{"id":30138,"date":"2025-12-04T11:35:28","date_gmt":"2025-12-04T10:35:28","guid":{"rendered":"https:\/\/ichp.lukasiewicz.gov.pl\/product-registration-documentation\/"},"modified":"2026-04-08T10:03:25","modified_gmt":"2026-04-08T08:03:25","slug":"product-registration-documentation","status":"publish","type":"page","link":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/product-registration-documentation\/","title":{"rendered":"Product registration documentation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"30138\" class=\"elementor elementor-30138 elementor-27206\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-72ab1d5d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"72ab1d5d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-14c91232\" data-id=\"14c91232\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-26b5d60f elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"26b5d60f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Department of Pharmaceutical Products<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4795d0f2 elementor-widget elementor-widget-spacer\" data-id=\"4795d0f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8fcd684 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"8fcd684\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Product registration documentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13bd43de elementor-widget elementor-widget-spacer\" data-id=\"13bd43de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-31fb17b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"31fb17b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-b817dc3\" data-id=\"b817dc3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-54447847 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"54447847\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3>Products manufactured at the Institute have:<\/h3><h3><strong>&#8211; GMP &amp; CEP certificates <\/strong><\/h3><h3><strong>&#8211; accreditations (e.g. in Japan)<\/strong><\/h3><h3><strong>&#8211; ASMF documentation <\/strong><\/h3><h3>We also offer support in preparing registration documentation and marketing authorisation.<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5422cfa8 elementor-widget elementor-widget-spacer\" data-id=\"5422cfa8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-4da5c8ca\" data-id=\"4da5c8ca\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-483e73d4 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"483e73d4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"580\" height=\"387\" src=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/dokumentacja-rejestracyjna-1.jpg\" class=\"attachment-large size-large wp-image-31611\" alt=\"\" srcset=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/dokumentacja-rejestracyjna-1.jpg 768w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/dokumentacja-rejestracyjna-1-300x200.jpg 300w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/dokumentacja-rejestracyjna-1-24x16.jpg 24w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/dokumentacja-rejestracyjna-1-36x24.jpg 36w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/dokumentacja-rejestracyjna-1-48x32.jpg 48w\" sizes=\"(max-width: 580px) 100vw, 580px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-169a36ac elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"169a36ac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-621dc366 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"621dc366\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7494e428\" data-id=\"7494e428\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4ee1740 elementor-widget elementor-widget-text-editor\" data-id=\"4ee1740\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h4><span style=\"color: #46d600\"><strong>Good Manufacturing Practice Certificate (GMP)<\/strong><\/span><\/h4><p><span style=\"color: #000000\">Confirming compliance of manufacturing conditions with GMP requirements for tested medicinal products intended for human use<\/span><\/p><p><span style=\"color: #000000\">Publisher: Chief Pharmaceutical Inspector (GIF)<\/span><br><span style=\"color: #000000\">Certificate No.: ISF.405.93.2025.MP.5; WTC\/0079_01_01\/203<\/span><\/p><p><span style=\"color: #000000\"><a style=\"color: #000000\" href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/1-Certyfikat-GMP_badany-produkt-leczniczy_pl.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline\">Download<\/span><\/a><\/span><\/p><h4><span style=\"color: #46d600\"><strong>Good Manufacturing Practice Certificate (GMP)<\/strong><\/span><\/h4><p><span style=\"color: #000000\">Confirming compliance of manufacturing conditions with GMP requirements for medicinal products intended for human use<\/span><\/p><p><span style=\"color: #000000\">Publisher: Chief Pharmaceutical Inspector (GIF)<\/span><br><span style=\"color: #000000\">Certificate No.: ISF.405.93.2025.MP.4; WTC\/0079_01_01\/202<\/span><\/p><p><span style=\"color: #000000\"><a style=\"color: #000000\" href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/4-Certyfikat-GMP_produkt-leczniczy-dla-ludzi_pl.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline\">Download<\/span><\/a><\/span><\/p><h4><span style=\"color: #46d600\"><strong>Good Manufacturing Practice Certificate (GMP)<\/strong><\/span><\/h4><p><span style=\"color: #000000\">Confirming the quality of active substance manufacturing: Alfacalcidol, Calcifediol hydroxide, Tacalcitol hydroxide, Anastrozole, Latanoprost, Imatinib mesylate, Carvedilol, Cladribine, Sunitinib malate <\/span><\/p><p><span style=\"color: #000000\">Publisher: Chief Pharmaceutical Inspector (GIF)<\/span><br><span style=\"color: #000000\">Certificate No.: ISF.405.29.2026.IP.1 WTC\/0079_01_02\/50 <\/span><\/p><p><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/04\/Certificate-of-GMP-API-27_03_2026_EN-1.