Marketing Authorisation Holder definition

Marketing Authorisation Holder means the holder of the relevant Marketing Authorisation;
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Marketing Authorisation Holder means a manufacturer or supplier that holds a marketing authorisation;
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Marketing Authorisation Holder means the holder of a Marketing Authorisation;
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Examples of Marketing Authorisation Holder in a sentence

  • Marketing authorisation holder shall submit an application for a variation requiring assessment to a competent authority or to the Agency.

  • Where a human medicinal product is concerned, the Marketing authorisation holder shall provide to the Institute data and documentation related to the quality, safety, and efficacy, including any changes implemented since the issue of the marketing authorisation so that complex data and documentation for the concerned medicinal product be available.

  • Marketing authorisation holder and manufacturer • According to the Medicines Act, the party responsible for marketing the product must submit the application for registration in the register.

  • In addition, the Marketing authorisation holder (MAH) took the opportunity to introduce minor editorial changes to the PI.The variation proposes amendments to the Summary of Product Characteristics and to the Risk Management Plan (RMP).

  • The RMP version 2.0 has also been submitted.In addition, the Marketing authorisation holder (MAH) took the opportunity to submit a corrected version of the final report of study B1971016, which was included in the initial marketing authorisation application.The variation requested amendments to the Summary of Product Characteristics and Package Leaflet and to the Risk Management Plan (RMP).


More Definitions of Marketing Authorisation Holder

Marketing Authorisation Holder means, in respect of a Marketing Authorisation, the holder of such Marketing Authorisation from time to time.
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Marketing Authorisation Holder means a legal person seated in the Republic of Croatia holding an authorisation for the marketing of a drug product in the Republic of Croatia,
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Marketing Authorisation Holder means the holder of a marketing authorisation, as defined in Regulation 3(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007);
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Marketing Authorisation Holder means any natural or legal person established in the European Union that is in possession of a marketing authorisation issued by the Agency for Medicinal Products and Medical Devices or the European Commission and that is responsible for placing medicinal products on the market,
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Marketing Authorisation Holder. (MAH) means the Party named on the Marketing Authorisation for a specific product in a particular country
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Marketing Authorisation Holder means a natural or legal person in possession of a licence or marketing authorization issued by the Board for a Pharmaceutical Product to be marketed in Southern Sudan
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Marketing Authorisation Holder shall in all text refer to Licensor.
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