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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