{"id":1245,"date":"2017-02-23T11:31:55","date_gmt":"2017-02-23T11:31:55","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=1245"},"modified":"2026-07-22T07:40:53","modified_gmt":"2026-07-22T04:40:53","slug":"lizibilitate","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/lizibilitate\/","title":{"rendered":"Readability"},"content":{"rendered":"

> Status of company accreditation<\/a>
\n> Readability specific legislation<\/a><\/p>\n

Readability notifications<\/strong><\/span><\/p>\n\n\n\n\n
02.07.2026<\/b><\/td>\nTo the attention of interested persons<\/strong>
\nFor the implementation of the Guideline on the details of various categories of changes, the application of the procedures referred to in Sections II, IIa, III and IV of Commission Regulation (EC) No 1234\/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use, as well as the documentation to be submitted thereof, the readability tests<\/span> containing the consultation with the target patient groups shall be submitted in the form of a Type IB\/C.11 variation<\/span>.
\nIn line with Order of the Minister of Health no. 888\/2014, the fee for this variation is 500 Euros<\/span>.\n<\/td>\n<\/tr>\n
08.03.2024<\/b><\/td>\nTo the attention of interested persons<\/strong>
\nWe would like to inform you that as of the 8th of March 2024, the Form for payment of the fees for Types IA, IB and II variations, the transfer of marketing authorisation and other changes to the marketing authorisation for nationally authorised medicinal products through the \u201cReadability test\u201d national procedure have been modified.\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/p>\n

Status of company accreditation<\/strong><\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
04.11.2015<\/b><\/td>\nCompanies accredited for consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
14.01.2015<\/b><\/td>\nCompanies accredited for consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
13.03.2013<\/b><\/td>\nStatus of accreditation related to applications for grant of Certificate for consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
04.04.2012<\/b><\/td>\nOriginal package leaflet or mock-up.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
02.04.2012<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
27.03.2012<\/b><\/td>\nDetailed implementation deadlines for readability testing.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
23.01.2012<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
30.11.2011<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
06.09.2011<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
21.06.2011<\/b><\/td>\nReport on readability test results to be assessed on NAMMD approval of\/agreement with package leaflet used for testing.
\nFor amendments to NAMMD previously approved\/agreed package leaflet (e.g., following initial testing), testing continues with the new package leaflet version, after NAMMD approval, within the same variation.<\/td>\n<\/tr>\n
16.06.2011<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
04.03.2011<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
25.02.2011<\/b><\/td>\nOne of the topics of the Workshop on the Summary of Product Characteristics and Leaflet, to take place within the CERF project, in the Council Room of the “Carol Davila” Faculty of Medicine in Bucharest on 25 March, will be consultation with the target patient groups and deadlines for submission of reports providing summaries of these consultations.
\nQuestions related to this topic must be submitted to the informatii@anm.ro<\/a>.<\/td>\n<\/tr>\n
24.01.2011<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet 2.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
15.12.2010<\/b><\/td>\nAn overview of activities related to accreditation of companies conducting consultation with target patient groups for the Package Leaflet is provided in the attached report and was presented to the NAMMD Scientific Council on 13.12.2010. It has been approved by Scientific Council Decision no 35\/ 13.12.2010, provided under Legislation.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
10.12.2010<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
17.11.2010<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
18.10.2010<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
06.10.2010<\/b><\/td>\nStatus of accreditation of companies conducting consultation with target patient groups for the Package Leaflet.
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

> Status of company accreditation > Readability specific legislation Readability notifications 02.07.2026 To the attention of interested persons For the […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":467,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1245","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1245","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=1245"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1245\/revisions"}],"predecessor-version":[{"id":12238,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1245\/revisions\/12238"}],"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=1245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}