Announcement of the Commencement of Operation of Dental Laboratories

From National Registry of Administrative Public Services
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575aa4b3-5095-419e-877f-95b5713b3b5d 711070 Αναγγελία Έναρξης Λειτουργίας Οδοντοτεχνικών Εργαστηρίων

At a glance

Points of service

Regional units, Points of Single Contact (ΚΕΠ – EKE), Directorate of Public Health, Department of Health Services and Professions of the relevant Regional Authority

Digital provision points

Number of required documents

12 to 15 + (
3
)

Fees

38 €

Deadline of completion

3 months

Description

The procedure concerns the announcement of the operation of dental laboratories by a natural or legal person.

Basic information

Competent body

MINISTRY OF HEALTH

Authority/Public body’s Unit responsible for the institutional framework of the procedure

Service / organizational unit of a authority entity

Directorate of Public Health, Department of Health Services and Professions of the relevant Regional Authority


Last update

26/06/2024

Application

Application Type

Application / Solemn Declaration

Submission by:

Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

Submitted by:

Legal entities, Persons

Title

Αpplication – Solemn Declaration of the interested party (article 8 of law 1599/1986) on the subject: "Announcement of the commencement of operation of the dental laboratory by a natural and legal person"


What you will need

Means of authentication, identification and signature

Identification document, Identification with TAXISnet codes

    Print

    Requirements

      Fees

        Related


        Means of redress or appeal:

        Judicial redress

        Rules concerning a lack of reply from the competent authority and the legal consequences for the use:

        Tacit approval

        After the expiration of the three (3) months deadline, the interested party operates the said laboratory freely (art. 3 of Law 3919/2011, Government Gazette 32 / A / 2011). The interested party, in the case of tacit approval, can request the relevant certificate of operation from the administrative authority responsible for the issuance of the act, according to par. 4 of article 10 of law 3230/2004 (Government Gazette 44 / A / 2004).

        NACE

        • 32.50 Manufacture of medical and dental instruments and supplies

        Output & Results

        Output

        Administrative Act

        Steps

          Digital steps

            Other information

            Official title

            Announcement of the Commencement of Operation of Dental Laboratories

            Languages supported

            Greek, English

            Ways of provision

            Establishment

            Legislation

              Categories

              Τype of procedure

              Trigger

              Applied for

              Trigger (submission method)

              Application (digital), Application (handwritten)

              Type

              Outgoing
              N1

              ,,,


            • 1 Company law Business formation (individual, corporate)
              • For company establishment see the link below

              No No

            • 2 Possession of passwords to enter software The applicant shall have a TAXISnet username and password.

              No No

            • 3 Conditions for non-commission of criminal offenses The interested body (applicant legal or natural person) must not have been irrevocably convicted of a felony or any of the misdemeanors of theft, embezzlement, fraud, extortion, forgery, grievous bodily harm, breach of drug laws or ethical provisions.


              No No

            • 4 Ownership The interested party must own or rent the premises


              No No

            • 5 Building The space should have the following specifications, depending on the number of employees in the space: 1. Minimum space 25 sq.m. where up to 2 people will be employed or 2. Minimum space 40 sq.m. where up to 4 people will be employed or 3. Minimum space 70 sq.m. where up to 7 people will be employed or 4. Minimum space 90 sq.m. where up to 10 people will be employed or 5. Minimum space 130 sq.m. where up to 15 people will be employed or 6. Minimum space 160 sq.m. where up to 20 people will be employed or 7. For each employed person beyond 20 people 10 sq.m. In addition In the above scale is recognized a deviation that exceeds 5%.


              No No

            • 6 Urban planning The building permit must indicate the use of the building or areas of the building for which the permit is requested or in any case that is indicated in the identity of the building according to no. 5 of Law 4067/2012 (Government Gazette 79 / A / 2012).


              No No

            • 7 Technical The space must meet the conditions of installation and operation of the machines to ensure the health and integrity of employees (safety relay).


              No No

            • 8 Technical The site must meet fire protection rules


              No No

            • 9 Administrative Scientific manager shall have obtained the Certificate of Announcement for the profession of Dental technician and therefore to meet legal requirements for practicing the profession.


              No No

            • 10 Labour The interested party must declare the scientifically responsible person for the dental laboratory.


              No No

            • 11 Labour The scientifically responsible employee must declare responsibly that he accepts his appointment as "scientifically responsible" and state the days and hours in which he will be in person at the dental lab.


