{"id":2056,"date":"2025-03-27T16:21:03","date_gmt":"2025-03-27T16:21:03","guid":{"rendered":"https:\/\/www.ibarrapg.com\/?p=2056"},"modified":"2026-04-12T02:44:40","modified_gmt":"2026-04-12T02:44:40","slug":"accord-on-guidelines-for-the-submission-of-documents-ensuring-good-manufacturing-practices-for-pharmaceutical-drugs","status":"publish","type":"post","link":"https:\/\/www.ibarrapg.com\/es\/accord-on-guidelines-for-the-submission-of-documents-ensuring-good-manufacturing-practices-for-pharmaceutical-drugs\/","title":{"rendered":"Acuerdo sobre Lineamientos para la Presentaci\u00f3n de Documentos que Garanticen Buenas Pr\u00e1cticas de\nFabricaci\u00f3n de F\u00e1rmacos"},"content":{"rendered":"<p style=\"text-align: justify;\">The purpose of this note is to inform you that, on March 19th, the Ministry of Health published in the Federation\u2019s Official Gazette the Accord issuing the <strong>Guidelines for the Submission of Documents Ensuring Good Manufacturing Practices<\/strong> (\u201c<span style=\"text-decoration: underline;\">GMP\u00b4s<\/span>\u201d). This regulation impacts applications for new sanitary registrations, its renewals and modifications of pharmaceutical drug products, medications and medical devices.<\/p>\n<p style=\"text-align: justify;\">Below, we outline the main aspects to be considered:<\/p>\n<h4 style=\"text-align: justify;\">Key Changes in GMP\u00b4s Certification<\/h4>\n<p style=\"text-align: justify;\"><strong>Mandatory Documentation:<\/strong> In order to obtain or modify a marketing authorization, it will be necessary to submit a Good Manufacturing Practices Certificate (\u201c<span style=\"text-decoration: underline;\">GMPC<\/span>\u201d) or an equivalent document that ensures the quality, safety and efficacy of the products.<\/p>\n<p style=\"text-align: justify;\"><strong>Recognition of Foreign Certifications: <\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li>GMPC\u00b4s issued by recognized National Regulatory Authorities (\u201c<span style=\"text-decoration: underline;\">NRA\u00b4s<\/span>\u201d) that are members of Pharmaceutical Inspection Cooperation Schemes [1] will be accepted.<\/li>\n<li>Certifications issued by the World Health Organization and international bodies, such as the European Union\u2019s EudraGMDP [2] , will be recognized.<\/li>\n<li>Certificates of Pharmaceutical Product will be accepted in cases where the country of origin does not issue GMPC\u00b4s.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>New Requirements for Document Submission:<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li>Foreign GMPC\u00b4s must be apostilled [3] or legalized, unless they are issued electronically and can be verified online.<\/li>\n<li>If the document is not in Spanish or English, an official translation must be provided.<\/li>\n<li>Documents must be submitted either in physical format or as digital files through COFEPRIS\u2019s DIGIPRiS platform.<\/li>\n<\/ul>\n<h4 style=\"text-align: justify;\">Specific Requirements for Different Types of Products<\/h4>\n<p style=\"text-align: justify;\"><strong>For Domestically Manufactured Pharmaceuticals and Drug Products:<\/strong> A GMPC issued by COFEPRIS [4] must be submitted.<\/p>\n<p style=\"text-align: justify;\"><strong>For Foreign-Manufactured Pharmaceuticals:<\/strong> Depending on their origin (biotechnological, biological, homeopathic, herbal, etc.), the following may be submitted:<\/p>\n<ul style=\"text-align: justify;\">\n<li>GMPC issued by COFEPRIS.<\/li>\n<li>GMPC issued by recognized NRA\u00b4s or by the regulatory authority of the country of origin.<\/li>\n<li>Quality audit certificate issued under ISO 134855 [5] (in specific cases).<\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>For Medical Devices<\/strong>:<\/p>\n<ul style=\"text-align: justify;\">\n<li>The Medical Device Single Audit Program Audit Certificate in accordance with ISO 13485 will be accepted.<\/li>\n<li>The CE Mark Certificate [6] issued by a notified body approved by the European Commission will also be accepted.<\/li>\n<\/ul>\n<h4><\/h4>\n<h4 style=\"text-align: justify;\">Validity and Renewals of GMPC\u00b4s<\/h4>\n<p style=\"text-align: justify;\"><strong>Initial Validity:<\/strong> 30 months from the date of issuance.<\/p>\n<p style=\"text-align: justify;\"><strong>Single Renewal:<\/strong> For up to an additional 15 months, provided that:<\/p>\n<ul style=\"text-align: justify;\">\n<li>The renewal request is submitted within 60 days prior to the certificate\u2019s expiration date.<\/li>\n<li>No safety measures have been imposed by the Ministry of Health.<\/li>\n<li>Evidence is provided, demonstrating that the renewal process for the certification is underway.<\/li>\n<\/ul>\n<h4 style=\"text-align: justify;\"><\/h4>\n<h4 style=\"text-align: justify;\">Harmonization with International Standards<\/h4>\n<p style=\"text-align: justify;\">These guidelines, which entered into force on <strong>March 21st, 2025<\/strong> aim to harmonize Mexican regulation with international standards, facilitating access to new treatments while maintaining a high level of sanitary control.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><strong>[1] <\/strong>The Pharmaceutical Inspection Cooperation Scheme is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of GMP\u00b4s of medicinal products for human or veterinary use.<\/p>\n<p style=\"text-align: justify;\"><strong>[2]<\/strong> EudraGMDP is the name for the Union that contains the following information: Manufacturing and import authorizations, GMP\u00b4s certificates, statements of non-compliance with GMP\u00b4s, GMP\u00b4s inspection planning in third countries.<\/p>\n<p style=\"text-align: justify;\"><strong>[3]<\/strong> The apostille is a simplified method of document legalization for the purpose of verifying its authenticity in the field of private international law.<\/p>\n<p style=\"text-align: justify;\"><strong>[4]<\/strong> Federal Commission for the Protection against Sanitary Risks, abbreviated in Spanish as COFEPRIS.<\/p>\n<p style=\"text-align: justify;\"><strong>[5]<\/strong> ISO 13485 is the standard related to the quality management system applicable to medical devices.<\/p>\n<p style=\"text-align: justify;\"><strong>[6]<\/strong> CE marking indicates that a product has been assessed by the manufacturer and deemed to meet European Union safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The purpose of this note is to inform you that, on March 19th, the Ministry of Health published in the Federation\u2019s Official Gazette the Accord issuing the Guidelines for the Submission of Documents Ensuring Good Manufacturing Practices (\u201cGMP\u00b4s\u201d). This regulation impacts applications for new sanitary registrations, its renewals and modifications of pharmaceutical drug products, medications [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":2121,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2056","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-otros"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/posts\/2056","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/comments?post=2056"}],"version-history":[{"count":11,"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/posts\/2056\/revisions"}],"predecessor-version":[{"id":3688,"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/posts\/2056\/revisions\/3688"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/media\/2121"}],"wp:attachment":[{"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/media?parent=2056"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/categories?post=2056"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ibarrapg.com\/es\/wp-json\/wp\/v2\/tags?post=2056"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}