Authorisation for the retail sale of veterinary medicinal products

From National Registry of Administrative Public Services



9ac76ea1-5ec1-4f91-82a2-4a625cb00c28 104857

At a glance

Points of service

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

Digital provision points

    Number of required documents

    7

    Fees

    0
    €

    Estimated time

    50 Days

    Description

    This is a procedure for granting an authorisation for the retail sale of veterinary medicinal products 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 provisions shall apply to issuing an authorisation for the retail sale of veterinary medicinal products: (a) only one authorisation shall be granted once for a specific geographical location in the territory of Greece, which needs not be renewed; (b) the authorisation holder shall notify the competent regional veterinary authority concerned of any change relating to the requirements for issuing the authorisation, within 5 days of the change; (c) the authorisation may not be transferred or ceded; (d) no authorisation is required for: (i) rural veterinary clinics operated by regional veterinary authorities; (ii) legally operating pharmacies, which must, however, notify their activity to the regional veterinary authority concerned within 1 month of commencement thereof and meet the relevant legal requirements applying to the retail sales of veterinary medicinal products; (iii) private veterinary clinics, establishments and offices for productive animals, which are allowed to supply, after issuing a veterinary prescription, necessary medicinal products to owners of animals which are under their care or surveillance for preventive or therapeutical purposes, but are not allowed to supply any medicinal products prescribed by another veterinarian.

    Validity Duration

    Provided to

    Businesses, Cooperatives (to whom it is provided)

    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 an authorisation for the retail sale of veterinary medicinal products

    Relevant link

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

    Notes:

    The application / solemn declaration form contains more detailed fields, in which the applicant shall declare that: (a) they have not been convicted by irrevocable judgment of, or referred to a court of law by irrevocable order for, theft, embezzlement, fraud, extortion, forgery, sexual offences, defamation associated with acts relating to the conduct of their occupation, counterfeiting and breach of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated breach of Article 11 of the above Law, that they have not been convicted by irrevocable judgment of a felony or a repeated misdemeanour for which he was banned from public affairs; (b) they do not hold a salaried post in the public sector or at a legal person governed by public or private law; (c) they are not a pensioner; (d) they have not been punished for breaching the veterinary legislation; and (e) they have not been granted an authorisation to sell veterinary medicinal products on the retail or wholesale market which was withdrawn definitively later on. As regards the Region of Attica and the Region of Central Macedonia, a relevant application shall be submitted online at 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 Civil Procedure)Other

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

          Tacit approval / tacit rejectionOther

          (a) If the 50-day deadline from the date of submission of an application with all the required supporting documents to the competent regional veterinary authority expires without any reply given, the application shall be approved tacitly and shall be deemed to have been issued; (b) If the deadline specified in writing by the competent regional veterinary authority for remedying any deficiencies – as detected by the on-the-spot check carried out to verify that the applicable requirements are met – expires without any action taken to that effect, the application shall be rejected.

          NACE

          • 75 Veterinary activities

          Output & Results

          Output

          Administrative Act

          Steps

            Digital steps

              Other information

              Alternative titles

              Authorisation for the retail sale of veterinary medicinal products

              Official title

              Issuing an authorisation for the retail sale of veterinary medicinal products


              Legislation

                Categories

                Trigger

                Applied for

                Trigger (submission method)

                Application (digital), Application (handwritten), email

                Life events

                Livestock farming, Licences and compliance, Retail trade - Wholesale

                Type

                Outgoing
                N1

                ,,,


              • 1 Labour An authorisation to sell veterinary medicinal products may be granted to natural persons, (general/limited) partnerships, public limited companies, limited liability companies and cooperative organisations, provided that they have in place a scientist in charge at their retail veterinary medicinal product store throughout its operating days and hours (in the case of natural persons the scientist in charge may be the natural person himself/herself or another person).


                No No

              • 2 Educational The scientist in charge employed while the retail veterinary medicinal product store is in operation must hold a degree from a domestic University Veterinary School, or a degree from a Higher Technical and Occupational Education Centre (KATEE) referred to in Article 5 of Presidential Decree 463/1987 (Government Gazette, Series I, No 216), or a degree from a Technological Education Institution (TEI) referred to in Article 4 of Presidential Decree 109/1989 (Government Gazette, Series I, No 47), or an equivalent degree or diploma in a relevant discipline from a foreign school, or a degree from a domestic University Pharmacy School, or an equivalent degree from a foreign school.


