{"id":4613,"date":"2025-05-05T14:20:38","date_gmt":"2025-05-05T12:20:38","guid":{"rendered":"https:\/\/www.piwet.pulawy.pl\/control-of-immunological-veterinary-medicinal-products-omcl\/"},"modified":"2026-02-27T10:18:26","modified_gmt":"2026-02-27T09:18:26","slug":"control-of-immunological-veterinary-medicinal-products-omcl","status":"publish","type":"page","link":"https:\/\/www.piwet.pulawy.pl\/en\/control-of-immunological-veterinary-medicinal-products-omcl\/","title":{"rendered":"Control of Immunological Veterinary Medicinal Products (OMCL)"},"content":{"rendered":"\n<p style=\"font-size:20px\"><strong>Control of Immunological Veterinary Medicinal Products (OMCL)<\/strong><\/p>\n\n<p style=\"font-size:16px\">On May 26, 1994, the European Union (EU) Commission and the Council of Europe decided to establish the Network of Official Medicines Control Laboratories (OMCL). This network performs activities related to pre- and post-marketing quality control of medicinal products used in humans and animals, ensuring the protection of public health and animal health. In European Union member states, the registration and marketing authorization of medicinal products and medical devices are directly linked to their quality, safety, and therapeutic efficacy. This activity is coordinated by the European Directorate for the Quality of Medicines (EDQM), subordinate to the Council of Europe.     <\/p>\n\n<p style=\"font-size:16px\">National Veterinary Research Institute on January 16, 2017 obtained full member status in the Network of Official Medicines Control Laboratories (OMCL), within which it conducts quality control of immunological veterinary medicinal products through preliminary batch control and quality testing of immunological veterinary medicinal products.<\/p>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-4a76524d28527131e2665a76b4c3eb59\" style=\"color:#1a8314;font-size:20px\"><strong>Preliminary Batch Control of Immunological Veterinary Medicinal Products<\/strong><\/h3>\n\n<p style=\"font-size:16px\"><strong>The National Veterinary Research Institute &#8211; National Research Institute conducts preliminary batch control of immunological veterinary medicinal products (IVMP) in accordance with Article 128 of Regulation (EU) 2019\/6 of the European Parliament and of the Council, issuing European OCABR\/OBPR certificates. <br\/><br\/>Preliminary batch control of IVMP is conducted upon request from:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:16px\">the marketing authorization holder<\/li>\n\n\n\n<li style=\"font-size:16px\">the representative of the marketing authorization holder<\/li>\n\n\n\n<li style=\"font-size:16px\">the wholesale distributor<\/li>\n\n\n\n<li style=\"font-size:16px\">the entity authorized for parallel import<\/li>\n<\/ul>\n\n<p style=\"font-size:16px\"><strong>Regarding the conduct of preliminary batch control of IVMP, two application purposes are distinguished:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:16px\"><span style=\"text-decoration: underline;\">conducting preliminary batch control of IVMP for the purpose of:<\/span><br\/>&#8211; issuing an opinion<br\/>&#8211; issuing an OCABR certificate<br\/>&#8211; issuing an OBPR certificate<\/li>\n\n\n\n<li style=\"font-size:16px\"><span style=\"text-decoration: underline;\">exemption from preliminary batch control of IVMP and issuing an opinion based on:<\/span><br\/>&#8211; OCABR certificate<br\/>&#8211; OBPR certificate<\/li>\n<\/ul>\n\n<p style=\"font-size:16px\"><strong>List of requirements for applicants requesting preliminary batch control of