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.
Renewals
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
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.
License Transfers
TRAC specialises in Chemistry, Manufacturing and Controls (CMC) regulatory services with significant experience supporting manufacturing site transfers to deliver projects on time and within budget.
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).
If you have any further questions regarding licenses or marketing authorisations download our free guide Obtaining Marketing Authorisations (MA) or please Contact Us.
Guide: Obtaining Marketing Authorisations
This guide, as well as other information can be downloaded from our download centre.