| 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.
| 760 | |
| 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 | |
| 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. |
| 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 | |
| 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 0,7 % of turn-over.
| 964 | |
| 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. |
| Renewal | https://legemiddelverket.no/english/regulatory-affairs/renewal | Renewal | A marketing authorisation is generally valid for five years.
| 779 | |
| 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. |
| marketing interruption and withdrawal - notification | https://legemiddelverket.no/english/regulatory-affairs/notification-of-marketing-interruption-of-a-medicinal-product-in-norway-including-withdrawal | marketing interruption and withdrawal - notification | 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.
| 768 | The MA-holder shall notify the competent authority if the product ceases to be placed on the market of the Member State. |
| Variations | https://legemiddelverket.no/english/regulatory-affairs/variations-regarding-marketing-authorisation | Variations | | 776 | Implementation in central procedure, completion of variations etc. |
| 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 | |
