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Licence for Retail Sale of Veterinary Medicinal Products

Basic information

Institutional Body

MINISTRY OF RURAL DEVELOPMENT AND FOOD

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

At a glance

Points of ServicePoints of Single Contact (ΚΕΠ – EKE), Regional units, Veterinary Medicine Authorities of Regional Units
Number of Documents0
Cost
Process Diagram

Conditions

Business formation (individual, corporate) *For company establishment see the link below

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

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

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

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).

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).

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).

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).

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.

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".

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.

What you will need

Identification and signature verification means
Identification document, Identification with TAXISnet codes
  • Application – Solemn Declaration for the issuance of a licence for retail sale of veterinary medicinal products
    Filed by
    Submitted by the applicant (in person or by post)
    Applicant status
    Legal entities, Persons
Licence for Retail Sale of Veterinary Medicinal Products
What you will need
1Photocopy 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
Filed by
Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
2Floor plan of the store, with its dimensions (1:1000 scale, signed by an engineer)Drawings/studies by an engineer/architect
Filed by
Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
3Copy of the property title or of the lease contract of the storeProperty titles
Filed by
Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
4Certificate of the Fire Service that the store has a fire safety system or adequate means of extinguishing fire.Certificate
Filed by
Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
5Photocopy of the degree title of the scientific manager.Proof of Study
Filed by
Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
6Solemn Declaration of article 8 of law 1599/1986 (GG Α 75), of the interested party and the scientific managerSolemn Declaration
Filed by
Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
7A 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
Filed by
Submitted by the applicant (in person or by post)
Applicant status
Legal entities

Legislation

  • 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
  • Description
    Issuance of veterinary perscription
    Legal references
  • Description
    Prerequisites for exercising the process and harmonization with EU Direction 2001/82. Amended by JMD 240399/2010 (GG Β 74).
    Legal references
  • Description
    Terms and Prerequisites for circulation of veterinary medical products aimed exclusively for aquarium fishes and cage birds.
    Legal references
  • Description
    Circulation, control, terms of preparation and clinical standards of veterinary drugs.
    Legal references
  • 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
  • Description
    Amendment of Law 2538/1997
    Legal references
  • Description
    Amendment of article 6 of Law 2538/1997: Licence beneficiaries for trade veterinary drugs
    Legal references
  • Description
    Provisions regarding prerequisites of process.
    Legal references
  • Description
    Amendment of article 5 of Law 2538/1997: Prerequisites
    Legal references
  • Description
    As amended. Includes provisions for prerequisites and required evidence for exercising the process.
    Legal references

About

Process code
198952
NACE code
75
Description of NACE code
Veterinary activities
Legal means of protection or appeal
Other Administrative redress/appeal
Rules for non-response by the competent authority and legal consequences
Tacit approval

Other Information

Languages supported
English
Ways of provision
Establishment

Remarks

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.

Online request

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ID: 198952

Name: Licence for Retail Sale of Veterinary Medicinal Products