{"id":69034,"date":"2016-03-24T17:28:17","date_gmt":"2016-03-24T17:28:17","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=745097719becba3294973c31a2501b2b"},"modified":"2016-03-24T17:28:17","modified_gmt":"2016-03-24T17:28:17","slug":"news-story-changes-to-the-way-mock-ups-are-dealt-with-guidance-for-marketing-authorisation-holders","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=69034","title":{"rendered":"News story: Changes to the way mock-ups are dealt with: Guidance for Marketing Authorisation Holders"},"content":{"rendered":"<div class=\"govspeak\">\n<p>We are changing the way we deal with mock-ups from 1st April 2016. <\/p>\n<p>This applies to all Marketing Authorisation (MA) and veterinary homeopathic remedy (VHR) applications not dealt with via the centralised application procedure.<\/p>\n<p>The key change is that you will only have to provide revised mock-ups in some cases rather than for all applications that affect them. <\/p>\n<h2 id=\"when-will-we-want-to-see-revised-mock-ups\">When will we want to see revised mock-ups<\/h2>\n<ul>\n<li>For all new MA and VHR applications<\/li>\n<li>For all variation-extension applications<\/li>\n<li>For renewal and variation applications where the number and \/ or type of change being proposed means it would be easier to see revised mock-ups rather than annotating the changes ourselves<\/li>\n<li>For any application on a product where we do not currently hold electronic versions of the mock-ups<\/li>\n<\/ul>\n<p>Where mock-ups are not requested, we will annotate the agreed changes onto the latest authorised versions and issue these to you. <\/p>\n<p>All mock-ups will be assessed by the same team during a separate mock-up phase; this will help ensure consistency of approach. <\/p>\n<p>Mock-ups should reflect the agreed Quality Review of Documentation (QRD) and we will be placing more emphasis on the assessment and maintenance of QRD text.<\/p>\n<p>All mutually recognised products have agreed QRD text, but most nationally authorised products do not. To help us get QRD text for all nationally authorised products and to facilitate mock-up procedures for these products, please see Getting QRD text for national products.<\/p>\n<p>Revised guidance can be found on the <a href=\"\">SPCs and Product Literature page<\/a>. <\/p>\n<h2 id=\"transition-period\">Transition period<\/h2>\n<p>National applications that pass validation on \/ after 1st April 2016 will be subject to the new procedures. <\/p>\n<p>An application that is already in the system and passed\/s validation before 1st April will be subject to current mock-up procedures.<\/p>\n<p>EU applications that have already entered the national phase will be subject to current mock-up procedures.<\/p>\n<h2 id=\"getting-qrd-text-for-national-products\">Getting QRD text for national products<\/h2>\n<p>You should submit QRD text for review against the latest authorised mock-ups and SPC, using this <span id=\"attachment_1472703\" class=\"attachment-inline\"><br \/>\n  <a href=\"\/government\/uploads\/system\/uploads\/attachment_data\/file\/511004\/_951529-v1_Application_form_QRD_text.docx\">QRD Text form<\/a><br \/>\n  (<span class=\"type\">MS Word Document<\/span>, <span class=\"file-size\">49.6KB<\/span>)<br \/>\n<\/span><br \/>\n by 31st July 2017; no fee will apply.<\/p>\n<p>If your product is due for renewal, you can submit QRD text for approval as part of the renewal process instead.<\/p>\n<p>We will check your QRD text and aim to issue the agreed version back to you within 90 days of receipt. Once QRD text has been agreed, please submit a revised version with all future applications that affect it.<\/p>\n<p>If you wish to submit revised QRD text and mock-ups for assessment, ie. to update the QRD using the latest template, please do so under cover of a Type IB variation (C.II.6(b)), which will be dealt with under normal variation procedures.<\/p>\n<h2 id=\"other-changes\">Other changes<\/h2>\n<p>We will no longer identify non-marketed pack sizes on the memorandum document.<br \/>\nWhen submitting mock-ups for assessment, please use the category C.II.6(b), not C.I.z.<\/p>\n<h2 id=\"contact\">Contact<\/h2>\n<p>For further information, email <a href=\"mailto:postmaster@vmd.defra.gsi.gov.uk\">postmaster@vmd.defra.gsi.gov.uk<\/a> and put \u2018Revised Mock-Up Procedure\u2019 in the subject line.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Effective from 1st April 2016. This applies to Marketing Authorisation and veterinary homeopathic remedy applications.<\/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\/69034"}],"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=69034"}],"version-history":[{"count":0,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/69034\/revisions"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=69034"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=69034"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=69034"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}