CHMP Referral - national implementationhttps://legemiddelverket.no/english/regulatory-affairs/chmp-referral-national-implementationCHMP Referral - national implementationThe Norwegian Medicines Agency implements CHMP arbitration updates nationally as the respective Commission Decisions are issued.759
Homeopathic medicinal productshttps://legemiddelverket.no/english/regulatory-affairs/homeopathic-medicinal-productsHomeopathic medicinal productsAll homeopathic medicinal products intended to be sold in Norway after 12.01.2017 have to be registered as a homeopathic medicinal product in Norway or an application for registration must be submitted to the NoMA before the same date. 760All homeopathic medicinal products intended to be sold in Norway have to be registered.
Marketing Authorisation Applicationshttps://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applicationsMarketing Authorisation ApplicationsThe different procedures for granting a marketing authorisation for a medicinal product are described in Notice to Applicants and on the main page for Regulatory affairs. 765
Marketing interruption and withdrawal - notificationhttps://legemiddelverket.no/english/regulatory-affairs/notification-of-marketing-interruption-of-a-medicinal-product-in-norway-including-withdrawalMarketing interruption and withdrawal - notificationAccording to art 23a of the Directive 2001/83/EC the MA-holder shall notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. 768The MA-holder shall notify the competent authority if the product ceases to be placed on the market of the Member State.
Medicinal products to be distributed without medical prescriptionhttps://legemiddelverket.no/english/regulatory-affairs/otc-statusMedicinal products to be distributed without medical prescriptionAll medicinal products that are distributed without a prescription in Norway are called OTC (Over The Counter) medicines.769
Product Information - templates and guidancehttps://legemiddelverket.no/english/regulatory-affairs/product-information-templates-and-guidanceProduct Information - templates and guidance1038Information about QRD templates, naming, blue box requirements for PIL, labelling etc.
Submission of applicationshttps://legemiddelverket.no/english/regulatory-affairs/submission-of-applicationsSubmission of applications774Electronic Application Forms (eAF) are mandatory in all procedures for initial marketing authorisations, variations and renewals.
Regulatory Feeshttps://legemiddelverket.no/english/regulatory-affairs/regulatory-feesRegulatory FeesHolders of marketing authorisations (MAH) have to pay a regulatory fee when they apply for marketing authorisation. MAHs in the Norwegian market are also liable to pay a supplier tax of 1,0 % of turn-over. 964
Renewalhttps://legemiddelverket.no/english/regulatory-affairs/renewalRenewalA marketing authorisation is generally valid for five years. 779
Regulatory information regarding Brexithttps://legemiddelverket.no/english/regulatory-affairs/regulatory-information-regarding-brexitRegulatory information regarding BrexitMarketing authorisation holders (MAHs) are required to transfer several important activities from the United Kingdom (UK) to the Union (EEA) when UK leaves the EU. 2071
Sunset Clausehttps://legemiddelverket.no/english/regulatory-affairs/sunset-clause-information-in-englishSunset ClauseA market authorisation shall cease to exist if the marketing authorisation is not followed by the actual placing on the market.780
WHO-certificateshttps://legemiddelverket.no/english/regulatory-affairs/who-certificatesWHO-certificates775Information and fee regarding Certificate of Pharmaceutical Product.
Variationshttps://legemiddelverket.no/english/regulatory-affairs/variations-regarding-marketing-authorisationVariations776Implementation in central procedure, completion of variations etc.
Whom to contact regarding regulatory questions?https://legemiddelverket.no/english/regulatory-affairs/whom-to-contact-regarding-regulatory-questionsWhom to contact regarding regulatory questions?At NoMA the area of responsibility "timely access" holds the responsibility for regulatory affairs until the MA for a medicinal product is issued. The area of responsibility "proper use" holds the responsibility for actions after this point of time. 773

​Fant du det du lette etter?