Regulis leveraged their regulatory expertise on the switching requirements and process, and their working relationship with the regulatory authorities to successfully change a product from prescription only medicine (POM) to pharmacy medicine status.
An EU-headquartered company, a client of Regulis, acquired a POM from a large, multinational pharmaceutical company. The multinational had twice tried and failed to change the legal status of the product in the UK from POM to P. The MHRA rejected their applications because they considered the indication was not suitable for self-diagnosis; self-diagnosis and treatment would mask more serious underlying conditions and increase the risk of serious adverse events.
The challenge was to identify a regulatory affairs strategy and path for a proposed switch that would overcome the MHRA’s previous objections. This objective was made more difficult because, if successful, this would be the first time a product with this active ingredient would be classified as an OTC medicine in the UK.
Using our significant knowledge and experience of legal status switches, Regulis quickly developed a potential path to approval. By swiftly grasping the complexities of the therapeutic area and the previously identified areas of concern for safe OTC use, Regulis produced robust, evidence-driven arguments and a compelling benefit-risk assessment to support the proposed switch.
- Arranged and held a positive scientific advice meeting with the MHRA to pave the way for a successful switch
- Identified new data and authored a strong, supportive clinical overview and safety assessment
- Initiated interactions with patient and pharmacy groups, and potential patients in order to generate a suitable SmPC, PIL, quality assurance via a risk management plan and pharmacy materials
- Proposed proportionate risk minimisation measures that were acceptable to both the client and MHRA.
Regulis’ engagement delivered:
- Access to a new OTC market worth a potential £486M per annum
- Preservation of the POM and its existing sales
- A switch dossier that could be used in other EU and ROW markets.
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