The TRAC team are fully qualified to advise on all of the scientific disciplines required for the successful registration and maintenance of a Marketing Authorisation.
Marketing authorisations are granted for periods of up to five years, after which the MA holder is required to submit a renewal application which must reflect all the up-to-date knowledge about the product including any necessary actions from the most recent periodic safety update report (PSUR).
Variations to marketing authorisations are necessary when there are changes to the technical or scientific progress, a need to introduce additional safeguards, or changes to therapeutic indications. It is common practice for new products to be varied many times, particularly in the first couple of years the product is marketed.
TRAC will process all Type IA and IB and Type II variations as well as line extensions to ensure your product continues to meet the necessary standards of safety, efficacy and quality.
Reclassification of Medicines
TRAC also supports applications to reclassify medicines from Prescription Only Medicine (POM) to Pharmacist (P), or from P to GSL (General Sales License).