Specific Local Requests from Participating NRAs and the Company’s Position
| Country | Request | Company’s Position |
|---|---|---|
| Argentina | Translate dossier into Spanish as it is a legal requirement. Otherwise, Argentina cannot participate. | Accepted to translate the dossier to allow Argentina to participate. Translation was done in-house to ensure accuracy. The dossier content was unchanged. |
| Columbia | Impact analysis report for the supply and distribution of the finished product (i.e., shipping qualification data for vial finished goods from the new manufacturing site in France to markets) or a letter signed by manufacturer indicating if the supply and distribution have some impact. | The company provided the requested letter. |
| Germany | In order to be able to supply the validation batches with the appropriate shelf-life, the German authority requested the possibility to approve the dossier earlier than in the 6-month timeframe, as the approval is a condition for release of the batches they are responsible for. | The Company clarified that NRAs who are willing to review and approve faster than the proposed 6-months timeframe were welcome to do so. |
| Saudi Arabia | Detailed inspection report from the French NRA of the French manufacturing site. | Accepted in the frame of a separate submission for licensing the French manufacturing site. Two submissions are needed in Saudi Arabia for this type of change. Sanofi provided the appropriate section of the report to allow SFDA to review. |