{"id":56373,"date":"2015-04-15T14:31:04","date_gmt":"2015-04-15T14:31:04","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=04975d06283546ff86ac8041888f1a45"},"modified":"2015-04-15T14:31:04","modified_gmt":"2015-04-15T14:31:04","slug":"news-story-biopharmaceutical-products-or-products-containing-a-pbt-substance","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=56373","title":{"rendered":"News story: Biopharmaceutical products or products containing a PBT substance"},"content":{"rendered":"<div class=\"govspeak\">\n<p>Work is currently being undertaken by the <abbr title=\"Committee for Medicinal Products for Veterinary Use\">CVMP<\/abbr> to provide greater clarity on the authorisation of products containing substances designated as persistent bio accumulative and toxic (<abbr title=\"persistent bio accumulative and toxic\">PBT<\/abbr>) to the environment.<\/p>\n<p>The potential for <abbr title=\"persistent bio accumulative and toxic\">PBT<\/abbr> substances to have harmful effects on the environment will form part of the benefit:risk evaluation where the overall need for the product will be considered against potential risks.<\/p>\n<p>The outcome of this evaluation has to be positive for a Marketing Authorisation (<abbr title=\"Marketing Authorisation\">MA<\/abbr>) to be granted. Therefore, it is important that the <abbr title=\"persistent bio accumulative and toxic\">PBT<\/abbr> aspects of a product are considered early in product development. <\/p>\n<p>During product development, should you discover or have concerns, that a product you are developing contains a <abbr title=\"persistent bio accumulative and toxic\">PBT<\/abbr> substance, we advise you to come in for a company meeting before applying for a <abbr title=\"Marketing Authorisation\">MA<\/abbr>.<br \/>\nLikewise for biopharmaceutical products, it would be helpful to meet with you prior to the submission of your application. <\/p>\n<p>Biopharmaceuticals are outside the usual type of application and a meeting beforehand will help the <abbr title=\"Veterinary Medicines Directorate\">VMD<\/abbr> to better understand your product and assign the appropriate assessors.<\/p>\n<p>To arrange a company meeting please contact Chris Abbott: <a href=\"mailto:c.abbott@vmd.defra.gsi.gov.uk\">c.abbott@vmd.defra.gsi.gov.uk<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Clarification about applications for biopharmaceutical products or products containing a persistent bio accumulative and toxic (PBT) substance to the environment<\/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\/56373"}],"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=56373"}],"version-history":[{"count":0,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/56373\/revisions"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=56373"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=56373"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=56373"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}