                No No

              • 3 Professional The scientist in charge employed while the retail veterinary medicinal product store is in operation must hold an authorisation to pursue their occupation in Greece, if necessary.


                No No

              • 4 Citizenship The person concerned and the scientist in charge employed while the retail veterinary medicinal product store is in operation must be Greek nationals or citizens of an EU Member State.


                No No

              • 5 Military The person concerned and the scientist in charge employed while the retail veterinary medicinal product store is in operation must have fulfilled their military service obligations or must have been lawfully exempted from those obligations.


                No No

              • 6 Conditions for non-commission of criminal offenses The person concerned and the scientist in charge employed while the retail veterinary medicinal product store is in operation must not have been convicted by irrevocable judgment of, or referred to a court of law by irrevocable order for, theft, embezzlement, fraud, extortion, forgery, sexual offences, defamation associated with acts relating to the conduct of veterinary occupation, counterfeiting and breach of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated breach of Article 11 of the above Law, and they must have not been convicted by irrevocable judgment of a felony or a repeated misdemeanour for which they were banned from public affairs.


                No No

              • 7 Professional The person concerned and the scientist in charge employed while the retail veterinary medicinal product store is in operation must not hold a salaried post in the public sector or at a legal person governed by public or private law and must not be in an employment relationship relating to the object of their occupation.


                No No

              • 8 Insurance The person concerned and the scientist in charge employed while the retail veterinary medicinal product store is in operation must not have obtained a pension for health reasons from any social security organisation and must not have reached the maximum age or meet the requirements for obtaining a pension, even if they have waived, or proceed to waive, the right to pension.


                No No

              • 9 Administrative The person concerned and the scientist in charge employed while the retail veterinary medicinal product store is in operation must have not been punished for breaching the veterinary legislation and must have not been granted an authorisation to sell veterinary medicinal products on the retail or wholesale market which was withdrawn definitively later on.


                No No

              • 10 Labour The scientist in charge of the retail veterinary medicinal product store must be employed at the store at all times, being there in person and shall be responsible for its orderly operation and the proper sale of veterinary medicinal products. If the scientist in charge is absent (for training, health or other important reasons), they shall be replaced by their lawful substitute. The scientist in charge may be replaced after a relevant request is submitted and the replacement is authorised by the competent Head of Region for a period of up to 6 months.


                No No

              • 11 Building A person wishing to obtain an authorisation to sell veterinary medicinal products must have a store which meets the following requirements: (a) it must be an independent facility with a floor area of not less than 25 m2 on the ground floor of a building; (b) it must have a separate storage room on the ground floor, on an upper floor or in the basement which belongs to the same building as the ground floor store and is suitable for storing stocks of veterinary medicinal products, in accordance with the amount of business carried out at the main store; (c) it must have sufficient natural and artificial lighting, ventilation and height in accordance with the General Building Regulation; (d) it must meet all the requirements laid down in the Health Regulation with regard to water supply, sewage/drainage, hygiene facilities, etc.; (e) it must be so designed as to ensure that neighbours are not disturbed and employees and clients are not faced with risks while being in the store; (f) it must have a fire safety system or adequate fire-fighting equipment in place; (g) it must have an electric refrigerator for preserving products that are perishable under ambient temperature conditions (vaccines, etc.); (h) it must have a sign at a conspicuous place on the front side of the store featuring the ‘V’ symbol in a circle of at least 70 cm in diameter, in green. A ‘VETERINARY MEDICINAL PRODUCTS’ sign must also be put up. It is prohibited to operate both a retail and a wholesale veterinary medicinal product store in the same premises. Moreover, it shall be prohibited to operate both a retail veterinary medicinal product store and any other commercial store, veterinary clinic/establishment, animal accommodation and animal-selling store in the same facility.


                No No

              • 12 Possession of passwords to enter software One’s Taxisnet credentials are required to apply online.

                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 legal title Property titles

                Copy of the legal title

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

                Submitted by: Legal entities, Persons

                Notes: Provide a copy of the legal title to the facility to be used as a retail veterinary medicinal product store.

                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: Provide a copy of the lease agreement for the facility to be used as a retail veterinary medicinal product store.

