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MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence

Recently (09 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on the "150-Day Assessment for National Applications for Medicines" where sections on New active substances and biosimilar products applications were updated.

In order to facilitate the availability of medicines for patients in the UK, the MHRA offers a 150-day assessment timeline where MHRA will evaluate and assess a valid application for the UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation within 150 days after submitting the application.

A company or sponsor can apply for marketing authorisation (MA) for new active substances and biosimilar products or existing active substances. The standard procedure of 180 days (excluding stop-clocks).

Click this LINK to know more about how to apply, validation, fees, etc...

The guidance explains how to get a parallel import licence for medicine in the UK, including pharmacovigilance requirements and submitting your application. Parallel Import Licence application categories fall into 3 categories: Parallel import (simple), Parallel import (complex) and Parallel import (standard).

A tell-and-do (TaD) variation allows you to submit a variation for a change to the imported product, and MHRA will assess the variation while the product is repackaged and distributed. To make a TaD variation the imported product must be in MR-DC product list. A PLPI is granted for 5 years and Renewals must be submitted in the 3 months before the licence expires.

Click this LINK to know more about the Documents for submission.


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