Approval and maintenance of marketing authorisation (MA)
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- : The text has been written in more detail, and the content has been updated. The following paragraphs are new: Through the EEA agreement, Norway adopted the complete Community acquis on medicinal products. Application for Marketing Authorisation. Follow-up of the Marketing Authorisation
In the MA application, the applicant must document the product`s quality, safety, and efficacy. If the requirements are met, it will be approved. After approval, the MA holder must monitor adverse reactions and ensure high production and control quality.
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Through the EEA agreement, Norway adopted the complete Community acquis on medicinal products
Through the EEA Agreement, Norway has committed to implementing the EU's regulations for the approval of medicinal products. This regulatory framework has been implemented in Norway through the Medicines Act and associated regulations. When new regulations and directives are incorporated into the EEA Agreement, they will be transposed into legally binding acts in Norway.
Application for Marketing Authorisation
If a product is classified as a medicinal product, a marketing authorisation issued by NOMA is required to place the medicinal product on the market in Norway. Read more about the application requirements, procedures, approval, or refusal of the application on the website "Application for Marketing Authorization."
Follow-up of the Marketing Authorisation
The marketing authorisation grants the MA holder the right to sell the medicinal product in Norway in accordance with the authorisation. The MA holder must also comply with other relevant regulations.
The marketing authorisation holder must be established in the EEA and is responsible for the product. The MA holder is obliged to monitor the use of the product to ensure that medicine remain safe and effective. It is also required that the MA holder keep up with the technical and scientific progress. If changes to the documentation and/or product information are required, the MA holder must submit an application to NOMA.
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