{"id":53210,"date":"2015-02-02T10:33:05","date_gmt":"2015-02-02T10:33:05","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=52091879dad16be0d97c33562bf32181"},"modified":"2015-02-02T10:33:05","modified_gmt":"2015-02-02T10:33:05","slug":"news-story-changes-to-marketing-authorisation-documentation-memorandum","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=53210","title":{"rendered":"News story: Changes to marketing authorisation documentation: memorandum"},"content":{"rendered":"<div class=\"govspeak\">\n<h2 id=\"changes-to-be-introduced-on-all-memorandum-documents-issued-after-9-february-2015\">Changes to be introduced on all memorandum documents issued after 9 February 2015<\/h2>\n<p>The memorandum document (memo-doc) unofficially forms part of a medicinal product\u2019s marketing authorisation (<abbr title=\"marketing authorisation\">MA<\/abbr>). <\/p>\n<p>The memo-doc is not a public document and is only shared with the <abbr title=\"marketing authorisation\">MA<\/abbr> holder of the product concerned.<\/p>\n<p>Information is being duplicated with a list of completed applications at the end of the memo-doc which is also provided in the product\u2019s post authorisation assessment (<abbr title=\"Post Authorisation Assessment\">PAA<\/abbr>) document. This document is published in the <a rel=\"external\" href=\"http:\/\/www.vmd.defra.gov.uk\/ProductInformationDatabase\/\">Product Information Database<\/a>.<\/p>\n<p>The level of information in the <abbr title=\"Post Authorisation Assessment\">PAA<\/abbr> is not as detailed as that provided in the memo-doc, but the extra detail in the memo-doc, mostly in relation to variations, is included on the approval certificate issued to the <abbr title=\"marketing authorisation\">MA<\/abbr> holder at the end of an application procedure.<\/p>\n<h3 id=\"changes-to-be-introduced\">Changes to be introduced:<\/h3>\n<ul>\n<li>tidying up of wording in the opening paragraphs<\/li>\n<li>removing the date of original authorisation which is on the <abbr title=\"Summary of Product Characteristics\">SPC<\/abbr>\n<\/li>\n<li>removing the history table which lists completed applications<\/li>\n<li>removing the reference to who it was prepared by, authorised and date sections<\/li>\n<li>introducing the version control procedure used for SPCs and mock-ups<\/li>\n<li>only issuing an updated memo-doc following completion of an application procedure that results in changes to the content <\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Duplication of information identified following a review of authorisation documentation issued to the authorisation holder.<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"_links":{"self":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/53210"}],"collection":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=53210"}],"version-history":[{"count":0,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/53210\/revisions"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=53210"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=53210"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=53210"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}