Marketing
Authorisations
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 (EMEA).
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)
National Procedure
The
list of products
with a national marketing authorisation in Malta and the
respective approved Summary of Product Characteristics (SmPC)
and Package Leaflet (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 (EMEA).
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
EMEA
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 CMD(h)
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
The Medicines
Authority will be accepting applications as Reference
Member State in the Decentralised and Mutual Recognition
Procedure.
Until further
notice, the applications considered will be those for
immediate solid oral dosage forms 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 specific
pre-submission form
should be filled in and sent to the Medicines Authority
at least 6 months before the proposed submission date.
Authorisation*
in line with article 4(2) of the Medicines (Marketing
Authorisations) 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.
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.
Details regarding the procedure involved and how to fill
in the application form can be found in the
Guidelines
for the placing of products on the market in
Malta through an application for an Authorisation in
line with article 4(2) of the Medicines (Marketing
Authorisations) 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.
In order
to apply for this authorisation, the proposed
product authorisation holder must submit the
application form,
all necessary
documentation,
and
fees,
to the Medicines Authority.
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.
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 variation to the authorised
product (SPC, package leaflet and/or immediate and/or
outer labelling and packaging) approved in the Member
State.
The Variations Notifications
Form
for an Authorisation in line with article 4(2) of
the Medicines (Marketing Authorisations) Regulations
needs to be submitted before the product having these
changes is placed on the Maltese market.
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 a
Renewal Form.
List of Authorisations in line with article 4(2) of the
Medicines (Marketing Authorisations) 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 -
Latest Update
-
24/06/2008 |
