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Home / Activities / Registration / Post Authorisation Procedures / Notification of changes according to Article 61(3)

Notification of changes according to Article 61(3)

Introduction

Minor changes which do not affect the SmPC but affect the PL and/or labelling can be submitted under article 61(3) of Directive 2001/83/EC as a notification application.

Article 61(3) of Directive 2001/83/EC states that:

"All proposed changes to an aspect of the labelling or the package leaflet covered by this Title and not connected with the summary of product characteristics shall be submitted to the authorities competent for authorising marketing. If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect."

Hence, Marketing Authorisation Holders (MAH) are required to inform the Medicines Authority of all changes made to the labelling (outer and immediate) and Package Leaflets (PL) of all authorised medicinal product, that are not connected with changes to the Summary of Products Characteristics (SmPC).

Submission of Notification

For such notification for national products, applicants should make use of the Notification Form for Changes to Labels and Patient Information Leaflets. This Notification Form should be completely filled in and full colour mock-ups should be provided if available. The proposed final version of the packaging components and package leaflet affected by the change must accompany the notification.

The Notification Form may be used to inform the Medicines Authority of more than one change relating to a product.  A form per product must be filled in. However, the marketing authorisation holder must ensure that all changes implemented are covered by the Guidelines on Notification of Changes to Labelling and Package Leaflets  in accordance with Article 61(3) of Directive 2001/83/EC.  Marketing Authorisation Holders are informed that any changes introduced to the packaging components but not formally notified, or not covered by the guideline, may render the notification invalid.

Marketing Authorisation Holders should be aware that the responsibility for the information presented on the packaging and in the PL rests solely with the MAH.

Parallel imported products and products authorised in line with article 126(a) of Directive 2001/83/EC, as amended

This notification process does not apply to parallel imported products and products authorised in line with article 126(a) of Directive 2001/83/EC, as amended.  The appropriate forms, found in the specific sections for each type of application, for notification for a variation, must be used for products authorised through these procedures.

Products authorised via Mutual Recognition and Decentralised Procedures

One may find the relevant documentation and information for article 61(3) notifications on the CMD(h) website: