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This guide explains how rules commonly associated with the United States Food and Drug Administration - the FDA - relate to companies and individuals located in Hrubieszów, Poland. The FDA is a United States federal agency whose laws and regulations apply primarily inside the United States and to products exported to or imported from the United States. In Poland the primary regulatory framework for food, medicines, medical devices, cosmetics and related products is set by European Union law and by Polish national authorities.
That said, FDA requirements can become directly relevant to businesses in Hrubieszów when they export products to the United States, seek US partners, or adopt US standards as part of their internal compliance. This guide outlines when FDA rules might matter, which local Polish and EU authorities govern similar areas, typical legal issues that arise, and how to proceed if you need professional legal help.
This information is general and for educational purposes only. It does not create an attorney-client relationship and should not be relied on as legal advice.
Legal help can be important when regulatory complexity, commercial risk, or enforcement exposure is present. Typical situations where a lawyer can add value include:
- Export to the United States. If you plan to sell food, supplements, cosmetics, medicines, medical devices or other regulated products in the US market, you will likely need to comply with FDA requirements such as facility registration, product listing, labeling, and good manufacturing practices.
- Import to Poland from the US. Understanding how products that comply with FDA rules interact with EU requirements is important to avoid duplicate non-compliance issues.
- Product registration and approvals. Obtaining approvals or notifications for medicines, medical devices, food additives or biocides in the EU and Poland often requires legal and regulatory submissions handled by specialized counsel or consultants.
- Regulatory inspections and enforcement. If your facility is inspected by US or Polish authorities, or you receive enforcement notices, warnings, recalls, or seizure actions, a lawyer can manage responses and reduce legal exposure.
- Labeling and advertising claims. Claims about safety, efficacy or nutritional benefits must meet EU and Polish rules; an attorney can review labels, advertising and promotional materials to reduce the risk of sanctions for misleading claims.
- Clinical trials and research. Drafting contracts, informed-consent forms, and complying with EU clinical trial regulations usually requires legal expertise.
- Contracts and transactions. Sales, distribution, manufacturing and licensing agreements frequently need legal drafting and negotiation to allocate regulatory risk and responsibilities.
Regulation of medicines, medical devices, food and related products in Hrubieszów is governed primarily by EU law and by Polish implementing and enforcement authorities. Key aspects to know:
- European Union law is directly applicable. Major EU rules that affect Poland include the General Food Law (Regulation (EC) No 178/2002), the Medical Devices Regulation (MDR, Regulation (EU) 2017/745), the In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746), and pharmaceutical regulations and directives that set standards for marketing authorization, pharmacovigilance and good manufacturing practices.
- Polish regulatory authorities enforce EU and national rules. Important authorities include:
- Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (URPL) - Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. URPL handles registration, approvals and supervision in these areas.
- Główny Inspektorat Farmaceutyczny (GIF) - Chief Pharmaceutical Inspectorate - enforces pharmaceutical quality and safety requirements.
- Główny Inspektorat Sanitarny (GIS) - Chief Sanitary Inspectorate - oversees public health and food safety matters in cooperation with local sanitary stations (Sanepid).
- Powiatowy Lekarz Weterynarii and Inspekcja Weterynaryjna - veterinary and food-of-animal-origin controls.
- Państwowa Inspekcja Sanitarna (Sanepid) - local public health inspectorate for hygiene and food safety controls.
- For consumer protection and competition matters, UOKiK (Urząd Ochrony Konkurencji i Konsumentów) plays a role.
- If you export to the US, US FDA requirements can apply in addition to EU rules. Examples of FDA-relevant requirements include facility registration and product listing, US labeling and ingredient rules, current good manufacturing practices (cGMP), and import entry documentation for US customs and FDA checks.
- Criminal and administrative sanctions can arise from non-compliance. These range from fines and administrative penalties to product seizures, recalls, and in serious cases criminal liability for egregious misconduct or risk to public health.
The FDA is a United States federal agency. Its laws apply in the United States and to products imported into or exported from the US. FDA law does not automatically regulate products sold only in Poland. However, Polish companies that export to the US or work with US partners must comply with relevant FDA requirements in addition to EU and Polish rules.
No - you generally do not need FDA approval to sell products within Poland. You must meet EU and Polish regulatory requirements instead. FDA approval is required only for access to the US market or where a US partner demands FDA-compliant documentation.
