{"id":9832,"date":"2023-03-31T10:53:17","date_gmt":"2023-03-31T07:53:17","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=9832"},"modified":"2025-08-14T15:44:48","modified_gmt":"2025-08-14T12:44:48","slug":"informatii-despre-nitrozamine-pentru-dapp","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/informatii-despre-nitrozamine-pentru-dapp\/","title":{"rendered":"Information about nitrosamines for MAHs"},"content":{"rendered":"<div class=\"infopublic\"><ul class=\"display-posts-listing\"><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-15-02-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>15.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of marketing authorisation holders<\/strong><\/span><br \/>\n<strong>Request for assessment of the risk of the presence of nitrosamine impurities in human medicinal products containing active substances obtained by chemical and biological synthesis<\/strong><br \/>\nRegarding the referral procedure initiated according to the provisions of Art. 5 (3) of Regulation no. 726\/2004, we remind you that the deadline for marketing authorisation holders to send to the NAMMDR the result of stage 1 &#8211; Evaluation of the risk of nitrosamine impurities in medicinal products for human use containing active substances obtained by chemical synthesis is 31 March 2021, and the deadline for medicinal products for human use containing biological active substances if 1 July 2021.<br \/>\nThe documents shall be sent to <a href=\"mailto:nitrozamine@anm.ro\">nitrozamine@anm.ro<\/a> in the format established by the European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh)<br \/>\nPlease consult the updated versions:<br \/>\n\u2013 <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/referral-procedures\/nitrosamine-impurities\" target=\"_blank\">https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/referral-procedures\/nitrosamine-impurities<\/a><br \/>\n\u2013 <a href=\"https:\/\/www.hma.eu\" target=\"_blank\">https:\/\/www.hma.eu<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-16-11-2020\/\">Press release<\/a><div class=\"content\"><p><strong>16.11.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nNitrosamines: EMA aligns recommendations for sartans with those for other medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Sartans%20press%20release_revised%20AP.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-22-10-2020\/\">Press release<\/a><div class=\"content\"><p><strong>22.10.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEU authorities are investigating the presence of a nitrosamine impurity, 1-Nitroso-4-methyl piperazine (MeNP), in some batches of active substances used in medicinal products containing rifampicin<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20de%20presa%20-%20Rifampicina.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-10-2020\/\">Press release<\/a><div class=\"content\"><p><strong>20.10.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEU regulators require testing for nitrosamine impurities in metformin-containing medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Traducere%20comunicat%20de%20presa%20nitrozamine%2016.10.2020.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-20-08-2020\/\">Important notification<\/a><div class=\"content\"><p><strong>20.08.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of marketing authorisation holders<\/strong><\/span><br \/>\nAs part of the EU-wide measures following the outcome of the assessment carried out by the EMA Committee for Medicinal Products for Human Use (CHMP) in accordance with the requirements of Art. 5(3) (the legal basis for the so-called &#8220;referral procedure&#8221;), the process for risk assessment of the presence of nitrosamine impurities in all medicinal products for human use containing active substances obtained by chemical synthesis has been ongoing since September 2019.<br \/>\nIn this context, in July 2020, the request for risk assessment of the presence of nitrosamine impurities was extended to medicinal products containing biological active substances.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/ANUNTURI%20IMPORTANTE\/Evaluare%20risc%20nitrozamine_Iulie%202020%20.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-09-07-2020\/\">Press release<\/a><div class=\"content\"><p><strong>09.07.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on the finalization of the opinion on the presence of nitrosamine impurities in medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Nitrozamine_art%205(3).pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-26-03-2020\/\">Important notification<\/a><div class=\"content\"><p><strong>26.03.2020<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of marketing authorisation holders<\/strong><\/span><br \/>\nInformation on nitrosamine impurities for marketing authorisation holders<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/ANUNTURI%20IMPORTANTE\/inf%20nitrozamine%20CMDh_26mart2020.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-20-12-2019\/\">Press release<\/a><div class=\"content\"><p><strong>20.12.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQUESTIONS AND ANSWERS regarding the document &#8220;Information on nitrosamines, to the attention of marketing authorisation holders&#8221; &#8211; Consolidated version, December 2019.