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Licence for Wholesale Trade in Veterinary Medicinal Products

Basic information

Institutional Body

MINISTRY OF RURAL DEVELOPMENT AND FOOD

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)

At a glance

Points of ServicePoints of Single Contact (ΚΕΠ – EKE), Regions, Veterinary Medicine Authorities of Regional Units, MINISTRY OF RURAL DEVELOPMENT AND FOOD
Number of Documents0
CostProvided without cost
Deadline of Implementation3 months
Process Diagram

Conditions

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

It is not allowed to collocate (same premises) a wholesale store of veterinary medicinal products with a retail store.

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

The natural person (beneficiary) must hold the Greek or an EU Member-State citizenship.

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.

They must not hold a salaried position in the Civil Service nor in a legal entity under Public or Private Law.

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.

What you will need

Identification and signature verification means
Identification document, Identification with TAXISnet codes
  • Application – Solemn Declaration from the beneficiary, natural or legal person.
    Filed by
    Submitted by the applicant (digital), Submitted by the applicant (in person or by post)
    Applicant status
    Legal entities, Persons
Licence for Wholesale Trade in 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).Identification document
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
2In 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
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entities
3Floor 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 (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
4Copy of the property title or of the lease contract of the storeProperty titles
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
5Certificate 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 (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons
6Photocopy 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
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
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.).
7Solemn 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 lawSolemn Declaration
Filed by
Submitted by the applicant (digital)Submitted by the applicant (in person or by post)
Applicant status
Legal entitiesPersons

Online request

Submit a new application for the selected procedure.

Legislation

  • Description
    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
    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
  • 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
    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
  • Description
    Amendment of relevant legislation for agricultular and veterinary drugs, debt settlement of cooperative societies and other provisions.
    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 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

About

Process code
802778
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

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. The licence does not require a renewal, as it remains valid for as long as the prerequisites are met. Only one licence is granted for each store, which has one specific base (within the Greek territory)

ID: 802778

Name: Licence for Wholesale Trade in Veterinary Medicinal Products