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RE: Translations of registered active substances for OMPD submission
If your client is an SME, they can be exempt from providing translations. However, if your client is not an SME, it will be necessary to provide translations of both the active ingredient(s) and proposed orphan condition at the time of submission, whether they have been previously registered or not. For consistency you can refer to previously agreed upon translations (if available in the relevant Public Summary of Opinion published on EMA website).
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