Luxembourg
The LU agency (DPM) has updated its internal guidance document outlining all steps related to market authorization procedures in Luxembourg.
Key Amendments:
Decentralised, Mutual Recognition, and Repeat Use Procedures (MRP/DCP/RUP)
- Variations Type IA / Type IB / Notification 61.3 & MAH Transfer
- The national form “notification de modification” (Formulaire (AMM) variation Type I) is no longer required as an attachment to the notification email.
- The email notification to DPM remains mandatory for Type IA and Type IB variations in MRP/DCP.
- Renewals
- Updated requirements for documents to be attached to the email to DPM. The “Formulaire (AMM) renouvellement” is no longer required.
Centralised Procedure (CP)
- Variations Type IA / IB / II / Notifications
- The LU agency requests to be informed by email of any changes impacting packs or product presentation (e.g., deletion/addition of packs) and/or any changes affecting LU information on the European MA.
National Procedure (NP)
- Mandatory Worksharing (WS) Procedure – Article 20 of the Variation Regulation
- MAHs must submit the same Type IB/II variation (or variation group) across several MAs in a single WS application, including both the country of origin and LU in the same procedure.
- Type IB variations: The national form “notification de modification” (Formulaire (AMM) variation Type I) is no longer required.
- MAHs must submit the same Type IB/II variation (or variation group) across several MAs in a single WS application, including both the country of origin and LU in the same procedure.
- Renewals
- Updated requirements for documents to be attached to the email to DPM (the “Formulaire (AMM) renouvellement” is no longer required).
Source: Procédures internes au Luxembourg – Portail Santé – Luxembourg