What are variations?
- administrative changes, e.g. a change of company name, address, or a new product name (e.g. after a marketing authorisation transfer)
- changes to the characteristics of a product that can affect its quality, such as a change to its composition, CEP updates (Certificate of suitability), changes in the supply chain, packaging, or test methods
- changes to the safety, efficacy or pharmacovigilance of the product, e.g. inclusion of new text due to requests from the competent authority or new safety information.
Variations are sent to the competent authority through the Common European Submission Portal (CESP) which provides a secure method of communication with regulatory agencies. We can organise your setup to the CESP system and manage the whole submission procedure. Thanks to this electronic system it is easier to handle the variations for a product.
How long does it take until variations are approved?
It depends on the complexity of the change. For some administrative changes, there is no waiting time and you are allowed to implement the change immediately. For more complicated changes, especially those to the composition or manufacturing process of the product, approval procedures may easily take 6 -9 months. We can support you with the preparation and submission so that you are able to submit a variation that will be accepted easily by the authorities.