Licence for selling veterinary medicinal products in wholesale

From National Registry of Administrative Public Services



242d31dc-6de1-4ffc-b9b4-0bafc485b5a8 729122

At a glance

Points of service

Points of Single Contact (ΚΕΠ – EKE), Regional units, Regions, TECHNICAL CHAMBER OF GREECE

Digital provision points

    Number of required documents

    7

    Fees

    0
    €

    Estimated time

    3 Months

    Description

    This procedure concerns the granting of a licence for selling veterinary medicinal products in wholesale to interested natural or legal persons.

    Basic information

    Related links

    Competent body

    MINISTRY OF RURAL DEVELOPMENT AND FOOD

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

    ΓΕΝΙΚΗ ΔΙΕΥΘΥΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ; ΔΙΕΥΘΥΝΣΗ ΠΡΟΣΤΑΣΙΑΣ ΤΩΝ ΖΩΩΝ, ΦΑΡΜΑΚΩΝ ΚΑΙ ΚΤΗΝΙΑΤΡΙΚΩΝ ΕΦΑΡΜΟΓΩΝ

    Authority responsible for the provision of the procedure

    TECHNICAL CHAMBER OF GREECE

    Notes

    The following shall apply to the licence to sell veterinary medicinal products in wholesale: (a) it is granted once and without the need for renewal; (b) it obligates the holder to notify the relevant regional veterinary authority of any change to the conditions for granting it within a period of 5 days from the date of that change; and (c) it may not be transferred or assigned.

    Validity Duration

    Provided to

    Businesses

    Last update

    Application

    Application Type

    Application / Solemn Declaration

    Submission by:

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

    Submitted by:

    Legal entities, Persons

    Title

    Granting a licence for selling veterinary medicinal products in wholesale

    Relevant link

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

    Notes:

    The application / solemn declaration form shall contain more specific fields; by completing said fields the interested party declares that the following cases do not apply: (a) an irrevocable sentence for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of pharmacist or veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a repeat offence (misdemeanour), for which a the penalty of deprivation of their civil rights was imposed, or a referral by irrevocable order for any of the above offences; (b) holding a salaried position in the State or a legal person governed by public or private law. Specifically for the Regions of Attica and Central Macedonia, the application shall be submitted online via gov.gr.

    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:

          Report (Article 27 of the Code of Administrative Procedure)Other

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

          Tacit approval

          (a) If the deadline of 90 days from the submission of the request and all the necessary supporting documents to the competent regional veterinary authority expires, the relevant application shall be tacitly approved and the licence shall be deemed to have been issued; (b) if the deadline set by the competent regional veterinary authority in writing for remedying the deficiencies found during the on-site inspection with regard to the compliance with the conditions laid down is exceeded, the request shall be rejected.

          NACE

          • 75 Veterinary activities

          Output & Results

          Output

          Administrative Act

          Steps

            Digital steps

              Other information

              Alternative titles

              Licence for selling veterinary medicinal products in wholesale

              Official title

              Issuing a licence for the sale of veterinary medicinal products in wholesale


              Legislation

                Categories

                Trigger

                Applied for

                Trigger (submission method)

                Application (digital), Application (handwritten)

                Life events

                Livestock farming, Licences and compliance, Retail trade - Wholesale

                Type

                Outgoing
                N1

                ,,


              • 1 Labour The licence to sell veterinary medicinal products in wholesale shall be granted if the interested party has a scientist in charge that is employed full time and is personally present in the store, checking the proper sale of veterinary medicinal products.


                No No

              • 2 Educational The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall be a holder of a university degree of the Veterinary school or a holder of a university degree in Pharmacology from a Greek university or an equivalent foreign university.


                No No

              • 3 Professional The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall have a licence to practice the profession in Greece.


                No No

              • 4 Citizenship The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall be a Greek national or a citizen of a Member State of the EU.


                No No

              • 5 Military The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall have completed their national service or be duly exempted from it.


                No No

              • 6 Conditions for non-commission of criminal offenses The interested party and the scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall not have been irrevocably sentenced or referred with an irrevocable order for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, application / solemn144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a felony or repeat offence (misdemeanour), for which the penalty of deprivation of their civil rights was imposed.


                No No

              • 7 Professional The interested party and the scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall not hold a salaried position in the State or a legal person governed by public or private law.


                No No

              • 8 Labour The scientist in charge who is employed during the operation of the wholesale veterinary medicinal products store shall be a full-time employee and be present in person in the store, checking the proper sale of veterinarian pharmaceutical products.


                No No

              • 9 Building The interested party for granting a licence for selling veterinary medicinal products in wholesale shall have suitable premises and the appropriate equipment that meet the following conditions: (a) a ground floor store with an area of at least 40 square metres; (b) a special storage room in direct contact with the ground store, suitable for storing sufficient quantities of veterinary medicinal products; (c) premises with appropriate natural or artificial lighting, temperature, ventilation and height, in accordance with the General building regulation; (d) meet all the requirements of the health regulation as regards water supply, sanitation, sanitary facilities, etc.; (e) have a fire safety system or adequate fire-fighting equipment; (f) have an electric refrigerator for preserving products susceptible to normal temperature (e.g. vaccines); (g) where medicinal products for human use are also sold by the store, the premises must be clearly separated; (h) on the façade of the store and in a prominent place a sign marked ‘V’ shall be within a circle of at least seventy (70) cm in diameter, in green, accompanied by the words ‘VETERINARY MEDICINAL PRODUCTS’. A wholesale veterinary medicinal products store may not be in the same premises with a retail veterinary medicinal products store, nor may a wholesale veterinary medicinal products store be in the same premises as any other commercial store, veterinary clinic, veterinarian practice, animal accommodation or animal shops.


