Updating risk factors in form 10 q


20-Dec-2017 15:31

New or revised Q&As are marked as 'New' or 'Rev.' with the relevant date.

If an issue is not resolved by the Q&As below, please send a question to the European Medicines Agency.

Companies or firms formed in accordance with the law of a Member State and having their registered office, central administration or principal place of business within the EEA will be treated in the same way as natural persons who are nationals of Member States.

An applicant should demonstrate that it is duly established in the EEA.

updating risk factors in form 10 q-80

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To exercise the Union’s competences, the institutions may adopt regulations, directives, decisions, recommendations and opinions.Due to the timelines required to translate the product information, the Agency will initiate translations through the Centre for Translation (Cd T) in Luxembourg prior to CHMP/CVMP opinion (normally around day 180 of the procedure).These translations will then be checked through the national competent authorities in the Member States (see also “QRD product information - Tools used by the EMA to facilitate the streamlining of the European Decision Making process”).References Incentives and assistance are available from EMA for SMEs, which focus on reducing financial and administrative entry hurdles for SMEs in pre-marketing authorisation procedures such as scientific advice, the application for marketing authorisation and inspections.

These include: In determining which companies are eligible for SME incentives, EMA applies the EU-definition of micro, small and medium-sized enterprises provided in Commission Recommendation 2003/361/EC.

Translation assistance Because translating product information into all EU languages represents a considerable financial and administrative burden to SMEs entering the EU market, the EMA will provide for translation of product information documents (summary of product characteristics, conditions of the marketing authorisation, label and package leaflet) required for the grant of an EU marketing authorisation.



These questions and answers Q&As provide an overview of the European Medicines Agency’s EMA advice on issues that are typically addressed in discussions or.… continue reading »


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