              No No

            • 12 Educational The scientifically responsible employee must be a graduate of dental technology of the Higher Technological Educational Institutions (ATEI /) of the domestic or foreign country. In case the interested party is a citizen of an EU member state and has acquired his professional qualifications in another Member State - either as a self-employed person or as an employee, his professional qualifications must have been recognized by the competent authority of the country.


              No No

            • 13 Technical The space must have the necessary mechanical and other equipment according to the number Ministerial Decision Α4β / 1016 / 24-3-88 Υ.Α. (Government Gazette 214 / Β / 1988)


              No No

            • 14 Bankruptcy law If the person concerned is a legal entity, it must not have been declared bankrupt


              No No

            • 1 Treasury fee 38 €

              Cost Calculation One-off

              Method of Payment Tax Office cashier

              Type of Cost Administrative Fee (not provided by e-paravolo webpage)

              No

            • 1 A copy of a criminal record of general use, issued in the last quarter or an equivalent document, when the applicant is a citizen of another EU member state. Criminal Record Copy for General Use

              A copy of a criminal record of general use, issued in the last quarter or an equivalent document, when the applicant is a citizen of another EU member state.

              Submission by: Ex officio (manual), Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons

              Notes: (Ex officio sought in the cases it is issued by the domestic competent authorities) In the absence of a copy of a criminal record, an equivalent document issued by a competent judicial or administrative authority of the country of origin or origin is required to show that the requirements are met. If the country of origin does not issue such a document, it may be replaced by an affidavit, or in the case of a non-affidavit, by a solemn declaration submitted by the person concerned to the competent judicial or administrative authority or to the notary of the country of origin or origin, who issues a certificate of the affidavit provision or official declaration.

              Document submitted under requirements: No


              No 4750

            • 2 Property titles or leasing agreement Property titles

              Property titles or leasing agreement

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 2905

            • 3 Architectural plans of floor plans and sections of the spaces in duplicate signed by a qualified engineer member of Technical Chamber of Greece and considered from a functional point of view by the competent Service of the Regional Authority. (The acceptance of architectural plans is handled internally in the public service itself) Floor plan

              Architectural plans of floor plans and sections of the spaces in duplicate signed by a qualified engineer member of Technical Chamber of Greece and considered from a functional point of view by the competent Service of the Regional Authority. (The acceptance of architectural plans is handled internally in the public service itself)

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons

              Notes: The visa is issued internally

              Document submitted under requirements: No


              No 2903

            • 4 Copy of the building permit, or settlement of Law 4178/2013 (Government Gazette 174 / A / 2013) certified by the competent Building Service, which should indicate the use of the building or premises for which the licensing is requested or in any case that is indicated in the identity of the building according to article 5 of law 4067/12 (Government Gazette 79 / A / 2012) Certificate from town planning

              Copy of the building permit, or settlement of Law 4178/2013 (Government Gazette 174 / A / 2013) certified by the competent Building Service, which should indicate the use of the building or premises for which the licensing is requested or in any case that is indicated in the identity of the building according to article 5 of law 4067/12 (Government Gazette 79 / A / 2012)

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 4558

            • 5 Certificate of (active) fire protection from the competent fire service Certification

              Certificate of (active) fire protection from the competent fire service

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 8619

            • 6 Copy of police ID card or another equivalent document of the interested party (natural or legal person) Proof of Citizenship

              Copy of police ID card or another equivalent document of the interested party (natural or legal person)

              Submission by: Ex officio (manual), Submitted by the applicant (digital)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 2712

            • 7 Copy of the Certificate of Announcement for the practice of the profession of dental technician for the scientifically responsible Notification / Announcement / Reporting

              Copy of the Certificate of Announcement for the practice of the profession of dental technician for the scientifically responsible

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 5743

            • 8 Validated Solemn Declaration (article 8 of law 1599/1986) of the scientifically responsible employee in which he accepts his appointment as scientifically responsible and declares the days and hours in which he will be in person at the dental lab Solemn Declaration

              Validated Solemn Declaration (article 8 of law 1599/1986) of the scientifically responsible employee in which he accepts his appointment as scientifically responsible and declares the days and hours in which he will be in person at the dental lab

              Relevant link: https://www.gov.gr/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons

              Relevant Procedure: Solemn declaration and electronic solemn declaration

              Document submitted under requirements: No


              No 7320

            • 9 Solemn Declaration of the interested body (article 8 of law 1599/1986) of the interested party who will mention the list of machines, tools and instruments Solemn Declaration

              Solemn Declaration of the interested body (article 8 of law 1599/1986) of the interested party who will mention the list of machines, tools and instruments

