EU Directive on Clinical Trials implemented through regulations supplements and largely replaces the Control of Clinical Trial Act. Products used in clinical trials may include new products or variations from those authorised.<\/p>\n
An ethics opinion committee is required from the regulator before conducting and a consent before conducting a trial. There are provisions regarding the manufacture, importation, supply and labelling of investigational medical products. They deal with pharmacovigilance and need to comply with good clinical practice and manufacturing practices.<\/p>\n
There are provisions in relation to the establishment of an ethics committee. They must be independent, comprising healthcare professionals and lay persons. They must confirm the suitability of the protocol and investigators, adequacy of facilities, appropriate insurance, indemnity compensation, etc.<\/p>\n
Medical trials must be conducted in accordance with internationally recognised ethical and scientific quality requirements. There are requirements for reporting and recording clinical trials involving humans.<\/p>\n
There are detailed provisions regarding consent due by participants, including in particular with reference to children and persons who lack capacity.<\/p>\n
There are exceptions for doing interventional studies and trials, which is where the products and medicinal products are prescribed in the usual manner in accordance with the marketing authorisation.<\/p>\n\n
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Medical Product Authorisation A medicinal product is any substance or combination of substances presented as having properties for treating or preventing disease in human beings or any substance or combination which may be administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[141],"tags":[],"_links":{"self":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10355"}],"collection":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/comments?post=10355"}],"version-history":[{"count":7,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10355\/revisions"}],"predecessor-version":[{"id":32217,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10355\/revisions\/32217"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=10355"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=10355"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=10355"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}