CHMP Referral - national implementation Referral - national implementationThe Norwegian Medicines Agency implements CHMP arbitration updates nationally as the respective Commission Decisions are issued.759
Homeopathic medicinal products 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
Marketing Authorisation Applications 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
Marketing interruption and withdrawal - notification 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.
Medicinal products to be distributed without medical prescription 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
Product Information - templates and guidance Information - templates and guidance1038Information about QRD templates, naming, blue box requirements for PIL, labelling etc.
Regulatory Fees 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 1,0 % of turn-over. 964
Submission of applications of applications774Electronic Application Forms (eAF) are mandatory in all procedures for initial marketing authorisations, variations and renewals.
Renewal marketing authorisation is generally valid for five years. 779
Sunset Clause ClauseA market authorisation shall cease to exist if the marketing authorisation is not followed by the actual placing on the market.780
WHO-certificates and fee regarding Certificate of Pharmaceutical Product.
Variations in central procedure, completion of variations etc.
Whom to contact regarding regulatory questions? 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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