                No No

              • 10 Possession of passwords to enter software For submitting the application online, the use of taxisnet codes is required.

                Link https://www.gov.gr/arxes/anexartete-arkhe-demosion-esodon-aade/anexartete-arkhe-demosion-esodon-aade/elektronike-eggraphe-diakheirise-kodikon-taxisnet

                No No

              • 1 Copy of the premises’ title deed. Property titles

                Copy of the premises’ title deed.

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

                Submitted by: Legal entities, Persons

                Notes: A copy of the title to the premises to be used as a wholesale veterinary medicinal products store shall be submitted.

                Document submitted under requirements: No


                No 2905

              • 2 Copy of the lease agreement. Private Agreement

                Copy of the lease agreement.

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

                Submitted by: Legal entities, Persons

                Notes: A copy of the lease agreement for the premises to be used as a wholesale veterinary medicinal products store shall be submitted, certified by the competent Tax office.

                Document submitted under requirements: No


                Yes 8972

              • 3 Store floor plan. Drawings/studies by an engineer/architect

                Store floor plan.

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

                Submitted by: Legal entities, Persons

                Notes: A floor plan of the premises to be used as a wholesale veterinary medicinal products store, with its dimensions, shall be submitted.

                Document submitted under requirements: No


                No 5768

              • 4 Certificate of active protection by the Fire department Certificate

                Certificate of active protection by the Fire department

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

                Submitted by: Legal entities, Persons

                Notes: A certificate of the relevant Fire department shall be submitted, certifying that the premises to be used as a wholesale medicinal products store has a fire safety system or sufficient fire-fighting equipment.

                Document submitted under requirements: No


                No 9703

              • 5 ID Card Identification document

                ID Card

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

                Submitted by: Legal entities, Persons

                Notes: A photocopy of the ID card, certifying the Greek nationality of the scientist in charge of the operation of the store, shall be submitted.

                Document submitted under requirements: No


                No 2244

              • 6 Equivalent identification document Copy of document

                Equivalent identification document

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

                Submitted by: Legal entities, Persons

                Notes: A photocopy of an equivalent identification document, proving the that the scientist in charge of the store’s operation is a national of one of the Member States of the European Union, shall be submitted.

                Document submitted under requirements: No

                Alternative document of: 5

                Yes 6866

              • 7 Copy of University degree Proof of Study

                Copy of University degree

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

                Submitted by: Legal entities, Persons

                Notes: A photocopy of the degree from the Veterinary School or a degree from the Pharmacy School of a Greek university, or an equivalent foreign degree, shall be submitted for the scientist in charge of the wholesale veterinary medicinal products store.

                Document submitted under requirements: No


                No 2825

              • 8 Copy of the licence to practice the profession Permit

                Copy of the licence to practice the profession

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

                Submitted by: Legal entities, Persons

                Notes: A photocopy of the licence to practise the profession of the scientist in charge of the operation of the wholesale veterinary medicinal products store shall be submitted.

                Document submitted under requirements: No


                No 4627

              • 9 A solemn declaration of the scientist in charge of the wholesale veterinary medical products store shall be submitted, stating that the following do not apply: (a) an irrevocable sentence for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of pharmacist or veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a repeat offence (misdemeanour), for which a the penalty of deprivation of their civil rights was imposed, or a referral by irrevocable order for any of the above offences; (b) holding a salaried position in the State or a legal person governed by public or private law. Solemn Declaration

                A solemn declaration of the scientist in charge of the wholesale veterinary medical products store shall be submitted, stating that the following do not apply: (a) an irrevocable sentence for theft, embezzlement, fraud, extortion, forgery, crimes against morals, defamation for acts related to the exercise of the profession of pharmacist or veterinarian, counterfeiting, falsification and violation of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated violation of Article 11 of the same law, or an irrevocable conviction for a repeat offence (misdemeanour), for which a the penalty of deprivation of their civil rights was imposed, or a referral by irrevocable order for any of the above offences; (b) holding a salaried position in the State or a legal person governed by public or private law.

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

                Submission by: Presented by the applicant (email), 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

              • Law 6 2538 1997 242 Α

                Description Amendment of the current legislation on agricultural and veterinary medicinal products, settlement of debts of co-ops and other provisions.

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

              • Law 15 4711 2020 145 Α

                Description Simplification of the framework for carrying out economic activities that fall within the responsibility of the Ministry of rural development and food and other provisions.

