Cmdh Cover Letter Template Variation

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bfarm variations submission of variations the cover letter should include the e mail address of the person in charge in the variation application form use the full german name of the medicinal product as it is authorised and indicate the german marketing authorisation holder as well as the germanmarketing authorisation number variation a variation is a change in the dossier of an authorised product there are four different types of variations type ia type ib type ii and line extension practical guidance for submission of applications for the cover letter should state which format is being used ectd or nees please refer to the please refer to the hma website for a cover letter template see link below re mended by the cmdh for

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