Over The Counter (OTC) products
This is a very special field with great diversity. It combines the requirements for licensed medicines with additional provision regarding the population targeted having a direct impact on the size of the market covered and the way it is sold to the public. To add to the complications different authorities in EU may have different regulatory requirements not necessarily unified to become a difficult task to achieve. Having worked for MHRA for more than seven years dealing with this kind of products as an additional responsibility, the following services are provided:
- Review and assessment of the proposed product and eligibility for OTC status.
- Planning regulatory strategy to ensure progress of application in timely manner
- Review and assessment of the dossier to ensure compliance with the regulatory requirements and provision given within the relevant guidelines.
- Assist in the proposal of the name of the medicinal product to comply with the naming policies of the different agencies including legal status.
- Assist in the outer pack design and compliance with the agencies polices governing this aspect.