All About Regulatory Affairs - Granzer

All About Regulatory AffairsForum Heidelberg August 2010Dr. Ulrich of procedure When do we have a choice of procedure for a generic medicinal product? When the originator product was approved centrally New pharmaceutical forms with new features are no generics When it is a classical small molecule Independent of indication! When it fulfils the eligibility criteria for the centralized procedure Innovation Novel (new) technology3 MRP and DCPS cope4 Scope of MRP/DCP: New active substances (if not mandatory for the centralised procedure) Generic medicinal products to authorised reference medicinal products Informed consent Well established use (WEU; bibliographic applications) line extensions to national authorisations known substances in new combination New indications/new pharmaceutical forms for known substances5 Article 17 of Directive 2001/83/EC 1..Applications for marketing authorizations in two or more Member States in respect of the same medicinal product shall be submitted in accordance with Articles 27 to Where a Member State notes that another marketing authorization application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 27 to 39 apply.

9 Application to first member state Assessment report including SPC, PIL First Authorization: RMS 210 days Applicant request on mutual recognition of first

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