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
Number of required documents
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
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
Related
Means of redress or appeal:
Rules concerning a lack of reply from the competent authority and the legal consequences for the use:
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
Other information
Official title
Announcement of the Commencement of Operation of Dental Laboratories
Languages supported
Greek, English
Ways of provision
Establishment
Categories
Trigger (submission method)
Application (digital), Application (handwritten)
N1
ΔΔ
4
0
0
19476
No
698700
698700
Identification document, Identification with TAXISnet codes
862790
32.50
5587, 7135
EU-GO, SDG"SDG" is not in the list (EU-GO, EU-GO (support)) of allowed values for the "Process source" property.
Supporting document
The procedure concerns the announcement of the operation of dental laboratories by a natural or legal person.
38.00
38.00
12
3
3
3 months}}
}}
}}
,,,
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
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
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
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
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
Law
par. ΙΒ΄
4093
2012
222
Α
Law
1
4208
2013
252
Α
Circular
Υ3β/Γ.Π./οικ.20227
2012
Law
186 186 para. II(1) art. Z
3852
2010
87
Α
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
Presidential Decree
2
83
1989
37
Α
Law
1666
1986
200
Α
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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