For a medicinal product which already has a marketing authorization, a type II variation application has to be submitted to apply for a change in the classification of prescription status. This application should be in accordance with the relevant legislation and the European guideline: “A guideline on changing the classification for the supply of a medicinal product for human use”.
An application for OTC legal status should always be justified.
Points to remember in an application for OTC legal status
- A clinical review
The review should include a critical analysis of the suitability, the potential for misuse/abuse and the safety in self-medication for the OTC indication of the medicinal product. It’s important that the OTC indication has a target patient population, and that the written indication is self-explanatory for all potential users.
If the proposed OTC use falls within what has already been approved for the active substance(s) in question, a published OTC substance report can replace a clinical review. In these cases, the proposed indication shall be identical or narrower than the indication in the OTC substance report.
If the application is not within the range of the already approved OTC status for the therapeutic area, target group or pack size, the applicant should elaborate on the parts of the application that are different from what is already approved. In the clinical review, the applicant must argue why OTC status is acceptable based on the efficacy and safety in the target patient population.
- Product information
The application should contain the proposed SmPC, PIL and mock-ups. If an OTC substance report is available, the product information should be in line with the existing report. If the active substance is classified as prescription group CF two different PILs are required; one PIL for use in packs that are not subject to medical prescription (OTC) and one PIL for use in packs that are subject to medical prescription (Rx).