Updating risk factors in form 10 q

Fee Reductions/Deferrals SME applicants wishing to request a fee reduction and/or deferral should address a letter of intent to the SME Office (see below) of the EMA.

It should be noted that fee reductions and deferrals can only be considered once the applicant has been assigned SME status by the EMA and are subject to the SME status remaining valid at the time that their application or request is validated by the Agency.

For more information on fees, please refer to Fees payable to the European Medicines Agency.

To be eligible for translation assistance the applicant’s SME status must be valid at the time the translations are initiated.

Companies wishing to benefit from SME incentives should visit the SME Office section of the EMA website first.

The granting of a marketing authorisation by a competent authority does not discharge the holder from civil and criminal liability as provided for by European Union law. The MAH of a centralised marketing authorisation must be established within the European Economic Area (EEA; Norway, Iceland, Liechtenstein and the Member States of the European Union).

In order to fulfil this requirement, the MAH must have a permanent legal structure that is formed in accordance with the law of an EEA Member State and allows the concerned holder to assume the duties and responsibilities as well as to perform the tasks laid down by Union law.

This section provides useful information on how to request SME status, and provides a link to useful information sources (e.g.

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