IVMP:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li style=\"font-size:16px\">delivery of IVMP sample \u2013 if preliminary batch control will be conducted based on quality testing of the product and completion of <a href=\"https:\/\/www.piwet.pulawy.pl\/wp-content\/uploads\/2025\/10\/PO-07_F-10.docx\" target=\"_blank\" rel=\"noreferrer noopener\">PO-07\/F10<\/a> <\/li>\n\n\n\n<li style=\"font-size:16px\">completion of the <a href=\"https:\/\/www.piwet.pulawy.pl\/wp-content\/uploads\/2025\/06\/Wniosek-1.docx\">application<\/a><\/li>\n\n\n\n<li style=\"font-size:16px\">submission of the quality control certificate for the given IVMP batch or batch manufacturing report for the given IVMP batch issued by a qualified person<\/li>\n\n\n\n<li style=\"font-size:16px\">submission of the marketing authorization for IVMP (<span style=\"text-decoration: underline;\">if the previous one has expired<\/span>)<\/li>\n\n\n\n<li style=\"font-size:16px\">submission of an <span style=\"text-decoration: underline;\">OCABR certificate<\/span> \u2013 confirming the performance of preliminary batch control testing for the given IVMP batch, issued by the competent authorities in one of the European Union member states or European Free Trade Association (EFTA) member states or an <span style=\"text-decoration: underline;\">OBPR certificate<\/span> confirming the review of documentation containing quality test results for the given IVMP batch, issued by the authority of another European Union member state or European Free Trade Association (EFTA) member state \u2013 <span style=\"text-decoration: underline;\">only in the case of an application whose purpose is exemption from preliminary batch control<\/span><\/li>\n\n\n\n<li style=\"font-size:16px\">submission of the Marketing Information Form for the IVMP batch for which OCABR\/OBPR was issued (on a form compliant with the current edition of EU Official Control Authority Batch Release, Official Batch Protocol Review Immunological Veterinary Medicinal Products) &#8211; <span style=\"text-decoration: underline;\">only in the case of an application whose purpose is exemption from preliminary batch control<\/span><\/li>\n<\/ul>\n\n<p style=\"font-size:16px\">In cases <strong><u>where preliminary batch control will be conducted based on quality testing of IVMP and documentation review<\/u><\/strong>, the Applicant is required to submit a testing order together with the IVMP sample, application, and required documents to the <strong>Central Sample Reception Point (CPP)<\/strong>.<\/p>\n\n<p style=\"font-size:16px\">In cases <strong><u>where preliminary batch control will be conducted based on documentation review<\/u><\/strong>, the Applicant is required to submit the application together with the required documents:<\/p>\n\n<p style=\"font-size:16px\">(1) via the eIWPL platform <a href=\"https:\/\/eiwpl.piwet.pulawy.pl\/\" target=\"_blank\" rel=\"noopener\">https:\/\/eiwpl.piwet.pulawy.pl\/<\/a><br\/><br\/><span style=\"color:red\">Note:<\/span> Access to the eIWPL platform can be obtained after prior contact with the Veterinary Medicinal Products Control Department. Applications submitted via the platform must be signed with a qualified electronic signature. <br\/><br\/>(2) <strong>electronically<\/strong> to the email address: <strong>ksw_iwpl@piwet.pulawy.pl<\/strong><br\/><br\/><span style=\"color:red\">Note:<\/span> The application must be signed with a qualified electronic signature. One email should contain data relating to one application, and the message subject should include the name and batch number of the IVMP. <br\/><br\/>(3) <strong>in paper form<\/strong> &#8211; in the absence of a qualified electronic signature.