{ "metadata": { "process": { "official_title": "Licence for Retail Sale of Veterinary Medicinal Products", "description": "The procedure concerns the issuance of a license for retail sale of veterinary medicinal products. The proper – under specific prerequisites – trade and provision of veterinary drugs through retail stores aims to control their proper circulation, whist it intends to protect animals’ health and, therefore, consumers’ health, along with protection of the environment.\nConcerns: Natural/Legal Persons", "org_owner_is_private": false, "org_owner": { "id": "85324", "title": "MINISTRY OF RURAL DEVELOPMENT AND FOOD" }, "provision_org_owner_directory": [ { "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" } }, { "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" } } ], "provision_org_group_remote": [ { "id": "3621", "title": "myKEPlive (information only)" } ], "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.\nConcerns: Natural/Legal Persons\nOnly one licence is granted for each store, which has one specific base (within the Greek territory)\nThe licence does not require a renewal, as it remains valid for as long as the prerequisites are met.", "deadline_duration": "P50D", "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" ], "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": "P1M1DT1H", "total_duration_steps_max": "P2M2DT4H", "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 (in person or by post)" ], "application_owner": [ "Legal entities", "Persons" ], "application_description": "Application – Solemn Declaration for the issuance of a licence for retail sale of veterinary medicinal products" }, "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": "Administrative", "conditions_name": "Application Submission – Solemn Declaration (Natural and Legal Persons)." }, { "conditions_num_id": 4, "conditions_alternative": false, "conditions_type": "Citizenship", "conditions_name": "They must hold the Greek or an EU Member-State citizenship (natural and legal person)." }, { "conditions_num_id": 5, "conditions_alternative": false, "conditions_type": "Military", "conditions_name": "They must have completed their army service or must have been legally exempted from it (natural and legal person)." }, { "conditions_num_id": 6, "conditions_alternative": false, "conditions_type": "Conditions for non-commission of criminal offenses", "conditions_name": "They 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 (natural and legal person)." }, { "conditions_num_id": 7, "conditions_alternative": false, "conditions_type": "Labour", "conditions_name": "They must not hold a salaried position in the Civil Service or in any legal entity under Private Law and they must not have any other employ-ment related to the subject to their profession (natural and legal person)." }, { "conditions_num_id": 8, "conditions_alternative": false, "conditions_type": "Labour", "conditions_name": "They must not be retired for health reasons from any pension entity and must not have reached the pension ceiling for the provision of pension nor meet the prerequisites for a pension, even if they have waived their right to receive their pension (natural and legal person)." }, { "conditions_num_id": 9, "conditions_alternative": false, "conditions_type": "Conditions for non-commission of criminal offenses", "conditions_name": "They must not have received any penalty for violating the veterinary legislation and they must have any permanent revocations of their licence to sell veterinary medicinal products under their name (natural and legal person)." }, { "conditions_num_id": 10, "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-\tCompletion of army service or legal exemption from it\n-\tThey must hold a Veterinary School degree from a Greek Higher Educational Institution (AEI) or a degree from Centers of Higher Technical and Professional Training (KATEE) as provided in article 5 of the Presidential Decree 463/1987 (A’ 216), or a degree from a Technological Educational Institution (TEI) as provided in article 4 of the Presidential Decree 109/1989 (A’ 47), or an equivalent degree or diploma from respective specialties from Schools abroad, a license to practice the specific profession in Greece (if required), or a degree from the Pharmacy School from a native Higher Educational Institution (AEI) or from an equivalent degree from a foreign educational institution. \n-\tThey 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-\tThey must not hold a salaried position in the Civil Service nor in a legal entity under Public or Private law and must not have any other employment related to the subject to their profession\n-\tThey must not be retired for health reasons from any pension entity and must not have reached the pension ceiling for the provision of pension nor meet the prerequisites for pension, even if they have waived their right to receive their pension.