Most of you will have seen the latest EMA guidance by now (all 484 pages of it) – and read the much more digestible 4-page article by Andrew Marr in Scrip. Andrew’s article is an excellent summary of what’s required, and I thought it might be useful to reflect on the points he raises and translate his ‘what you need to do’ into a ‘how to do it’.
I’ve divided the points up into a discussion about the new fields, how to improve the quality of your data, the impact of the tidying up the controlled vocabularies, local language SmPCs (summaries of product characteristics) and timelines. I’ll talk about the new fields this time, and the rest in the next couple of blogs.
Oh no, not more data!
Yes, there are five new fields; they have been added because the EMA is planning to use EVMPD data to calculate pharmacovigilance fees. However some will be harder than others to populate. Let’s go through them.
The SME information is easy. Each MAH (Marketing Authorisation Holder) will know whether they’re an SME, and will have their SME number if they are. Even the largest organisations will have a reasonably small number of organisation records to update here, and the more records you have the more likely it is that you’re not an SME.
Medicinal product type
The next easiest is probably the medicinal product type. This is to identify homeopathic and herbal products, products for paediatric use and three more unusual product types (parallel distributed/imported product, conditional marketing authorisation and exceptional circumstances marketing authorisation). The list is here:http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/01/WC500160462.xls.
For most products the value will be simply the last option – ‘Other’ – and for those with in-house XEVMPD software tools, their vendor should be able to create a database script to set all values to ‘Other’, so that all you have to do is fill in the exceptions. This is what Samarind will be doing for its customers.
Authorised pharmaceutical form
That leaves just ‘Authorised pharmaceutical form’ and ‘Legal basis’. For many organisations, the authorised pharmaceutical form will be fairly easy too, because the value already in your database as the administered pharmaceutical form will very often be the same as the authorised form. A product authorised as a tablet is administered as a tablet after all. So again a database script can be created to automatically copy all the administered forms to the authorised forms, then the exceptions identified. Most good databases will have a readily available way to list all forms in use so finding which products need to be updated will be straightforward.
Now, ‘Legal basis’. This is the awkward one. The list is here:http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/01/WC500160461.xls. Basically, what you have to do it establish which Article of EU Directive No. 2001/83/EC was used to gain authorisation for marketing the product. If your product pre-dates this directive you need to decide what the legal basis would be if the product was being authorised today.
Now, if your database contains this sort of information already you’re fine; in Samarind RMS, for example, we have entries like “Generic application” and “Well-established use application” and we’ll just be giving users a way to link their existing entry to the correct EVMPD value. For some organisations, all (or the majority) of their MAs might be the same (many generics manufacturers for example) so the same scripting technique can be used.
However for those without this information it may come down to going through all their products, reviewing the original application and choosing the appropriate value manually. There is one other legal basis value – relating to Article 58 of Regulation (EC) No 726/2004, which applies to products intended for markets outside the EU – but I doubt many organisations will have this type of product.