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  • Home
  • Grants and services
  • Authorisation for optical practices or optician departments in pharmacies
  • Apply for operating health authorisation for an optical practice
8945 - Autorització dels establiments d’òptica o de les seccions d’òptica en oficines de farmàcia. Departament de Salut accio
  • What do you need to know?
  • What is it?
  • Who is it for?
  • Deadlines
  • Documentation
  • Requirements
  • Fees
  • Other information

Steps to follow

  1. 1. Apply
  2. 2. Check the status of the application
  3. 3. Pay the fee
  4. 4. Aportar documentació
  5. 5. Get a reply from the Administration
  • Go to: Apply for operating health authorisation for an optical practice
  • Go to: What is it?
  • Go to: Who is it for?
  • Go to: Deadlines
  • Go to: Documentation
  • Go to: Requirements
  • Go to: Fees
  • Go to: Other information
  • Go to: Steps to follow

Authorisation for optical practices or optician departments in pharmacies

Apply for operating health authorisation for an optical practice

WHO
Companies and professionals | Entities
HOW
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WHEN
At any time

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Authorisation for optical practices or optician departments in pharmacies

Apply for operating health authorisation for an optical practice

Online Start
WHEN
At any time

WHO
HOW
Companies and professionals | Entities Online

Do you need any help?

Do you need any help?

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Regulation

  • DECRET 224/2013, de 10 de setembre, pel qual es modifica el Decret 126/2003, de 13 de maig, pel qual s'estableixen els requisits tecnicosanitaris dels establiments d'òptica.

    . Open in a new window. (DOGC  no.  6460  posted  16/09/2013)
  • DECRET 126/2003, de 13 de maig, pel qual s'estableixen els requisits tecnicosanitaris dels establiments d'òptica.

    . Open in a new window. (DOGC  no.  3889  posted  22/05/2003)

What do you need to know?

What is it?

In order to safeguard people’s eye health, optical practices and optician departments in pharmacies based in Catalonia need authorisation from the Ministry of Health to open and operate. This authorisation may only be given once it has been confirmed that the owner complies with the technical and health requirements specified in regulations governing these practices.

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 you check the electronic processing help section and the instructions in the ‘Related documents’ 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 are provided for applications and/or notifications in this procedure, which must be used. These forms can be downloaded from this same page. If the application and/or notification is submitted using other forms, they will be deemed not to have been submitted pursuant to Article 16.8 of the Law 39/2015, of 1 October, on the common administrative procedure of public administrations, and consequently the date on which the application and/or notification is deemed to have been submitted is the date of entry of the specific form indicated.

Applicable regulation

Authority responsible

  • Departament de Salut
  • Servei d'Ordenació i Qualitat Farmacèutiques
Who is it for?
Companies and professionals
Entities

Individuals or legal entities owning optical practices and pharmacies with an optician department.

Deadlines

You can apply for authorisation at any time but you must have it before you start operating.

Documentation

You must attach the following documents to your application form:

  1. Statement by the chief technical officer (this document must be signed electronically).
  2. A copy of the academic qualification that entitles the chief technical officer to perform the duties of this role and/or for the other situations shown in Article 4 of Decree 126/2003:
    • Diploma in optics and ocular prosthetics (Decree of 22 June 1956).
    • Document accrediting them as a beneficiary of the transitional provision of Decree 1387/1961 of 20 July.
    • Diploma in optics (Decree 2842/1972 of 15 September).
    • Diploma in optics issued by the schools of Ophthalmic Optics and Audiometric Acoustics of the University of Barcelona and of Audiometric Optics and Acoustics of the University of Santiago de Compostela (ministerial orders of 18 February 1975).
    • Diploma in Optics and Optometry (Royal Decree 1419/1990 of 26 October).
    • Degree in Optics and Optometry (Royal Decree 1393/2007 of 29 October).
    • Foreign qualifications that have been recognised by the Spanish academic authorities as equivalent to a diploma in optics (Decree 2842/1972 of 15 September) or to a diploma in optics and optometry (Royal Decree 1419/1990 of 26 October).
  3. Detailed plan of the practice or department showing the floor area of each zone and the equipment available in them, which is issued and signed by a qualified specialist.
  4. Copy of the receipt for the bank deposit certifying that the fee has been paid.

