WebThe Agency fulfils its obligation to check the conditions of parallel distribution by means of five procedures.. Initial Notification. An initial notification is a parallel distributor’s notification to the Agency, informing of their intent to source, repackage and distribute a centrally authorised medicinal product from one or more Member States to one or more Member … Web• imposed as an obligation in accordance with REG Art 9(4)(cb) and Art 10a(1)(a) and with DIR Art 21a(b) and Art 22a(1)(a) (category 1 of studies in GVP Module V); • imposed as a specific obligation in the framework of a marketing authorisation granted under exceptional circumstances (category 2 of studies in GVP Module V);
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WebMay 11, 2024 · Requests for product-specific waivers have to be based on one of the three existing legal grounds: • disease or condition not existing in a specified age-subset WebDec 21, 2024 · EMA has developed, in cooperation with national competent authorities and other interested parties, a draft scientific guideline on PAES which outlines how companies should design these studies in order to support regulatory decision making in the European Union: Scientific guidance on post-authorisation efficacy studies Expand section fair trading bond refund form
Periodic safety update reports (PSURs) European …
Web1. Types of applications and applicants 2. Steps prior to submitting the application 3. Preparing the dossier 3.1 Product name, product information and prescription status 3.2 Orphan and paediatric requirements 3.3 Quality 3.4 Compliance, environmental risk assessment and pharmacovigilance 3.5 Risk management plan (RMP) 4. WebEMA's role Inspections: verifying compliance All organisations involved in the development, marketing, manufacture and distribution of medicines are responsible for ensuring that they comply with all relevant standards set out in European Union (EU) legislation and guidelines on pharmaceuticals. WebDec 21, 2024 · The European Commission can impose on the marketing authorisation holder (MAH) the obligation to conduct post-authorisation measures. These obligations can be imposed at the time … fair trading bond data