<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/INTREBARI%20SI%20RASPUNSURI_nitrozamine_consolidat_dec2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/useful-information-related-to-nitrosamine-impurities-13-12-2019\/\">Useful information related to nitrosamine impurities<\/a><div class=\"content\"><p><strong>13.12.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nPractical guide developed by the CMDh for the attention of Marketing Authorisation Holders (MAHs) for medicinal products authorised nationally (also through Mutual Recognition Procedures &#8211; MRP\/Decentralised Procedure &#8211; DCP) in relation to the referral procedure triggered under the provisions of Article 5(3) of Regulation No 726\/2004, relating to nitrosamine impurities.<br \/>\n<a href=\"\/_\/NITROZAMINE\/Ghid evaluare nitrozamine CMDh 412 2019 Rev 1.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download the guide &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><br \/>\n<a href=\"\/_\/NITROZAMINE\/Formulare nitrozamine 13-12-2019.rar\" target=\"_blank\" rel=\"noopener noreferrer\">download the forms &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/package-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-18-10-2019\/\">Press release<\/a><div class=\"content\"><p><strong>18.10.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQuestion and Answer Document for marketing authorisation holders in the process of evaluating the potential presence of nitrosamine impurities in manufactured medicinal products for human use and analysing medicinal products at risk<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Update_nitrozamine_18%20oct2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-30-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>30.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nQUESTIONS AND ANSWERS regarding the document &#8220;Information on nitrosamines, to the attention of marketing authorisation holders&#8221;<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20EMA%20Nitrozamine_Qand%20A_ro.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-27-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>27.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release \u2013 INFORMATION ON NITROSAMINES to the attention of marketing authorisation holders<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/comunicat%20EMA_%20INFORMA%C8%9AII%20despre%20NITROZAMINE%20pt%20DAPP_SEPT2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-17-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>17.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on initiating the re-evaluation of ranitidine-containing medicinal products following the detection of the impurity N-nitrosodimethylamine (NDMA) impurity<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20EMA%20_ranitidina%20NDMA_ro.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-26-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>26.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on EMA recommendation to companies about taking measures to avoid the occurrence of nitrosamine impurities in medicinal products for human use<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/Comunicat%20EMA%20catre%20companii%20ref%20impuritati%20nitroz_sept2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-13-09-2019\/\">Press release<\/a><div class=\"content\"><p><strong>13.09.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on EMA&#8217;s decision to provide guidance on avoiding the presence of nitrosamine impurities in medicinal products for human use<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/COMUNICAT%20EMA%20ref%20decizia%20EMA%20de%20a%20oferi%20%C3%AEndrum%C4%83ri%20pt%20evitarea%20prezentei%20nitrozaminelor%20in%20medicamente.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-05-2019\/\">Press release<\/a><div class=\"content\"><p><strong>03.05.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on updating information on nitrosamine impurities and continuing EMA actions to prevent the appearance of impurities in medicinal products<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/actualizare_nitrozamine_ro_apr_2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/press-release-03-02-2019\/\">Press release<\/a><div class=\"content\"><p><strong>03.02.2019<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of interested persons<\/strong><\/span><br \/>\nEMA press release on the request addressed to pharmaceutical companies that manufacture medicinal products containing sartans, to review manufacturing processes in order to avoid the presence of nitrosamine impurities<br \/>\n<a href=\"https:\/\/www.anm.ro\/_\/COMUNICATE%20DE%20PRESA\/sartani_1%20feb2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">download document &#8230;<\/a> <img loading=\"lazy\" decoding=\"async\" src=\"\/imagini\/icon\/Adobe-Acrobat-Reader-CS2-icon.png\" width=\"32\" height=\"32\" align=\"absmiddle\" border=\"0\" \/><\/p>\n<\/div><\/li><\/ul><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":467,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-9832","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/9832","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=9832"}],"version-history":[{"count":4,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/9832\/revisions"}],"predecessor-version":[{"id":9838,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/9832\/revisions\/9838"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/467"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}