| 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 | All homeopathic medicinal products intended to be sold in Norway have to be registered. |
| Marketing Authorisation applications | https://legemiddelverket.no/english/regulatory-affairs/marketing-authorisation-applications | Marketing Authorisation applications | Application 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 dispensing | https://legemiddelverket.no/english/regulatory-affairs/guideline-on-use-of-bulk-packages-with-automated-dose-dispensing | Guideline on use of bulk packages with automated dose dispensing | The 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 - application | https://legemiddelverket.no/english/regulatory-affairs/application-license-to-sell-foreign-packs | License to sell foreign packages - application | NoMA can make exceptions to the requirement of a Norwegian marketing authorization when marketing interruption consequences would affect public health. | 2317 | |
| 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. |
| 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. |
| 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 supplier tax of 1.0 % of turn-over.
| 964 | |
| Renewal | https://legemiddelverket.no/english/regulatory-affairs/renewal | Renewal | A marketing authorisation is generally valid for five years.
| 779 | |
| 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 | |
| Parallel import | https://legemiddelverket.no/english/regulatory-affairs/parallel-import | Parallel import | General guidance on marketing authorisations for parallel import | 3119 | Guideline on marketing authorisation for parallel import and post-authorisation obligations |
| Product information - recommended updates | https://legemiddelverket.no/english/regulatory-affairs/product-information-recommended-updates | Product information - recommended updates | Market authorisation holdes (MAHs) are responsible for updating product information according to new information about relevant medicinal products. | 1021 | |
| Product information - templates and guidance | https://legemiddelverket.no/english/regulatory-affairs/product-information-templates-and-guidance | Product information - templates and guidance | Product 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. | 1038 | Information about QRD templates, naming, blue box requirements for PIL, labelling etc. |
| 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. |
| 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 | |
