Cleanroom contractor in Poland: rules for buyers

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your plant

Article 38 of the Pharmaceutical Law of 6 September 2001, in the consolidated text Dz.U.2026.0.612, says starting a business that makes or imports medicinal products requires a manufacturing or import permit. The Chief Pharmaceutical Inspector issues, refuses, withdraws and amends the permit by decision (ArsLege, Prawo farmaceutyczne article 38).

Under paragraph 3 of the same article, the Chief Pharmaceutical Inspector issues a certificate on the basis of an inspection by its manufacturing inspectors where a medicine is imported from a third country, and paragraph 5 puts the cost of that inspection on the applicant (ArsLege, article 38). The EU Commission lists Annex 1 of the EU GMP Guide, on sterile products, as fully applicable since 25 August 2024.

Who builds cleanrooms here

Holders of GIF manufacturing permits that make sterile medicines are the regulated buyers, because Annex 1 sets the sterile standard. This reading comes from the rules, not from market statistics. Ask the owner whether the project adds a new site, which the permit would need to cover.

What a foreign supplier must arrange

The EU Construction Products Regulation, Regulation (EU) 2024/3110, entered into force on 7 January 2025 and became generally applicable on 8 January 2026 (DIBt). For self-supporting double-skin metal insulating panels, CE marking is compulsory under EN 14509 (Tecnalia, 6 June 2023). A panel supplier from outside the EU should therefore expect to be asked for CE marking and a declaration of performance for each product. Agree with the owner who places the panels on the market.

What to send for a first scope

Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether the plant is new or existing, whether the rooms are sterile, and whether the owner is applying for a new permit or changing one. Name the voivodeship.

Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. CE-marked and FM-approved panels can be supplied for projects that require them, and other certification can be arranged per project.

Who does the site work

Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.

Related guides

• The Cleanroom Project Lifecycle
• How to Import a Cleanroom from China
• Cleanroom cost per m²: published ranges by ISO class
• Writing a cleanroom URS: contents and testable wording
• Turnkey cleanroom contractor
• Room list builder

Sources

• ArsLege, Prawo farmaceutyczne article 38, Dz.U.2026.0.612 (checked 1 November 2026)
• European Commission, EudraLex Volume 4, Annex 1 listed as fully applicable since 25 August 2024 (checked 1 November 2026)
• DIBt, revised Construction Products Regulation (EU) 2024/3110: in force 7 January 2025, generally applicable 8 January 2026
• Tecnalia, Insulating panels with CE marking according to EN 14509 (6 June 2023)
• PIC/S, list of participating authorities (checked 1 November 2026)