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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).
Many types of businesses require additional certification or permits beyond the Basic Business License and registration. D.C. requires a "Clean Hands Self-Certification" from most applicants, which is an affidavit stating that the applicant does not owe more than $100 to the District. Tour Guides must submit a Physician's Certificate.
Image credits: midnightsunofab**ch #3. My daughter was born with Cystic Fibrosis. We knew she was going to have this due to genetic testing that was done before she was born.
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.
Take the Brooklyn Nets, for example, who are terrible but rank sixth in 3-point attempts per game (40.1), ninth in makes (14.4) and are off to a surprising 4-4 start.
The Longhorns have dominated this series and have had bragging rights for the past 13 years after winning the last meeting in 2011 on a last-second field goal. Texas A&M’s running game vs. the ...