Rx-to-OTC Switches

Rx-to-OTC switches are the transfer of proven prescription drugs (Rx) to non-prescription, OTC (Over the Counter) status. At JensonR+, our regulatory specialists can assist with changes in legal status for your prescription medicine portfolio.

Medicine switches have been an important part of the health landscape for well over 40 years, but the COVID-19 pandemic has had an unprecedented impact across primary care. The reduction in GP consultations has been widely reported, resulting in fewer services, face-to-face visits and access to clinical support.

RX to OTC

The alternative to regular doctor and clinic visits is to manage illnesses with self-care. This includes self-medication, which is the use of approved medicines that are available without prescription to treat ailments and conditions. Reclassifying (or switching) medicines from prescription to non-prescription (Rx-to-OTC switches) is a likely contributor to the ability to self-medicate.

If you feel there is a potential for a medicine in your portfolio to switch and be offered to consumers for self-management of their conditions, then this guide will help to identify the steps needed to achieve your goals in a timely and efficient manner.

Before submitting a reclassification application package for assessment, there are 3 key steps to the preparation:

  • Company selection and internal evaluation of switch candidate

  • Scientific Advice Meeting(s) (SAMs) with one or more regulatory agencies

  • Compilation of the Rx to OTC switch application – taking into account advice from SAMs

RX-to-OTC switches

Reclassifications can be time-consuming, complex processes, which involve cross-departmental collaboration.

JensonR+ can guide you through each step of the process, helping you achieve success in your reclassification goals. Our experts will liaise with the relevant regulatory authorities and healthcare professionals and consumer-patient organisations to determine current opinion and assist in the development of the regulatory affairs strategy for your Rx-to-OTC switches. We will also prepare the registration package and manage the regulatory process from SAM meeting to the application outcome.

Get in touch with us to find out more