The Spanish Agency for Medicines and Medical Devices (AEMPS) has published updated guidance regarding the inclusion of waste management information in the documentation for veterinary medicinal products. This guidance is particularly relevant for all marketing authorisation holders, as it sets out clear expectations for the correct placement and wording of waste-related statements in product documentation.
Scope of the Guidance
The update applies to a broad range of products, including:
- Veterinary medicinal products currently under evaluation for authorisation
- Products that have already been approved
- Products authorised through national procedures, the Decentralised Procedure (DCP), or the Mutual Recognition Procedure (MRP)
Required Updates
As part of this guidance, marketing authorisation holders are required to include a standardised waste disposal statement in the following documents:
- Summary of Product Characteristics (SPC) – Section 5.5
- Package Leaflet (PL) – Section 12
This measure aims to ensure the environmentally responsible disposal of veterinary medicines and to align with current regulatory and sustainability standards.
Next Steps for Marketing Authorisation Holders
AEMPS has provided a summary document outlining specific instructions and timelines, depending on the status of your product. It is essential to review this document carefully and determine whether updates are needed for your product portfolio.
If you are unsure how to proceed or need assistance with evaluating your case, preparing documentation, or submitting variations, our regulatory affairs team is available to help.
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