Tag Archive for: batch specific request

HPRA update on Batch-specific requests for safety features

The recent medicinal products newsletter (issue 61) published by the HPRA includes an article about batch-specific requests (BSRs) and safety features.  This is an update on the Falsified Medicines Directive safety features information.
The Commission Delegated Regulation (EU) 2016/161 with detailed rules for the safety features appearing on the packaging of medicinal products for human use, came into force in Ireland on the 9th February 2019.

BSRs will be considered for medicines for the Irish market that come within the scope of the regulation but do not bear safety features (UI and ATD).

The article outlines the details the MAH must provide in the BSR application.
Furthermore, the MAH must confirm that safety features have already been registered with the HPRA and if not a simultaneous Article 61 (3) notification must be submitted with the BSR application. 

For full details on this issue the full article can be found here: https://www.hpra.ie/homepage/about-us/publications-forms/newsletters/item?id=55950b26-9782-6eee-9b55-ff00008c97d0&t=/docs/default-source/publications-forms/newsletters/hpra-medicinal-products-newsletter—issue-number-61

Written by:

Claire Brown