Submissions for application for switch of OTC status:
- A clear rationale for the OTC application is needed as for all medicinal products.
- A clinical overview, including a critical analysis of the suitability and safety for self medication of the medicinal product, should be submitted by the applicant. The proposed OTC indication, dosage or pack-size, should reflect the target population and must be in line with other similar products available OTC, or otherwise justified.
- The proposed SmPC, PL and labelling, including proposed mock up, should be included in the application.
- It is recommended that the background documents are submitted also in an electronic format to allow an expedite process.