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 process, a need to introduce additional safeguards or changes to therapeutic indications. It is common practice for products to be varied many times, particularly in the first couple of years of their being marketed.
TRAC processes 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.
We specialise in chemistry, manufacturing and controls (CMC) regulatory affairs services and manufacturing site transfers. Our thorough approach covers all the angles and delivers projects that maximize the commercial potential of our clients’ products.
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).
As part of our post marketing approval support we also provides user testing and eCTDservices using our in-house software.
Download our free guide – Obtaining Marketing Authorisations – where you can find out more about licensing and marketing authorisations. If you have any further questions, please do get in touch.