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EU SME STATUS REQUESTS

Are you a micro, small or medium-sized enterprise (SME) and do you wish to benefit from SME status?

Among the benefits of SME status during the drug submission process are:

• 90% fee reduction for scientific advice
• 90% fee reduction for EMEA-requested GMP, GCP and GLP inspections and the possibility to request deferred payment
• Deferred payment up to 45 days for the fee for the marketing authorization application (MAA)
• Waiver of the fee for MAAs in the event of a negative outcome, where scientific advice has previously been sought from the EMEA and taken into account in the development of the product
• Translation into all EU official languages of the product information documents (summary of product characteristics, conditions of the marketing authorizations, label and package leaflet), leaving only Norwegian and Icelandic translations to be provided by the Sponsor.

We can help in the structuring and content of your application file, or review your own file prior to submission, and help you in all related administrative issues with the EMEA.

Please contact us to learn more.