Following the publication of the latest EMA guidance – which was updated again on 5th March – my previous blogs examined the five new fields that are required by the EMA and the XEVMPD data quality and controlled vocabularies. Here in the final blog of this set I’m covering local language SmPCs and timelines, and offering my opinion on the situation and how best to achieve compliance.
Watch your languages
For the July 2012 deadline English SmPC texts were accepted for mutual recognition procedure (MRP) and de-centralised procedure (DCP) authorisations. EMA now want these to be provided in the local language. You will have these available somewhere; it’s just a case of finding them and, of course, checking that you have the latest version. Sadly, as far as I know there’s no tool available to check a document language for you – it will need to be done manually.
Those with a RIM system are most likely in a better position here, as the local language SmPCs should already be in the system as part of the ‘master data’ for their products.
Time is of the essence
At least with the new guidance the timing of the various activities is straightforward. Details of new MAs must be submitted within 15 days; anything else that changes the EVMPD data needs to be sent within 30 days. There’s some discussion about “30 days from when” but generally it’s pretty clear. The good news for software vendors is that all changes get sent as an ‘Update’; the ‘Variation’ operation type is not to be used.
One question I am being asked is whether MA holders need to submit all the changes since July 2012 separately, in the correct sequence. The answer (thankfully) is ‘No’. Some time between 16th June and 31st December 2014 every product must be updated to correct any existing errors and add in the new mandatory information. Once that’s done you need to keep it up to date from then on.
Finally, the processes for changing the status of MAs and transferring ownership have been explained in some detail, and there are some good flow diagrams near the end of Chapter 3.II that explain these. We’re currently mapping our own statuses to the EMA ones and – along with a few new dropdown boxes – these will be handled nicely within our system.
So then I’m done, right?
Well yes, barring your regular updates, then you’re done … until ISO IDMP comes along in 2016! Which brings me on to the message and I and many industry experts are saying; now is the time to start managing your product information in a logical and standardised manner.
My parting message this week is to say please don’t regard this as another necessary evil, something that you just have to comply with. Take this as an opportunity to create your own ‘single place of truth’ for all your medicinal product information.
Let the data work for you. Choose a submission-independent software solution that can output the data in whatever format is required – XEVMPD, IDMP, eCTD, RPS, and so on – without you having to reinvent the wheel each time. There really are so many benefits.