A manufacturer wants to gain approval for an OTC product already approved for a different indication by a competitor in a Reference Member State. Which filing is required?

To gain approval for an OTC product that has already been approved for a different indication by a competitor in a Reference Member State, the manufacturer would need to file a new Marketing Authorisation Application (MAA). This is because the existing approval pertains to a specific indication and the new application pertains to a different indication, thereby requiring a new comprehensive evaluation by the regulatory authority.

Submitting an abbreviated New Drug Application (NDA) or requesting an extension of the existing approval would not be appropriate in this case. An abbreviated NDA is typically used for drugs that have previously been approved and are being reformulated, while requesting an extension usually applies when a manufacturer wants to extend an indication or approval to additional populations or formulations based on an existing product. In terms of applying for a clinical trial exemption, this option involves conducting additional studies before gaining market access, which is not necessary when filing an MAA for an already approved product but under a different indication. Therefore, filing a new MAA is the correct and necessary step for the manufacturer in this scenario.