              Relevant link: https://www.gov.gr/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons

              Relevant Procedure: Solemn declaration and electronic solemn declaration

              Document submitted under requirements: No


              No 7320

            • 10 Copy of the bachelor’s degree of high or higher education institution of Greece. or Professional equivalence decision of the Independent Department for the Implementation of European Legislation (Α.Τ.Ε.Ε.Ν.) or Copy of the bachelor’s degree of high or higher education institution of a third country. and Equivalence act of I.TE. or of D.O.A.T.A.P. Proof of Study

              Copy of the bachelor’s degree of high or higher education institution of Greece. or Professional equivalence decision of the Independent Department for the Implementation of European Legislation (Α.Τ.Ε.Ε.Ν.) or Copy of the bachelor’s degree of high or higher education institution of a third country. and Equivalence act of I.TE. or of D.O.A.T.A.P.

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 2825

            • 11 In case the interested party is a legal entity, Articles of Association of the company and any amendments thereto, with the respective Official Gazettes of their publication and any amendments thereto. or Certificates of registration in the company books of the Court of First Instance of the registered office of the company Legal documents from legal entities

              In case the interested party is a legal entity, Articles of Association of the company and any amendments thereto, with the respective Official Gazettes of their publication and any amendments thereto. or Certificates of registration in the company books of the Court of First Instance of the registered office of the company

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities


              Document submitted under requirements: Yes

              Document’s requirement: Company law

              No 9338

            • 12 In case the interested party is a legal entity, Certificate of Corporate Changes issued for Limited Liability Company, Limited Partnership Company, General Partnership Company, Societe Anonyme by the competent authority Legal documents from legal entities

              In case the interested party is a legal entity, Certificate of Corporate Changes issued for Limited Liability Company, Limited Partnership Company, General Partnership Company, Societe Anonyme by the competent authority

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities


              Document submitted under requirements: Yes

              Document’s requirement: Company law

              No 9338

            • 13 In case the interested party is a legal entity, Certificate of non-declaration of the legal entity in bankruptcy by the competent Court of First Instance Certificate from a court

              In case the interested party is a legal entity, Certificate of non-declaration of the legal entity in bankruptcy by the competent Court of First Instance

              Relevant link: https://www.gov.gr/en/arxes/oloi-foreis/dikaiosunes/pistopoietika-dikasterion

              Submission by: Ex officio (manual), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities

              Notes: (Sought internally in case issued by national authorities) In the absence of a Certificate of non-declaration of the legal entity in bankruptcy , an equivalent document issued by a competent judicial or administrative authority of the country of origin or origin is required to show that the requirements are met. If the country of origin does not issue such a document, it may be replaced by an affidavit, or in the case of a non-affidavit, by a solemn declaration submitted by the person concerned to the competent judicial or administrative authority or to the notary of the country of origin or origin, who issues a certificate of the affidavit provision or official declaration.

              Document submitted under requirements: Yes

              Document’s requirement: Bankruptcy law

              No 8289

            • 14 In case the interested party is a legal entity, Legal documents to submit the application on behalf of the legal entity Legal documents from legal entities

              In case the interested party is a legal entity, Legal documents to submit the application on behalf of the legal entity

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities


              Document submitted under requirements: Yes

              Document’s requirement: Company law

              No 9338

            • 15 Special declaration of exemption from installation and operation license, by the Development Directorate of the relevant Regional Authority Unit. Declaration

              Special declaration of exemption from installation and operation license, by the Development Directorate of the relevant Regional Authority Unit.

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 9429

            • 16 Solemn Declaration (Article 8 of Law 1599/1986) by a licensed electrician, who has a license corresponding to the installed capacity, validated. Solemn Declaration

              Solemn Declaration (Article 8 of Law 1599/1986) by a licensed electrician, who has a license corresponding to the installed capacity, validated.

              Relevant link: https://www.gov.gr/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons

              Relevant Procedure: Solemn declaration and electronic solemn declaration

              Document submitted under requirements: No


              No 7320

            • 17 Solemn declaration (Article 8 of Law 1599/1986) of the scientifically responsible person certified that he accepts his appointment as scientifically responsible person and states the days and hours he will be present in person at the said dental laboratory. Solemn Declaration

              Solemn declaration (Article 8 of Law 1599/1986) of the scientifically responsible person certified that he accepts his appointment as scientifically responsible person and states the days and hours he will be present in person at the said dental laboratory.

