Citing reference products
The Veterinary Medicines Regulations and the Northern Ireland Protocol make it clear that the reference product cited in an application for a generic product
- submitted to GB – must have a reference product that is authorised in the UK
- submitted to Northern Ireland, either nationally or via the Decentralised Procedure with Northern Ireland as a Concerned Member State – must cite a reference product authorised within the EU.
Parallel submissions of generic applications in GB and NI
To submit parallel submissions in GB and NI, the respective reference products in the UK and the EU must be qualitatively and quantitatively identical in terms of composition with identical SPCs. If not, then a parallel submission is not possible as the products are not considered to be the same. In such cases separate GB and NI submissions must be made.
Qualitative and quantitative identicality
It cannot be assumed that products authorised on a national only basis in the EU and the UK are the same from a qualitative and quantitative perspective even if they have the same Marketing Authorisation Holder.
Applicants should provide confirmation within a covering letter, or include an application note in VMDS, that a parallel application is justified.
If during our assessment it transpires that the respective reference products are not qualitatively or quantitatively identical or where the SPCs are not identical, depending on the data provided it may not be possible to conclude positively. For example if the EU reference product was used as the comparator product in bioequivalence studies or comparative/deconvolution studies were conducted on the EU reference product to support a bioequivalence waiver, this would not be appropriate for GB even though a similar product is marketed by the same Marketing Authorisation Holder in GB.
Where it cannot be assured that the respective reference products are qualitatively and quantitatively the same we would expect to see that the data package provided in support of the GB and NI submissions reflect the use and comparison to the appropriate reference product.
Examples of scenarios which might be suitable for parallel submission
Although not an exhaustive list, possible scenarios where the respective EU and UK reference products might be qualitatively and quantitatively identical and therefore suitable for parallel submission (subject to the SPCs also being identical) are those:
with an authorisation history where the UK and EU reference products were authorised via a European procedure and the post authorisation activities have been mirrored
where an auto-generic is being applied for and the applicant can demonstrate that the respective reference products are qualitatively and quantitatively identical
where the products have simple identical formulations, such as 100% active ingredient or a simple 2 component solution
We will update the application form to provide further guidance at the point of submission and include this information in our Information Hub.
- July 15, 2021 at 5:24 pm by Editor (displayed above)
- July 15, 2021 at 5:24 pm by Editor