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What do you need to know?
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.
Authority responsible
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).
It must be requested prior to the start of the activity. This authorization must be obtained before commencing the activity.
- Final construction documentation
If you already have prior construction authorisation, you must provide the final construction certificate signed by a competent technician (architect, engineer, technical architect, or technical engineer), confirming that the authorised works have been completed in accordance with the technical project submitted for the prior construction authorisation.
- Basic technical project
If you do not have prior construction authorisation or there are changes to the initial project, you must submit a new technical project signed by a competent technician (architect, engineer, technical architect, or technical engineer). This project must include:
- Location and site plans.
- Floor plans showing room layout, uses, surfaces, furniture, and equipment.
- Installation plans (fire protection, ventilation, air conditioning, etc.).
- Technical report justifying compliance with applicable regulations (accessibility, Technical Building Code, Building Thermal Installations Regulation, Low Voltage Electrotechnical Regulation, urban planning regulations, etc.).
If the centre or service is mobile (in a vehicle), you must also provide:
- Vehicle registration certificate.
- Vehicle technical inspection card (ITV).
- Descriptive report and layout plan of the mobile unit, including justification of compliance with accessibility regulations.
- Documentation proving availability of the property or vehicle
If you are not the owner of the property or vehicle, you must provide documentation that legitimises its use (space assignment agreement, rental contract, etc.).
- Documentation regarding professionals
- Organisational chart identifying responsible persons: clinical director, medical device safety officer (in hospital and surgical centres, including dental clinics), and patient safety officer), including full name, ID/NIE, qualification, and professional registration number where applicable.
- Acceptance of appointment for each responsible role.
- Updated list of all healthcare staff with full name, ID/NIE, qualification, and professional registration number where applicable.
- Professional relationship agreements between the centre and healthcare professionals (employment contracts, service agreements, etc.).
- Documentation regarding equipment and facilities
- List of equipment, materials, instruments, and tools.
- If you have radiodiagnostic or radiotherapy equipment:
- Authorisation documentation for the devices and quality assurance programme.
- Registration in the X-ray installation register for medical diagnosis.
- If you have nuclear medicine equipment:
- Authorisation documentation for the devices and quality assurance programme.
- If you have magnetic resonance equipment:
- Installation plans issued by the supplier showing the 5-gauss magnetic field boundary.
- Documentation regarding organisation of the healthcare centre or service
- Functional plan describing the care offering (services, techniques, procedures).
In addition, if you wish to have pharmaceutical services at the centre:
A) Medicine storage unit, or
B) Pharmacy service, or
C) Radiopharmacy unit
You must also submit the following documentation:
A) Medicine storage unit
- Location plan of the storage unit within the centre, signed by a competent technician.
- Detailed plan of the room where the storage unit is located, signed by a competent technician, including furniture and equipment layout (refrigerator, safe for narcotics, shelving, work table).
- Responsible declaration from the pharmacy owner or head of pharmacy service responsible for supply and control of the storage unit. If there is more than one pharmacy owner, one signature is sufficient. Use the provided template without modifying its format.
B) Pharmacy service
- Annex for creation of a pharmacy service (use provided template without modification).
- Descriptive report of facilities including:
- Location and access
- Usable surface
- Equipment
- Facilities
- Specific areas (receiving and storage, special warehouses, dispensing area including outpatient dispensing, management area, medicines information area, laboratory area, and other areas depending on activity such as parenteral nutrition preparation or cytostatic reconstitution areas).
- Operational report including:
- Type and care purpose of the centre
- Medicine supply and dispensing control systems
- Temperature and humidity conditions
- Stock management
- Storage conditions for thermolabile, narcotic, flammable, and high-risk medicines
- Expiry date control frequency
- System for dissemination of pharmaceutical alerts
- System for reporting suspected adverse drug reactions
- Staffing plan with qualifications and workload details
- Technical project of the pharmacy service (if not included in the overall centre project), including:
- Engineering report (utilities, electrical power, water flow, thermal consumption, etc.)
- Certificate of regulatory compliance signed by a competent technician
- Plans (general and detailed layout, equipment and area placement)
- Construction timeline
- Air conditioning conditions for sterile or cytostatic preparation areas
C) Radiopharmacy unit
- Annex for creation of a radiopharmacy unit (use provided template without modification).
- Technical project report including:
- Activities and types of radiopharmaceuticals
- Facility layout
- Available equipment
- Organisational chart and staff roles
- Organisational and functional relationship with other units
- Certificate of compliance with construction and safety regulations
- General and detailed layout plans of the unit within the centre, including equipment and room layout.
Quota base per a centres amb internament: 431,10 €.
Quota base per a centres sense internament: 184,70 €.
Per cada servei a autoritzar: 28,70 €.
Per cada programa de garantia de qualitat assistencial (radiodiagnòstic, radioteràpia i medicina nuclear) : 92 €.
The fee amount is variable and is calculated by the form itself.
If you wish to request authorization for the installation and operation of a medicine storage unit, a pharmacy service, or a radiopharmacy unit, in the application form you must go to the “Service offer” tab, select the service “Medicine storage unit” or “Pharmacy service” or “Radiopharmacy” (depending on what you want to apply for), and then select “Add”.
Steps to follow
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Step one
Apply for
This procedure can only be completed online.
