One of the top Indian multinational companies has been selling an antihistamine in the UK as Prescription Only Medicine (POM). DDReg was assigned with the task to assess the feasibility of change in the legal status of the product and thereafter support the regulatory strategy by way of developing safety rationale with regulatory documentation in support of the proposed change.

With extensive medical writing experience for complex agencies like US FDA, MHRA, BfArM, MEB, ANVISA, SFDA & NPRA etc., the team first gathered the evidence of molecule’s safety aspects, including from the company’s in-house data. Based on the body of available evidence as well as regulatory precedence, a sound rationale was authored that covered all desired aspects of MHRA’s requirement for POM to GSL switch.

RFI’s raised on the submitted application by MHRA were responded with adequate rationale and a switch of the legal status from POM to GSL was eventually granted.

With this switch, the customer organization was benefitted through wider market access, first-mover advantage and full compliance with all safety obligations met.