\n-\tThey must not have received any penalty for violating the veterinary legislation and they must have any permanent revocations of their licence to sell veterinary medicinal products under their name.\nA natural person can also hold the role of the scientific manager if the necessary prerequisites are met." }, { "conditions_num_id": 11, "conditions_alternative": false, "conditions_type": "Technical", "conditions_name": "They must have a store that meets the requirements below:\na. It must be an independent independent space of at least twenty five (25) square meters and must be located on the ground floor\nb. It must have as a warehouse a special room on the ground floor, upstairs or basement that is a building after the ground floor of the store. The warehouse must be suitable for storing quantities of veterinary medicinal products proportional to the movement of the main store\nc. It must have adequate natural and artificial lighting, ventilation and height in accordance with the General Building Regulations\nd. It must meet all the requirements of the sanitary regulation regarding water supply, sewerage, sanitary facilities, etc.\ne. It must ensure the undisturbed of the neighborhoods and the safety of the stay of the employees and traders\nf. It must have a fire safety system or adequate means of firefighting\ng. It must have an electric refrigerator for the maintenance of products susceptible to the normal temperature (vaccines, etc.)\nh. 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\"." }, { "conditions_num_id": 12, "conditions_alternative": false, "conditions_type": "Building", "conditions_name": "It is not allowed to collocate (same premises) a retail store of veterinary medicinal products with a wholesale store. It is also not allowed to collocate in the same area of a retail store of veterinary medicinal products with any other commercial store, veterinary clinic, animal habitat and pet store." } ], "process_evidences": [ { "evidence_num_id": 1, "evidence_type": 2712, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "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_related_url": "https://www.gov.gr/en/ipiresies/oikogeneia/oikogeneiake-katastase/pistopoietiko-ithageneias", "evidence_title": "Proof of Citizenship" }, { "evidence_num_id": 2, "evidence_type": 5768, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "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": 3, "evidence_type": 2905, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "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": 4, "evidence_type": 9703, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "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": 5, "evidence_type": 2825, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities", "Persons" ], "evidence_description": "Photocopy of the degree title 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 ac-companied 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.).", "evidence_title": "Proof of Study" }, { "evidence_num_id": 6, "evidence_type": 7320, "evidence_is_under_prerequisite": false, "evidence_alternative": false, "evidence_submission_type": [ "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", "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", "evidence_note": "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 veterinary pro-fession 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 theyhave 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 \nc.\tThey are not retired\nd.\tThey have not have received any penalty for violating the veterinary legislation and they do not have any permanent revocations of their licence to sell veterinary medicinal products under their name (wholesale/retail sale)", "related": { "id": "265882", "ns": "ΔΔ", "title": { "el": "Υπεύθυνη δήλωση και ηλεκτρονική υπεύθυνη δήλωση", "en": "Solemn declaration and electronic solemn declaration" } }, "evidence_title": "Solemn Declaration" }, { "evidence_num_id": 7, "evidence_type": 9338, "evidence_is_under_prerequisite": true, "evidence_prerequisite": [ "Company law" ], "evidence_alternative": false, "evidence_submission_type": [ "Submitted by the applicant (in person or by post)" ], "evidence_owner": [ "Legal entities" ], "evidence_description": "A coded Articles of