242d31dc-6de1-4ffc-b9b4-0bafc485b5a8
729122
Άδεια χονδρικής πώλησης κτηνιατρικών φαρμάκων
At a glance
Points of service
Regional units,
Points of Single Contact (ΚΕΠ – EKE),
Regions
Number of required documents
Description
This procedure concerns the granting of a licence for selling veterinary medicinal products in wholesale to interested natural or legal persons.
Basic information
Competent body
MINISTRY OF RURAL DEVELOPMENT AND FOOD
Authority/Public body’s Unit responsible for the institutional framework of the procedure
,
Application
Application Type
Application / Solemn Declaration
Submission by:
Submitted by the applicant (digital), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Title
Granting a licence for selling veterinary medicinal products in wholesale
Notes:
The application / solemn declaration form shall contain more specific fields; by completing said fields the interested party declares that the following cases do not apply: (a) an irrevocable sentence for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of pharmacist or veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a repeat offence (misdemeanour), for which a the penalty of deprivation of their civil rights was imposed, or a referral by irrevocable order for any of the above offences; (b) holding a salaried position in the State or a legal person governed by public or private law.
Specifically for the Regions of Attica and Central Macedonia, the application shall be submitted online via gov.gr.
What you will need
Means of authentication, identification and signature
Identification with TAXISnet codes, Identification document
Related
Means of redress or appeal:
Other
Report (Article 27 of the Code of Administrative Procedure)
Rules concerning a lack of reply from the competent authority and the legal consequences for the use:
(a) If the deadline of 90 days from the submission of the request and all the necessary supporting documents to the competent regional veterinary authority expires, the relevant application shall be tacitly approved and the licence shall be deemed to have been issued; (b) if the deadline set by the competent regional veterinary authority in writing for remedying the deficiencies found during the on-site inspection with regard to the compliance with the conditions laid down is exceeded, the request shall be rejected.
Output & Results
Output
Administrative Act
Other information
Alternative titles
Licence for selling veterinary medicinal products in wholesale, Get a licence for the wholesale of veterinary medicinal products (for veterinary shop owners)
Official title
Issuing a licence for the sale of veterinary medicinal products in wholesale
Languages supported
Greek, English
Ways of provision
Establishment
Categories
Trigger (submission method)
Application (handwritten), Application (digital)
N1
ΔΔ
5
0
0
85324
No
3284400
864900
Indefinite
Identification with TAXISnet codes, Identification document
465801, 654620
75
16008
5587, 7135, 9603
EU-GO
Supporting document
This procedure concerns the granting of a licence for selling veterinary medicinal products in wholesale to interested natural or legal persons.
0.00
0.00
7
0
0
3 months}}
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,
1
Labour
The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall be a full-time employee and be present in person in the store, checking the proper sale of veterinarian pharmaceutical products.
No
No
2
Labour
The licence to sell veterinary medicinal products in wholesale shall be granted if the interested party has a scientist in charge that is employed full time and is personally present in the store, checking the proper sale of veterinary medicinal products.
No
No
3
Educational
The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall be a holder of a university degree of the Veterinary school or a holder of a university degree in Pharmacology from a Greek university or an equivalent foreign university.
No
No
4
Labour
The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall have a licence to practice the profession in Greece.
No
No
5
Citizenship
The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall be a Greek national or a citizen of a Member State of the EU.
No
No
6
Military
The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall have completed their national service or be duly exempted from it.
No
No
7
Conditions for non-commission of criminal offenses
The interested party and the scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall not have been irrevocably sentenced or referred with an irrevocable order for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, application / solemn144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a felony or repeat offence (misdemeanour), for which the penalty of deprivation of their civil rights was imposed.
No
No
8
Labour
The interested party and the scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall not hold a salaried position in the State or a legal person governed by public or private law.
No
No
9
Building
The interested party for granting a licence for selling veterinary medicinal products in wholesale shall have suitable premises and the appropriate equipment that meet the following conditions:
- (a) a ground floor store with an area of at least 40 square metres;
- (b) a special storage room in direct contact with the ground store, suitable for storing sufficient quantities of veterinary medicinal products;
- (c) premises with appropriate natural or artificial lighting, temperature, ventilation and height, in accordance with the General building regulation;
- (d) meet all the requirements of the health regulation as regards water supply, sanitation, sanitary facilities, etc.;
- (e) have a fire safety system or adequate fire-fighting equipment;
- (f) have an electric refrigerator for preserving products susceptible to normal temperature (e.g. vaccines);
- (g) where medicinal products for human use are also sold by the store, the premises must be clearly separated;
- (h) on the façade of the store and in a prominent place a sign marked ‘V’ shall be within a circle of at least seventy (70) cm in diameter, in green, accompanied by the words ‘VETERINARY MEDICINAL PRODUCTS’. A wholesale veterinary medicinal products store may not be in the same premises with a retail veterinary medicinal products store, nor may a wholesale veterinary medicinal products store be in the same premises as any other commercial store, veterinary clinic, veterinarian practice, animal accommodation or animal shops.
