Do you supply to customers in Northern Ireland – If you do, then you will be aware of a range of issues following Brexit and that we are still some way away from a long term agreement. However, we wanted to highlight a specific issue.
If you supply products that were licenced through the Centralised Application Procedure (CAP) the licenses for most of these were grandparented across to GB Product Licenses (PLGB). This means that unless the MAH has applied to convert these to a UK wide MA, you may only be able to supply these products to Northern Ireland if they appear on the Northern Ireland MHRA Authorised Route (NIMAR) list.
The issue is that this licensing route was compulsory for some types of drugs and particularly affects many new treatments:
- Treatment of cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, viral diseases, Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS).
- Medicines derived from biotechnology processes, such as genetic engineering.
- Gene-therapy, somatic cell-therapy or tissue-engineered medicines (advanced-therapy medicines).
- Medicines used for rare human diseases
The Grandparenting process involved nearly 2500 products and currently there are only 70 to 80 products on the NIMAR list. You need to check your inventory to identify any products that currently only have PLGB status (this can be identified from the SPC), and these will need to removed from the list of stock available to Northern Ireland customers, unless of course, the product is included on the latest NIMAR list.