Keeping the Ball Rolling with EVMPD FAQs
Written by: Andrew Marr, Managing Director, Marr Consultancy Ltd.
In one of my previous blogs, I began helping to unravel some of questions and doubts that have lingered over the EVMPD and its implementation. But questions for EMA abound, and in this second Q&A blog, I continue to address some uncertainties facing industry.
In some countries the authorisation is at the presentation level and in others at the strength level. But if a 10mg tablet has three presentations, in some countries each would have a separate authorisation, so three different authorisation numbers, while in others there would be one authorisation covering all three presentations. However, there can only be one package description section in any record and so the recommendation is that section 6.5 of the SmPC is used as the description. EMA has suggested that each pack should be described and separated by commas e.g. PVC blisters of 14 tablets, PVC blisters of 28 tablets, PVC blisters of 56 tablets.
Scanned documents as PPI
Scanned documents are not acceptable. They must come from an electronic source.
Cardinality of the Short Name
In the breakdown of the parts of the Presentation Name the short name is required. However, for a generic product there is no short name, just a generic name. At present you are required to use the generic name as a short name and then of course the generic name itself is not used. EMA has said it will release an amendment to the schema for the name parts cardinalities including short names to better address the generic products.
Discrepancies in Controlled Vocabulary names are intentional
In cases where there are differences with the CV names – such as ‘Substance Class’ and ‘Substance Classification’ or more significant ones such as ‘Method of Measure’ and ‘Molecular Weight Method’ or ‘Organism name’ and ‘Gene Sequence Origin’ -- the EMA has indicated that both are correct and that the CV names will not be changed.
Updating products submitted under the old EVPRM
For products already in EVMPD there are two potential ways that a new record could be submitted, either to update the old record or to submit a new one. EMA has indicated that both options would be acceptable.
Scope of products to be submitted
It is not required to submit products where the license has been withdrawn. However, if the product has a license but is not on the market these need to be submitted.
Use of the Public Domain flag in the SSI
This refers to whether the information being presented is in the public domain, not the source of that information. For example, a chemical name for the substance may have been obtained from the Marketing Authorisation Application. The chemical name is in the public domain and is declared as such but obviously the MAA is not.
Inclusion of a JPEG for chemical structure
The provision of a structural representation is optional but if provided it should be given as a JPEG. It is not a separate attachment file and the JPEG should be encoded using Base64 (RFC 2045) and embedded within the SSI XML. Apache Codec provides a Java implementation and can be accessed at http://commons.apache.org/codec .