Quality & complianceOfficial

AIFA GMP office sets out how paper and digitally signed measures are notified

🇮🇹 AIFA · Wed 04 Nov 2026

Italy's medicines agency explains how companies receive paper GMP measures by registered post and points to earlier notices governing digitally signed documents and online submissions.

AIFA's Office for GMP Inspections and Authorisations for medicinal products (GMPMED) has published a notice on how it notifies its measures, distinguishing between documents produced on paper and those issued electronically with a digital signature. The notice is dated 4 November 2026 and comes with an attached notification list of the same date.

For paper documents, companies can ask for the measures listed in the annex to be sent by registered post with acknowledgement of receipt. The request may be made on plain paper by the company's legal representative or a delegate, with a copy of the requester's identity document, and must give the exact delivery address.

AIFA also notes that each paper measure or certificate requires a €16 revenue stamp for every four pages. The lists show, next to each company name or the name of the qualified person (QP), how many stamps are needed for notification. Companies receive a form with the measure, which they must complete, sign and return to confirm receipt.

The second category covers measures and certificates that GMPMED has prepared in electronic format and signed digitally. The notice says all such documents appear in the list, and refers readers to AIFA communications of 17 January 2022 for the notification arrangements and the rules on paying stamp duty on digitally originated documents.

The agency also reminds companies of earlier notices on the electronic handling of applications by GMPMED: the second phase from 1 September 2022, new rules for submitting applications from 1 November 2022, further provisions from 1 August 2023, and a new online service for QPs in operation from 1 December 2025.

What it means for your team

  • GMP authorisation holders and QP-related staff should check the 4 November 2026 annex to see whether any of their measures are available only on paper.
  • Companies wanting paper measures sent by registered post must submit a signed request with ID and a precise address, and plan for the stamp requirement of €16 per four pages.
  • Regulatory teams should keep the returned acknowledgement-of-receipt form in their records, as it confirms that a paper measure was received.
  • Teams should confirm their internal processes reflect the earlier GMPMED notices on electronic submissions and the online QP service.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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