Search results
Results from the WOW.Com Content Network
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).
The authorization certificate works in conjunction with a public key certificate (PKC). While the PKC is issued by a certificate authority (CA) and is used as a proof of identity of its holder like a passport, the authorization certificate is issued by an attribute authority (AA) and is used to characterize or entitle its holder like a visa ...
Canadian Prime Minister Justin Trudeau promised President-elect Donald Trump that Canada would toughen controls over the long undefended joint border, a senior Canadian official said on Sunday.
Darren Criss became a fan favorite on the hit TV series "Glee," and won an Emmy for "American Crime Story." Now he's starring in the acclaimed musical "Maybe Happy Ending." He talks about his road ...
Luigi Mangione had a busy Thursday, with a whirlwind two-state courthouse tour turned spectacle featuring a helicopter ride, a throng of escorts – including the mayor of New York City at one ...
product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).