Association with an alterations certificate and 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_note": "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" } ], "process_rules": [ { "rule_type": "Joint Ministerial Decision", "rule_decision_number": "375/133799", "rule_decision_year": "2014", "rule_description": "Carrying out administrative processes through KEP-EKE. \nAbolishment 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": "Ministerial Decision", "rule_decision_number": "314738", "rule_decision_year": "2009", "rule_description": "Issuance of veterinary perscription", "rule_gazette_doc_number": 1835, "rule_gazette_doc_issue": "Β", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20090201835" }, { "rule_type": "Joint Ministerial Decision", "rule_decision_number": "282371", "rule_decision_year": "2006", "rule_description": "Prerequisites for exercising the process and harmonization with EU Direction 2001/82.\nAmended by JMD 240399/2010 (GG Β 74).", "rule_gazette_doc_number": 731, "rule_gazette_doc_issue": "Β", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20060200731" }, { "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 clinical standards of veterinary drugs.", "rule_gazette_doc_number": 456, "rule_gazette_doc_issue": "Β", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=19980200456" }, { "rule_type": "Law", "rule_decision_number": "4711", "rule_decision_year": "2020", "rule_article": "15", "rule_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", "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": "Amendment 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": "3955", "rule_decision_year": "2011", "rule_article": "10", "rule_description": "Amendment of article 6 of Law 2538/1997: Licence beneficiaries for trade veterinary drugs", "rule_gazette_doc_number": 89, "rule_gazette_doc_issue": "Α", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20110100089" }, { "rule_type": "Law", "rule_decision_number": "3698", "rule_decision_year": "2008", "rule_article": "18-24", "rule_description": "Provisions regarding prerequisites of process.", "rule_gazette_doc_number": 198, "rule_gazette_doc_issue": "Α", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20080100198" }, { "rule_type": "Law", "rule_decision_number": "2945", "rule_decision_year": "2001", "rule_article": "22", "rule_description": "Amendment of article 5 of Law 2538/1997: Prerequisites", "rule_gazette_doc_number": 223, "rule_gazette_doc_issue": "Α", "rule_url": "https://www.et.gr/api/DownloadFeksApi/?fek_pdf=20010100223" }, { "rule_type": "Law", "rule_decision_number": "2538", "rule_decision_year": "1997", "rule_article": "5-12", "rule_description": "As amended. Includes provisions for prerequisites and required evidence for exercising the process.", "rule_url": "http://www.et.gr/idocs-nph/search/pdfViewerForm.html?args=5C7QrtC22wEWFzYWFtEvQndtvSoClrL8FjnGp5F0IbN5MXD0LzQTLWPU9yLzB8V68knBzLCmTXKaO6fpVZ6Lx3UnKl3nP8NxdnJ5r9cmWyJWelDvWS_18kAEhATUkJb0x1LIdQ163nV9K--td6SIufMGe4jPzp3csHprrsdAx3SjZsuENhgGtycTpcKDnajM" } ], "process_steps": [ { "step_num_id": 1, "step_exit": false, "step_child": false, "step_title": "Submission of application and of required documents", "step_official": "Other", "step_implementation": "Manual Action", "step_duration_min": "PT1H", "step_duration_max": "PT4H", "step_description": "The applicant submits the required documents for the license of retail trade of 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": "P1M", "step_duration_max": "P2M", "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 for outcome", "step_official": "Competent Directorate", "step_implementation": "Manual Action", "step_duration_min": "P1D", "step_duration_max": "P2D", "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/69f521cb-1688-4093-a09b-f1e886a10ab3/" } ], "process_useful_links": [ { "useful_link_title": "Manual of trade-disposal-use of veterinary medical products drugs (EL)", "useful_link_url": "http://www.minagric.gr/index.php/el/for-farmer-2/animal-production/ktiniatrikafarmakeytika/4797-egxeiridio-dia-xrhshs-kthfarma" }, { "useful_link_title": "Veterinary medical products-antimicrobial Resistance", "useful_link_url": "http://www.minagric.gr/index.php/el/for-citizen-2/ktiniatrikafarmakeytika-politis" } ] }, "ns": "ΔΔ", "title": { "en": "Licence for Retail Sale of Veterinary Medicinal Products", "el": "Άδεια Λιανικής ή Χονδρικής Πώλησης Κτηνιατρικών Φαρμακευτικών Προϊόντων" }, "id": "198952", "uuid": "69f521cb-1688-4093-a09b-f1e886a10ab3", "url": "https://id.mitos.gov.gr/198952/en", "last_updated": "2023-10-27T08:55:01+03:00" }