what happens next - my understanding

There seem to be a few questions being asked now about what happens next and how long it will take. From my research the pathway seems to actually be a bit clearer now that VG has been classified as Class III under rule 13.

Here is the link which details the pathway but I will summarise it to the best of my ability:

http://www.mhra.gov.uk/home/groups/es-era/documents/websiteresources/con076011.pdf

1. BIS has verified the substance is "useful" and sought opinion from MHRA re scientific opinion, quality and safety. In doing so they have formed the opinion that benefit outweighs any risk. (see 1.1)

2. MHRA has had 3 assessors providing individual reports which were combined to form the final decision from MHRA to BIS (see 3.2) and the report was available within 90 days (see 3.3, and I have no idea why BIS told TIS it would be 30 days)

3. This document seems to provide details about the consultation preocess with the EMA:

http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004337.pdf

Interestingly it seems to indicate that BIS would take advice from MHRA and EMA but it would be BIS making the final decision.

4. 4.1 of the above document makes me a little nervous as it seems to indicate that an "intention to submit" letter is required 6 months before submission to the EMA. Could someone please clarify this at the AGM??

5. The assessment period followed by the EMA is a "maximum" of 210 days BUT there may be "clock stops" for the applicant to reply to questions. It appears that the 210 days may start from the date of submission which may be 6 months from now (see 4 above)

6. Finally some good news "The CHMP can be asked to shorten the procedure in the following cases:
??
the device is for use in serious diseases (life threatening or heavily disabling diseases);
??
a known medicinal substance or human blood derivative from a known source is used and when CHMP considers that the evaluation needed is less extensive"

Please read the above documents to check my thinking and please ask at the AGM the following questions:

Do we have to wait for 6 months before submitting to the EMA?
Can we invoke the shortened procedure defined at point 6 above due to the fact that VG may both save lives and save limbs?

I won't be there so please report back what you find out.

Thanks,

Rev