From September 1st EMA no longer accepts old PDFs for medicine variations
The European Medicines Agency completes the transition to the mandatory electronic form for variation applications for medicines authorised under the centralised procedure. WHO publishes the summary of the second edition of its guidelines on cognitive decline.
The timetable closed on September 1st. From that date, variation applications for human medicines sent to the European Medicines Agency using the old interactive PDF form no longer follow the standard procedure: the new electronic form is now mandatory in its place. The transition had been announced by the agency in April 2026 and is reconstructed in the review of EMA and CMDh communications published by Pharmavibes and on the news channels of the European Medicines Agency itself.
Three dates, not one
The transition took place in successive stages, and the distinction matters for those submitting applications:
| Date | What changes |
|---|---|
| 3 August 2026 | the updated form can be used for new variation applications submitted to EMA and national authorities |
| 24 August 2026 | the updated form becomes mandatory for all new applications |
| 1 September 2026 | applications sent to EMA with the old interactive PDF no longer follow the standard procedure |
The EMA/CMDh explanatory notes on the variation application form have been updated and republished in the procedural guidance.
A variation is a change to a marketing authorisation already granted: a manufacturing detail, a text, a specification changes, and the holder must request approval for it. It is not a matter the public encounters directly, but it concerns the ordinary channel through which marketing authorisation holders interact with the agencies. The shift from a fillable document to a structured electronic form serves to make the fields automatically readable by the authorities’ systems.
Two WHO publications
On September 2nd, 2026, the World Health Organization published the executive summary of the second edition of its own guidelines on reducing the risk of cognitive decline and dementia. The document, disseminated through the official news and publications channels of the WHO, presents the key recommendations of the new edition. We do not report its content: the excerpts available to us record the publication and its nature, not the list of recommendations, and this newspaper does not report health guidance it cannot read in the original text. Those wishing to consult it will find the document on the organisation’s website. The news currently comes from a single source (the WHO itself, a primary institutional source); no independent confirmation available.
The value of these documents lies in their intended purpose: WHO guidelines are not advice to the individual, they are reference material with which health ministries build their prevention policies. The distinction between a policy document for health systems and an individual suggestion is precisely the one this newspaper is bound not to blur.
What we don’t know
We do not know how the second edition of the guidelines differs from the first, nor which recommendations have been modified, added or removed: the summary exists, its content is not in the excerpts. On the European front we do not know the treatment reserved for variation applications submitted with the old form before September 1st and not yet processed, nor whether exceptions are planned for procedures already under way.
The operational fact, for companies submitting applications to EMA and national agencies, is that from September 1st applications sent with the old interactive PDF no longer follow the standard procedure.
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