|Whom to contact regarding regulatory questions?||https://legemiddelverket.no/english/regulatory-affairs/whom-to-contact-regarding-regulatory-questions||Whom 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 Applications||https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications||Marketing Authorisation Applications||The 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|
|Renewal||https://legemiddelverket.no/english/regulatory-affairs/renewal||Renewal||A marketing authorisation is generally valid for five years.
|Variations||https://legemiddelverket.no/english/regulatory-affairs/variations-regarding-marketing-authorisation||Variations||776||Implementation in central procedure, completion of variations etc.|
|CHMP Referral - national implementation||https://legemiddelverket.no/english/regulatory-affairs/chmp-referral-national-implementation||CHMP Referral - national implementation||The Norwegian Medicines Agency implements CHMP arbitration updates nationally as the respective Commission Decisions are issued.||759|
|Homeopathic medicinal products||https://legemiddelverket.no/english/regulatory-affairs/homeopathic-medicinal-products||Homeopathic medicinal products||All 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.
|Medicinal products to be distributed without medical prescription||https://legemiddelverket.no/english/regulatory-affairs/otc-status||Medicinal products to be distributed without medical prescription||All medicinal products that are distributed without a prescription in Norway are called OTC (Over The Counter) medicines.||769|
|Notification of marketing interruption, including withdrawal||https://legemiddelverket.no/english/regulatory-affairs/notification-of-marketing-interruption-of-a-medicinal-product-in-norway-including-withdrawal||Notification of marketing interruption, including withdrawal||According 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.
|Product Information - templates and guidance||https://legemiddelverket.no/english/regulatory-affairs/product-information-templates-and-guidance||Product Information - templates and guidance||1038||Information about QRD templates, naming, blue box requirements for PIL, labelling etc.|
|Regulatory Fees||https://legemiddelverket.no/english/regulatory-affairs/regulatory-fees||Regulatory Fees||Holders 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.
|Submission of applications||https://legemiddelverket.no/english/regulatory-affairs/submission-of-applications||Submission of applications||774||Electronic Application Forms (eAF) are mandatory in all procedures for initial marketing authorisations, variations and renewals. |
|Sunset Clause||https://legemiddelverket.no/english/regulatory-affairs/sunset-clause-information-in-english||Sunset Clause||A market authorisation shall cease to exist if the marketing authorisation is not followed by the actual placing on the market.||780|
|WHO-certificates||https://legemiddelverket.no/english/regulatory-affairs/who-certificates||WHO-certificates||775||Information and fee regarding Certificate of Pharmaceutical Product.|
|Medical devices||https://legemiddelverket.no/english/regulatory-affairs/medical-devices||Medical devices||The 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. ||447||The Norwegian Directorate of Health is competent authority for medical devices.|