{"id":191,"date":"2013-04-02T09:48:19","date_gmt":"2013-04-02T07:48:19","guid":{"rendered":"http:\/\/dev.laaketietokeskus.fi\/vnrwiki\/?page_id=191"},"modified":"2024-06-14T13:17:34","modified_gmt":"2024-06-14T10:17:34","slug":"no-impact-on-vnr-when-an-article-andor-package-is-changed","status":"publish","type":"page","link":"https:\/\/wiki.vnr.fi\/?page_id=191","title":{"rendered":"NO: The changes to an Vnr introduced to the market"},"content":{"rendered":"<p>For the common Nordic regulatory framework on changes, see Nordic Instructions.<br \/>\nOn the topics of changes in the Nordic Instructions, please note the following elaborations:<\/p>\n<p><strong>Change of trade name<\/strong><\/p>\n<p>Any change of trade name should be followed by a new Vnr. Adjustments or minor changes in the name may be allowed as long as the product appears principally unchanged.<\/p>\n<p><strong>Change of package type<\/strong><\/p>\n<p>Change of package type, e.g. from blister to container, requires a new Vnr. For changes to <em>package materials<\/em> with no impact on pricing, the Vnr can be kept. The register distinguishes between ordinary blisterpack and unitdose blisterpacks to facilitate handling in hospitals and hospital pharmacies.<\/p>\n<p><strong>Change of prescription group for medicines with MA<\/strong><\/p>\n<p>When changing the prescription group from C (prescription) to F (non-prescription), a new Vnr is required. The package must be approved by the NOMA if the prescription group is to be changed from C to F.<\/p>\n<p>When changing the prescription group from F to C, a new Vnr is normally required due to logistic and medicine statistic requirements. With respect to medicine statistics, it is required to differentiate between prescription and non-prescription sales.<\/p>\n<p><strong>Notification of change<\/strong><\/p>\n<p>The pharmaceutical company must notify Farmalogg on changes to information elements maintained by Farmalogg. A guideline on what information the company must communicate is available at farmalogg.no after logging in.<\/p>\n<p>There is no link between the systems for NNC and Vareregisteret. Thus, any relevant changes concerning the Vnr must be communicated to both Farmalogg and NNC.<\/p>\n<p>Please note that new Vnrs always must be registered and processed as <em>new<\/em> products in Vareregisteret. It is not possible to change the Vnr on an already marketed Vnr.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For the common Nordic regulatory framework on changes, see Nordic Instructions. On the topics of changes in the Nordic Instructions, please note the following elaborations: Change of trade name Any change of trade name should be followed by a new Vnr. Adjustments or minor changes in the name may be &#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":99,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"footnotes":""},"language":[7],"class_list":["post-191","page","type-page","status-publish","hentry","language-no","column","twocol"],"_links":{"self":[{"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=\/wp\/v2\/pages\/191","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=191"}],"version-history":[{"count":22,"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=\/wp\/v2\/pages\/191\/revisions"}],"predecessor-version":[{"id":3372,"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=\/wp\/v2\/pages\/191\/revisions\/3372"}],"up":[{"embeddable":true,"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=\/wp\/v2\/pages\/99"}],"wp:attachment":[{"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=191"}],"wp:term":[{"taxonomy":"language","embeddable":true,"href":"https:\/\/wiki.vnr.fi\/index.php?rest_route=%2Fwp%2Fv2%2Flanguage&post=191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}