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Nandita Vijay, Bengaluru January 16 , 2021
Brexit now brings in a slew of changes into licensing procedures including prioritizing access to new medicines to patients. Indian pharma will encounter extra paper work & compliances.  

India exports 25 per cent of its generics each to the UK and the EU. Therefore, companies will see a major impact as it gears up to keep pace with the changes because both UK and EU are a huge market for pharmaceutical formulations, active pharma ingredients (APIs), biological and biosimilar exports. As the transition period comes to an end, new rules in the field of medicinal products no longer apply to the UK. This results in changes in the licensing aspects in the EU.

According to Pravin Iyer, chairman, pharma, healthcare expert committee, BCIC and managing director, Relicare Tech Services, though the entire negotiations of Brexit are still ongoing and dynamic, there are new rules for business from January 1, 2021.

“There are a lot of changes to grapple with as Brexit comes into being not just for UK and EU but for companies across the world.  This essentially means that while it is free movement of goods with some arrangements made to ensure there are no taxes and tariffs for the present, additional paper work and compliances are there. However, it is still not clear on the impact of services with the UK -EU and the world with Brexit. But there are a lot of new rules across the business that are being framed,” he added.

India will have a major impact and we need to see how our pharma industry  is able to keep up with the change, said Iyer at the Bangalore Chamber of Industry and Commerce (BCIC) event on Brexit and its impact on new UK regulatory compliance for pharma industry.

Stating that Brexit is the newest and a contemporary topic in regulatory affairs of pharmaceuticals, Santosh Kashyap, AVP, Regulatory Affairs, Adcock Ingram India (Relicare Tech Services) said the Marketing Authorization Holder (MAH) established in the UK will be transferred to a holder in the EU. It will be amended from UK MAH to EU MAH. The reference medicinal products (RefMP) will be referred to as the EU Ref MP. “Therefore it is critical for pharma companies to match the information of the generic product that is manufactured. Principally even if it was submitted before Brexit, the UK RefMP will be accepted but it is still required that the applicant will have to refer to the EU 27 member countries RefMP.”

In the case of bioequivalence studies too conducted with the RefMP and submitted before BREXIT, then the company needs to contact the competent authorities to discuss particular circumstances. For the literature published after well established use, the data sourced from the UK before the end of the transition period can be taken into account, he added.

Decentralised procedure (DCP) is a European authorisation route resulting in a mutually recognised product (MRP). Anil Kanth Tamma, AGM-RA, Adcock Ingram India (Relicare Tech Services) said provided the guidance on handling DCP and MRP for drugs approved before Brexit or pending clearance. He also highlighted on how to handle the variations in marketing authorization of brands.

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