{ "metadata": { "process": { "official_title": "Licence for Wholesale Trade in Veterinary Medicinal Products", "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.\nLimitations: Only one licence is granted for each store, which has one specific base (within the Greek territory)", "org_owner_is_private": false, "org_owner": { "id": "85324", "title": "MINISTRY OF RURAL DEVELOPMENT AND FOOD" }, "provision_org_owner_directory": [ { "id": "465801", "parent_id": "85324", "title": { "el": "ΓΕΝΙΚΗ ΔΙΕΥΘΥΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ" }, "active": true, "metadata": { "fulladdress": "ΕΛΛΑΔΑ 10438 ΔΗΜΟΣ ΑΘΗΝΑΙΩΝ ΒΕΡΑΝΖΕΡΟΥ 46", "adminunitlevel1": "1", "adminunitlevel2": "11013", "postcode": "10438", "supervisorunitcode": "616922", "organizationcode": "85324" } }, { "id": "654620", "parent_id": "85324", "title": { "el": "ΔΙΕΥΘΥΝΣΗ ΠΡΟΣΤΑΣΙΑΣ ΤΩΝ ΖΩΩΝ, ΦΑΡΜΑΚΩΝ ΚΑΙ ΚΤΗΝΙΑΤΡΙΚΩΝ ΕΦΑΡΜΟΓΩΝ" }, "active": true, "metadata": { "fulladdress": "ΕΛΛΑΔΑ 10438 ΔΗΜΟΣ ΑΘΗΝΑΙΩΝ ΒΕΡΑΝΖΕΡΟΥ 46", "adminunitlevel1": "1", "adminunitlevel2": "11013", "postcode": "10438", "supervisorunitcode": "465801", "organizationcode": "85324" } } ], "provision_org_group": [ { "id": "8210", "title": "Reported or supervised body" }, { "id": "7135", "title": "Points of Single Contact (ΚΕΠ – EKE)" }, { "id": "9603", "title": "Regions" } ], "provision_org_directory": [ "Veterinary Medicine Authorities of Regional Units" ], "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.\nThe licence does not require a renewal, as it remains valid for as long as the prerequisites are met.\nOnly one licence is granted for each store, which has one specific base (within the Greek territory)", "deadline_duration": "P3M", "provided_language": [ "English" ], "border_provision": [ "Establishment" ], "see_also": [ "Commencement of Operations and Attribution of Tax Registration Number to Service Providers", "Legal Entities (with Establishment)" ], "evidence_identification_type": [ "Identification document", "Identification with TAXISnet codes" ], "type": "Outgoing", "trigger": [ "Applied for" ], "trigger_type": [ "Application (handwritten)" ], "usage": [ "Supporting document" ], "output_type": [ "Document Production", "Registry update" ], "source": [ "EU-GO", "SDG" ], "provided_to": [ "Businesses", "Legal Entities" ], "tax_type": [ "Marketing Authorisations" ], "life_events": [ "Retail trade - Wholesale" ], "sdg_resource": "Other", "sdg_resource_other": "Administrative redress/appeal", "sdg_lack_of_response_rule": "Tacit approval", "bpmn_source": "EUGO", "bpmn_digital_source": "EUGO", "total_duration_steps_min": "P2DT4H", "total_duration_steps_max": "P2DT4H", "evidence_alternative_total_number": "0", "evidence_prerequisite_total_number": 1, "evidence_total_number": 6, "nace_codes": [ { "title": { "el": "Κτηνιατρικές δραστηριότητες", "en": "Veterinary activities" }, "id": "75", "full_code": "75.00", "light_code": "75", "searched_code": "75.0" } ], "sdg_codes": [ { "title": { "el": "Απόκτηση αδειών, εξουσιοδοτήσεων ή εγκρίσεων", "en": "Acquiring licences, authorisations or permits" }, "description": { "el": "απόκτηση αδειών, εξουσιοδοτήσεων ή εγκρίσεων με σκοπό την έναρξη και τη λειτουργία επιχείρησης στην Ελλάδα", "en": "acquiring licences, authorisations or permits with a view to starting and operating a business in Greece" }, "id": "N1", "searched_code": "N1" } ], "application_type": "Application", "application_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "application_owner": [ "Legal entities", "Persons" ], "application_description": "Application – Solemn Declaration from the beneficiary, natural or legal person." }, "process_conditions": [ { "conditions_num_id": 1, "conditions_alternative": false, "conditions_type": "Company law", "conditions_name": "Business formation (individual, corporate)\n*For company establishment see the link below", "conditions_url": "https://www.gov.gr/en/ipiresies/epikheirematike-drasterioteta/enarxe-kai-luse-epikheireses/sustase-epikheireses" }, { "conditions_num_id": 2, "conditions_alternative": false, "conditions_type": "Possession of passwords to enter software", "conditions_name": "The applicant shall have a TAXISnet username and password.", "conditions_url": "https://www.gov.gr/en/arxes/anexartete-arkhe-demosion-esodon-aade/anexartete-arkhe-demosion-esodon-aade/elektronike-eggraphe-diakheirise-kodikon-taxisnet" }, { "conditions_num_id": 3, "conditions_alternative": false, "conditions_type": "Technical", "conditions_name": "It is not allowed to collocate (same premises) a wholesale store of veterinary medicinal products with a retail store." }, { "conditions_num_id": 4, "conditions_alternative": false, "conditions_type": "Citizenship", "conditions_name": "The natural person (beneficiary) must hold