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Variations


 

Variations

Following approval, a Marketing Authorisation may be varied, for instance, to add a new manufacturing site, to change the method of manufacture or to add a new indication. Variations are either Type IA or Type IB (minor variations), or Type II (major variations, which may be simple or complex), as defined in Commission Regulation 1084/2003.
Applications for variations to a Marketing Authorisation, which was issued as a result of a national procedure, are made directly to the Medicines Authority.

Further information on dossier requirements for national variations is available in Chapter 5 of the Volume 2A of the Notice to Applicants. National variation applications for products with a marketing authorisation authorised through the PMA/MA process have to be submitted as national variation applications

Further information on requirements for MRP variations is available in requirements for submission for National and MRP Variations.

Fees for Variations

Fees charged for variations can be found in the Medicines Authority (Fees) Regulations.

Fees for variations for products authorised both through the Mutual Recognition Procedure or Decentralised Procedures with Malta as Concerned Member State, are included in the annual fee of each product.  

Fees for products authorised through the national procedure (PMA/MA and their line extensions) are also included in the annual fees for each authorised product.  However, the national variation fees (as per Schedule 2 of the Fees legal notice – Legal Notice 315 of 2006) are applicable when the variation has not been approved in the country of source at the time of submission.  A copy of the approval should be included with the application form.  If the approval is not present at time of submission of the variation application, the variation fees as outlined in Schedule 2 of the Legal Notice on fees are due.  If the variations are only applicable for the product on the market in Malta, the fees for national variations are due.  From 1 October 2008, application forms must be accompanied by an approval letter or a proof of payment on submission.  Lacking either, the applications will not be processed.

Fees for variation applications through the MR and DC procedures with Malta as Reference Member State (RMS), and for variations for national products NOT authorised through the PMA/MA process (or their line extensions) are charged as per the current Medicines Authority (Fees) Regulations. 

Notification for changes to Labelling and Package Leaflets in accordance with Article 61(3) of Directive 2001/83/EC (Regulation 8(3) of the Medicinal Products (Packaging and Labelling) Regulations.

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 authorizing 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 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).

 For such notification, 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 of 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 Guidance, may render the notification invalid.

 The Medicines Authority will acknowledge the receipt of such notification forms. MAHs should be aware that the responsibility for the information presented on the packaging and in the PL rests solely with the MAH.

 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 those products authorised through these procedures.

Fees for notification procedures are included in the annual fee.

 

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