Documents

Declaration of responsibility by the technical director

Requirements
  1. Qualifications and human resources

Management, supervision and responsibility for the roles laid down in Article 2 of Decree 126/2003 must be provided by a licensed optician or optometrist who is the chief technical officer.

A person may only be the chief technical officer of a single optical practice or department. At least one licensed optician or optometrist must be present during the optician’s opening hours.

The temporary absence of the chief technical officer must be covered by a licensed optician or optometrist who will be responsible for the roles set out in Article 2 of Decree 126/2003.

For the purposes of the aforementioned Decree, optician or optometrist means people who are in one of the following situations:

  • Hold the diploma in optics and ocular prosthetics (Decree of 22 June 1956)
  • Are beneficiaries of the transitional provision of Decree 1387/1961 of 20 July.
  • Hold the diploma in optics (Decree 2842/1972 of 15 September).
  • Hold the diploma in optics issued by the schools of Ophthalmic Optics and Audiometric Acoustics of the University of Barcelona and of Audiometric Optics and Acoustics of the University of Santiago de Compostela (ministerial orders of 18 February 1975).
  • Hold the diploma in optics and optometry (Royal Decree 1419/1990 of 26 October).
  • Hold the degree in optics and optometry (Royal Decree 1393/2007 of 29 October).
  • Hold foreign qualifications which have been recognised by the Spanish academic authorities as equivalent to a diploma in optics (Decree 2842/1972 of 15 September) or to a diploma in optics and optometry (Royal Decree 1419/1990 of 26 October).
  1. Facilities and equipment

Optical practices and optician departments of pharmacies must comply with the technical and health requirements set out in Article 6 of Decree 126/2003:

  • At the main entrance to the optician’s there must be a sign bearing the word “Optician’s” in conspicuous letters. There must also be a plaque at the entrance to the premises bearing the full name of the chief technical officer and their professional association membership number.
  • The optician’s may be on one or more directly connected floors and, depending on the operations carried out in the practice or department, it must have the following areas marked out and separated from each other:
    • Customer service area.
    • This area must be clearly marked and allow for individual customer service and the sale of optical items. It must have a minimum floor area of 10 square metres.
    • Optometry and/or contact lens area.
    • Optometric and contact lenses roles must be performed in this area. It must be clearly marked out, have a minimum floor area of eight square metres and be fitted with sufficient lighting. It must also have a non-manual hand washbasin with liquid soap and disposable paper towels.
    • The minimum equipment or tools that must be available in this area are listed in the annex to Decree 126/2003. Equipment and tools must be calibrated and maintained in accordance with their technical specifications under the responsibility of the practice’s technical management.
    • Workshop area.
    • This area must be separated from the other areas so as to allow checking of optical items and any cutting and assembly that may be required. It must have a minimum floor area of four square metres.
    • The minimum equipment or tools that must be available in this area are listed in the annex to Decree 126/2003. Technical management must ensure that equipment and tools are calibrated and maintained in accordance with their technical specifications.
    • Storage area.

This area must be separate from the other areas and provide storage in appropriate conditions of the materials and products used in these practices.

  1. Health and hygiene conditions

Health and hygiene conditions in opticians’ and all their areas or facilities must be optimal in order to ensure excellent and appropriate care and service.

  1. Activity and maintenance logs

Under the responsibility of the technical management, opticians’ must keep the following records:

  • Daily logbook of optical prescriptions made.
  • Individualised record per customer of the results of vision evaluation carried out in the optician’s using optometric tests.
  • Calibration and maintenance logs for all equipment and tools requiring it.
Fees

Per sol·licitar l'autorització d'obertura i funcionament: 290,80 €.
L'ingrés es fa a nom del Col·legi d'Òptics Optometristes i Òptiques Optometristes de Catalunya, al compte de "la Caixa" ES7021000923760200204391.

