b7b778a5-b8f7-4c73-ba3c-2a3b483d3228
802778
Άδεια Χονδρικής Πώλησης Κτηνιατρικών Φαρμακευτικών Προϊόντων
At a glance
Points of service
Points of Single Contact (ΚΕΠ – EKE), Regions, Veterinary Medicine Authorities of Regional Units, MINISTRY OF RURAL DEVELOPMENT AND FOOD
Number of required documents
Description
The procedure concerns the issuance of a license for wholesale trade in veterinary medicinal products. The proper – under specific prerequisites – trade and provision of veterinary drugs through wholesale stores aims to control their proper circulation, whist it intends to protect animals’ health and, therefore, consumers’ health along with environments protection.
Limitations: Only one licence is granted for each store, which has one specific base (within the Greek territory)
Basic information
Competent body
MINISTRY OF RURAL DEVELOPMENT AND FOOD
Authority/Public body’s Unit responsible for the institutional framework of the procedure
Διεύθυνση Προστασίας των Ζώων, Φαρμάκων και Κτηνιατρικών Εφαρμογών; ΓΕΝΙΚΗ ΔΙΕΥΘΥΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ
Authority responsible for the provision of the procedure
MINISTRY OF RURAL DEVELOPMENT AND FOOD
Service / organizational unit of a authority entity
Veterinary Medicine Authorities of Regional Units
Application
Application Type
Application
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Title
Application – Solemn Declaration from the beneficiary, natural or legal person.
What you will need
Means of authentication, identification and signature
Identification with TAXISnet codes, Identification document
Related
Means of redress or appeal:
Other
Administrative redress/appeal
Rules concerning a lack of reply from the competent authority and the legal consequences for the use:
NACE
- 75.0 Veterinary activities
Output & Results
Output
Registry update, Document Production
Other information
Official title
Licence for Wholesale Trade in Veterinary Medicinal Products
Languages supported
English
Ways of provision
Establishment
Categories
Trigger (submission method)
Application (handwritten)
N1
ΔΔ
3
0
0
85324
No
172800
172800
Identification with TAXISnet codes, Identification document
Διεύθυνση Προστασίας των Ζώων"Διεύθυνση Προστασίας των Ζώων" is not a number., Φαρμάκων και Κτηνιατρικών Εφαρμογών; ΓΕΝΙΚΗ ΔΙΕΥΘΥΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ"Φαρμάκων και Κτηνιατρικών Εφαρμογών; ΓΕΝΙΚΗ ΔΙΕΥΘΥΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ" is not a number.
85324
75.0
8210, 9603, 7135
EU-GO, SDG
Supporting document
The procedure concerns the issuance of a license for wholesale trade in veterinary medicinal products. The proper – under specific prerequisites – trade and provision of veterinary drugs through wholesale stores aims to control their proper circulation, whist it intends to protect animals’ health and, therefore, consumers’ health along with environments protection.
Limitations: Only one licence is granted for each store, which has one specific base (within the Greek territory)
0
0
6
1
0
90 days}}
}}
}}
,,
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
Other
It is not allowed to collocate (same premises) a wholesale store of veterinary medicinal products with a retail store.
No
No
4
Administrative
Application Submission – Solemn Declaration
Submitted by Natural and Legal Persons (beneficiaries).
No
No
5
Citizenship
The natural person (beneficiary) must hold the Greek or an EU Member-State citizenship.
No
No
6
Conditions for non-commission of criminal offenses
Beneficiary must have not been irrevocably convicted for any penalty or must have not been remitted through an irrevocable indictment for theft, embezzlement, fraud, extortion, forgery, crimes against ethics, defamation for acts related to the practice of the veterinary profession counterfeiting, forgery and violation of the provisions of articles 5 and 12 of Law 1729/1987 (Government Gazette 144 A`), as in force, and in recurrence of article 11 of the same law, and they must have not been irrevocably convicted of a crime or recidivism for a misdemeanor, for which he/she has been deprived of his/her political rights.
No
No
7
Labour
They must not hold a salaried position in the Civil Service nor in a legal entity under Public or Private Law.
