The European Medicines Agency has announced on 6th July that the Agency will continue its operations as usual, in accordance with the timelines set by its rules and regulations.
It adds that the current situation is unprecedented and “The implications for the seat and operations of EMA depend on the future relationship between the UK and the EU. This is unknown at present and therefore we will not engage in any speculations”, which essentially translates into “currently status quo; but expect changes in the near term”.
The last thing the industry wants is another market implementing its own set of regulations.
At present, whether it’s Pharma or Food, most of the regulations on safety, quality standards, Labeling are harmonised across the 28 EU countries.
Indeed, even if the UK were free to set its own rules, the industry would probably lobby for it to copy EU ones.
As per analysts, it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest.
Companies need to look into details of their Labeling, their sourcing and map out the impact of potential changes.
- EU food law requires the food label to include details of the food business operator in the EU responsible for labelling. If this is a UK entity, then companies should make plans for listing a different Member State entity going forward. This is particularly important for foods with a long shelf-life (two to three years) since these products may still be on the market post-Brexit.
- The UK may implement specific legislation about traffic light labelling, something the EU has chosen recently not to do, which would increase the Labeling cost and affect the timelines of product launches
- Most of the companies are ready for the EU Food Information Regulations (FIR) which become mandatory on 13th December, 2016. There is no way of knowing if and when UK-only regulations will be introduced, necessitating further changes to Labeling and effectively wasting the previous investment in FIR compliance.
- With a typical large retailer having over 10,000 SKUs, the costs of adapting products for any new regulation could once again run into the tens of millions.
- Artworks of Companies whose Marketing Authorisation Holder is based out of UK would be affected