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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.
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).
The FDA, in its letter on Wednesday, said the company was marketing kits which include certain misbranded piston syringes made by China's Jiangsu Shenli Medical Production and neither had approval ...
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 ...
The online renewal process may be used by any EMS attendant or Instructor Coordinator, unless the following apply: It is more than 30 days past your renewal date, You have not met continuing ...
The letters sought to create a false sense of urgency, with phrases like 'final notice,' and 'immediate response requested.'" These types of phrases could cause any consumer to stop in their tracks.
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