- If you are a legal entity (the holding entity), you must sign the form using a digital representation certificate, either as a representative or as an associated person.
- If you are a natural person and the applicant, you may sign using idCAT Mobile or a personal digital certificate.
By Internet
Apply for health authorization to start the activity of my healthcare centre or service (HTML form)
Start . Go to Apply for health authorization to start the activity of my healthcare centre or service (HTML form)How to do it?
Step 1: Fill in the online form
- (Identify yourself using a digital certificate)
- Complete the form:
- You do not need to download it. Fill it in directly online.
- Attach the documentation:
- Click the “Attach” button and select the file from your computer.
- Make sure the file name does not contain spaces, hyphens, accents, or umlauts.
- Submit the form:
- If mandatory data is missing or incorrect, an error message will appear and the fields to be corrected will be highlighted.
- Signature:
- Sign the form using a digital certificate. You can only sign as a natural person if you are the applicant using idCAT Mobile or a personal certificate, or with a representative or linked person certificate if the holder is a legal entity. You can consult the page “How to digitally sign an HTML form” for more information.
- In case of doubt:
- If you have any questions, consult the “Web-based forms” section of Tràmits gencat.
Step 2: Confirm the submission
- Submission receipt:
- If the application is successfully submitted, the registration receipt will appear on screen (you need Adobe Acrobat to open it).
- Save or print this document, as it contains:
- The entry record (start date of the procedure).
- The procedure identification code (to track the status in the Private Area).
- Errors in the application:
- If the application contains an error, it will not be submitted and an error message will be displayed.
If you have any doubts about the procedure, first consult the recommendations in the “Online processing support” section of Canal Empresa or call the 012 telephone assistance service.
We remind you that to carry out procedures through the online channel you must have a valid digital certificate. In this regard, we recommend that you review the different accepted certificates, as well as the other requirements for online processing.
Secondly, once you have verified that you have all the necessary tools and have followed the process as indicated, you can check whether there is any service interruption or incident in the “Service notices and outages” section of the Electronic Office. If you are unable to complete the procedure due to a system issue, please try again later.
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Step two
Fer el pagament
Pagament en línia En el moment d’enviar el formulari: Apareixerà un enllaç per pagar amb targeta bancària. Més tard: Amb identificació digital: Ves a l’Àrea privada, selecciona el tràmit i [...]
Pagament en línia
- En el moment d’enviar el formulari: Apareixerà un enllaç per pagar amb targeta bancària.
- Més tard:
- Amb identificació digital: Ves a l’Àrea privada, selecciona el tràmit i paga.
- Sense identificació digital: Ves a l’Estat de les meves gestions, introdueix el codi de tràmit (ID) i el teu número d’identificació, i paga.
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Amb Bizum:
- Pots triar aquesta forma de pagament quan enviïs el formulari. Tingues el teu mòbil a mà.
- La plataforma et demanarà el número de telèfon associat al compte bancari.
- Un cop introdueixis el número de telèfon, prem el botó ‘Continua amb la compra’. Si cal, hauràs d’autoritzar l’operació amb la teva aplicació bancària.
Pagament amb carta de pagament
- Descarrega la carta de pagament des de l’Àrea privada o l’Estat de les meves gestions.
- Paga amb el codi RIN que trobaràs a la carta.
Recorda: Has de pagar la taxa per continuar la tramitació.
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Step three
Aportar la documentació requerida
Com aportar la documentació requerida:
Com aportar la documentació requerida:
1. Accedeix a la teva Área privada:
- Entra a la teva Área privada del tràmit.
2. Pestanya “Requeriments”:
- Ves a la pestanya “Requeriments” per veure la llista de documents que pots adjuntar segons el tipus de sol·licitud tramitada.
- Només has de respondre als requeriments dels documents corresponents, segons l’objecte i les especificitats de l’autorització sol·licitada, que trobaràs a l’apartat de “Documentació” d’aquesta pàgina.
3. Pes màxim dels documents:
- Cada document que enviïs pot tenir un pes màxim de 100 MB.
- Es generarà un acusament de rebuda per cada document enviat.
4. Ajuda:
- Si necessites ajuda, consulta aquest vídeo tutorial sobre com aportar documents a un requeriment.
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Step four
Consultar l'estat del tràmit
Pots fer-ho a:
Pots fer-ho a:
- A l'Àrea privada (amb idCAT Mòbil o certificat digital)
- A l'Estat de les meves gestions (amb el codi de sol·licitud del tràmit i el DNI/NIF).
- Telèfon 012 (amb l’identificador del tràmit i el DNI/NIF).
Més informació a Com accedir i fer seguiment dels meus tràmits.
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Step five
Rebre resposta de l'Administració
Quan rebré la resposta?
Quan rebré la resposta?
L’Administració té un termini màxim de tres mesos, des de la presentació de la sol·licitud per dictar i notificar la resolució. Si transcorre aquest període i no s’ha dictat una resolució expressa, la sol·licitud s’entendrà desestimada per silenci administratiu.
Com rebré la resposta?
Rebràs unanotificació mitjançant e-NOTUM.
Puc presentar un recurs?
Sí, en el termini d'un mes a comptar de l'endemà de rebre la notificació, podràs interposar recurs d'alçada davant la persona titular de la Secretaria General del Departament de Salut.