the Greek or an EU Member-State citizenship." }, { "conditions_num_id": 5, "conditions_alternative": false, "conditions_type": "Conditions for non-commission of criminal offenses", "conditions_name": "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." }, { "conditions_num_id": 6, "conditions_alternative": false, "conditions_type": "Labour", "conditions_name": "They must not hold a salaried position in the Civil Service nor in a legal entity under Public or Private Law." }, { "conditions_num_id": 7, "conditions_alternative": false, "conditions_type": "Labour", "conditions_name": "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:\n-\tGreek or EU Member-State citizenship \n-\tHe 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 \n-\tCompletion of army service or legal exemption from it\n-\tHe 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.\n-He must not hold a salaried position in the Civil Service nor in a legal entity under Public or Private law\nThe natural person that apply can also hold the role of the scientific manager if the necessary prerequisites are met." }, { "conditions_num_id": 8, "conditions_alternative": false, "conditions_type": "Technical", "conditions_name": "They must have a store and equipment that meet the requirements below:\na.\tIt must be an ground floor independent space of at least forty (40) square meters \nb.\tIt 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 \nc.\tIt must have adequate natural and artificial lighting, ventilation and height in accordance with the General Building Regulations\nd.\tIt must meet all the requirements of the sanitary regulation regarding water supply, sewerage, sanitary facilities, etc.\ne.\tIt must have a fire safety system or adequate means of firefighting\nf.\tIt must have an electric refrigerator for the maintenance of products susceptible to the normal temperature (vaccines, etc.)\ng.\tIt 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\"\nh.\tIf there is a circulation of medicinal products of human use, then there must be a clear distinction of the areas" } ], "process_evidences": [ { "evidence_num_id": 1, "evidence_type": 2244, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities", "Persons" ], "evidence_description": "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).", "evidence_title": "Identification document" }, { "evidence_num_id": 2, "evidence_type": 9338, "evidence_is_under_prerequisite": true, "evidence_prerequisite": [ "Company law" ], "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities" ], "evidence_description": "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.", "evidence_title": "Legal documents from legal entities" }, { "evidence_num_id": 3, "evidence_type": 5768, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities", "Persons" ], "evidence_description": "Floor plan of the store, with its dimensions (1:1000 scale, signed by an engineer)", "evidence_title": "Drawings/studies by an engineer/architect" }, { "evidence_num_id": 4, "evidence_type": 2905, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities", "Persons" ], "evidence_description": "Copy of the property title or of the lease contract of the store", "evidence_title": "Property titles" }, { "evidence_num_id": 5, "evidence_type": 9703, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities", "Persons" ], "evidence_description": "Certificate of the Fire Service that the store has a fire safety system or adequate means of extinguishing fire.", "evidence_title": "Certificate" }, { "evidence_num_id": 6, "evidence_type": 2825, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Persons" ], "evidence_description": "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.", "evidence_note": "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.\n 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.).", "evidence_title": "Proof of Study" }, { "evidence_num_id": 7, "evidence_type": 7320, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (digital)", "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities", "Persons" ], "evidence_description": "Solemn Declaration of article 8 of law 1599/1986 (GG Α 75), of the interested party and the scientific manager that:\na.\tThey 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.\nb.