                Document submitted under requirements: No

                Alternative document of: 1

                Yes 8972

              • 3 Floor plan of the store Drawings/studies by an engineer/architect

                Floor plan of the store

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

                Submitted by: Legal entities, Persons

                Notes: Provide a floor plan of the facility to be used as a retail veterinary medicinal product store, showing its dimensions.

                Document submitted under requirements: No


                No 5768

              • 4 Active protection certificate from the Fire Department Certificate

                Active protection certificate from 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: Provide an active protection certificate from the Fire Department concerned to the effect that the facility to be used as a retail veterinary medicinal product store has a fire safety system or adequate fire-fighting equipment in place.

                Document submitted under requirements: No


                No 9703

              • 5 Police ID card Identification document

                Police ID card

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


                Notes: Provide a photocopy of the police ID card evidencing that the applicant and the scientist in charge of the operation of the store (if different persons) are Greek nationals.

                Document submitted under requirements: No


                No 2244

              • 6 Equivalent identification document Identification 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: Provide a photocopy of equivalent identification evidencing that the applicant and the scientist in charge of the operation of the store (if different persons) are citizens of an EU Member State.

                Document submitted under requirements: Yes

                Document’s requirement: Citizenship

                Alternative document of: 5

                Yes 2244

              • 7 Photocopy of a degree/diploma Driving license

                Photocopy of a degree/diploma

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

                Submitted by: Legal entities, Persons

                Notes: The scientist in charge of the retail veterinary medicinal product store should submit a photocopy of a degree from a domestic University Veterinary School, or a degree from a Higher Technical and Occupational Education Centre (KATEE) referred to in Article 5 of Presidential Decree 463/1987 (Government Gazette, Series I, No 216), or a degree from a Technological Education Institution (TEI) referred to in Article 4 of Presidential Decree 109/1989 (Government Gazette, Series I, No 47), or an equivalent degree or diploma in a relevant discipline from a foreign school, or a degree from a domestic University Pharmacy School, or an equivalent degree from a foreign school.

                Document submitted under requirements: No


                No 1158

              • 8 Authorisation to pursue the occupation Permit

                Authorisation to pursue the occupation

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

                Submitted by: Legal entities, Persons

                Notes: The scientist in charge of the operation of a retail veterinary medicinal product store should provide a photocopy of the authorisation to pursue their occupation, if necessary.

                Document submitted under requirements: No


                No 4627

              • 9 The scientist in charge of the operation of a wholesale veterinary medicinal product store should submit a solemn declaration to the effect that: (a) they have not been convicted by irrevocable judgment of, or referred to a court of law by irrevocable order for, theft, embezzlement, fraud, extortion, forgery, sexual offences, defamation associated with acts relating to the conduct of their occupation, counterfeiting and breach of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated breach of Article 11 of the above Law, that they have not been convicted by irrevocable judgment of a felony or a repeated misdemeanour for which he was banned from public affairs; (b) they do not hold a salaried post in the public sector or at a legal person governed by public or private law; (c) they are not a pensioner; (d) they have not been punished for breaching the veterinary legislation; and (e) they have not been granted an authorisation to sell veterinary medicinal products on the retail or wholesale market which was withdrawn definitively later on. Solemn Declaration

                The scientist in charge of the operation of a wholesale veterinary medicinal product store should submit a solemn declaration to the effect that: (a) they have not been convicted by irrevocable judgment of, or referred to a court of law by irrevocable order for, theft, embezzlement, fraud, extortion, forgery, sexual offences, defamation associated with acts relating to the conduct of their occupation, counterfeiting and breach of the provisions of Articles 5 and 12 of Law 1729/1987 (Government Gazette, Series I, No 144), as currently in force, and repeated breach of Article 11 of the above Law, that they have not been convicted by irrevocable judgment of a felony or a repeated misdemeanour for which he was banned from public affairs; (b) they do not hold a salaried post in the public sector or at a legal person governed by public or private law; (c) they are not a pensioner; (d) they have not been punished for breaching the veterinary legislation; and (e) they have not been granted an authorisation to sell veterinary medicinal products on the retail or wholesale market which was withdrawn definitively later on.

