With huge uncertainty over what’s happening with Brexit at the moment, and whether there will be a deal or not, there’s no wonder a huge number of people who work in the medical sectors or studying a health economics online course are wondering what will happen?
Although at the moment it is still uncertain whether a deal will be made, the Government have taken steps to offer guidance to several different sectors as to what will happen if the UK leaves without any deal. Here, we take a brief look at the main points within the Government’s guidance on No Deal UK Marketing of biosimilars should we leave without striking a deal with the EU.
Principles Will Remain The Same
When it comes to the regulation of biosimilars, the MHRA will go ahead and continue to abide by the same principles that are in place already. Details on these principles are found in 'The Human Medicines Regulations 2019' - specifically regulation 58 of the amendment, which amends The Human Medicines Regulations '2012's regulation 53.
Any new applications to the MHRA are then assessed at a national level. Procedures for submitting these are according to existing national procedures. Also, after the final opinion has been given from the EMA CHMP committee, biosimilars would be eligible for the targeted assessment procedures. These procedures aim to help with ensuring new medicines for UK patients are available promptly. CHMP reports and the MHRA application will be assessed, and opinions on approvability will be given within 67 days of the valid application to the MHRA.
Applications Submitted After The UK Exit Day
Should a biosimilar application be submitted after the day of exit, it is essential to note the following. Only applications for products that comply with the Human Medicines Regulations 2012 (Regulation 48) will be allowed. Products that have been authorised for eight years or more in the UK, products that have received a conversion authority from EU Marketing authorisations and those where an EU Marketing authorisation was still in force on the day of exit but was not converted into UK marketing authorisation because the holder had opted out are included here also.
Entitlements For Market and Data Exclusivity
Period entitlements for market and data exclusivity for reference products approved prior to the UK exit day will remain applicable in the United Kingdom after exit day. It may be essential to note that data that has been generated on products for reference that have been sourced according to the Guidelines on similar biological medicinal products CHMP/437/04/Rev1 will continue to be accepted by the UK.
While the future is still uncertain on Brexit and the state of things to come, it would be wise for those working in the field to check this guidance from the government regularly as things progress, as things may change in the future that affect the current guidance.