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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.
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 ...
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.
Pupford Beef Liver Training Freeze-Dried Dog Treats We gave these to our tester Isaiah for his dog Hayes to try. He reports back that they're his new favorite treat and are a suitable size for ...
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 ...
Natalie Wood’s tragic death at age 43 left many to question the circumstances surrounding her fatal drowning for decades.. Beginning her career in Hollywood at the age of 5, Wood became an ...