Renewals
In which cases may a competent higher federal authority mandate a further renewal and how will this be communicated to the applicant?
According to Section 31 sub-section 1a AMG the competent higher federal authority may mandate a further renewal under the regulation in Section 31 sub-section 1 sentence 1 No. 3 associated with sub-Section 2 AMG in order to ensure further safe marketing of the medicinal product.
Do the regulations of the CMDh for the shortened renewal procedure also apply to purely national marketing authorisations?
National renewals according to § 31 Absatz 3 AMG of purely national marketing authorisations licensed on the basis of Article 10(1) of Directive 2001/83/EC (Generics) can be carried out as „shortened renewal“ in accordance with the requirements of the CMDh Renewal Best Practice Guide.