Licence for Wholesale Trade in Veterinary Medicinal Products

From National Registry of Administrative Public Services



b7b778a5-b8f7-4c73-ba3c-2a3b483d3228 802778 Άδεια Χονδρικής Πώλησης Κτηνιατρικών Φαρμακευτικών Προϊόντων

At a glance

Points of service

Points of Single Contact (ΚΕΠ – EKE), Regions, Veterinary Medicine Authorities of Regional Units, MINISTRY OF RURAL DEVELOPMENT AND FOOD

Digital provision points

Number of required documents

6 to 7

Fees

Provided without cost

Deadline of completion

3 months

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)

Basic information

Competent body

MINISTRY OF RURAL DEVELOPMENT AND FOOD

Authority/Public body’s Unit responsible for the institutional framework of the procedure

,

Service / organizational unit of a authority entity

Veterinary Medicine Authorities of Regional Units

Provided to

Related links

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.

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)

Last update

28/06/2024

Application

Application Type

Application / Solemn Declaration

Submission by:

Submitted by the applicant (digital), Submitted by the applicant (in person or by post)

Submitted by:

Legal entities, Persons

Title

Application – Solemn Declaration from the beneficiary, natural or legal person.


What you will need

Means of authentication, identification and signature

Identification document, Identification with TAXISnet codes

    Print

    Requirements

      Fees

        Related


        Means of redress or appeal:

        Other Administrative 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

        Document Production, Registry update

        Steps

          Digital steps

            Other information

            Official title

            Licence for Wholesale Trade in Veterinary Medicinal Products

            Languages supported

            English

            Ways of provision

            Establishment

            Legislation

              Categories

              Τype of procedure

              Trigger

              Applied for

              Trigger (submission method)

              Application (handwritten)

              Type

              Outgoing
              N1

              ,


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


              No No

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


              No No

            • 5 Conditions for non-commission of criminal offenses 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.


              No No

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


              No No

            • 7 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
              • 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.


              No No

            • 8 Technical 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


              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). Identification document

              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).

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

              Submitted by: Legal entities, Persons


              Document submitted under requirements: No


              No 2244

            • 2 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. Legal documents from legal entities

              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.

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

              Submitted by: Legal entities


              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 (digital), 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 (digital), 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 (digital), 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 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

              Photocopy 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.

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

              Submitted by: 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.).

              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 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 law Solemn Declaration

              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 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 law

              Relevant link: https://www.gov.gr/en/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses

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

              Submitted by: Legal entities, Persons

              Relevant Procedure: Solemn declaration and electronic solemn declaration

              Document submitted under requirements: No


              No 7320

            • Joint Ministerial Decision 375/133799 2014 2921 Β

              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 https://www.et.gr/api/DownloadFeksApi/?fek pdf=20140202921

            • Joint Ministerial Decision 282371 2006 731 Β

              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 https://www.et.gr/api/DownloadFeksApi/?fek pdf=20060200731

            • Law 15 4711 2020 145 Α

              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 https://www.et.gr/api/DownloadFeksApi/?fek pdf=20200100145

            • Law 14 4691 2020 108 Α

              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 https://www.et.gr/api/DownloadFeksApi/?fek pdf=20200100108

            • Law 5-12 2538 1997 242 Α

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

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=19970100242

            • Ministerial Decision 225783 2003 561 Β

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

              Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20030200561

            • Joint Ministerial Decision 310584 1998 456 Β

              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 https://www.et.gr/api/DownloadFeksApi/?fek pdf=19980200456

            • 1 Submission of application and of required documents

              Responsible for Implementation Competent Employee

              Μethod of Implementation Manual Action

              Description The applicant submits the required documents for the license of wholesale trade in 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

              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


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