{"id":7555,"date":"2022-11-21T01:37:16","date_gmt":"2022-11-21T01:37:16","guid":{"rendered":"https:\/\/cinmed.me\/regulativa\/smjernice-dobre-prakse\/"},"modified":"2026-03-23T11:02:35","modified_gmt":"2026-03-23T10:02:35","slug":"good-practice-guidelines","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/legislation\/good-practice-guidelines\/","title":{"rendered":"Good Practice guidelines"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7555\" class=\"elementor elementor-7555 elementor-1117\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b1cc3b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1cc3b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b11a068\" data-id=\"b11a068\" 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-ce4b035 elementor-widget elementor-widget-image\" data-id=\"ce4b035\" 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=\"800\" height=\"450\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/shutterstock_1947414004-1-2.jpg\" class=\"attachment-large size-large wp-image-1970\" alt=\"\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/shutterstock_1947414004-1-2.jpg 800w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/shutterstock_1947414004-1-2-300x169.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/11\/shutterstock_1947414004-1-2-768x432.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-bdcac82 elementor-widget elementor-widget-heading\" data-id=\"bdcac82\" 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\">Good Practice guidelines<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ee826fc elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"ee826fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-ee826fc\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"ee826fc\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"good-manufacturing-practice-gmp-guidelines\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-2501\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><span class=\"eael-accordion-tab-title\">Good Manufacturing Practice (GMP) guidelines<\/span><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><\/div><div id=\"elementor-tab-content-2501\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"good-manufacturing-practice-gmp-guidelines\"><ul><li><p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/2011_intro_en_0.pdf\" target=\"_blank\" rel=\"noopener\">Introduction<\/a><\/p><\/li><li><p><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/glos4en200408_en_0.pdf\" target=\"_blank\" rel=\"noopener\">Glossary<\/a><\/p><\/li><\/ul><p>Part I &#8211; Basic Requirements for Medicinal Products<\/p><ul><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/vol4-chap1_2013-01_en.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 1 &#8211; Pharmaceutical Quality System <\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2014-03_chapter_2.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 2 &#8211; Personnel\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/chapter_3.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 3 &#8211; Premise and Equipment\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/chapter4_01-2011_en.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 4 &#8211; Documentation\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/chapter_5_0.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 5 &#8211; Production\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2014-11_vol4_chapter_6.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 6 &#8211; Quality Control\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/vol4-chap7_2012-06_en.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 7 &#8211; Outsourced activities\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2014-08_gmp_chap8.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 8 &#8211; Complaints and Product Recall<\/a> (published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/cap9_en.pdf\" target=\"_blank\" rel=\"noopener\">Chapter 9 &#8211; Self Inspection\u00a0<\/a>(published 9.4.2021.)<\/li><\/ul><p>Part II &#8211; Basic Requirements for Active Substances used as Starting Materials<\/p><ul><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2014-08_gmp_part1.pdf\" target=\"_blank\" rel=\"noopener\">Basic requirements for active substances used as starting materials\u00a0<\/a>(published 9.4.2021.)<\/li><\/ul><p>Part III &#8211; GMP related documents<\/p><ul><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2011_site_master_file_en.pdf\" target=\"_blank\" rel=\"noopener\">Site Master File\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/09\/ICH-guideline-Q9-R1-on-quality-risk-management-mp_ich_q9guideline-ra_en.pdf\" target=\"_blank\" rel=\"noopener\">Q9 Quality Risk Management\u00a0<\/a>(published 8.9.2025.)<\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human_en.pdf\" target=\"_blank\" rel=\"noopener\">Q10 Note for Guidance on Pharmaceutical Quality System<\/a> (published 9.4.2021.)<\/li><li><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/mra_batch-certificate_05-2011_0.pdf\" target=\"_blank\" rel=\"noopener\">MRA Batch Certificate<\/a> (published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/gmp\/2013_01_28_template.pdf\" target=\"_blank\" rel=\"noopener\">Template for the &#8220;written confirmation&#8221; for active substances exported to the European Union for medicinal products for human use\u00a0<\/a>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf\" target=\"_blank\" rel=\"noopener\">Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities<\/a><br \/><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:52015XC0321(02)&amp;from=EN\" target=\"_blank\" rel=\"noopener\">Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use<\/a><i> (all language versions are available <a href=\"http:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv:OJ.C_.2015.095.01.0010.01.ENG\" target=\"_blank\" rel=\"noopener\">here<\/a>).<\/i>(published 9.4.2021.)<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/template_imp_batch_certification.docx\">Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536\/2014 on Clinical Trials)<\/a> (published 9.4.2021.)