New Procedure for Supergroups of Variations of medicines by AEMPS

The Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) has recently introduced a significant update to the procedure for submitting variations to marketing authorizations for medicines. This new procedure, established in accordance with Commission Regulation (EU) No 712/2012 with regards to the Variations Regulation (Commission Regulation (EC) No 1234/2008), allows laboratories to submit multiple variations in a single application, streamlining the process and eliminating the need for prior confirmation of supergroup requests. 

Key Changes in the Procedure

• Elimination of Prior Confirmation: One of the most notable changes introduced by the AEMPS is the removal of the prior confirmation procedure for supergroup requests. Previously, laboratories had to seek confirmation from the AEMPS before submitting a supergroup of variations. This step has now been eliminated, simplifying the process and reducing the administrative burden on laboratories.
  
  
• Unified Submission for Multiple Variations: The new procedure allows laboratories to present multiple modifications to marketing authorizations in a single application. This is applicable as long as the medicines are from the same marketing authorization holder (MAH) and have been authorized through the national procedure. This change is expected to enhance efficiency and reduce the time required for the approval of variations.

Instructions for Submitting Supergroups of Variations for authorized medicines through the national procedure

The detailed instructions for submitting supergroups of variations have been updated consequently by the AEMPS. In particular the laboratory will have to include in its form to submit supergroups to the AEMPS, the disclosure of which of the following requirements the variations group has:

• Supergroups Type IB: These include variations where at least one is a type IB variation and affects more than one marketing authorization (MA).
• Supergroups Type II: These include variations where at least one is a type II variation and affects more than one MA.
• Supergroups Line Extension: These include variations where at least one is a line extension and affects more than one MA.
• Variations listed in Annex III of the Variations Regulation (Cases for grouping variations) and the "Examples for acceptable and not acceptable groupings for MRP/DCP products" from the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh).

Additionally, (i) all the affected MAs included in the proposal must be considered to belong to the same MAH; (ii) the variation(s) must affect all MAs included in the proposal equally; and (iii) none of the included MAs must authorized by any other European procedure or authorized by national procedure in any other country than Spain.

Evaluation Process

The Division of Management and Registration Procedures of the Department of Human Medicines (División de Gestión y Procedimientos de Registro del Departamento de Medicamentos de Uso Humano) will jointly verify the validity of the supergroup based on the information provided by the laboratory. This verification is subject to confirmation or rejection during the evaluation of the documentation.

Conclusion

The new procedure for submitting supergroups of variations introduced by the AEMPS marks a significant step towards streamlining the regulatory process for marketing authorizations of medicines. By allowing multiple variations to be submitted in a single application and eliminating the prior confirmation step, the AEMPS aims to enhance efficiency and reduce administrative burdens on laboratories. Laboratories must ensure compliance with the detailed instructions provided to benefit from this new procedure.