69f521cb-1688-4093-a09b-f1e886a10ab3
198952
At a glance
Points of service
Points of Single Contact (ΚΕΠ – EKE), Regions, Veterinary Medicine Authorities of Regional Units
Number of required documents
Description
The procedure concerns the issuance of a license for retail sale of veterinary medicinal products. The proper – under specific prerequisites – trade and provision of veterinary drugs through retail stores aims to control their proper circulation, whist it intends to protect animals’ health and, therefore, consumers’ health, along with protection of the environment.
Concerns: Natural/Legal Persons
Basic information
Authority/Public body’s Unit responsible for the institutional framework of the procedure
,
Application
Application Type
Application
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Title
Application – Solemn Declaration for the issuance of a licence for retail sale of veterinary medicinal products
What you will need
Means of authentication, identification and signature
Identification document, Identification with TAXISnet codes
Related
Means of redress or appeal:
Administrative redress/appealOther
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
Document Production, Registry update
Other information
Official title
Licence for Retail Sale of Veterinary Medicinal Products
Languages supported
English
Ways of provision
Establishment
Categories
Trigger (submission method)
Application (handwritten)
N1
ΔΔ
0
0
0
85324
No
5371200
2682000
1
4320000
Identification document, Identification with TAXISnet codes
465801, 654620
75.0
7135, 9603
EU-GO, SDG
Supporting document
,
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
Administrative
Application Submission – Solemn Declaration (Natural and Legal Persons).
No
No
4
Citizenship
They must hold the Greek or an EU Member-State citizenship (natural and legal person).
No
No
5
Military
They must have completed their army service or must have been legally exempted from it (natural and legal person).
No
No
6
Conditions for non-commission of criminal offenses
They 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 (natural and legal person).
No
No
7
Labour
They must not hold a salaried position in the Civil Service or in any legal entity under Private Law and they must not have any other employ-ment related to the subject to their profession (natural and legal person).
No
No
8
Labour
They must not be retired for health reasons from any pension entity and must not have reached the pension ceiling for the provision of pension nor meet the prerequisites for a pension, even if they have waived their right to receive their pension (natural and legal person).
No
No
9
Conditions for non-commission of criminal offenses
They must not have received any penalty for violating the veterinary legislation and they must have any permanent revocations of their licence to sell veterinary medicinal products under their name (natural and legal person).
No
No
10
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
- Completion of army service or legal exemption from it
- They must hold a Veterinary School degree from a Greek Higher Educational Institution (AEI) or a degree from Centers of Higher Technical and Professional Training (KATEE) as provided in article 5 of the Presidential Decree 463/1987 (A’ 216), or a degree from a Technological Educational Institution (TEI) as provided in article 4 of the Presidential Decree 109/1989 (A’ 47), or an equivalent degree or diploma from respective specialties from Schools abroad, a license to practice the specific profession in Greece (if required), or a degree from the Pharmacy School from a native Higher Educational Institution (AEI) or from an equivalent degree from a foreign educational institution.
- They 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.
- They must not hold a salaried position in the Civil Service nor in a legal entity under Public or Private law and must not have any other employment related to the subject to their profession
- They must not be retired for health reasons from any pension entity and must not have reached the pension ceiling for the provision of pension nor meet the prerequisites for pension, even if they have waived their right to receive their pension.
- They must not have received any penalty for violating the veterinary legislation and they must have any permanent revocations of their licence to sell veterinary medicinal products under their name.
A natural person can also hold the role of the scientific manager if the necessary prerequisites are met.
No
No
11
Technical
They must have a store that meets the requirements below:
a. It must be an independent independent space of at least twenty five (25) square meters and must be located on the ground floor
b. It must have as a warehouse a special room on the ground floor, upstairs or basement that is a building after the ground floor of the store. The warehouse must be suitable for storing quantities of veterinary medicinal products proportional to the movement of the main store
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 ensure the undisturbed of the neighborhoods and the safety of the stay of the employees and traders
f. It must have a fire safety system or adequate means of firefighting
g. It must have an electric refrigerator for the maintenance of products susceptible to the normal temperature (vaccines, etc.)
h. 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".
No
No
12
Building
It is not allowed to collocate (same premises) a retail store of veterinary medicinal products with a wholesale store. It is also not allowed to collocate in the same area of a retail store of veterinary medicinal products with any other commercial store, veterinary clinic, animal habitat and pet store.
No
No
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).
Proof of Citizenship
No
2712
2
A coded Articles of Association with an alterations certificate and 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
A coded Articles of Association with an alterations certificate and 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
Notes:
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.
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 the scientific manager.
Proof of Study
Photocopy of the degree title of the scientific manager.
Submission by:
Submitted by the applicant (in person or by post)
Submitted by:
Legal entities, Persons
Notes:
The copy of a foreign diploma or degree, which has been awarded from educational institutions from EU Member-States, must also be ac-companied 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
Solemn Declaration
Solemn Declaration of article 8 of law 1599/1986 (GG Α 75), of the interested party and the scientific manager
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:
Solemn declaration and electronic solemn declaration
Notes:
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 veterinary pro-fession 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 theyhave 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
c. They are not retired
d. They have not have received any penalty for violating the veterinary legislation and they do not have any permanent revocations of their licence to sell veterinary medicinal products under their name (wholesale/retail sale)
Document submitted under requirements:
No
No
7320
Joint Ministerial Decision
375/133799
2014
2921
Β
Description
Carrying out administrative processes through KEP-EKE.
Abolishment of the Application- Solemn Declarations form for retail and wholesale trade in Veterinary Medicinal Products licence of JMD 307752/2010 and substitution with new form.
Legal references
https://www.et.gr/api/DownloadFeksApi/?fek pdf=20140202921
Ministerial Decision
314738
2009
1835
Β
Joint Ministerial Decision
282371
2006
731
Β
Ministerial Decision
225783
2003
561
Β
Joint Ministerial Decision
310584
1998
456
Β
Law
15
4711
2020
145
Α
Law
14
4691
2020
108
Α
Law
10
3955
2011
89
Α
Law
18-24
3698
2008
198
Α
Law
22
2945
2001
223
Α
Law
5-12
2538
1997
1
Submission of application and of required documents
Responsible for Implementation
Other
Μethod of Implementation
Manual Action
Description
The applicant submits the required documents for the license of retail trade of 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 for outcome
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
EUGO portal (information only)
Manual of trade-disposal-use of veterinary medical products drugs (EL)
Legislation for veterinary medical products
Veterinary medical products-antimicrobial Resistance
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