<\/li><\/ul><p>Annexes<\/p><ul><li>Annex 1 &#8211; <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/12\/Annex-1-Manufacture-of-Sterile-Medicinal-Products.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Sterile Medicinal Products<\/a> (published on 3.11.2023.)<\/li><li><p>Annex 2 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/2018_annex2_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Biological active substances and Medicinal Products for Human Use<\/a> (published 9.4.2021.)<\/p><\/li><\/ul><p><i>Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.<\/i><\/p><ul><li><p>Annex 3 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2008_09_annex3_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Radiopharmaceutical<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 4 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/anx04en200408_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 5 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/anx05en200408_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Immunological Veterinary Medicinal Products<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 6 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2009_07_annex6.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Medicinal Gases<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 7 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/vol4_an7_2008_09_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Herbal Medicinal Products<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 8 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/anx08_en.pdf\" target=\"_blank\" rel=\"noopener\">Sampling of Starting and Packaging Materials<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 9 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/anx09_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Liquids, Creams and Ointments<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 10 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/anx10_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 11 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\" rel=\"noopener\">Computerised Systems<\/a> (published 9.4.2021.)<\/p><\/li><li>Annex 12 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/anx12_en.pdf\" target=\"_blank\" rel=\"noopener\">Use of Ionising Radiation in the Manufacture of Medicinal Products<\/a> (published 9.4.2021.)<\/li><li><p>Annex 13 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2009_06_annex13.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Investigational Medicinal Products<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 14 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex14_rev30-03_2011_en.pdf\" target=\"_blank\" rel=\"noopener\">Manufacture of Products derived from Human Blood or Human Plasma<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 15 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/2015-10_annex15.pdf\" target=\"_blank\" rel=\"noopener\">Qualification and validation<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 16 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/v4_an16_201510_en.pdf\" target=\"_blank\" rel=\"noopener\">Certification by a Qualified Person and Batch Release<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 17 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/2018_annex17_en.pdf\" target=\"_blank\" rel=\"noopener\">Parametric release<\/a> (published 9.4.2021.)<\/p><\/li><li><p>Annex 19 &#8211; <a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/pdfs-en\/2005_12_14_annex19_en.pdf\" target=\"_blank\" rel=\"noopener\">Reference and Retention Samples<\/a> (published 9.4.2021.)\u017e<\/p><\/li><\/ul><p>Part IV &#8211; <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/ad33d9dd-03f0-4bef-af53-21308ce2187d_en?filename=2017_11_22_guidelines_gmp_for_atmps.pdf\">Good Manufacturing Practice Guidelines specific to Advanced Therapy Medicinal Products<\/a><\/p><p>\u00a0<\/p><p><strong>Standardised GMP forms<\/strong><\/p><ul><li><p><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/08\/Dozvola-za-proizvodnju-ljekova.pdf\" target=\"_blank\" rel=\"noopener\">Manufacturing authorisation for medicines\u00a0<\/a>(update on 5.6.2025.)<\/p><\/li><li><p><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/01\/GMP-certificate.pdf\" target=\"_blank\" rel=\"noopener\">GMP certificate\u00a0<\/a>(update on 28.1.2026.)<\/p><\/li><li><p><a href=\"\/wp-content\/uploads\/2022\/11\/Izvjestaj-o-primjeni-smjernica-Dobre-proizvodjacke-prakse-Izvjestaj-GMP-inspekcije.pdf\" target=\"_blank\" rel=\"noopener\">GMP Inspection Report Format <\/a>(published 16.4.2021.)<\/p><\/li><\/ul><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"good-distribution-practice-guidelines\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-2502\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><span class=\"eael-accordion-tab-title\">Good Distribution Practice guidelines<\/span><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><\/div><div id=\"elementor-tab-content-2502\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"good-distribution-practice-guidelines\"><ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/04\/Guidelines-on-Good-Distributive-practice-for-medicinal-products-for-human-use.pdf\" target=\"_blank\" rel=\"noopener\">Guidelines on Good Distributive practice for medicinal products for human use<\/a> <i>(published on 12\/10\/2020.)