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  2. Marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation

    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.

  3. Marketing Authorisation Application - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation...

    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.

  4. Certificate of pharmaceutical product - Wikipedia

    en.wikipedia.org/wiki/Certificate_of...

    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).

  5. Europe revokes marketing authorization for generic versions ...

    www.aol.com/news/europe-revokes-marketing...

    While the patent for Biogen's drug has expired in the United States, it had scored a win in Europe in March after the EU's Court of Justice blocked generic versions of Tecfidera in the region.

  6. Consolidated Appropriations Act, 2022 - Wikipedia

    en.wikipedia.org/wiki/Consolidated...

    Manufacturers that do submit a PMTA to the FDA by the May 14, 2022 deadline can continue marketing their products until July 13, 2022, after which time the products must be removed from retail stores unless the FDA has issued a PMTA marketing authorization order by the July 13, 2022 deadline date. [11] [12]

  7. Supplementary protection certificate - Wikipedia

    en.wikipedia.org/wiki/Supplementary_protection...

    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 ...

  8. DocuSign (DOCU) Q3 2025 Earnings Call Transcript - AOL

    www.aol.com/finance/docusign-docu-q3-2025...

    Image source: The Motley Fool. DocuSign (NASDAQ: DOCU) Q3 2025 Earnings Call Dec 05, 2024, 5:00 p.m. ET. Contents: Prepared Remarks. Questions and Answers. Call ...

  9. Brand licensing - Wikipedia

    en.wikipedia.org/wiki/Brand_licensing

    Brand licensing is a well-established business, in both patents and trademarks.A concept established in British business, the world's first licensed character was a soft toy of Peter Rabbit, a fictional character created by Beatrix Potter and patented in 1903, to be sold alongside the first public edition of The Tale of Peter Rabbit.

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