<br\/><br\/><strong>Contact:<\/strong><br\/>ksw_iwpl@piwet.pulawy.pl<br\/>tel. 81 889 32 97<br\/>tel.  81 889 31 40<\/p>\n\n<p style=\"font-size:16px\"><strong>Deadlines for Individual Stages of the Procedure<\/strong><\/p>\n\n<figure style=\"font-size:16px\" class=\"wp-block-table\"><table><thead><tr><td><strong>Application Purpose<\/strong><\/td><td><strong>Issuance of Opinion\/Certificate*<\/strong><\/td><\/tr><\/thead><tbody><tr><td>Conducting preliminary batch control based on IVMP documentation review and issuing an opinion<\/td><td>7 days<\/td><\/tr><tr><td>Conducting preliminary batch control based on documentation review and IVMP sample testing and issuing an opinion<\/td><td>60 days<\/td><\/tr><tr><td>Conducting preliminary batch control based on documentation review and IVMP sample testing and issuing an OCABR certificate<\/td><td>60 days<\/td><\/tr><tr><td>Conducting preliminary batch control based on IVMP documentation review and issuing an OBPR certificate<\/td><td>15 days<\/td><\/tr><tr><td>Exemption from preliminary batch control of IVMP based on OCABR or OBPR certificate and issuing an opinion<\/td><td>7 days<\/td><\/tr><\/tbody><\/table><\/figure>\n\n<h3 class=\"wp-block-heading\" style=\"font-size:16px\">* deadline is counted from the date of delivery to NIVet-NRI of a complete application together with test samples (if applicable)<\/h3>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-aaf6a873aec1a2d3586e8d5b973a4a83\" style=\"color:#1a8314;font-size:20px\"><br\/><strong>Quality Testing of Immunological Veterinary Medicinal Products<\/strong><\/h3>\n\n<p style=\"font-size:16px\">The National Veterinary Research Institute &#8211; National Research Institute conducts quality testing of immunological veterinary medicinal products as part of preliminary batch control of IVMP, national and European monitoring, as well as service testing, in accordance with the following list of testing procedures.<\/p>\n\n<p><strong><a href=\"https:\/\/www.piwet.pulawy.pl\/wp-content\/uploads\/2025\/09\/05-WYKAZ-PROCEDUR-BADAWCZYCH-2025-09-19.docx\" data-type=\"link\" data-id=\"https:\/\/www.piwet.pulawy.pl\/wp-content\/uploads\/2025\/09\/05-WYKAZ-PROCEDUR-BADAWCZYCH-2025-09-19.docx\" target=\"_blank\" rel=\"noreferrer noopener\">List of Testing Procedures<\/a><\/strong><\/p>\n\n<div id=\"pricelist\" class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p class=\"has-text-color has-link-color wp-elements-c10a773d4546f2a48125cee644801114\" style=\"color:#1a8314;font-size:20px\"><strong>Price List<\/strong><\/p>\n\n\n\n<div class=\"input-group mb-3\">\n  <span class=\"input-group-text\" style=\"background-color: #1a8314; color: #fff;\"><i class=\"fa fa-search\" aria-hidden=\"true\"><\/i><\/span>\n  <input id=\"search-field\" style=\"width:1%;\" class=\"form-control\" placeholder=\"Enter a search phrase to filter the list\" type=\"text\" value=\"\" data-tmp_keywords=\"produkty lecznicze weterynaryjne\/kontrola immunologicznych weterynaryjnych produktow leczniczych (OMCL)\" aria-label=\"Szukaj\" aria-description=\"Wyszukiwarka pozycji cennika. Wpisz szukan\u0105 fraz\u0119 aby przefiltrowa\u0107 list\u0119 pozycji planu\"\/>\n<\/div>\n\n\n\n<figure id=\"pricelistTable\" class=\"wp-block-table is-style-stripes\"><table><thead><tr><th>Price List Item<\/th><th>Name<\/th><th>Accreditation<\/th><th>Gross Price<\/th><th>Express Test Price<\/th><\/tr><\/thead><tbody><tr><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/div>\n\n<div class=\"modal fade\" id=\"pricelistModal\" tabindex=\"-1\" aria-labelledby=\"ekran