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
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
Renewalhttps://legemiddelverket.no/english/regulatory-affairs/renewalRenewalA marketing authorisation is generally valid for five years. 779
Variationshttps://legemiddelverket.no/english/regulatory-affairs/variations-regarding-marketing-authorisationVariations776Implementation in central procedure, completion of variations etc.
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
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
Notification of marketing interruption, including withdrawalhttps://legemiddelverket.no/english/regulatory-affairs/notification-of-marketing-interruption-of-a-medicinal-product-in-norway-including-withdrawalNotification of marketing interruption, including withdrawalAccording 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. 768
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.
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 control fee of 0,6 % of turn-over. 964
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.
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.
Medical deviceshttps://legemiddelverket.no/english/regulatory-affairs/medical-devicesMedical devicesThe Norwegian Directorate of Health is competent authority for medical devices, and has administrative and advisory responsibilities related to legislation and supervisory authority over manufacturers, distributors and notified bodies. 447The Norwegian Directorate of Health is competent authority for medical devices.