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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.
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
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.
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
A special type of approval is the paediatric-use marketing authorisation (PUMA), which can be granted for medical products intended exclusively for paediatric use. [ 16 ] The CHMP is obliged by the regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further ...
Many people give Wikipedia permission to reuse their content (text, images, video, audio, etc.). We are grateful for this. However, we receive many unclear or ambiguous statements of permission (such as "I allow Wikipedia to reuse my photos").
But I do include two statistics that people are usually amazed by: the number of English Wikipedia articles (i.e., more than 6 million) and the number of visits to the Wikipedia page on which I'll link their image (I get this by clicking "Page information" under the "Tools" heading in the page sidebar, then noting "Page views in the past 30 ...
Thus, in case C-392/97, [3] the European Court of Justice held that: "where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and ...