No
No
8
Other
There must be an employment of a scientific manager, who works at all times via physical presence and has the following qualifications and meets the below requirements:
- Greek or EU Member-State citizenship
- He must hold a degree of Pharmacy or Veterinary Medicine from an Higher Educational Institution (AEI) as well as they must hold a licence to practice the profession
- Completion of army service or legal exemption from it
- He must have not been irrevocably convicted for any penalty for theft, embezzlement, fraud, extortion, forgery, crimes against ethics, defamation for acts related to the practice of the veterinary or pharmacist profession, counterfeiting, forgery and violation of the provisions of articles 5 and 12 of Law 1729/1987 (GG 144 A`), as in force, and in recurrence of article 11 of the same law, or not to have been irrevocably convicted of a crime or recidivism for a misdemeanor, for which he/she has been deprived of his/her political rights, or must have not been remitted through an irrevocable indictment for any of the above crimes.
-He must not hold a salaried position in the Civil Service nor in a legal entity under Public or Private law
The natural person that apply can also hold the role of the scientific manager if the necessary prerequisites are met.
No
No
9
Other
They must have a store and equipment that meet the requirements below:
a. It must be an ground floor independent space of at least forty (40) square meters
b. It must have as a warehouse a special room that is connected to the ground floor, which must be suitable for storing quantities of veterinary medicinal products
c. It must have adequate natural and artificial lighting, ventilation and height in accordance with the General Building Regulations
d. It must meet all the requirements of the sanitary regulation regarding water supply, sewerage, sanitary facilities, etc.
e. It must have a fire safety system or adequate means of firefighting
f. It must have an electric refrigerator for the maintenance of products susceptible to the normal temperature (vaccines, etc.)
g. It must have on the front of the store and in a visible place a sign with the mark "V" in a circle with a diameter of at least seventy (70) cm in green color and also to have the indication "VETERINARY MEDICINES"
h. If there is a circulation of medicinal products of human use, then there must be a clear distinction of the areas
No
No
Joint Ministerial Decision
375/133799
2014
2921
Β
Joint Ministerial Decision
282371
2006
731
Β
Description
Harmonization of greek law with equivalent european concerning production and circulation of veterinary medicine, in compliance with Directions 2001/82/ΕP and 2004/28/ΕP of European Parliament and Council concerning EU legal code for veterinary medicine
Legal references
https://www.et.gr/api/DownloadFeksApi/?fek pdf=20060200731
Law
15
4711
2020
145
Α
Law
14
4691
2020
108
Α
Description
Veterinary medical products: Amendment of article 10 (Sanctions) and 11 (Controls for implementation and compliance to the provisions of trade, disposal and use of veterinary medical products of Law 2538/1997.
Legal references
https://www.et.gr/api/DownloadFeksApi/?fek pdf=20200100108
Law
5-12
2538
1997
242
Α
Ministerial Decision
225783
2003
561
Β
Joint Ministerial Decision
310584
1998
456
Β
Description
Circulation, control, terms of preparation and analytical pharmacotoxicological and clinical standards and protocols for testing veterinary medical and immunological products in conformity to Directions 81/851/EEC, 81/852/ EEC, 90/167/EEC, 90/676/EEC,90/677EEC, 92/18/EEC, 93/40/EEC & 93/41/EEC.
Legal references
https://www.et.gr/api/DownloadFeksApi/?fek pdf=19980200456
1
Submission of application and of required documents
Responsible for Implementation
Competent Employee
Μethod of Implementation
Manual Action
Description
The applicant submits the required documents for the license of wholesale trade in veterinary medicinal products at the Veterinary Medicine Authority (Department or Directorate) or the competent Regional Unit or at KEP-EKE.
In cases of where the application is submitted to KEP-EKE, the required documents are forwarded to the Veterinary Medicine Authority (Department or Directorate) or the competent Regional Unit via KEP-EKE.
No
No
2
Evaluation of documents and on-site inspection
Responsible for Implementation
Collective body
Μethod of Implementation
Inspection
Description
The application and the submitted documents are examined from a 3-member committee of the competent Regional Unit, which conducts an on-site audit of the store in order to assess whether the legal requirements are met or not.
No
No
3
Notification of the interested party
Responsible for Implementation
Competent Directorate
Μethod of Implementation
Manual Action
Description
The committee recommends to the Veterinary Medicine Authority the granting or not the licence.
In case the recommendation is negative, the Veterinary Medicine Authority informs the interested party accordingly.
In case the recommendation is positive, the Veterinary Medicine Authority sends the licence to the interested party.
