Manufacture and Import of Investigational Medicinal Product

Manufacture and Import of Investigational Medicinal Product The authorisation shall be required for both total and partial manufacture and for the various processes of dividing up, packaging, and presentation. To obtain this authorisation, the applicant must meet at least the following requirements: Specify the types of products to be manufactured or imported and the manufacturing…

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Commencement Of a Clinical Trial

Commencement Of A Clinical Trial In starting a Clinical Trial, an application submitted by the sponsor and approval by the competent authority in Member State where the trial will take place is required, in which a 60-day system is proposed. In any case where the authority does not accept the request, the sponsor is given…

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