                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)

                Relevant Procedure: Solemn declaration and electronic solemn declaration

                Document submitted under requirements: No


                No 7320

              • Law 5-12 2538 1997 242 Α

                Description Amending the legislation in force on pesticides and veterinary medicinal products, settling the debts of cooperative organisations, and other provisions

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

              • Law 22 2945 2001 223 Α

                Description National system for the protection of farming activity and other arrangements falling under the remit of the Ministry of Agriculture

                Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20010100223

              • Law 20, 21 3698 2008 198 Α

                Description Regulating stock farming matters, and other provisions

                Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20080100198

              • Law 10 3955 2011 89 Α

                Description Single register of traders of farming products, supplies and inputs, and other provisions

                Legal references https://www.et.gr/api/DownloadFeksApi/?fek pdf=20110100089

              • Law 15 4711 2020 145 Α

                Description Simplifying the framework for carrying out economic activities falling under the remit 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 375/13379 2014 2921 Β

                Description Amending Joint Ministerial Decision No 307752/18.10.2010 (Government Gazette, Series II, No 1865) on carrying out administrative procedures through the Citizen Service Centres as Points of Single Contact.

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

              • 1 Submitting an 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 natural or legal person concerned shall submit a relevant application / solemn declaration, along with the required supporting documents. The application / solemn declaration may be submitted to the competent regional veterinary authority concerned or to a Citizen Service Centre – Point of Single Contact.

                Notes As regards the Region of Attica and the Region of Central Macedonia, a relevant application shall be submitted online at gov.gr.

                No No


              • 2 Checking whether the requirements are met or not

                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 A three-member committee shall check whether the legal requirements for granting the authorisation are met or not. The committee shall be set up by decision of the Head of Region concerned and shall comprise a veterinarian, a physician and an engineer from the respective departments of the Regional Unit concerned.

                No No


              • 3 If it is established that the requirements are not met. The application shall be rejected and the applicant shall be notified accordingly.

                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 established that the legal requirements are not met, the application shall be rejected and the applicant shall be notified accordingly.

                Yes Yes


              • 4 If it is established that the requirements are 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 established that the requirements are met, the competent committee shall, through the regional veterinary authority concerned, recommend that an authorisation for the retail sale of veterinary medicinal products be granted.

                Yes No


              • 5 Issuing an authorisation for the retail sale of veterinary medicinal products

                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 authorisation for the retail sale of veterinary medicinal products shall be granted by decision of the Head of Region concerned.

                Yes No


              • 6 Delivery of an authorisation for the retail sale of veterinary medicinal products

                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 authorisation for the retail sale of veterinary medicinal products shall be delivered to the applicant: (a) by registered letter at their address; (b) at the department to which they submitted the relevant application / solemn declaration (to the person himself/herself or their representative); (c) by email at the email address provided in the their application.

                Yes Yes


              • 7 If it is established that the file is incomplete (missing supporting documents): The applicant shall be notified in writing of the need to provide additional supporting documents

                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 established that certain documents are missing, the competent three-member committee shall notify the applicant in writing of the need to take corrective steps, also setting a deadline for those steps.

                Notes As the competent three-member committee may set a different deadline in each case at discretion, the length of that deadline shall be added to the time needed to carry out the procedure.

                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 applicant shall be reviewed

                No No


              • 9 If it is established that there are still missing supporting documents: 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 applicant fails to respond within the deadline set in the written notification from the competent three-member committee in order to provide the missing supporting documents detected by the check, the application shall be rejected.

                Yes Yes


              • 10 If it is established that there are no missing supporting documents. 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 established that there are no missing supporting documents, the competent committee shall, through the regional veterinary authority concerned, recommend that an authorisation for the retail sale of veterinary medicinal products be granted.

                Yes No


              • 11 Issuing an authorisation for the retail sale of veterinary medicinal products

                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 authorisation for the retail sale of veterinary medicinal products shall be granted by decision of the head of the region concerned.

                No No


              • 12 Delivery of an authorisation for the retail sale of veterinary medicinal products

                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 authorisation for the retail sale of veterinary medicinal products shall be delivered to the applicant: (a) by registered letter at their address; (b) at the department to which they submitted the relevant application / solemn declaration (to the person himself/herself or their representative); (c) by email at the email address provided in their application.

                No Yes


              • Points of Single Contact – EUGO portal


              • gov.gr


              • Website of the Ministry of Rural Development and Food: Veterinary Medicinal Products – Antimicrobial Resistance


              • Manual for the sale/ supply/ use of veterinary medicinal products, including application templates
                • Retrieved from "https://en.mitos.gov.gr/index.php?title=ΔΔ:Authorisation_for_the_retail_sale_of_veterinary_medicinal_products&oldid=61929"
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