The regulator may appoint officers to inspect and obtain information in accordance with general regulatory powers in order to ensure ongoing compliance with the requirements.<\/p>\n
Records must be kept of all products supplied and dispatched, including dates, details of consignee, supplier, etc.\u00a0 They must be maintained for five years. They must be capable of identifying products in batches that may not conform with requirements.<\/p>\n
Dispatch notes must be kept and retained in respect of supplies and sales. The requirements also apply to importers of parallel importers from other EU States.<\/p>\n
There are procedural provisions in respect of the grant, revocation, suspension and variation of the terms of a wholesaler’s authorisation.\u00a0\u00a0 Wholesalers may be authorised to import from other EU States for distribution under the terms of their authorisation.\u00a0 Broadly, similar obligations apply as apply generally.<\/p>\n\n
\n <\/div>\n\n","protected":false},"excerpt":{"rendered":"
Manufacture Authorisation The regulations on the manufacture of medicinal products are based on EU Directives.\u00a0 The competent authority is the Health Products Regulatory Authority. A manufacturer\u2019s authorisation allows the manufacture of medicinal products for supply in the European Economic Area (EU plus EFTA countries) or for export outside the EEA. \u00a0The manufacture of ingredients per […]<\/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\/10353"}],"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=10353"}],"version-history":[{"count":3,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10353\/revisions"}],"predecessor-version":[{"id":32220,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10353\/revisions\/32220"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=10353"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=10353"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=10353"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}