<\/i><\/li><\/ul><p><strong>Standardised GMP forms<\/strong><\/p><ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/08\/GDP-sertifikat-Ljekovi-za-humanu-upotrebu.pdf\" target=\"_blank\" rel=\"noopener\">GDP certificate for medicine for human use<\/a> <i>(update on 16\/4\/2025)<\/i><\/li><li><a href=\"\/wp-content\/uploads\/2022\/11\/GDP-sertifikat-aktivne-supstance.pdf\" target=\"_blank\" rel=\"noopener\">GDP certificate for active substance<\/a> <i>(published on 12\/10\/2020)<\/i><\/li><li><a href=\"\/wp-content\/uploads\/2022\/11\/Izvje_taj-GDP-inspekcije.pdf\" target=\"_blank\" rel=\"noopener\">GDP Inspection Report Format<\/a> <i>(published on 12\/10\/2020)<\/i><\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/08\/Dozvola-za-promet-ljekova-za-humanu-upotrebu-na-veliko.pdf\" target=\"_blank\" rel=\"noopener\">Wholesale authorisation for medicines for human use<\/a> <i>(Updated on 04\/6\/2025)<\/i><\/li><\/ul><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"good-clinical-practice-guidelines\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-2503\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><span class=\"eael-accordion-tab-title\">Good Clinical Practice guidelines<\/span><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><\/div><div id=\"elementor-tab-content-2503\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"good-clinical-practice-guidelines\"><ul><li><u><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/GCP-smjernice-1.pdf\" target=\"_blank\" rel=\"noopener\">Guideline for Good Clinical Practice<\/a><\/u> <i>(published on 31\/10\/2025) <\/i><i>(Note: These guidelines are published in the Montenegrin language)<\/i><\/li><li><u><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/GCP-CG-pedijatrijske-prevod-na-eng.pdf\" target=\"_blank\" rel=\"noopener\">Clinical Investigation of Medicinal Products in the Paediatric Population<\/a><\/u> <i>(published on 28\/01\/2014.)<\/i><\/li><\/ul><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"good-pharmacovigilance-practice-guidelines\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"4\" aria-controls=\"elementor-tab-content-2504\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><span class=\"eael-accordion-tab-title\">Good Pharmacovigilance Practice Guidelines<\/span><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><\/div><div id=\"elementor-tab-content-2504\" class=\"eael-accordion-content clearfix\" data-tab=\"4\" aria-labelledby=\"good-pharmacovigilance-practice-guidelines\"><p>In accordance with the <a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Law-on-medicines-Official-Gazette-of-Montenegro-080-20-unofficial-translation.pdf\" target=\"_blank\" rel=\"noopener\">Law on medicines<\/a>, <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/good-pharmacovigilance-practices\" target=\"_blank\" rel=\"noopener\">Good Pharmacovigilance Practice Guidelines<\/a> are applied in the field of pharmacovigilance, which are available on the website of the European Medicines Agency (EMA)<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"guidelines-of-good-distribution-practice-for-active-substances-used-as-starting-materials-in-veterinary-medicinal-products\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"5\" aria-controls=\"elementor-tab-content-2505\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><span class=\"eael-accordion-tab-title\">Guidelines of good distribution practice for active substances used as starting materials in veterinary medicinal products<\/span><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><\/div><div id=\"elementor-tab-content-2505\" class=\"eael-accordion-content clearfix\" data-tab=\"5\" aria-labelledby=\"guidelines-of-good-distribution-practice-for-active-substances-used-as-starting-materials-in-veterinary-medicinal-products\"><p><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/03\/Guidelines-of-good-distribution-practice-for-active-substances-used-as-starting-materials-in-veterinary-medicinal-products.pdf\">Guidelines of good distribution practice for active substances used as starting materials in veterinary medicinal products<\/a> <i>(\u201cOfficial Gazette of Montenegro\u201d, No. 22\/26) <\/i><i>\u00a0<\/i><\/p><\/div>\n\t\t\t\t\t<\/div><\/div>\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-top-column elementor-element elementor-element-c99dd92\" data-id=\"c99dd92\" 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-d1b992c elementor-widget elementor-widget-shortcode\" data-id=\"d1b992c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"relative pt-10 rounded bg-primary pb-72\">\n\t<h1 class=\"ml-10 text-4xl text-white \">Search <span class=\"font-bold\">register<\/span><\/h1>\n\t<div class=\"mt-8 \">\n\t\t<h3 class=\"mb-4 ml-10 text-secondary text-medium \">Here you can search for medicines in our register<\/h3>\n\t\t<div class=\"relative inline-block w-4\/5 ml-10 text-left\" style=\"width:80%\">\n\t\t\t<div>\n\t\t\t\t<select onchange=\"javascript:handleSelect(this)\" 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       <\/p>\n      <\/div>\n    <\/form>\n\n      <\/div>\n\n  \t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-0 left-0 w-[380px] \" src=\"\/wp-content\/uploads\/2022\/11\/newsletter.png\" \/>\n<\/div>\t\t<div class=\"elementor-shortcode\"><\/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>Good Practice guidelines Good Manufacturing Practice (GMP) guidelines Introduction Glossary Part I &#8211; Basic Requirements for Medicinal Products Chapter 1 &#8211; Pharmaceutical Quality System (published 9.4.2021.) Chapter 2 &#8211; Personnel\u00a0(published 9.4.2021.) Chapter 3 &#8211; Premise and Equipment\u00a0(published 9.4.2021.) Chapter 4 &#8211; Documentation\u00a0(published 9.4.2021.) Chapter 5 &#8211; Production\u00a0(published 9.4.2021.) Chapter 6 &#8211; Quality Control\u00a0(published 9.4.2021.) Chapter [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7551,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"cinmed-template-custom.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-7555","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Good Practice guidelines - Cinmed<\/title>\n<meta name=\"description\" content=\"Good Practice guidelinesGood Manufacturing Practice (GMP) guidelinesGood Distribution Practice (GDP) guidelinesGood Clinical Practice (GCP) guidelinesGood Distribution Practice guidelines for Medical Devices (GDPMD)\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cinmed.me\/regulativa\/smjernice-dobre-prakse\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Good Practice guidelines - 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