\tThey do not hold a salaried position in the Civil Service nor in a legal entity under Public or Private law", "evidence_related_process": { "id": "265882", "title": { "en": "Solemn declaration and electronic solemn declaration", "el": "Υπεύθυνη δήλωση και ηλεκτρονική υπεύθυνη δήλωση" }, "ns": "ΔΔ", "last_updated": "2023-10-27T11:37:16+03:00" }, "evidence_related_url": "https://www.gov.gr/en/ipiresies/polites-kai-kathemerinoteta/psephiaka-eggrapha-gov-gr/ekdose-upeuthunes-deloses", "related": { "id": "265882", "ns": "ΔΔ", "title": { "el": "Υπεύθυνη δήλωση και ηλεκτρονική υπεύθυνη δήλωση", "en": "Solemn declaration and electronic solemn declaration" } }, "evidence_title": "Solemn Declaration" } ], "process_rules": [ { "rule_type": "Joint Ministerial Decision", "rule_decision_number": "375/133799", "rule_decision_year": "2014", "rule_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.", "rule_gazette_doc_number": 2921, "rule_gazette_doc_issue": "Β", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20140202921" }, { "rule_type": "Joint Ministerial Decision", "rule_decision_number": "282371", "rule_decision_year": "2006", "rule_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", "rule_gazette_doc_number": 731, "rule_gazette_doc_issue": "Β", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20060200731" }, { "rule_type": "Law", "rule_decision_number": "4711", "rule_decision_year": "2020", "rule_article": "15", "rule_description": "Amendment of article 8 of Law 2538/1997: \n Force, modification, withdrawal and fraudulent conveyance of licence for retail/wholesale trade of veterinary medical products", "rule_gazette_doc_number": 145, "rule_gazette_doc_issue": "Α", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20200100145" }, { "rule_type": "Law", "rule_decision_number": "4691", "rule_decision_year": "2020", "rule_article": "14", "rule_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.", "rule_gazette_doc_number": 108, "rule_gazette_doc_issue": "Α", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20200100108" }, { "rule_type": "Law", "rule_decision_number": "2538", "rule_decision_year": "1997", "rule_article": "5-12", "rule_description": "Amendment of relevant legislation for agricultular and veterinary drugs, debt settlement of cooperative societies and other provisions.", "rule_gazette_doc_number": 242, "rule_gazette_doc_issue": "Α", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=19970100242" }, { "rule_type": "Ministerial Decision", "rule_decision_number": "225783", "rule_decision_year": "2003", "rule_description": "Terms and Prerequisites for circulation of veterinary medical products aimed exclusively for aquarium fishes and cage birds.", "rule_gazette_doc_number": 561, "rule_gazette_doc_issue": "Β", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20030200561" }, { "rule_type": "Joint Ministerial Decision", "rule_decision_number": "310584", "rule_decision_year": "1998", "rule_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.", "rule_gazette_doc_number": 456, "rule_gazette_doc_issue": "Β", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=19980200456" } ], "process_steps": [ { "step_num_id": 1, "step_exit": false, "step_child": false, "step_title": "Submission of application and of required documents", "step_official": "Competent Employee", "step_implementation": "Manual Action", "step_duration_min": "PT4H", "step_duration_max": "PT4H", "step_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.\nIn 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." }, { "step_num_id": 2, "step_exit": false, "step_child": false, "step_title": "Evaluation of documents and on-site inspection", "step_official": "Collective body", "step_implementation": "Inspection", "step_duration_min": "P1D", "step_duration_max": "P1D", "step_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." }, { "step_num_id": 3, "step_exit": true, "step_child": false, "step_title": "Notification of the interested party", "step_official": "Competent Directorate", "step_implementation": "Manual Action", "step_duration_min": "P1D", "step_duration_max": "P1D", "step_description": "The committee recommends to the Veterinary Medicine Authority the granting or not the licence. \nIn case the recommendation is negative, the Veterinary Medicine Authority informs the interested party accordingly.\nIn case the recommendation is positive, the Veterinary Medicine Authority sends the licence to the interested party." } ], "process_provision_digital_locations": [ { "provision_digital_location_title": "EUGO portal (information only)", "provision_digital_location_url": "https://eugo.gov.gr/en/services/b7b778a5-b8f7-4c73-ba3c-2a3b483d3228/" } ], "process_useful_links": [ { "useful_link_title": "Manual of veterinary drugs (EL)", "useful_link_url": "http://www.minagric.gr/index.php/el/for-farmer-2/animal-production/ktiniatrikafarmakeytika/4797-egxeiridio-dia-xrhshs-kthfarma" } ] }, "ns": "ΔΔ", "title": { "en": "Licence for Wholesale Trade in Veterinary Medicinal Products", "el": "Άδεια Χονδρικής Πώλησης Κτηνιατρικών Φαρμακευτικών Προϊόντων" }, "id": "802778", "uuid": "b7b778a5-b8f7-4c73-ba3c-2a3b483d3228", "url": "https://id.mitos.gov.gr/802778/en", "last_updated": "2023-10-27T08:58:31+03:00" }