{"id":87325,"date":"2017-12-14T15:06:07","date_gmt":"2017-12-14T15:06:07","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=dee8b138311f2499fdd4493b930a13b8"},"modified":"2017-12-14T15:06:07","modified_gmt":"2017-12-14T15:06:07","slug":"news-story-animal-medicines-improvement-notice-bio-tech-solutions-ltd","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=87325","title":{"rendered":"News story: Animal medicines improvement notice: Bio-Tech Solutions Ltd"},"content":{"rendered":"<div class=\"govspeak\">\n<p>This notice was issued to Bio-Tech Solutions Ltd, following a pharmacovigilance (<abbr title=\"Pharmacovigilance\">PhV<\/abbr>) inspection which highlighted Bio-tech Solutions Ltd had contravened the Veterinary Medicines Regulation 2013:<\/p>\n<ul>\n<li>Schedule 1, paragraph 55 (Qualified persons responsible for pharmacovigilance)<\/li>\n<li>Schedule 1, paragraph 56 (Duties relating to the qualified person)<\/li>\n<li>Schedule 1, paragraph 57 (Adverse reactions to a veterinary medicinal product administered in the United Kingdom)<\/li>\n<li>Schedule 1, paragraph 59 (Periodic safety update reports)<\/li>\n<\/ul>\n<p>The improvements required are:<\/p>\n<ul>\n<li>Implement a back-up procedure covering all aspects of <abbr title=\"Pharmacovigilance\">PhV<\/abbr>\n<\/li>\n<li>Implement an appropriate training plan and training records for the Qualified Person for Pharmacovigilance (QPPV) and deputy<\/li>\n<li>Implement <abbr title=\"Pharmacovigilance\">PhV<\/abbr> agreements with all named distributors<\/li>\n<li>Establish a database to ensure all suspected adverse reactions are collated and accessible<\/li>\n<li>Migrate historical adverse events into the database once established<\/li>\n<li>Register with <abbr title=\"EudraVigilance Veterinary database\">EVVET<\/abbr>\n<\/li>\n<li>Ensure internal procedures are adequate to ensure reporting deadlines are not missed<\/li>\n<li>Ensure internal procedures are sufficient to ensure all <abbr title=\"Periodic safety update reports\">PSURs<\/abbr> contain all required information and are submitted on time<\/li>\n<li>\n<abbr title=\"Periodic safety update reports\">PSURs<\/abbr> with data lock point of 31\/12\/17 should be submitted to the VMD no later than 60 days after data lock point<\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Details of the improvement notice issued to Bio-Tech Solutions Ltd, Driffield, East Yorkshire, published in December 2017.<\/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\/87325"}],"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=87325"}],"version-history":[{"count":0,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/87325\/revisions"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=87325"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=87325"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=87325"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}