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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).
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
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.
An automatic renewal clause is used in the insurance and healthcare industries . An automatic renewal clause (also referred to as an evergreen clause), is activated towards the end of the contractual period whereby it automatically renews the terms of an agreement except when the contract is terminated (through mutual agreement or contract breach), or one of the contracting parties has sent a ...
Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products (i.e. authorisation to put these products on the market). [1] A supplementary protection certificate comes into force only after the corresponding general patent expires.
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 ...