ze szczeg\u00f3\u0142ami pozycji cennika\" aria-hidden=\"true\"><div class=\"modal-dialog modal-lg\"><div class=\"modal-content\"><div class=\"modal-header\"><h5 class=\"modal-title\" id=\"pricelistModalLabel\"><\/h5><span type=\"button\" class=\"btn-close\" data-bs-dismiss=\"modal\" aria-label=\"Zamknij okno dialogowe\"><i class=\"fa-solid fa-xmark fa-xl\"><\/i><\/span><\/div><div class=\"modal-body\">\n<dl class=\"row\">\n  <dt class=\"col-sm-3\">Item Number<\/dt>\n  <dd id=\"pricelistPosition\" class=\"col-sm-9\"><\/dd>\n\n  <dt class=\"col-sm-3\">Full Name<\/dt>\n  <dd id=\"pricelistName\" class=\"col-sm-9\"><\/dd>\n\n  <dt class=\"col-sm-3\">Method<\/dt>\n  <dd id=\"pricelistSymbol\" class=\"col-sm-9\"><\/dd>\n\n  <dt class=\"col-sm-3 text-truncate\">Price<\/dt>\n  <dd id=\"pricelistPrice\" class=\"col-sm-9\"><\/dd>\n\n  <dt class=\"col-sm-3\">Completion Time<\/dt>\n  <dd id=\"pricelistTime\" class=\"col-sm-9\"><\/dd>\n  \n  <dt class=\"col-sm-3\">Express Test Price<\/dt>\n  <dd id=\"pricelistPriceExpress\" class=\"col-sm-9\"><\/dd>\n  \n  <dt class=\"col-sm-3\">Express Test Completion Time<\/dt>\n  <dd id=\"pricelistTimeExpress\" class=\"col-sm-9\"><\/dd>\n  \n  <dt class=\"col-sm-3\">Description<\/dt>\n  <dd id=\"pricelistDescription\" class=\"col-sm-9\"><\/dd>\n  \n  <dt class=\"col-sm-3\">Possible Testing Directions<\/dt>\n  <dd id=\"pricelistDirections\" class=\"col-sm-9\"><\/dd>\n  \n  <dt class=\"col-sm-3\">Sample Type<\/dt>\n  <dd id=\"pricelistMatrixes\" class=\"col-sm-9\"><\/dd>\n  \n  <dt class=\"col-sm-3\">Species<\/dt>\n  <dd id=\"pricelistSpecies\" class=\"col-sm-9\"><\/dd>\n  \n  <dt class=\"col-sm-3\">Contact<\/dt>\n  <dd id=\"pricelistContact\" class=\"col-sm-9\"><\/dd>\n<\/dl>\n      <\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Control of Immunological Veterinary Medicinal Products (OMCL) On May 26, 1994, the European Union (EU) Commission and the Council of Europe decided to establish the Network of Official Medicines Control Laboratories (OMCL). This network performs activities related to pre- and post-marketing quality control of medicinal products used in humans and animals, ensuring the protection of [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"fullwidth-page.php","meta":{"footnotes":""},"class_list":["post-4613","page","type-page","status-publish","hentry"],"rttpg_featured_image_url":null,"rttpg_author":{"display_name":"Marta Antas","author_link":"https:\/\/www.piwet.pulawy.pl\/en\/author\/mantas\/"},"rttpg_comment":0,"rttpg_category":" <a href=\"https:\/\/www.piwet.pulawy.pl\/en\/?taxonomy=translation_priority&#038;term=optional\" rel=\"tag\">Optional<\/a>","rttpg_excerpt":"Control of Immunological Veterinary Medicinal Products (OMCL) On May 26, 1994, the European Union (EU) Commission and the Council of Europe decided to establish the Network of Official Medicines Control Laboratories (OMCL). This network performs activities related to pre- and post-marketing quality control of medicinal products used in humans and animals, ensuring the protection of&hellip;","_links":{"self":[{"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/pages\/4613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/comments?post=4613"}],"version-history":[{"count":1,"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/pages\/4613\/revisions"}],"predecessor-version":[{"id":4617,"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/pages\/4613\/revisions\/4617"}],"wp:attachment":[{"href":"https:\/\/www.piwet.pulawy.pl\/en\/wp-json\/wp\/v2\/media?parent=4613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}