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  • Authorisation of health centres or services
8447 - Autorització de centres o serveis sanitaris Departament de Salut accio
  • What do you need to know?
  • What is it?
  • Who is it for?
  • Documentation
  • Go to:
  • Go to: What is it?
  • Go to: Who is it for?
  • Go to: Documentation

Authorisation of health centres or services

WHO
Companies and professionals
HOW
WHEN
At any time

Do you need any help?

Find out more

Authorisation of health centres or services

WHEN
At any time

WHO
HOW
Companies and professionals

Do you need any help?

Do you need any help?

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Regulation

  • Real decret 1976/1999, de 23 de desembre, pel qual s’estableixen els criteris tècnics de qualitat en radiodiagnòstic.

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  • Reial Decret 1085/2009, de 3 de juliol, pel qual s’aprova el Reglament sobre instal·lació i utilització d’aparells de raigs X amb finalitats de diagnòstic mèdic.

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  • Llei 31/1991, de 13 de desembre, d'ordenació farmacèutica de Catalunya

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  • Ordre de 10 de juny de 1986, per la qual es regulen els Dipòsits de Medicaments en els Centres hospitalaris.

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  • Reial decret 1345/2007, d’11 d’octubre, pel qual es regula el procediment d’autorització, registre i condicions de dispensació dels medicaments d’ús humà fabricats industrialment.

    . Open in a new window.
  • Ordre SND/939/2022, de 29 de setembre, per la qual s'aproven les normes de correcta preparació extemporània de radiofàrmacs.

    . Open in a new window.
  • Reial Decret 1085/2009, de 3 de juliol, pel qual s’aprova el Reglament sobre instal·lació i utilització d’aparells de raigs X amb finalitats de diagnòstic mèdic.

    . Open in a new window.
  • Llei 31/1991, de 13 de desembre, d'ordenació farmacèutica de Catalunya

    . Open in a new window.
  • Llei 31/1991, de 13 de desembre, d'ordenació farmacèutica de Catalunya

    . Open in a new window.
  • DECRET 151/2017, de 17 d'octubre, pel qual s'estableixen els requisits i les garanties tecnicosanitàries comunes dels centres i serveis sanitaris i els procediments per a la seva autorització i registre.

    . Open in a new window. (DOGC  no.  7477  posted  19/10/2017)
  • Reial decret legislatiu 1/2015, de 24 de juliol, pel qual s'aprova el text refós de la Llei de garanties i ús racional dels medicaments i productes sanitaris.

    . Open in a new window. (BOE  no.  177  posted  25/07/2015)
  • Reial Decret 1277/2003, de 10 d' octubre, per al que s'estableixen les bases generals sobre autorització de centres, serveis i establiments sanitaris.

    . Open in a new window. (BOE  no.  254  posted  23/10/2003)
  • Llei 39/2015, d'1 d'octubre, del procediment administratiu comú de les administracions públiques.

    . Open in a new window. (BOE  no.  236  posted  02/10/2015)
  • LLEI 16/2010, del 3 de juny, de modificació de la Llei 21/2000, del 29 de desembre, sobre els drets d'informació concernent la salut i l'autonomia del pacient, i la documentació clínica.

    . Open in a new window. (DOGC  no.  5647  posted  10/06/2010)
  • LLEI 21/2000, de 29 de desembre, sobre els drets d'informació concernent la salut i l'autonomia del pacient, i la documentació clínica.

    . Open in a new window. (DOGC  no.  3303  posted  11/01/2001)
  • DECRET 27/1999, de 9 de febrer, de la gestió dels residus sanitaris.

    . Open in a new window. (DOGC  no.  2828  posted  16/02/1999)
  • DECRET 92/2002, de 5 de març, pel qual s'estableixen la tipologia i les condicions funcionals dels centres i serveis sociosanitaris i se'n fixen les normes d'autorització.

    . Open in a new window. (DOGC  no.  3597  posted  18/03/2002)
  • Reial decret llei 16/2012, de 20 d'abril, de mesures urgents per garantir la sostenibilitat del Sistema Nacional de Salut i millorar la qualitat i la seguretat de les seves prestacions

    . Open in a new window. (BOE  no.  98  posted  24/04/2012)
  • ORDRE de 20 de febrer de 1991, reguladora dels tractaments que contempla el Reial Decret 75/1990, de 19 de gener.

    . Open in a new window. (DOGC  no.  1414  posted  04/03/1991)
  • DECRET 209/2023, de 28 de novembre, pel qual s'aprova el Codi d'accessibilitat de Catalunya.

    . Open in a new window. (DOGC  no.  9052  posted  30/11/2023)

What do you need to know?

What is it?

Health services and centres, regardless of their level, category or owner, need administrative authorisation of operation in order to start operations or make any significant changes in operations. Therefore, they must do this procedure in the following cases:

  • Start of operations

  • Changes:
  • Substantial changes in the care offered.
  • Substantial changes in the functional or physical structure.
  • Move of the centre to another address with changes in the care offered.
  • Move of the centre to another address without changes in the care offered.
  • Changes in ownership of the centre or service.
  • Installation (construction).
  • Closure.

This procedure may only be done by Internet. The documentation you provide by any other channel shall not be considered or counted for the purposes of the submission date. Before starting the application, we recommend that you check the section on help with electronic documentation and the instructions on the Related documentation tab.

When you send the form, you have to identify yourself with a digital certificate or idCAT Mòbil if you are the owner of the company, or with the digital certificate of representation if you are its representative.

Specific forms have been created for applications and/or notifications in this procedure which must be used. These forms can be downloaded from this same file. If the application and/or notification is submitted via other forms, they will be considered not submitted in accordance with article 16.8 of Law 39/2015, of 1 October 2015, on the common administrative procedure of the public administrations, and therefore the date on which the application and/or notification is considered submitted shall be the date on which the aforementioned specific form is submitted.

Applicable regulation

Authority responsible

  • Departament de Salut
  • Direcció General d'Ordenació i Regulació Sanitària
Who is it for?
Companies and professionals

Companies and professionals, and specifically for:

- Healthcare centres. A healthcare centre is an organised complex of installations and technical means where trained professionals, either via an official degree or professional authorisation, under the direction of the healthcare professional in charge, deliver health activities to care for people’s health.

- Healthcare services. A healthcare service is a functional care unit with a distinct organisation manned by trained professionals, either via an official degree or professional authorisation, and technical resources to provide specific healthcare activities within a healthcare centre integrated into an organisation whose main activity may not be healthcare.

Healthcare establishments (pharmacy offices, first-aid kits, opticians’, orthopaedic centres and hearing aid establishments) which should be governed by their own specific regulations are excluded from the scope of application of this procedure.


These entities are obligated to interact electronically with the public administrations for any administrative procedure according to article 14.2 of Law 39/2015, of 1 October 2015 (BOE no. 236, of 2 October 2015) and Order PDA/20/2019, of 14 February 2019 (DOGC no. 7814, of 20 February 2019).

Documentation

Documents

Section on help with electronic documentation

Update date 01/09/2026

Related procedures

  • Authorisation for physiotherapy practices
  • Accreditation of sports medicine centres and services
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