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Europe

Poland

God, Honour, Fatherland

Population:
40.2 million (incl. refugees)
Capital:
Warsaw
Official Language:
Polish

Poland, as a member of the European Union, fully implements all EU product compliance regulations, including CE marking, REACH, RoHS, WEEE, eco-design, and other EU harmonized directives. Products sold or imported into Poland must comply with the same technical and regulatory requirements applicable across the EU.


Key Authorities:

  • Polish Committee for Standardization (PKN) – Adopts and develops Polish Standards (PN), often harmonized with EN, ISO, and IEC.

  • Office of Competition and Consumer Protection (UOKiK) – Oversees market surveillance, CE marking enforcement, and product recalls.

  • Chief Pharmaceutical Inspectorate (GIF) – Regulates pharmaceuticals and medical devices, in collaboration with the European Medicines Agency (EMA).

  • Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) – Handles product registration of health-related goods.

  • Office of Electronic Communications (UKE) – Regulates telecom and RF equipment, ensuring RED compliance and frequency management.

  • Polish Customs Service (KAS) – Verifies import compliance and EU regulatory documentation.


Key Compliance Elements:

  • CE Marking:

    • Required for EU-regulated product categories, such as:

      • Electrical/electronic devices

      • Toys

      • Machinery

      • Medical devices

      • Personal protective equipment

    • Products must include:

      • Declaration of Conformity (DoC)

      • Technical file demonstrating compliance with relevant directives

      • CE mark affixed on product/packaging

  • Product Registration:

    • Required for:

      • Medicines and vaccines (via GIF/EMA)

      • Medical devices (via URPL/EUDAMED)

      • Food supplements and cosmetics (via national and EU portals)

    • Products registered via EU mechanisms (e.g., EMA, EUDAMED, CPNP) are valid in Poland.

  • Telecom Equipment (UKE):

    • All RF and telecom devices must comply with the EU Radio Equipment Directive (RED).

    • No local type approval is needed beyond CE marking and RED compliance.

    • UKE may request technical documentation or conduct checks as part of market surveillance.

  • Labeling Requirements:

    • Labels must be in Polish, and include:

      • Product name

      • Manufacturer/importer contact

      • CE mark (if applicable)

      • Usage instructions and safety warnings

      • Batch/expiry date (for health-related goods)

      • Country of origin

  • Environmental & Safety Requirements:

    • Poland enforces:

      • REACH (chemical safety)

      • RoHS (restriction of hazardous substances)

      • WEEE (e-waste management)

      • Eco-design and energy labeling

  • Import Oversight:

    • Importers must provide:

      • CE documentation and DoC

      • Product registration evidence (if applicable)

      • Certificate of origin

      • Invoice and customs declaration

  • Market Surveillance:

Carried out by UOKiK and sectoral authorities such as UKE, URPL, and Customs. Inspections include label audits, sampling, and technical documentation checks. Non-compliant goods may be fined, recalled, or banned.

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