Once approved, a marketing authorization is subject to post-licensing activities that ensure the medicinal product remains safe and compliant with changing regulations. Updates to the marketing authorization may also be made as the product evolves over time, and various strategies are used to extend its commercial value. Sadhanainfotech can provide regulatory support for your post-licensing activities.
After the initial approval of marketing authorization, any changes to the quality, safety or efficacy of the medicinal product during its lifetime must be notified to the competent authorities using the variations procedure. This requires a thorough understanding of the categories of variations and the extent of supportive documentation which is required for approval of the change in question.
A marketing authorization is valid for 5 years, after which time it must be renewed and re-evaluated with respect to the risk-benefit balance. A consolidated file relating to the quality, safety, and efficacy of the medicinal product must be submitted to the regulatory authorities at least 9 months before the marketing authorization ceases to be valid.
Strategies to provide additional value to the patient, or extend the financial life of a medicinal product, can include the creation of product line extensions.
Safety update reports detailing an evaluation of the risk-benefit balance of the medicinal product, which may result in the need to submit proposed changes to the product information should be sent to all national regulatory authorities and the European Medicines Agency at defined time points after authorization.