This content is translated with an automatic translation tool: the text may contain inaccurate information.

Authorisation to use automated drug preparation system in RSA

  • Active

RSAs may apply for the use of an automated system for the preparation of solid oral drug therapies in a unit dose for their own residents and/or for residents in other RSAs (so-called RSA spoke)

Description

The DGP no. 987 of 27 June 2025 approved the technical-operating requirements and regulated the methods by which the Assisted Living Residences (RSAs) equipped with suitable automated systems may proceed with the customised preparation of solid oral therapies in unit doses for their own residents and/or residents in other RSAs (so-called RSA spoke).

In particular, the DGP approves Attachment 1 composed of sections A "Technical-operative requirements for the adoption of an automated system for the preparation of solid oral pharmacological therapies in unit doses at RSAs" and section B "Procedures for the activation of automated systems".

Who it's for

Managing bodies of public and private RSAs

What you need

Documents to be submitted

Application form for authorisation to use an automated system for the preparation of oral solid drug therapies in unit dose in RSA;

attached Privacy Policy Statement ex EU Regulation no. 679 of 2016;

Medicines management procedure, integrated with the procedure for unit dose preparation by means of an automated system, certifying possession of the organisational and technical requirements envisaged in point 3 of section A of Attachment 1 of DGP no. 927/2025.

Forms

Timeframes and deadlines

The application may be submitted at any time of the year.

90 days

Maximum no. of waiting days

from the day after the application is made

Costs

revenue stamp
16,00

Documents

Reference regulations

Sistemi automatizzati per la preparazione di terapie farmacologiche orali solide in dose unitaria presso le Residenze Sanitarie e Assistenziali (RSA) della Provincia autonoma di Trento.

Read more

Additional information

Last modified: 18/12/2025 7:32 pm

Sito web OpenCity Italia · Site editors access