19/02/2026
โ ๏ธ If you are planning a , submitting , or a within the , it is essential to consider the updated requirements for the Summary of Product Characteristics ( ) and ( ), which are already applied in regulatory practice. These changes directly affect the structure and content of product information as well as approaches to preparing regulatory documentation.
The last updates were introduced by of the Council of the Eurasian Economic Commission No.18 dated 21 February 2025. The document amended previously applicable requirements and aims to standardise approaches, improve transparency of information for healthcare professionals and patients, and further align EAEU practices with .
๐ถ Key Changes in Practice
The amendments affect the structure and content of and sections, clarify certain wording requirements, update expectations for presenting , and , and further standardise terminology and document format.
As a result, applicants should review their current templates and internal medical writing practices to ensure alignment with the updated requirements.
๐ถ Practical Implications for MAHs and Applicants
In practice, companies are expected to conduct of existing SmPCs and PLs, review submitted and planned dossiers and update internal medical writing and processes.
The revised requirements are particularly important when preparing new registrations, variations, and dossier alignment procedures within the EAEU framework.
๐ถ Bringing Documentation into Compliance
Companies should prioritise documents requiring updates, assess potential regulatory risks, and plan revisions accordingly. In some cases, this may involve revising and sections, including indications, warnings, interactions, and clinical pharmacology information, in line with the updated regulatory expectations.
๐ถ Key Challenges and Approaches to Documentation Updates
Regulatory experience shows that non-compliance with updated requirements is often identified during expert review, leading to additional questions and procedural delays. Therefore, companies should focus not only on formal document updates but also on implementing consistent approaches to document preparation across internal teams and external vendors.
๐ How to Minimise Regulatory Risks
Inpharmatis Team supports applicants at all stages of working with and in the โ from expert review and assessment to preparation of updated documents and support during and update procedures. This support reduces regulatory risks and ensures timely compliance with current requirements.
๐ More details - https://inpharmatis.com/smpc-and-package-leaflet-requirements-in-the-eaeu/
