BRITAIN’S exit from the European Union will have major ramifications for the pharmaceutical sector, according to Adrian Pittock, marketing director at pharma consumables supplier Valley Northern.
Adrian believes one of the biggest changes will concern packaging regulations. “For pharmaceutical manufacturers who change a drug’s batch release site or have to reapply for marketing authorisation, the medication must now be repackaged with a marketing authorisation number,” he explained. “A marketing authorisation number allows a product to be marketed and sold throughout the EU. Prior to Brexit, this approval process for new medication was decided in the EU by mutual recognition procedure (MRP). This process involved reviewing and assessing scientific evidence of the product, which must demonstrate that the benefits outweigh the risks. If approved, the product is awarded a marketing authorisation number, applicable for all EU countries.
“For drugs that have already been approved by the EU, the UK has decided that it will grant UK marketing authorisation. However, this license will require a new marketing authorisation number, which must be displayed on the outside of the packaging. This applies to products that have been approved in the UK, are sold in the EU and want to continue to be sold in the EU. The UK has given companies until the end of 2020 to make these adjustments to their packaging.”
Adrian said this could pose problems for manufacturers that outsource packaging artwork, meaning they must turn to design companies, contract packagers or contract manufacturers for help to manage the repackaging process.
“For large pharmaceutical manufacturing companies that keep thousands of units in stock, this could cause downtime as all products must essentially be recalled for repackaging,” he explained.
Adrian added that suppliers such as Valley Northern could step in to help. The firm also offers storage options and batch reservation services.
The other area of change regards medical devices, with Brexit set to impact on the Medical Device Regulation (MDR).
“Before Brexit, the Medicines and Healthcare products Regulatory Authority (MHRA) was responsible for licensing and regulating medical devices, ensuring all devices conformed to the safety and performance requirements of all relevant European medical device directives,” Adrian explained. “Medical devices could only be placed on the EU market following approval from a notified body (NB) that had been designated to assess the device and whether it met the specific requirements. Once approved, a CE certification mark could then be placed onto the product for it to be sold within the European Economic Area (EEA).
“Brexit, however, has made this process more difficult. To continue selling a product in the UK, manufacturers will need to use an NB based in the EU. Those wishing to sell a product in the EU could face difficulty with this, as NBs are no longer permitted to grant CE marks to those in the EU. As it becomes more difficult to certify a device under the MDR, the industry could face as a shortage of suitable NBs, resulting in delays in approval for critical medical devices.
“However, this does not mean that all hope should be lost for the future of UK medical devices. After all, the medical device manufacturing industry is one that has traditionally been proactive, rather than reactive, in finding ways to adapt to new scientific and technological advances, going above and beyond the basic requirements set out in law.
“With Brexit impacting how the UK trades with the EU, how products must be packaged and the approval process for medical devices, the industry must allow time to adjust. Although Brexit has caused disruption to the industry, all is not lost. The integrity and position of the UK pharmaceutical industry remains strong — and that will not be dimmed.”
