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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.
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 Certification Practice Statement (CPS) is a document from a certificate authority or a member of a web of trust which describes their practice for issuing and managing public key certificates. [1] Some elements of a CPS include documenting practices of: issuance; publication; archiving; revocation; renewal
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.
A certificate of deposit, also known as a CD, is an account that pays interest on your money for a set period of time. The end of the CD’s term — also referred to as the time it matures — is ...
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 ...