              Relevant link: https://www.gov.gr/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons

              Relevant Procedure: Solemn declaration and electronic solemn declaration

              Document submitted under requirements: No


              No 7320

            • 18 A copy of the identity card or other equivalent document of the scientific person in charge. Identification document

              A copy of the identity card or other equivalent document of the scientific person in charge.

              Submission by: Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 2244

            • Presidential Decree 15 121 2017 148 Α

              Description Organization of the Ministry of Health - Structure-Responsibilities of the Directorate of Primary Health Care.

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20170100148

            • Law par. ΙΒ΄ 4093 2012 222 Α

              Description Restrictions Obviation Amendment: Law 4461/2017 (GG 38/Α/2017) article 43 - Amendment par. ΙΒ΄ article 1 law 4093/2012 (Possibility to submit an application to natural and legal persons)

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20120100222

            • Law 1 4208 2013 252 Α

              Description The cohabitation of Primary Health Care companies Amendment: Law 4272/2014 (GG 145/Α/2014) article 46 - Amendment article 1 law 4208/2013 (The cohabitation of Primary Health Care companies)

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20130100252

            • Circular Υ3β/Γ.Π./οικ.20227 2012

              Description Application law 3919/2011 (GG 32/Α/2011)

              Legal references https://diavgeia.gov.gr/doc/%CE%9244%CE%9E%CE%98-%CE%9F%CE%A1%CE%A0?inline=true

              ΑΔΑ Β44ΞΘ-ΟΡΠ

            • Law 186 186 para. II(1) art. Z 3852 2010 87 Α

              Description New Architecture of Self-Government and Decentralized Administration - Kallikratis Project. Competencies of Regions.

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20100100087

            • Joint Ministerial Decision ΔΙΑΔΠ/Ε/24830 2003 1931 Β

              Description Prerequisites - Supporting Documents - Procedure - Inclusion in KEP-CSR - Application Forms Amendments: - J.M.D. Υ3β/ΓΠ/οικ.35578/2013 (GG 1011/Β/2013) - Amendment ofJ.M.D. Υ3β/ΓΠ/οικ.64432/2011 and ΔΙΑΔΠ/A1/13310/2002 - J.M.D. Υ3β/ΓΠ/οικ.64432/2011 (GG 1394/Β/2011) - Amendment of J.M.D. ΔΙΑΔΠ/A1/13310/2002

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20030201931

            • Ministerial Decision Α4β/1016 1988 214 Β

              Description Dental laboratory installation site specifications and equipment

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=19880200214

            • Presidential Decree 2 83 1989 37 Α

              Description Professional Rights of Graduates of the Department of Dentistry.

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=19890100037

            • Law 1666 1986 200 Α

              Description Dental profession - Dental laboratories and other provisions

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=19860100200

            • 1 Submission of application and of required documents

              Responsible for Implementation Competent Employee


              Description The interested party submits the Application – Solemn Declaration with attached the required supporting documents to the Protocol Office of the relevant Regional Authority or to the EU-GO Single Point of Contact.

              No No


            • 2 Application registration and charging

              Responsible for Implementation Competent Employee

              Μethod of Implementation Manual Action

              Description An Officer of the Protocol Office of the Directorate of Public Health or of the EU-GO Single Point of Contact receives and records the Application – Solemn Declaration with the attached required supporting documents and grants the protocol number to the interested party or the Certificate of Submission of the Application and then forwards them to the Directorate of Public Health so that they can be charged to the relevant official

              No No


            • 3 On-site inspection

              Responsible for Implementation Collective body

              Μethod of Implementation Manual Action

              Description Following internal action taken by the officials of the competent departments (administrative audits etc.), the Audit Committee of the relevant Regional Authority Unit carries out the on-site inspection of the company to be established

              Notes - In case the Audit Report has findings, an executive of the Department of Private Primary Health Care Units prepares a draft document with the findings that emerged from the Audit Report and signs it in order to inform the interested party. At this point in the procedure, the interested party does not have the right to operate the aesthetics laboratory and in order to obtain this right, he has to resubmit all the supporting documents. -In case the Audit Report does not record findings, an executive of the Department of Private Primary Health Care Units prepares a draft Certificate of Commencement of Operation and sends it to the hierarchy for signature.

              No No


            • 4 Delivery of Certificate to the interested party

              Responsible for Implementation Competent Employee

              Μethod of Implementation Manual Action

              Description An executive of the Department of Private Primary Health Care sends to the interested party the Certificate of Commencement of Operation of the aesthetics laboratory and files the relevant documents in the file maintained by the Department of Private Primary Health Care Units.

              No Yes


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