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In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
If you've been having trouble with any of the connections or words in Saturday's puzzle, you're not alone and these hints should definitely help you out. Plus, I'll reveal the answers further down
Ever since my kids grew up, I've used the holiday season to book long, international trips. I don't celebrate anyway, and I love traveling. I don't like celebrating Christmas.
The House Ethics Committee secretly voted earlier this month to release its report into the conduct of former Rep. Matt Gaetz before the end of this Congress, according to multiple sources with ...
Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products (i.e. authorisation to put these products on the market). [1] A supplementary protection certificate comes into force only after the corresponding general patent expires.
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