SPC Waiver Notifications

Notifications filed in accordance with Article 5(2) (b) or (c) of Regulation EC No. 469/2009 (as amended)

Date of Notification SPC No. Notification Type Name & Address of Maker Purpose of Making Additional Information
07 July 2025 2015/017 New Notification

Lotus Pharma Bulgaria EOOD,
102D Cherni Vrah Blvd.,
Floor 4, Sofia 1407, Bulgaria.

Storage
25 May 2025 2015/017 New Notification Eirgen Pharma Limited, Westside Business Park, Old Kilmeaden Road, Waterford, X91 YV67, Ireland Storage
05 February 2023 2009/015 New Notification Amgen Technology (Ireland) Unlimited, Pottery Road, Dun Laoghaire,  County Dublin Export Waiver notification withdrawn on 22 May 2023