Complementary information

 

Optical practices (not optician departments in pharmacies which pay as shown in their option) have to pay the fee before submitting their application by a wire transfer to the Col·legi d’Òptics Optometristes i Òptiques Optometristes de Catalunya in “La Caixa” account no. ES70-2100-0923-7602-00204391. The payment details should state: “Sol·licitud d’autorització de funcionament d’òptica” [‘Application for optician operating authorisation’].

You must attach proof of payment of the fees to your application.

Other information

Under Decree 126/2003, an optical practice is the centre or service which under the direction, supervision and professional responsibility of an optician or optometrist performs any of the following operations or roles:

  1. Cutting, assembly, adaptation, supply, sale, verification and control of the appropriate optical means for prevention, protection and improvement of visual acuity.
  2. Examination of the individual’s vision by means of optometric tests and determination of the appropriate optical aids to improve it.
  3. Fitting extraocular prostheses.
  4. The rest of the duties based on the optician’s academic qualifications and training.

This definition also includes departments in this speciality in pharmacies that carry out the operations or roles specified above.

Steps to follow

  1. 1

    Step one

    Apply

    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.

    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.

    By Internet

    Apply for operating health authorisation for an optical practice How to do it

    Start . Go to Apply for operating health authorisation for an optical practice How to do it

    How to do it

    Step 1. Download, fill in and validate the form

    • Download the form (if you have trouble downloading it, see how to download PDF forms) and fill it in.
    • Attach the statement by the chief technical officer (this document has to be signed electronically) and the documents required.
    • Validate it (the form is only validated if all the obligatory information has been filled out and all the obligatory documentation attached).
    • Save it to your computer.

    Step 2. Submit for processing

    • Go back to the online procedure. You can do this using the Online Processing link at the end of the form, before the Save
    • Select the file containing the completed and validated form and press the Submit button.
    • To send the file, you have to choose the type of certificate with which you are signing: digital certificate or the idCAT Mòbil system if you are the owner of the company, or a digital certificate of representation if you are its representative.

    Step 3. Confirmation of the processing carried out

    • If the application has been sent correctly, the system returns: the notification of correct sending and the acknowledgement of receipt as a PDF. It is important that you print the acknowledgement of receipt as this document contains the entry record, which is the date on which this procedure was begun and may be important in certain calculations and deadlines, and the procedure identifier (ID code), which you can use to access Status of my Procedures or the Private Area (‘My Folder’).
    • If the application contains an error, it will not be sent and a message will come up stating what the error is.

     

    Key points to bear in mind when making your application

    • Remember that you have to fill in all the fields marked in red. If you do not, you will get an error message when you validate your application and will not be able to send it until you sort out the problem.
    • If you click the Next button at the bottom of a page, the system will validate all the data entered on that page and tell you if there are any errors (field not filled in, incorrect formatting, etc.) so you can remedy it.
    • Pay special attention to the fact that there are dropdown lists in some fields.
    • To attach documents, click on the Attach button and browse your computer for the document and attach it. Remember that the size of the form plus the attached documents may not be greater than 5 Mb.
    • You cannot use the same form for different applications; once you have submitted an application, if you want to send another one, you will have to re-download the form template and fill it in again.
    • The procedure allows the signature of a legal entity and an individual. If you are a legal entity, you must submit the form using a certificate for the person listed on the form as a representative.
    • To access electronic notifications, see the following page in the Canal Empresa, which you may find useful.
    • You may watch the video tutorials on this procedure:  Processing with PDF form (download, fill in, validate and save)i  Processing with PDF form (submit for processing).

    In case of questions, check the security recommendations available on Tràmits Gencat or phone the telephone assistance services 012.

    Please remember that in order to do procedures remotely, you must have a valid digital certificate. In this sense, we recommend that you check the different certificates allowed as well as the other conditions for doing procedures online.

    If you have any processing problems, first check the recommendations in the Support to Processing section in Tràmits Gencat website.

    Secondly, once you have checked that you have all the means needed and have proceeded as instructed, you can check if there has been any service outage or incident in the Alerts and Service Outages on the Seu electrònica, which contains complete information on the type of incident and where it occurred; you can look for service incidents for the corresponding year (Incidents in 2019) and check the Start date and time field in descending order. If you cannot process it because of an incident in the system, please try again later.

