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Variations to Marketing Authorisations
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, or Type II, as defined in
Commission Regulation 1234/2008.
This new
regulation applies for products authorised through the
Centralised Procedure and those authorised through the
Decentralised and Mutual Recognition Procedures. The new
variations regulation replaces the former regulations –
Regulation EC 1084/2003 (MRP/DCP) and
Regulation EC 1085/2003 (centrally authorised products).
The new regulation will apply for applications submitted from
January 2010.
Detailed
information on the submission of variations through the MRP
and DCP can be found in the Variations Section on the
CMDh website. The European Commission has also published
updated
guidance documents and a
new application form to cover variations submitted in
accordance with Regulation EC 1234/2008.
Applications for variations to a Marketing Authorisation which
was issued as a result of a national procedure are to be made
directly to the Medicines Authority. The new
Directive 2009/53/EC
will be applicable for variations submitted for products
authorised through the national procedure. The date of
implementation for this directive in Malta will be published
during 2010. According to this Directive, the requirements
for national applications will be similar to those for
European procedures and worksharing and grouping of variations
will also be possible.
National
variation applications for products with a marketing
authorisation authorised through the PMA/MA process and their
line extensions may be submitted using the variation
application forms below:
Editable Word Format Variations Form (May 2008)
However,
until the implementation of Regulation 1234/2008 is affected
in Malta, both types of submissions will be accepted. Both
the above applications form and those in accordance with the
Regulation (link above) will be accepted.
An information
session for Marketing Authorisation Holders and/or their local
contact points is planned for 2010.
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.
A new fees
proposal to cover variation applications in accordance with
the new legislation will be announced at a later date.
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. 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.
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.
Fees for
notification procedures are included in the annual fee.
Updated 5 March 2010
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