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From time to time, changes are made to the Summary of Product Characteristics (SPC), labels and leaflets of veterinary medicinal products. These changes may be initiated by the company or may be required by the Veterinary Medicines Directorate (VMD). Here, Jackie Atkinson, director of authorisations at the VMD, explains why changes might be made and what the impact might be
CHANGES to the SPC and related information may be made because the company wishes to add new indications for a product or where new data (for example, residues data) have been generated which indicate that a withdrawal period needs to be changed.
In these circumstances, the company will apply for approval of a variation to the marketing authorisation and provide appropriate supporting data. Once the variation is approved, the company is usually expected to implement the change within six months.
On occasions, …