Rx-to-OTC switches

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 hopefully this guide will help with identifying the steps needed to achieve your goals in a timely and efficient manner.

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

Company selection and internal evaluation of switch candidate 

It is essential that the potential switch candidate is thoroughly evaluated prior to any SAM. This early evaluation of the benefit-risk profile should take into account all data available to you including:

• external expert advice
• non-prescription availability in other countries
• experience from previous switch applications

Early analysis using this framework will allow you to evaluate potential risk minimisation proposals which can then be discussed with the regulatory agency

However, the benefit-risk profile will only help to get the reclassification approved

To make the reclassification a commercial success, it is also important that you understand the patient journey as you transition them from reliance on a management in the clinical setting (patient) to self-care (consumer). You need to ensure the price point and pack sizes are correct for an OTC product and that you do not inadvertently cannibalise your Rx sales in the cases where a prescription medicine offering is maintained.

Scientific Advice Meeting

For most reclassification applications, the stage before submission is the key element of the procedure, during which the data requirements and content of the application will be established.  A Scientific Advice Meeting (SAM) with the regulatory authority in your lead target market is critical to guide your approach to developing the proposed reclassification. Issues for discussion may include likely evidence required, additional studies, the Risk Management Plan (RMP) and potential for exclusivity. The SAM phase (which may involve more than one meeting) is an important time to discuss the reclassification in relation to the following for the OTC product:

• target indication
• dose
• target population
• pack size
• name
• proposed controls for supply which may include –
  • patient information
  • pharmacy training and educational materials
  • data management and communications.

The ‘model’ (proposed circumstances for non-prescription supply) should then be further developed based on the advice and input from the agency.

Reclassification Application Development and Submission 

When planning to submit a reclassification application it is important to identify:

• the correct type of application to be submitted, which depends upon the nature of the proposed reclassification in the target country
• the most appropriate route to achieve the desired outcome (new Marketing Authorisation or variation to existing Marketing Authorisation)

Once the regulatory strategy has been decided and the outcomes from the SAMs have been built into your application, there should be no barrier to the approval you need.

JensonR+ can help you achieve a successful reclassification by guiding you through every step of the process. Our experts will liaise with relevant regulatory authorities, healthcare professional and consumer-patient organisations to determine current opinion and assist in the development of the regulatory affairs strategy, of your Rx-to-OTC switches.  We will also prepare the registration package and manage the regulatory process from SAM meeting to outcome of the application.