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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.
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.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
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.
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.
2. Evaluate your investments and take your RMDs. The end of the year is an ideal time to review your investment strategy to make sure your portfolio is still on the right track to meet your goals.
The Possum Pie is the Natural State's signature dessert with an animal in its name but not in the ingredients. Fox News Digital spoke to an Arkansas baker who describes what's actually in it.
This reform combined the business license, organization code certificate, and tax registration certificate into a single document called the "Three-in-One" business license, featuring a unique 18-digit identifier for every business called the Unified Social Credit Code. Building on the success of the "Three-in-One" reform, China combined the ...