Medicinal products marketed in Malta must have a
Marketing Authorisation (MA) to be placed on the
market, granted by the Medicines Authority
(through national, Mutual Recognition or
Decentralised Procedures) or the European
Commission (Centralised Procedure).
Marketing authorisations are granted nationally by
the Medicines Authority in accordance with the
Medicines Act, 2003 and the
Medicines (Marketing Authorisation) Regulations.
Marketing Authorisations are granted by the
European Commission in accordance with
Regulation 726/2004.
Currently the three main types of procedures
recognised for the granting of a marketing
authorisation and to place a product on the market
in Malta are:
· National Procedures (Regulation 4(1) and
4(2) of Medicines (Marketing Authorisation)
Regulations
· European Procedures (Mutual Recognition
(MRP) and Decentralised (DCP) Procedures)
Information on Parallel Importation of medicinal
products can be found in the section on
Parallel Importation.
National Procedures
Marketing Authorisation procedure in accordance
with regulation 4 (1) of the Medicines (Marketing
Authorisation) Regulations, in accordance with
articles 8 and 10 of Directive 2001/83/EC
In order to obtain Marketing Authorisations for
new products to be placed on the market in
Malta, a national application can be submitted
to the Medicines Authority. National Marketing
Authorisation applications are required for
products that are not already registered in any
country in the EU/EEA.
The
list of products
with a national marketing authorisation in Malta
is available and the respective approved Summaries
of Product Characteristics (SmPC) and Package
Leaflets (PL) can also be accessed for each
product by using the
search link
on this page.
Guidelines and Application forms
General information on marketing authorisations
and application forms are available in
Chapter 1 of Volume 2A –
Marketing Authorisation,of
the Notice to Applicants on the European
Commission 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 - 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.
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
now included with the other concerned 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 or as a ‘fast-track’
procedure. 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 these procedures. 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.
Those product authorisations granted in accordance
with article 126a for which a repeat use MR
procedure has in the meantime (since date of
authorisation) been carried out, and Malta was not
included as Concerned Member State, will not be
renewed.
Applications in accordance with article 126a
received for products for which a MRP procedure
(first or second wave) or a DC procedure have been
started from 1 August 2010 where Malta was not
included as Concerned Member State, will not be
accepted by the Medicines Authority.
From 1 August 2010, applications in accordance
with article 126a which should be submitted as
line extensions to products having a marketing
authorisation may not be accepted and applicants
will be directed submit these applications as
national line extensions.
Guidelines and Application forms
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].
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.
European Procedures
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.
Guidelines and Application forms
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
Volume 2A of Chapter 2 of the Notice to
Applicants – Mutual Recognition
and application forms can be downloaded
from
Chapter 1 of Volume 2A –
Marketing Authorisation 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 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.
Currently the Medicines Authority is filling in
slots for 2011 - 2012. Please send in the
pre-submission forms in due time for
consideration, at least six months before proposed
submission date. Once you are given a slot, you
are requested to inform the Medicines Authority
immediately should you not be able for any reason
to submit in the agreed timeline. The Medicines
Authority should be informed in good time about
any problems encountered that may lead to
postponement or cancellation of the slot that is
granted.
Information and guidance documents on the
decentralised procedure can be found on the
CMDh website.
Public assessment reports of products authorised
with procedures where Malta is RMS are being made
available on http://www.medicinesauthority.gov.mt/par.htm
Centralised Procedure
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.
Guidelines and Application forms
More information can also be accessed on the
EMA
website.
Marketing Authorisations lists, forms and
publications:
List
of Marketing Authorisations Issued
1
-
28/07/2010
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
1 -
Latest Update
(28/07/2010)
List
of authorised products withdrawn by the Marketing
Authorisation Holder - 17/06/2010
List
of Parallel Import Licences
1
-
28/07/2010
Application
for Transfer of MAH for an Authorised Product
- 7/4/09
Application
for MAH Transfer during Authorisation Procedure
- 7/4/09
Application
for notification in line with article 61(3) of
Directive 2001/83/EC, as amended
Form
for the withdrawal of a product authorisation or
licence -
23/7/09
MAH
Authorisation for Contact Person
- 8/1/10
1
Disclaimer: The information contained in this list
and in the SmPCs and package leaflets is for
general information purposes only and thus the
information in the list and the
published product information should not be used
officially as a substitute for the Marketing
Authorisation legal documents held by the
Marketing Authorisation Holders
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