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. 760
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
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

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