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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.
In the European Economic Area (European Union member countries, Iceland, Liechtenstein and Norway), a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent. It enters into force after expiry of a patent upon which it is based.
To sell or use these substances, manufacturers, importers, and retailers in the European Union (EU) must apply for authorization from the ECHA. The applicant is to submit a chemical safety report on the risks entailed by the substance, as well as an analysis of possible alternative substances or technologies including present and future ...
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 ...
What is the H-1B visa program? Created in 1990 by the Immigration Act, the H-1B is a temporary, nonimmigrant visa program that allows companies to request permission to hire very skilled foreign ...
The CCC certificate and the Permission of Printing, which allows the manufacturer to mark the CCC-certified product with the CCC mark, must be renewed annually in order to keep the validity of the certificate. The renewal can only be done through a follow-up certification. Part of the follow-up certification is a one-day factory audit.
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).