On the 2nd of December, INFARMED I. P. issued an Informative Note 136/CD/100.20.200 notifying a transitional period leading up to 15th January, 2026, after which the new Guidelines for Variations to the terms of Marketing Authorisations (MA) (C/2025/5045) will take place. From 15th January, variations submitted according to the categories defined in the current guidelines in force since 2013 will not be accepted.

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For Type IA variations:

• All variations implemented in 2025 must be included in an annual update in December 2025 or by the 14th January, 2026.

• The type IA variations not included on the annual update could be submitted on an anticipated annual update or by submission of a single IA variation.

• Variations foreseen as exceptions to the annual updates may be submitted as individual notifications.

• A new annual update cycle will start from the first implemented type IA variation after the 15th January 2026, excluding the exceptions to the annual updates.

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Concerning the SMUH-Alter platform, every variation submitted until 14th January 2026  with a payment issued will be assessed according to the current guidelines, however, all submissions after this date, the SMUH-Alter will only have available the variations covered by the new guidelines.

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As the industry moves toward the new legal framework reflecting the 2024 amendment of the Variations Regulation, proactive adaptation is essential for all ongoing and future variation submissions.

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