Country guide: Italy
Cleanroom contractor in Italy: rules for buyers
In Italy the Italian Medicines Agency (AIFA) authorises the owner's medicine plant, not the contractor. The rule applies even to medicines made solely for export, and AIFA has been a PIC/S participating authority since February 2000.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your plant
Article 50(1) of Legislative Decree 219/2006 says no one may manufacture a medicinal product in Italy, even solely for export, without AIFA authorisation. AIFA grants it after a direct inspection that checks the applicant has qualified personnel and technical-industrial means that comply with the decree (Normattiva, D.Lgs. 219/2006 article 50).
Article 53 says AIFA, in cooperation with the EMA, ensures through inspections, including inspections without notice, that the rules on medicines are respected (Normattiva, D.Lgs. 219/2006 article 53).
The EU Commission lists Annex 1 of the EU GMP Guide, on sterile products, as fully applicable since 25 August 2024. Ask the owner's quality team which Annex 1 sections drive the cleanroom layout.
| Facility | Rule |
|---|---|
| Medicine plant | AIFA authorisation, D.Lgs. 219/2006 article 50 |
| Export-only plant | Still covered by article 50(1) |
| Sterile products | EU GMP Guide Annex 1 |
Who builds cleanrooms here
Article 50 ties the authorisation to a direct inspection of premises and technical means. Owners of new or extended medicine plants are therefore the regulated buyers, including plants that make only for export. 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.
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 output is for Italy or for export only. Name the quality head who will receive the AIFA 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.
Questions
Common questions
Does AIFA approve cleanroom contractors?
No. AIFA authorises the owner's plant after a direct inspection. The owner chooses and manages the contractor.
Does the rule cover export-only plants?
Yes. Article 50(1) says no one may manufacture in Italy, even solely for export, without AIFA authorisation (Normattiva).
Can AIFA inspect without notice?
Yes. Article 53 refers to inspections, including inspections without notice (Normattiva, D.Lgs. 219/2006).
Is Italy a PIC/S member?
Yes. PIC/S lists AIFA with accession to the scheme in February 2000 (PIC/S, checked 1 November 2026).
Related guides
- The Cleanroom Project Lifecycle
- Cleanroom cost per m²: published ranges by ISO class
- How long does it take to build a cleanroom?
- How to audit a cleanroom panel factory, on site or by video
- Turnkey cleanroom contractor
- Room list builder
Sources
- Normattiva, D.Lgs. 219/2006 article 50 (checked 1 November 2026)
- Normattiva, D.Lgs. 219/2006 article 53 (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)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184