  2. 2

    Step two

    Check the status of the application

    You can do this in:

    You can do this in:

    • Private Area (‘My Folder’) (with idCAT Mòbil and/or digital certificate)
    • In Status of my Procedures (Tràmits Gencat) (with the procedure identifier and your DNI/NIF)
    • In Status of my Procedures (Canal Empresa) (with the procedure identifier and your DNI/NIF)
    • 012 helpline(with the procedure identifier and your DNI/NIF)

    For more information, see the Video tutorial “Check the status of My procedures”.

    What is the identification code (ID) of the application and where can I find it?

    It’s an alphanumerical code that you get with the confirmation of receipt once you have submitted the application, and it allows you to check the processing status and do certain procedures without the need to have a digital certificate.

  3. 3

    Step three

    Pay the fee

    Optical practices (not optician departments in pharmacies which pay as shown in their option) have to pay the fee before submitting their application by a wire transfer to the Col·legi d’Òptics [...]

    Optical practices (not optician departments in pharmacies which pay as shown in their option) have to pay the fee before submitting their application by a wire transfer to the Col·legi d’Òptics Optometristes i Òptiques Optometristes de Catalunya in “La Caixa” account no. ES70-2100-0923-7602-00204391. The payment details should state: “Sol·licitud d’autorització de funcionament d’òptica” [‘Application for optician operating authorisation’].

    The fee is €274.05.

    You must attach proof of payment of the fee to your application.

    The fee must be paid in order to continue the processing of the application. If you have not made the payment after this timeframe has elapsed, it is understood that the application will cease being processed and the procedure will be filed away.

  4. 4

    Step four

    Aportar documentació

    Un cop revisada la sol·licitud, l’Administració pot demanar-te documentació complementària. Pots enviar-la des de:

    Un cop revisada la sol·licitud, l’Administració pot demanar-te documentació complementària. Pots enviar-la des de:

    • L'Àrea privada (amb idCAT Mòbil o certificat digital)
    • L'Estat de les meves gestions (amb el codi identificador del tràmit i el NIF/NIE).

    Consulta el videotutorial sobre com aportar documents a un requeriment.

  5. 5

    Step five

    Get a reply from the Administration

    When do I get a reply?

    When do I get a reply?

    Applications must be ruled on and the authorisation decision notified within at most three months from the date of entry of the application in the register. Failure to respond shall be deemed a constructive grant of authorisation. However, the legal period for issuing and notifying the decision is suspended when you are asked to remedy deficiencies or provide documents and/or other items needed to make the decision. This suspension will last for the time between notification of the request and when you meet it or until the expiry of the time limit granted.

    Who gives a reply?

    The head of the Directorate General for Healthcare Planning and Regulation decides to award or deny authorisation once it has been confirmed that the applicant meets the health and technical requirements.

    How do I get a reply?

    You will receive the response via an electronic notification placed in the e-NOTUM notification portal. You have 10 calendar days from the date the notification is placed to accept or reject it. If you have not checked the notification after this timeframe, it will be understood as rejected. From the time you access the content of the notification, it is considered effective.

    You can check the electronic notifications from any of these channels:

    • From the link in the notice that you receive at the email or mobile phone you listed on the application.
    • From the Electronic notifications section.
    • From the Private Area (‘My Folder’) of Canal Empresa.

    You can access it via a digital certificate, idCAT Mòbil or a single-use code. If you do so via the Private Area (‘My Folder’), you have to previously identify yourself with idCAT Mòbil or a digital certificate.

    For more information, check the electronic notifications section of the Ministry of Health or Tràmits Gencat webistes. You can also check the Video tutorial “E-notification to the Administration of the Government of Catalonia”.

    Can appeals be submitted?

    The decision made by the Director General for Healthcare Planning and Regulation does not exhaust all available administrative remedies and you may lodge an administrative appeal against it with the Minister of Health within one month from the day after the date of notification as provided in the Law 39/2015, of 1 October, on the common administrative procedure of public administrations.

Update date 12/10/2024
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