No
No
10
Possession of passwords to enter software
For submitting the application online, the use of taxisnet codes is required.
No
No
1
Copy of the premises’ title deed.
Property titles
Copy of the premises’ title deed.
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A copy of the title to the premises to be used as a wholesale veterinary medicinal products store shall be submitted.
Document submitted under requirements:
No
No
2905
2
Copy of the lease agreement.
Private Agreement
Copy of the lease agreement.
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A copy of the lease agreement for the premises to be used as a wholesale veterinary medicinal products store shall be submitted, certified by the competent Tax office.
Document submitted under requirements:
No
Alternative document of:
1
Yes
8972
3
Store floor plan.
Drawings / studies by an engineer / architect
Store floor plan.
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A floor plan of the premises to be used as a wholesale veterinary medicinal products store, with its dimensions, shall be submitted.
Document submitted under requirements:
No
No
5768
4
Certificate of active protection by the Fire department
Certificate
Certificate of active protection by the Fire department
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A certificate of the relevant Fire department shall be submitted, certifying that the premises to be used as a wholesale medicinal products store has a fire safety system or sufficient fire-fighting equipment.
Document submitted under requirements:
No
No
9703
5
ID Card
Identification document
ID Card
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A photocopy of the ID card, certifying the Greek nationality of the scientist in charge of the operation of the store, shall be submitted.
Document submitted under requirements:
No
No
2244
6
Equivalent identification document
Identification document
Equivalent identification document
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A photocopy of an equivalent identification document, proving the that the scientist in charge of the store’s operation is a national of one of the Member States of the European Union, shall be submitted.
Document submitted under requirements:
No
Alternative document of:
5
Yes
2244
7
Copy of University degree
Proof of Study
Copy of University degree
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A photocopy of the degree from the Veterinary School or a degree from the Pharmacy School of a Greek university, or an equivalent foreign degree, shall be submitted for the scientist in charge of the wholesale veterinary medicinal products store.
Document submitted under requirements:
No
No
2825
8
Copy of the licence to practice the profession
Permit
Copy of the licence to practice the profession
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Notes:
A photocopy of the licence to practise the profession of the scientist in charge of the operation of the wholesale veterinary medicinal products store shall be submitted.
Document submitted under requirements:
No
No
4627
9
A solemn declaration of the scientist in charge of the wholesale veterinary medical products store shall be submitted, stating that the following do not apply: (a) an irrevocable sentence for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of pharmacist or veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a repeat offence (misdemeanour), for which a the penalty of deprivation of their civil rights was imposed, or a referral by irrevocable order for any of the above offences; (b) holding a salaried position in the State or a legal person governed by public or private law.
Solemn Declaration
A solemn declaration of the scientist in charge of the wholesale veterinary medical products store shall be submitted, stating that the following do not apply: (a) an irrevocable sentence for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of pharmacist or veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a repeat offence (misdemeanour), for which a the penalty of deprivation of their civil rights was imposed, or a referral by irrevocable order for any of the above offences; (b) holding a salaried position in the State or a legal person governed by public or private law.
Relevant link:
https://www.gov.gr/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses
Submission by:
Presented by the applicant (email), Submitted by the applicant (in person or by post)
Submitted by:
Persons, Legal entities
Relevant Procedure:
Solemn declaration and electronic solemn declaration
Document submitted under requirements:
No
No
7320
Law
6
2538
1997
242
Α
Law
15
4711
2020
145
Α
Joint Ministerial Decision
64
282371
2006
731
Β
Description
Harmonisation of Greek legislation with the relevant Community legislation on the production and marketing of veterinary medicinal products, in compliance with Directives 2001/82/EC and 2004/28/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.
Legal references
https://www.et.gr/api/DownloadFeksApi/?fek pdf=20060200731
Joint Ministerial Decision
375/13379
2014
2921
Β
Description
Amendment of Joint Ministerial Decision No 307752/18-10-2010 (Government Gazette, Series II, No 1865) on the handling of administrative procedures and through Citizens’ Service Centres acting as Points of Single Contact.
