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Announcement of the Commencement of Operation of Dental Laboratories

Basic information

Institutional Body

MINISTRY OF HEALTH

Description

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

At a glance

Points of ServicePoints of Single Contact (ΚΕΠ – EKE), Regional units, Directorate of Public Health, Department of Health Services and Professions of the relevant Regional Authority
Number of Documents0
Cost~ 38€
Process Diagram

Conditions

Business formation (individual, corporate) *For company establishment see the link below
Related link
https://www.gov.gr/en/ipiresies/epikheirematike-drasterioteta/enarxe-kai-luse-epikheireses/sustase-epikheireses

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.

The interested party must own or rent the premises

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%.

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).

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

The site must meet fire protection rules

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)

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.

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

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.

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.

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

Fees / Imposts

  • Treasury fee
    Payment type
    Tax Office cashier
    Type
    Administrative Fee (not provided by e-paravolo webpage)

What you will need

Identification and signature verification means
Identification document, Identification with TAXISnet codes

  • 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"
    Filed by
    Submitted by the applicant (digital), Submitted by the applicant (in person or by post)
    Applicant status
    Legal entities, Persons
Ministry of Digital Governance LogoEUGO LogoGovGR Logo
Announcement of the Commencement of Operation of Dental Laboratories
What you will need
1A 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
Filed by
Ex officio (manual)Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
2Property titles or leasing agreementProperty titles
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
3Architectural 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
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
4Copy 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
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
5Certificate of (active) fire protection from the competent fire serviceCertification
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
6Copy of police ID card or another equivalent document of the interested party (natural or legal person)Proof of Citizenship
Filed by
Ex officio (manual)Submitted by the applicant (digital)
Applicant status
Legal entitiesPersons
7Copy of the Certificate of Announcement for the practice of the profession of dental technician for the scientifically responsibleNotification/Announcement
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
8Validated 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 labSolemn Declaration
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
9Solemn Declaration of the interested body (article 8 of law 1599/1986) of the interested party who will mention the list of machines, tools and instrumentsSolemn Declaration
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
10Copy 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
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
11In 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 companyLegal documents from legal entities
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entities
12In 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 authorityLegal documents from legal entities
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entities
13In case the interested party is a legal entity, Certificate of non-declaration of the legal entity in bankruptcy by the competent Court of First InstanceCertificate from a court
Filed by
Ex officio (manual)Submitted by the applicant (in person or by post)
Applicant status
Legal entities
14In case the interested party is a legal entity, Legal documents to submit the application on behalf of the legal entityLegal documents from legal entities
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entities
15Special declaration of exemption from installation and operation license, by the Development Directorate of the relevant Regional Authority Unit.Declaration
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
16Solemn Declaration (Article 8 of Law 1599/1986) by a licensed electrician, who has a license corresponding to the installed capacity, validated.Solemn Declaration
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
17A copy of the identity card or other equivalent document of the scientific person in charge.Identification document
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
18Solemn 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
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons

Legislation

  • Description
    Organization of the Ministry of Health - Structure-Responsibilities of the Directorate of Primary Health Care.
    Legal references
    Link

  • 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
    Link

  • 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
    Link

  • Description
    Application law 3919/2011 (GG 32/Α/2011)
    Legal references
    Link

  • Description
    New Architecture of Self-Government and Decentralized Administration - Kallikratis Project. Competencies of Regions.
    Legal references
    Link

  • 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
    Link

  • Description
    Dental laboratory installation site specifications and equipment
    Legal references
    Link

  • Description
    Professional Rights of Graduates of the Department of Dentistry.
    Legal references
    Link

  • Description
    Dental profession - Dental laboratories and other provisions
    Legal references
    Link

About

Process code
711070
NACE code
32.5
Description of NACE code
Manufacture of medical and dental instruments and supplies
Legal means of protection or appeal
Judicial redress 
Rules for non-response by the competent authority and legal consequences
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).

Other Information

Languages supported
English
Ways of provision
Establishment

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