In accordance with the Medicines Act,
2003 (Act No III of 2003), as amended, and the
Medicines (Marketing Authorisations) Regulations,
all medicinal products marketed in Malta must have
a Marketing Authorisation (MA) or a licence to be
placed on the market granted by the Medicines
Authority and for Centrally Authorised products,
by the European Medicines Agency (EMA).
Currently the three main types of
procedures recognized for the granting of a
marketing authorisation and to place a product on
the market in Malta are:
· National Procedures
· European Procedures (Mutual Recognition
and Decentralised Procedures)
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National Procedure
The
list of products
with a national marketing authorisation in Malta
and the respective approved Summary of Product
Characteristics (SmPC) and Package Leaflets (PL)
can also be accessed for each product by using the
search link
on this page.
In order to obtain Marketing
Authorisations for new products to be placed on
the market in Malta, a national application must
be submitted to the Medicines Authority. National
Marketing Authorisation applications are required
for products that not already registered in any
country in the EU/EEA.
General information on marketing authorisations is given in
Chapter 1 of Volume 2A –
Marketing Authorisation,of
the Notice to Applicants.
********
European Procedures
In
order to obtain a community authorisation, through
the Centralised procedure a marketing
authorisation application must be submitted to the
European Medicines Agency (EMA). Products
authorised by the Centralised system (Centrally
Authorised Products) can be automatically marketed
in Malta, as their marketing authorisation is
valid in all EU/EEA countries. A list of these
products and more information on these products
can be found on the
EMA
website.
In cases where a national authorisation is required for a product that
is already registered in another member state of
the EEA the Mutual Recognition procedure has to be
used. Where a product is not already authorised,
both the Mutual Recognition and the Decentralised
procedures may be used for obtaining a Marketing
Authorisation for Malta. More detailed
information on the Mutual Recognition and
Decentralised Procedures and all documentation and
templates can be found in the
CMDh section
of the
Heads of Medicines
Agencieswebsite
Details on documentation to be supplied can be
found in
Chapter 2 of Volume 2A of
the Notice to Applicants – Mutual
Recognition
and application forms can be downloaded
from
Eudralex Volume 2
of the European Commission website.
Malta as Reference Member State in the
Decentralised Procedure
Since 2007 the Medicines Authority is accepting
applications as Reference Member State in the
Decentralised Procedure.
Until further notice, the applications considered
will be those for immediate release solid oral
dosage forms and oral solutions in accordance with
article 10 of Directive 2001/83/EC, as amended.
To
be able to consider such applications, some
information is requested to enable the Medicines
Authority to assess whether to accept the
submission of an application for a Marketing
Authorisation or not. The
Request Form
on the CMDh website should be
filled in and sent to the Medicines Authority at
least 6 months before the proposed submission
date. The requests should be sent by e-mail
directly to the
CMDh (MRP/DCP) contact point with a copy to
the e-mail address
prelicensing.mru@gov.mt.
The
slots for the 20 procedures planned for 2010 are
all booked. A few procedures are on the waiting
list should slots become available in case of
cancellation by the applicants. It is important
that any required changes in slots and/or products
to be submitted are discussed with the Medicines
Authority well in advance. Any foreseen
cancellations should also be communicated at the
earliest.
Currently we are filling in slots for 2011. Please
send in the pre-submission forms in due time for
consideration, at least six months before proposed
submission date.
Information and guidance documents on the decentralised
procedure can be found on the
CMDh website.
Authorisation*
in line with regulation 4(2) of the Medicines
(Marketing Authorisation) Regulations, in
accordance with article 126(a) of Directive
2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community Code
relating to medicinal products for human use, as
amended by Directive 2004/27/EC of the European
Parliament and of the Council of 31 March 2004. -
21/10/09
In
the absence of a marketing authorisation for a
medicinal product, the Licensing Authority may
authorise the placing of that medicinal product on
the market in Malta, provided that the said
product is authorised in another Member State (EU/EEA
country). An authorisation is thus granted
in accordance with Regulation 4(2) of the
Medicines (Marketing Authorisation) Regulations,
under the Medicines Act, 2003. A
link to the legislation page (Maltese Legislation)
of the Medicines Authority’s website can be found
here.
Details regarding the procedure involved and
guidance on filling in the application forms can
be found in the
Guidelines
[Guidelines for the placing of medicinal products
on the market in Malta through an application for
an Authorisation in line with regulation 4(2) of
the Medicines (Marketing Authorisation)
Regulations, in accordance with article 126(a) of
Directive 2001/83/EC of the European Parliament
and of the Council of 6 November 2001 on the
Community Code relating to medicinal products for
human use, as amended by Directive 2004/27/EC of
the European Parliament and of the Council of 31
March 2004].
This
authorisation procedure is being applied mainly to
cover the public health need created by the lack
of applications for marketing authorisations for
products which were on the derogation list and for
products which were authorised in the period
between the publication of the derogation list and
the date of accession. It is strongly
recommended that Malta is included with the
other member states in the Mutual Recognition and
in the Decentralised procedures.
It is to be stressed that this procedure should,
in no way, be considered as an easy way of
circumventing the current procedures stipulated by
the EU legislation. The Mutual Recognition
Procedure and the Decentralised Procedure have to
be used for the products that are being authorised
in the EU/EEA. Malta should be included as a
Concerned Member State in the procedure, if the
product is to be placed on the local market.
Applications for products for which the marketing
authorisation is withdrawn by the Marketing
Authorisation holder (other than for safety
reasons) and subsequently received through the
‘article 126(a)’ route, may not be considered.
After notification by the Medicines Authority of
the issue of an authorisation for a
medicinal product, the Authorisation holder must
notify the Medicines Authority of
any variations to the
authorised product, which have been approved in
the Member State (EU/EEA country of source) that
will affect the product information (that is the
SmPC and/or package leaflet and/or immediate
and/or outer labelling and packaging). The
Variations Notification
Form
[Variations Notification Form for an Authorisation
in line with regulation 4(2) of the Medicines
(Marketing Authorisation) Regulations, in
accordance with article 126(a) of Directive
2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community Code
relating to medicinal products for human use, as
amended by Directive 2004/27/EC of the European
Parliament and of the Council of 31 March 2004],
needs to be submitted before the product having
these changes is placed on the market in Malta.
The authorisation will be valid for five
(5) years. The Medicines Authority would need
to be notified of the intention for renewal (if
applicable) at least 3 months prior to the end of
validity of the authorisation by submission
of the
Renewal Form
[Renewal Form for an Authorisation in line with
regulation 4(2) of the Medicines (Marketing
Authorisation) Regulations, in accordance with
article 126(a) of Directive 2001/83/EC of the
European Parliament and of the Council of 6
November 2001 on the Community Code relating to
medicinal products for human use, as amended by
Directive 2004/27/EC of the European Parliament
and of the Council of 31 March 2004]. The licence
will not be renewed unless a Renewal Application
Form is submitted. If during the 5-year period
the product has been granted a marketing
authorisation, the Authorisation in line
with regulation 4(2) of the Medicines (Marketing
Authorisation) Regulations, will not be renewed.
A
List of Authorisations
in line with regulation 4(2) of the Medicines
(Marketing Authorisation) Regulations, [in
accordance with article 126(a) of Directive
2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community Code
relating to medicinal products for human use, as
amended by Directive 2004/27/EC of the European
Parliament and of the Council of 31 March 2004],
can be found on the Medicines Authority’s
website.
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