Legal references
https://www.et.gr/api/DownloadFeksApi/?fek pdf=20140202921
1
Submission of application / solemn declaration
Responsible for Implementation
Competent Employee
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Manual Action
Description
The interested natural or legal person shall submit an application / solemn declaration accompanied by the necessary supporting documents. The application / solemn declaration may be submitted either to the relevant competent regional veterinary authority or to a Citizens’ Service Centre - Point of Single Contact.
Notes
Specifically for the Regions of Attica and Central Macedonia, the application shall be submitted online via gov.gr.
No
No
2
Checking whether or not the conditions are met
Responsible for Implementation
Collective body
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Inspection
Description
The check on whether or not the legal conditions for granting the licence have been met shall be carried out by a three-member committee, which shall be set up by decision of the relevant Regional Governor and shall consist of a veterinarian, a physician and an engineer from the respective services of the relevant Regional Unit.
No
No
3
Finding that the conditions have not been met. The request shall be rejected and the interested party shall be notified.
Responsible for Implementation
Collective body
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Inspection
Description
If it is found that the legal conditions are not met, the competent committee shall recommend, through the relevant regional veterinary authority, that the request be rejected and the interested party shall be notified.
Yes
Yes
4
Finding that the conditions have been met: Recommendation by the competent committee
Responsible for Implementation
Collective body
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Signature
Description
If it is found that the legal conditions are met, the competent committee shall recommend, through the relevant regional veterinary authority, that the licence for wholesale veterinary medicinal products be granted.
Yes
No
5
Issuing a licence for the sale of veterinary medicinal products in wholesale.
Responsible for Implementation
Head of the Region
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Signature
Description
The licence to sell veterinary medicinal products in wholesale shall be issued by decision of the relevant Regional Governor.
Yes
No
6
Receiving the licence for selling veterinary medicinal products in wholesale
Responsible for Implementation
Competent Directorate
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Action of the executive / co-competent body
Description
The interested party shall receive the licence for selling veterinary medicinal products in wholesale:
(a) by registered letter sent to their address;
(b) by the service to which they submitted the relevant application / solemn declaration (in person or through their representative); (c) by email, to the address listed in their application.
Yes
Yes
7
Finding that the file was not complete (missing supporting documents): Written notification to the interested party for additional submission.
Responsible for Implementation
Collective body
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Action of the executive / co-competent body
Description
If it is found that some supporting documents for the licence for selling veterinary medicinal products in wholesale are missing, the relevant three-member committee shall notify the interested party in writing, so that they can take the necessary corrective action, within a specified deadline.
Notes
The deadline set by the competent three-member committee, as said committee varies according to the discretion of the collective body, is added to the time needed to complete the process.
Yes
No
8
Review
Responsible for Implementation
Collective body
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Action of the executive / co-competent body
Description
Any additional supporting documents provided by the interested party shall be reviewed.
No
No
9
Finding that the supporting documents are not complete: Tacit rejection
Responsible for Implementation
Collective body
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Action of the executive / co-competent body
Description
If the interested party does not respond within the deadline set for them in writing in the notification of the three-member committee, the request shall be rejected.
Yes
Yes
10
Finding that the supporting documents are complete. Recommendation of the competent Committee.
Responsible for Implementation
Collective body
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Signature
Description
If it is found that the supporting documents are complete, the competent committee shall recommend, through the relevant regional veterinary authority, the granting of the licence for the sale of veterinary medicinal products in wholesale.
Yes
No
11
Issuing a licence for the sale of veterinary medicinal products in wholesale
Responsible for Implementation
Head of the Region
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Signature
Description
The licence to sell veterinary medicinal products in wholesale shall be issued by decision of the relevant Regional Governor.
No
No
12
Receiving the licence for selling veterinary medicinal products in wholesale
Responsible for Implementation
Competent Directorate
Co-responsible for Implementation
NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)
Μethod of Implementation
Action of the executive / co-competent body
Description
The interested party shall receive the licence for selling veterinary medicinal products in wholesale:
(a) by registered letter sent to their address;
(b) by the service to which they submitted the relevant application / solemn declaration (in person or through their representative); (c) by email, to the address listed in their application.
No
Yes
Website of the Ministry of rural development and food: Veterinary Medicinal Products – Antimicrobial Resistance
Manual for marketing-disposal-use of veterinary medicinal products_with application templates
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