Cleanroom contractor in the Netherlands: rules for buyers

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

Which rules apply to your plant

Farmatec says the manufacturer's authorisation is mandatory for companies that fully or partly prepare, have prepared or import medicines. Packaging and labelling count as preparation. It is granted for an indefinite period. Complete applications go to IGJ for advice, and Farmatec decides on behalf of the minister (Farmatec, questions and answers).

The legal basis is Directive 2001/83/EC, mainly articles 40 to 53, and chapter 3 of the Medicines Act (Geneesmiddelenwet) with its decree and regulation (Farmatec, applicable laws).

IGJ says it carries out periodic inspections at all medicine manufacturers in the Netherlands, that inspections often take several days, and that it issues a GMP certificate when it finds the GMP guidelines observed. It adds that applications for permits go to Farmatec, not to IGJ (IGJ, GMP inspections and GMP certificates).

Who builds cleanrooms here

Companies that make, pack, label or import medicines are the regulated buyers, because the authorisation covers all of those activities. The EU Commission lists Annex 1 on sterile products as fully applicable since 25 August 2024. This reading comes from the rules, 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.

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 makes, packs or imports, whether the rooms are sterile, and whether the owner has applied to Farmatec. Name the quality head who will receive the IGJ inspection.

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

• How to audit a cleanroom panel factory, on site or by video
• What a cleanroom costs to run: energy, filters and testing
• 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

• Farmatec, Fabrikantenvergunning, who it is for (checked 1 November 2026)
• Farmatec, how an application is handled (checked 1 November 2026)
• Farmatec, how long a manufacturer's authorisation is valid (checked 1 November 2026)
• Farmatec, applicable laws (checked 1 November 2026)
• IGJ, GMP inspections and GMP certificates (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)