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #000000\"><span style=\"text-decoration: underline\">Download<\/span><\/span><\/a><\/p><h4><span style=\"color: #46d600\"><strong>Good Manufacturing Practice Certificate (GMP)<\/strong><\/span><\/h4><p><span style=\"color: #000000\">Confirming compliance of manufacturing conditions with GMP requirements for veterinary medicinal products<\/span><\/p><p><span style=\"color: #000000\">Publisher: Chief Pharmaceutical Inspector (GIF)<\/span><br><span style=\"color: #000000\">Certificate No.: ISF.405.93.2025.MP.3; WTC\/0034_01_01\/201<\/span><\/p><p><span style=\"color: #000000\"><span style=\"text-decoration: underline\"><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/7-Certyfikat-GMP_-weterynaryjny-produkt-leczniczy_pl.pdf\" target=\"_blank\" rel=\"noopener\">Download<\/a><\/span><\/span><\/p><h4><span style=\"color: #46d600\"><strong>Good Manufacturing Practice Certificate (GMP)<\/strong><\/span><\/h4><p><span style=\"color: #000000\">Confirming compliance of manufacturing conditions with GMP requirements for medicinal products intended for human use<\/span><\/p><p><span style=\"color: #000000\">Publisher: Chief Pharmaceutical Inspector (GIF)<\/span><br><span style=\"color: #000000\">Certificate No.: ISF.405.93.2025.MP.2; WTC\/0034_01_01\/200<\/span><\/p><p><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/8-Certyfikat-GMP_badany-produkt-leczniczy_pl-1.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #000000\"><span style=\"text-decoration: underline\">Download<\/span><\/span><\/a><\/p><h4><span style=\"color: #46d600\"><strong>Good Manufacturing Practice Certificate (GMP)<\/strong><\/span><\/h4><p><span style=\"color: #000000\">Confirming compliance of manufacturing conditions with GMP requirements for medicinal products intended for human use<\/span><\/p><p><span style=\"color: #000000\">Publisher: Chief Pharmaceutical Inspector (GIF)<\/span><br><span style=\"color: #000000\">Certificate No.: ISF.405.93.2025.MP.1; WTC\/0034_01_01\/199<\/span><\/p><p><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/11-Certyfikat-GMP_produkt-leczniczy-dla-ludzi_pl.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #000000\"><span style=\"text-decoration: underline\">Download<\/span><\/span><\/a><\/p><h4><span style=\"color: #46d600\"><strong>Accreditation in Japan<\/strong><\/span><\/h4><p><span style=\"color: #000000\">Accreditation of foreign manufacturers of medicinal products<\/span><\/p><p><span style=\"color: #000000\">Publisher: Ministry of Health, Labour and Welfare, Japan<\/span><br><span style=\"color: #000000\">Certificate No.: AG22300014<\/span><\/p><p><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2026\/03\/13-Akredytacja-Japonia-LUKASIEWICZ_AG22300014.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #000000\"><span style=\"text-decoration: underline\">Download<\/span><\/span><\/a><\/p><h4><span style=\"color: #46d600\"><strong>CEP Certificate<\/strong><\/span><\/h4><p>Certificate of Conformity with the European Pharmacopoeia for the substance: Calcifediol Monohydrate<br>Certificate No.: R0-CEP 2022-335 \u2013 Rev 00<\/p><h4><span style=\"color: #46d600\"><strong>CEP Certificate<\/strong><\/span><\/h4><p>Certificate of Conformity with the European Pharmacopoeia for the substance: Alfacalcidol<br><span style=\"color: #000000\">Certificate No.: R1-CEP 2000-399 \u2013 Rev 05<\/span><\/p><h4><span style=\"color: #46d600\"><strong>CEP Certificate<\/strong><\/span><\/h4><p>Certificate of Conformity with the European Pharmacopoeia for the substance: Takalcitol Monohydrate<br>Certificate No.: R0-CEP 2019-220<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-906a03c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"906a03c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f794728\" data-id=\"f794728\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9f0e0ca elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"9f0e0ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Department of Pharmaceutical Products Product registration documentation Products manufactured at the Institute have: &#8211; GMP &amp; CEP certificates &#8211; accreditations (e.g. in Japan) &#8211; ASMF documentation We also offer support in preparing registration documentation and marketing authorisation. Good Manufacturing Practice Certificate (GMP) Confirming compliance of manufacturing conditions with GMP requirements for tested medicinal products intended [&hellip;]<\/p>\n","protected":false},"author":125,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","inline_featured_image":false,"footnotes":""},"class_list":["post-30138","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-04-17 05:21:10","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"translation_priority","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages\/30138","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/users\/125"}],"replies":[{"embeddable":true,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/comments?post=30138"}],"version-history":[{"count":5,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages\/30138\/revisions"}],"predecessor-version":[{"id":32402,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages\/30138\/revisions\/32402"}],"wp:attachment":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/media?parent=30138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}