198952Licence for Retail Sale of Veterinary Medicinal Products

From National Registry of Administrative Public Services

69f521cb-1688-4093-a09b-f1e886a10ab3 198952 Άδεια Λιανικής ή Χονδρικής Πώλησης Κτηνιατρικών Φαρμακευτικών Προϊόντων

At a glance

Points of service

Points of Single Contact (ΚΕΠ – EKE), Regional units, Veterinary Medicine Authorities of Regional Units

Digital provision points

Remote Points of service

Number of required documents

6 to 7

Fees

Provided without cost

Deadline of completion

50 days

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

Service / organizational unit of a authority entity

Veterinary Medicine Authorities of Regional Units

Notes

If the competent authority does not respond before the above deadlines, then the business may operate. On this occasion (tacit approval), the applicant may request from the competent authority a formal attestation.

Concerns: Natural/Legal Persons

Only one licence is granted for each store, which has one specific base (within the Greek territory)

The licence does not require a renewal, as it remains valid for as long as the prerequisites are met.

Last update

03/12/2024

Application

Application Type

Application / Solemn Declaration

Submission by:

Submitted by the applicant (in person or by post)

Submitted by:

Persons, Legal entities

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 with TAXISnet codes, Identification document

  • 1 1 Photocopy of ID or any other document that proves the Greek citizenship of one the EU Member-States ... Proof of Citizenship

    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).

    Relevant link: Link

    Submission by: Submitted by the applicant (in person or by post)

    Submitted by: Persons, Legal entities

  • 2 2 Floor plan of the store, with its dimensions (1:1000 scale, signed by an engineer) ... Floor plan

    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: Persons, Legal entities

  • 3 3 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: Persons, Legal entities

  • 4 4 Certificate of the Fire Service that the store has a fire safety system or adequate means of extingu ... 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: Persons, Legal entities

  • 5 5 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: Persons, Legal entities

    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.).

  • 6 6 Solemn Declaration of article 8 of law 1599/1986 (GG Α 75), of the interested party and the scientif ... Solemn Declaration

    Solemn Declaration of article 8 of law 1599/1986 (GG Α 75), of the interested party and the scientific manager

    Relevant link: Link

    Submission by: Submitted by the applicant (in person or by post)

    Submitted by: Persons, Legal entities

    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)

  • 7 7 A coded Articles of Association with an alterations certificate and a document about its legal repr ... Legal documents from legal entities (conditional)

    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

Print

Requirements

  • 1 Company law Business formation (individual, corporate)
    • For company establishment see the link below

    Link Link

  • 2 Possession of passwords to enter software The applicant shall have a TAXISnet username and password.

    Link Link

  • 3 Administrative Application Submission – Solemn Declaration (Natural and Legal Persons).

  • 4 Citizenship They must hold the Greek or an EU Member-State citizenship (natural and legal person).

  • 5 Military They must have completed their army service or must have been legally exempted from it (natural and legal person).

  • 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).

  • 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).

  • 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).

  • 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).

  • 10 Labour 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.

  • 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".

  • 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.

Related

Means of redress or appeal:

OtherAdministrative redress/appeal

Rules concerning a lack of reply from the competent authority and the legal consequences for the use:

Tacit approval

NACE

  • 75.0 Veterinary activities

Output & Results

Output

Registry update, Document Production

Steps

  • 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.

  • 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.

  • 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.

Other information

Official title

Licence for Retail Sale of Veterinary Medicinal Products

Languages supported

Greek, English

Ways of provision

Establishment

Legislation

  • Law 4711/2020 (Government Gazette 145/Α) Articles 15

    Description Amendment of article 8 of Law 2538/1997: Force, modification, withdrawal and fraudulent conveyance of licence for retail/wholesale trade of veterinary medical products

    Legal references Link

  • Law 4691/2020 (Government Gazette 108/Α) Articles 14

    Description Amendment of Law 2538/1997

    Legal references Link

  • Law 3955/2011 (Government Gazette 89/Α) Articles 10

    Description Amendment of article 6 of Law 2538/1997: Licence beneficiaries for trade veterinary drugs

    Legal references Link

  • Law 3698/2008 (Government Gazette 198/Α) Articles 18-24

    Description Provisions regarding prerequisites of process.

    Legal references Link

  • Law 2945/2001 (Government Gazette 223/Α) Articles 22

    Description Amendment of article 5 of Law 2538/1997: Prerequisites

    Legal references Link

  • Law 2538/1997 Articles 5-12

    Description As amended. Includes provisions for prerequisites and required evidence for exercising the process.

    Legal references Link

  • Joint Ministerial Decision 375/133799/2014 (Government Gazette 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 Link

  • Joint Ministerial Decision 282371/2006 (Government Gazette 731/Β)

    Description Prerequisites for exercising the process and harmonization with EU Direction 2001/82. Amended by JMD 240399/2010 (GG Β 74).

    Legal references Link

  • Joint Ministerial Decision 310584/1998 (Government Gazette 456/Β)

    Description Circulation, control, terms of preparation and clinical standards of veterinary drugs.

    Legal references Link

  • Ministerial Decision 314738/2009 (Government Gazette 1835/Β)

    Description Issuance of veterinary perscription

    Legal references Link

  • Ministerial Decision 225783/2003 (Government Gazette 561/Β)

    Description Terms and Prerequisites for circulation of veterinary medical products aimed exclusively for aquarium fishes and cage birds.

    Legal references Link

Categories

Τype of procedure

Trigger

Applied for

Trigger (submission method)

Application (handwritten)

Type

Outgoing

End of Process

Ιndefinite

N1
Cookies help us deliver our services. By using our services, you agree to our use of cookies.