No
Yes
Manual of veterinary drugs (EL)
Legislation for veterinary medical products
1
Photocopy of ID or any other document that proves the Greek citizenship of one the EU Member-States (separate photocopies if the interested party is different to the scientific manager).
Photocopy of ID or any other document that proves the Greek citizenship of one the EU Member-States (separate photocopies if the interested party is different to the scientific manager).
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Document submitted under requirements:
No
No
6866
2
In case of legal persons: Documents that proves the legality of the legal person, based on its legal type. For example, a coded Articles of Association which has been legally published or certified by the First Instance Court, accompanied with an alterations certificate from the competent authority and a published GG for S.A. or LLC, as well as with a document about its legal representation and a copy of the ID or any other documents that proves the identity of the company’s legally responsible individual.
Legal documents from legal entities
In case of legal persons: Documents that proves the legality of the legal person, based on its legal type. For example, a coded Articles of Association which has been legally published or certified by the First Instance Court, accompanied with an alterations certificate from the competent authority and a published GG for S.A. or LLC, as well as with a document about its legal representation and a copy of the ID or any other documents that proves the identity of the company’s legally responsible individual.
Submission by:
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
3
Floor plan of the store, with its dimensions (1:1000 scale, signed by an engineer)
Drawings/studies by an engineer/architect
Floor plan of the store, with its dimensions (1:1000 scale, signed by an engineer)
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Document submitted under requirements:
No
No
5768
4
Copy of the property title or of the lease contract of the store
Property titles
Copy of the property title or of the lease contract of the store
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Document submitted under requirements:
No
No
2905
5
Certificate of the Fire Service that the store has a fire safety system or adequate means of extinguishing fire.
Certificate
Certificate of the Fire Service that the store has a fire safety system or adequate means of extinguishing fire.
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Document submitted under requirements:
No
No
9703
6
Photocopy of the degree title of Pharmacy or Veterinary Medicine from a Higher Educational Institution (AEI) in Greece or equivalent from abroad and licence to practice the profession in Greece of the Scientific Manager.
Proof of Study
Photocopy of the degree title of Pharmacy or Veterinary Medicine from a Higher Educational Institution (AEI) in Greece or equivalent from abroad and licence to practice the profession in Greece of the Scientific Manager.
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Persons
Notes:
The copy of a foreign diploma or degree, which has been awarded from educational institutions from EU Member-States, must also be accompanied with a plain translation in Greek.
On occasions where the degree title has been awarded from an educational institution from a country that does not belong to the EU, it is required to submit a certified copy of an equivalent certificate from the Hellenic National Recognition and Information Centre (DOATAP) or from another respective EU institution (NA.R.I.C.).
Document submitted under requirements:
No
No
2825
7
Solemn Declaration of article 8 of law 1599/1986 (GG Α 75), of the interested party and the scientific manager that:
a. They have not been irrevocably convicted for any penalty or have not been remitted through an irrevocable indictment for theft, embezzlement, fraud, extortion, forgery, crimes against ethics, defamation for acts related to the practice of the profession counterfeiting, forgery and violation of the provisions of articles 5 and 12 of Law 1729/1987 (Government Gazette 144 A`), as in force, and in recurrence of article 11 of the same law, and they have not been irrevocably convicted of a crime or recidivism for a misdemeanor, for which he/she has been deprived of his/her political rights.
b. They do not hold a salaried position in the Civil Service nor in a legal entity under Public or Private law
Solemn Declaration
Solemn Declaration of article 8 of law 1599/1986 (GG Α 75), of the interested party and the scientific manager that:
a. They have not been irrevocably convicted for any penalty or have not been remitted through an irrevocable indictment for theft, embezzlement, fraud, extortion, forgery, crimes against ethics, defamation for acts related to the practice of the profession counterfeiting, forgery and violation of the provisions of articles 5 and 12 of Law 1729/1987 (Government Gazette 144 A`), as in force, and in recurrence of article 11 of the same law, and they have not been irrevocably convicted of a crime or recidivism for a misdemeanor, for which he/she has been deprived of his/her political rights.
b. They do not hold a salaried position in the Civil Service nor in a legal entity under Public or Private law
Relevant link:
https://www.gov.gr/en/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Relevant Procedure:
ΔΔ:ΔΔ:Solemn declaration and electronic solemn declaration
Document submitted under requirements:
No
No
7320
Cookies help us deliver our services. By using our services, you agree to our use of cookies.
