Translations of registered active substances for OMPD submission

Dear all

For an OMPD submission, translation of the active substance/s and indication is required. 
We have a client which is using two already registered active substances as the active substances of its product. Should our client still translate these substances and the indication? only the indication? or are translations not required at all in this case?

Thank you in advance,
Liron 

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).

Thank you very much for the answer!

I have a follow up question on the subject of translations. We have an additional clients which registered its active substance. The active substance is a DNA molecule with modifications therefore its sequence is quite complex. When registering the RPI, the substance name appears as the complex chemical sequence, however, there is a public synonym name (company code) which is short and simple. For example ABBA-23.  
in the translations, should the complex substance name (sequence)  be translated or can the short synonym be translated?

Thank you!

Liron

The complex substance name should be used, not the company code (short synonym).

Thank you very much for the fast reply!