Practice, pharmacovigilance for medicines, and post-market surveillance for medical devices are mandatory and monitored by inspectorates. Non-compliance can lead to fines, product seizure or criminal liability in serious cases.
No. The U.S. FDA has no regulatory authority in Poland. Products marketed in Poland are governed by EU regulations and Polish national law enforced by Polish authorities. U.S. standards may be relevant for export or manufacturer certification, but you must meet EU and Polish requirements to sell in Poland.
Key authorities include the national Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Chief Pharmaceutical Inspectorate, and the Chief Sanitary Inspectorate. Locally you will also work with county sanitary-epidemiological stations and regional inspectorates that handle inspections and local compliance matters for Pułtusk County.
Classification depends on the product’s composition, intended use and claims. Small differences in claims can change the regulatory path. A regulatory lawyer or consultant can review your product, labelling and intended use and advise on the correct classification and legal requirements.
For medicinal products you generally need a marketing authorisation from the appropriate authority or through an EU centralised or mutual recognition procedure. Steps include preparing a dossier with quality, non-clinical and clinical data, submitting the application in Polish where required, paying fees, and responding to authority queries. The timeline varies by procedure and dossier complexity.
Yes. Medical devices placed on the EU market generally require CE marking that demonstrates conformity with the EU Medical Devices Regulation. The manufacturer must carry out conformity assessment, maintain technical documentation, and comply with post-market surveillance and vigilance reporting obligations.
Yes, but you must comply with Polish and EU rules on composition, labelling, safety, and product notifications. Online sales across the EU can trigger requirements in other member states, and rules on health claims and safety vary. Ensure correct registration or notification where required and that labelling and claims are compliant in each target market.
Inspectors can issue corrective orders, require product seizures or withdrawals, impose fines, and in serious cases initiate criminal proceedings. You will usually be given a chance to remedy issues, but timely, documented responses and legal representation can reduce the risk of harsher sanctions.
Notify the relevant authority promptly as required by law, preserve evidence and records, identify affected batches, stop distribution, notify customers and consumers as required, and follow the authority’s instructions for withdrawal or recall. Legal counsel can help coordinate regulatory notifications, communications and liability mitigation.
Penalties vary by breach and can include administrative fines, product seizures, suspension or withdrawal of authorisations, bans on marketing, and criminal prosecution in cases of deliberate or large-scale violations. Penalties are assessed under Polish law and can be significant, so proactive compliance is important.
Look for lawyers or law firms with expertise in regulatory, administrative and life sciences law. Check professional directories of Polish bar associations and chambers of legal advisors, review firm profiles for experience with medicines, medical devices, food or cosmetics, and ask for references and case examples. Confirm language ability if you need communication in English and verify whether the lawyer has experience with EU procedures as well as Polish administrative practice.
Helpful types of organisations and resources to consult when dealing with regulatory matters include:
- National regulatory authorities such as the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Chief Pharmaceutical Inspectorate for guidance and official procedures.
- Chief Sanitary Inspectorate and local sanitary-epidemiological stations for food safety and local public health oversight in Pułtusk County.
- European Union resources such as the European Medicines Agency for centrally authorised medicinal products and EU regulatory guidance on medical devices and chemicals.
- Professional associations and trade groups in the pharmaceutical, medical device, cosmetics and food sectors for practical compliance guidance and industry standards.
- Polish Bar Association and the national chamber of legal advisers to locate qualified regulatory lawyers and confirm credentials.
- Accredited testing and certification bodies for laboratory testing, notified bodies for medical device conformity assessment, and accredited consultants for GMP and quality systems.
If you believe you need legal assistance with a regulatory matter in Pułtusk, follow these practical steps:
- Define the issue clearly - gather product documentation, labels, promotional materials, technical data, contracts and any correspondence with authorities.
- Identify the likely product classification and the primary legal issues - whether registration, market authorisation, inspections, a safety incident or contract negotiations.
- Contact a specialised regulatory lawyer or law firm with experience in life sciences, medical devices, food law or pharmaceutical regulation. Ask about relevant experience, language skills and typical fees.
- Arrange an initial consultation - use it to confirm the scope of work, potential timelines, required documents and an estimate of costs. Make sure the lawyer explains the process in plain language and the possible outcomes.
- Prepare for administrative procedures - translate documents to Polish if needed, collect technical files and quality certificates, and follow the lawyer’s checklist to meet deadlines and regulatory formalities.
- Maintain communication with regulators - where appropriate your lawyer can liaise with inspectorates on your behalf to reduce misunderstanding and speed resolution.
Getting early legal advice often reduces risk, shortens resolution time and can save costs later. If you are unsure where to start, a short consultation with a regulatory lawyer will clarify your options and the next concrete steps.
