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The draft decision shall be notified to the ECB and the applicant for authorisation.
The decision taken in accordance with paragraphs 1a and 1b shall be notified by the national competent authority to the applicant for authorisation.
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The regulatory body may, in exercising its tasks, request relevant information from other competent authorities, terminal operators, applicants for authorisation and any third party involved within the territory of the Member State concerned.
The regulatory body may, in exercising its tasks, request relevant information from the competent authorities, terminal operators, applicants for authorisation and any third party involved within the territory of the Member State concerned.
Shortly afterwards there was a rush of applications for authorisation from London councils.
A comparative assessment may be initiated by an application for the authorisation of a new candidate product, for the renewal of an existing authorisation, or for the amendment of an authorisation for new uses of a candidate product.
The CPMP Note for Guidance 'Evaluation of anticancer medicinal products in man' (CPMP/EWP/205/95 rev.2, 19 September 2002) presents guidelines on the requirements for authorisation for all anticancer drugs, particularly cytotoxic/cytostatic agents, and is intended to assist applicants in regular and exceptional circumstances (http://www.emea.eu.int/).
To make an application, applicants are required to fill in the form, submit it to the head of the clinical department for authorisation (signature) and submit it to the pharmacy office.
Application for authorisation: establishing reference DNELs for BBP.
South Wales and Kent then also asked for authorisation.
In this paper, we propose a trust enhanced distributed authorisation architecture (TEDA) that provides a holistic framework for authorisation taking into account the state of a user platform.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com