If the company manufactures, packs, or holds products for distribution in the United States, or exports goods to the US, it should prepare. Preparation includes facility registration (where applicable), documented quality systems, traceability records, complaint handling, and readiness to demonstrate compliance with US good manufacturing practice standards.
Both jurisdictions regulate labeling and claims but with different specifics. The EU focuses on harmonized nutrition labeling, ingredient listings and health claims validated under EU rules. The US FDA has its own structure for nutrition facts, ingredient declarations, and permissible claims. When selling cross-border, you may need different labels or dual-compliant labeling strategies.
Typical steps include verifying product admissibility under US law, registering facilities with the FDA if required, meeting US labeling and ingredient rules, ensuring compliance with US cGMP or HACCP where applicable, arranging correct customs documentation, and preparing for possible US inspections or sampling at the US border.
Enforcement depends on the product type. For medicines and medical devices URPL and GIF are key; for food and hygiene matters GIS and Sanepid are responsible; for veterinary-food chain issues local veterinary inspectors enforce rules. Serious consumer-safety issues can also be brought to UOKiK. If you suspect a violation, contact the appropriate authority for your product type.
Penalties range from corrective notices and administrative fines to product recalls, suspension of marketing authorizations and in serious cases criminal charges. Penalty severity depends on the type of breach, its impact on public health, and whether it was intentional or negligent.
Look for attorneys or firms that specialize in regulatory law, life-sciences law, or international trade. Prefer professionals who list experience with pharmaceutical, medical-device, food or cosmetics regulation and with cross-border matters involving the US and EU. Ask for references, examples of similar matters, and whether they work with regulatory consultants if needed.
Costs vary widely depending on the scope of work. Simple label reviews or advisory memoranda may be modest in cost. Comprehensive services such as product registration, defense against enforcement actions, or support during FDA inspections are time-consuming and more expensive. Ask for an engagement letter with estimated fees and billing arrangements before starting work.
Yes. Implementing recognized standards such as cGMP or FDA-style quality systems can improve product quality, reduce risk, and make market entry to the US easier in the future. Many companies adopt international best practices to reassure customers and partners.
Useful organizations and authorities to consult or research when dealing with regulatory issues in Hrubieszów include:
- Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (URPL) - Polish office responsible for registration of medicinal products and medical devices.
- Główny Inspektorat Farmaceutyczny (GIF) - Chief Pharmaceutical Inspectorate.
- Główny Inspektorat Sanitarny (GIS) and local Sanepid offices - public health and food safety inspectors.
- Inspekcja Weterynaryjna - veterinary inspection for animal-derived food products.
- Urząd Ochrony Konkurencji i Konsumentów (UOKiK) - consumer protection and competition authority.
- European Medicines Agency and EU regulatory texts relevant to medicines and devices - for EU-wide rules and guidance.
- United States Food and Drug Administration - for guidance on US requirements if you plan to export to the US.
- Local business organizations, industry associations, and chambers of commerce - for practical guidance on export procedures and finding specialized consultants.
If you think you need legal assistance with regulatory matters related to FDA rules or their intersection with Polish and EU law, here are practical next steps:
- Identify the regulatory scope. Determine whether your product is considered a food, cosmetic, medical device, medicine, supplement or another regulated item and whether you plan to sell in Poland, the EU, the US or multiple markets.
- Gather documentation. Collect product specifications, labels, marketing materials, manufacturing and quality-system records, contracts, and any prior correspondence with regulators.
- Conduct a compliance gap assessment. Engage a lawyer or regulatory consultant to review current practices against applicable EU, Polish and - if relevant - US FDA requirements.
- Prepare a plan. Create a prioritized compliance plan covering labeling, registration or notification needs, quality-system upgrades, documentation improvements and timelines.
- Choose the right advisor. Select legal counsel experienced in regulatory matters for your product type and with cross-border experience if US requirements may apply.
- Maintain records and prepare for inspections. Ensure document retention, traceability and an internal system for handling complaints or adverse events.
- Communicate with authorities when needed. If you need clarifications or face enforcement actions, work through counsel to respond to regulators promptly and accurately.
Starting with a clear assessment and the right professional support will help you manage regulatory risk effectively and position your business for safe growth in domestic and international markets.
