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 applicationsApplication forms for mutual recognition procedure (MRP)/decentralised procedure (DCP) and centralised procedure (CP) must be used when submitting MA applications. SmPC/SPC, PL and labelling must also be submitted and approved.765
Guideline on use of bulk packages with automated dose dispensinghttps://legemiddelverket.no/english/regulatory-affairs/guideline-on-use-of-bulk-packages-with-automated-dose-dispensingGuideline on use of bulk packages with automated dose dispensingThe Norwegian medicinal product regulation Art 2-2 i) gives an exemption from the requirement for marketing authorisation for bulk packages that are dose dispensed by an automated process.2793
License to sell foreign packages - applicationhttps://legemiddelverket.no/english/regulatory-affairs/application-license-to-sell-foreign-packsLicense to sell foreign packages - applicationNoMA can make exceptions to the requirement of a Norwegian marketing authorization when marketing interruption consequences would affect public health.2317
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.
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
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
Parallel importhttps://legemiddelverket.no/english/regulatory-affairs/parallel-importParallel importGeneral guidance on marketing authorisations for parallel import 3119Guideline on marketing authorisation for parallel import and post-authorisation obligations
Product information - recommended updateshttps://legemiddelverket.no/english/regulatory-affairs/product-information-recommended-updatesProduct information - recommended updatesMarket authorisation holdes (MAHs) are responsible for updating product information according to new information about relevant medicinal products. 1021
Product information - templates and guidancehttps://legemiddelverket.no/english/regulatory-affairs/product-information-templates-and-guidanceProduct information - templates and guidanceProduct information should always be submitted in an electronic format. Summary of product characteristics (SmPC) and Package leaflet (PIL) should be submitted in word format (with tracked changes for variations) and mock-ups in pdf format.1038Information about QRD templates, naming, blue box requirements for PIL, labelling etc.
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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