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

              • Joint Ministerial Decision 64 282371 2006 731 Β

                Description Harmonisation of Greek legislation with the relevant Community legislation on the production and marketing 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 https://www.et.gr/api/DownloadFeksApi/?fek pdf=20060200731

              • Joint Ministerial Decision 375/13379 2014 2921 Β

                Description Amendment of Joint Ministerial Decision No 307752/18-10-2010 (Government Gazette, Series II, No 1865) on the handling of administrative procedures and through Citizens’ Service Centres acting as Points of Single Contact.

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

              • 1 Submission of application / solemn declaration

                Responsible for Implementation Competent Employee

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Manual Action

                Description The interested natural or legal person shall submit an application / solemn declaration accompanied by the necessary supporting documents. The application / solemn declaration may be submitted either to the relevant competent regional veterinary authority or to a Citizens’ Service Centre - Point of Single Contact.

                Notes Specifically for the Regions of Attica and Central Macedonia, the application shall be submitted online via gov.gr.

                No No


              • 2 Checking whether or not the conditions are met

                Responsible for Implementation Collective body

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Inspection

                Description The check on whether or not the legal conditions for granting the licence have been met shall be carried out by a three-member committee, which shall be set up by decision of the relevant Regional Governor and shall consist of a veterinarian, a physician and an engineer from the respective services of the relevant Regional Unit.

                No No


              • 3 Finding that the conditions have not been met. The request shall be rejected and the interested party shall be notified.

                Responsible for Implementation Collective body

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Inspection

                Description If it is found that the legal conditions are not met, the competent committee shall recommend, through the relevant regional veterinary authority, that the request be rejected and the interested party shall be notified.

                Yes Yes


              • 4 Finding that the conditions have been met: Recommendation by the competent committee

                Responsible for Implementation Collective body

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Signature

                Description If it is found that the legal conditions are met, the competent committee shall recommend, through the relevant regional veterinary authority, that the licence for wholesale veterinary medicinal products be granted.

                Yes No


              • 5 Issuing a licence for the sale of veterinary medicinal products in wholesale.

                Responsible for Implementation Head of the Region

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Signature

                Description The licence to sell veterinary medicinal products in wholesale shall be issued by decision of the relevant Regional Governor.

                Yes No


              • 6 Receiving the licence for selling veterinary medicinal products in wholesale

                Responsible for Implementation Competent Directorate

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Action of the executive / co-competent body

                Description The interested party shall receive the licence for selling veterinary medicinal products in wholesale: (a) by registered letter sent to their address; (b) by the service to which they submitted the relevant application / solemn declaration (in person or through their representative); (c) by email, to the address listed in their application.

                Yes Yes


              • 7 Finding that the file was not complete (missing supporting documents): Written notification to the interested party for additional submission.

                Responsible for Implementation Collective body

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Action of the executive / co-competent body

                Description If it is found that some supporting documents for the licence for selling veterinary medicinal products in wholesale are missing, the relevant three-member committee shall notify the interested party in writing, so that they can take the necessary corrective action, within a specified deadline.

                Notes The deadline set by the competent three-member committee, as said committee varies according to the discretion of the collective body, is added to the time needed to complete the process.

                Yes No


              • 8 Review

                Responsible for Implementation Collective body

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Action of the executive / co-competent body

                Description Any additional supporting documents provided by the interested party shall be reviewed.

                No No


              • 9 Finding that the supporting documents are not complete: Tacit rejection

                Responsible for Implementation Collective body

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Action of the executive / co-competent body

                Description If the interested party does not respond within the deadline set for them in writing in the notification of the three-member committee, the request shall be rejected.

                Yes Yes


              • 10 Finding that the supporting documents are complete. Recommendation of the competent Committee.

                Responsible for Implementation Collective body

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Signature

                Description If it is found that the supporting documents are complete, the competent committee shall recommend, through the relevant regional veterinary authority, the granting of the licence for the sale of veterinary medicinal products in wholesale.

                Yes No


              • 11 Issuing a licence for the sale of veterinary medicinal products in wholesale

                Responsible for Implementation Head of the Region

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Signature

                Description The licence to sell veterinary medicinal products in wholesale shall be issued by decision of the relevant Regional Governor.

                No No


              • 12 Receiving the licence for selling veterinary medicinal products in wholesale

                Responsible for Implementation Competent Directorate

                Co-responsible for Implementation NATIONAL ORGANISATION FOR THE CERTIFICATION OF QUALIFICATIONS AND VOCATIONAL GUIDANCE (EOPPEP)

                Μethod of Implementation Action of the executive / co-competent body

                Description The interested party shall receive the licence for selling veterinary medicinal products in wholesale: (a) by registered letter sent to their address; (b) by the service to which they submitted the relevant application / solemn declaration (in person or through their representative); (c) by email, to the address listed in their application.

                No Yes


              • Single Service Centres - EUGO portal


              • SPD-gov.gr


              • Website of the Ministry of rural development and food: Veterinary Medicinal Products – Antimicrobial Resistance


              • Manual for marketing-disposal-use of veterinary medicinal products_with application templates
                • Retrieved from "https://en.mitos.gov.gr/index.php?title=ΔΔ:Licence_for_selling_veterinary_medicinal_products_in_wholesale&oldid=62050"
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