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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 Service | Points of Single Contact (ΚΕΠ – EKE), Regional units, Veterinary Medicine Authorities of Regional Units |
| Number of Documents | 0 |
| Cost | Provided without cost |
| Deadline of Implementation | 3 months |
| Process Diagram |
Conditions
Business formation (individual, corporate)
*For company establishment see the link below
The applicant shall have a TAXISnet username and password.
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 with TAXISnet codes, Identification document
- Application – Solemn Declaration from the beneficiary, natural or legal person.Filed bySubmitted by the applicant (digital), Submitted by the applicant (in person or by post)Applicant statusPersons, Legal entities
Online request
Submit a new application for the selected procedure.
Useful links
Legislation
- DescriptionAmendment of Article 8 of Law 2538/1997 concerning the validity, amendment, revocation and transfer of retail and wholesale licences for veterinary medicinal products.Legal references
- DescriptionVeterinary medicinal products: amendment of Articles 10 (penalties) and 11 (inspections concerning the implementation of and compliance with the provisions on the sale, distribution and use of veterinary medicinal products) of Law 2538/1997.Legal references
- DescriptionAmendment of the legislation in force on agricultural and veterinary medicinal products, settlement of debts of cooperative organisations, and other provisions.Legal references
- DescriptionAmendment of Joint Ministerial Decision no. 307752/18−10−2010 (ΦΕΚ 1865, Series II), “Processing of administrative procedures also through Citizen Service Centres acting as Single Service Centres”.Legal references
- DescriptionProcessing of administrative procedures also through Citizens' Service Centres acting as Points of Single Contact.Legal references
- DescriptionAlignment of Greek legislation with the corresponding EU legislation on the production and circulation of veterinary medicinal products, in compliance with Directives 2001/82/EC and 2004/28/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.Legal references
- DescriptionMarketing, control, manufacturing conditions, and detailed pharmacotoxicological and clinical standards and protocols for the control of veterinary medicinal products and immunological veterinary medicinal products, in compliance with Directives 81/851/EEC, 81/852/EEC, 90/167/EEC, 90/676/EEC, 90/677 EEC, 92/18/EEC, 93/40/EEC and 93/41/EEC.Legal references
- DescriptionTerms and conditions for placing on the market veterinary medicinal products intended exclusively for aquarium fish, songbirds, etc.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
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)
