Form to report modifications (modification of data, increase in quantity, extension of period) to the initial notification of distribution of medicinal products under Article 105/1 of the Royal Decree of 14 December 2006.
Complete only the fields for data that have changed compared to the initial notification. Data that remain the same do not need to be filled in again.
Privacy statement
The personal data collected in the context of this notification, including the contact person's first name, surname, e-mail address and telephone number, will be used exclusively by the FAMHP to assess and process your notification for the temporary importation of medicinal products in situations of critical unavailability, in accordance with the Royal Decree of 12 September 2024 amending the Royal Decree of 14 December 2006 and the GDPR. This data will be kept for the time strictly necessary to manage the notification and will not be shared with third parties without prior consent. For more information, please consult our privacy statement.
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