As a result of an enquiry to TIS through their website I...

As a result of an enquiry to TIS through their website I clarified the following:

A letter was sent to EMA by BIS as soon as they found out from MHRA that the matter should be referred to EMA. That letter asked for a review start date ASAP and TIS believes that the 6 month period is not a hard and fast rule.

Secondly, they have not ruled out seeking an accelerated review process based on the advantages of VG but they don't believe it will be accepted as they have been led to understand that such acceleration is reserved for significant life threatening situations.

Finally I have done some research on the EMA website and found the following in relation to reviews such as ours:
- Only 9 reviews since 2005 have been listed on their website and all were approved. (Either they don't list non-approvals or they don't get many referrals - let's hope its the latter)
- The average time from application to start date is 40 days (range 10 to 87 days)
- The average time from application to final approval is 307 days (range 209 to 468 days)
- In every instance CHMP asked questions of the applicant and there was a delay while they were answered
- The longest delays were caused by the manufacturer rather tham EMA
- The median approval was about 262 days

If we assume VG goes along the same lines as the median previous product the review should start later this month and approval should be given in about June or July next year.

DYOR

Rev