Cleanroom contractor in Portugal: rules for buyers

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

Which rules apply to your plant

Decreto-Lei 176/2006, in the consolidated text that lists Decreto-Lei 117/2026 of 17 June as its latest amendment, makes total or partial manufacture of medicines in Portugal subject to INFARMED authorisation (article 55). The authorisation is also required for dividing, primary or secondary packaging, and presentation operations.

Article 56 grants the authorisation only if the applicant has duly licensed premises and adequate equipment, and follows good manufacturing practice. INFARMED services confirm this, by inspection or inquiry, before they decide. Article 57 sets a maximum of 90 days from a valid application, and says the authorisation applies only to the sites and medicines named in the application (PGDL Lisboa, consolidated text).

Article 58 says a change to the authorisation is decided within 30 days, extendable in exceptional cases to a total of 90 days.

Who builds cleanrooms here

Manufacturers, including contract packers, are the regulated buyers, because article 55 covers packaging operations as well as manufacture. Because the authorisation names specific sites, a new cleanroom site needs its own authorisation or an approved change. This reading comes from the legal text, not from market statistics.

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.

Article 56 refers to premises that are duly licensed. Ask the owner which licence the municipality must issue for the building, and who files it.

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 an extension, whether the rooms are sterile, and whether the owner has applied to INFARMED. In Portuguese the rooms are called salas limpas, so use that term when you brief suppliers.

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

• What a cleanroom costs to run: energy, filters and testing
• Building a cleanroom inside an existing building
• Cleanroom cost per m²: published ranges by ISO class
• How long does it take to build a cleanroom?
• Turnkey cleanroom contractor
• Room list builder

Sources

• PGDL Lisboa, Decreto-Lei 176/2006 consolidated text, 19th version including Decreto-Lei 117/2026 of 17 June (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)