MARKETING AUTHORISATION (FEES) ġ S.L.458.29 1
SUBSIDIARY LEGISLATION 458.29
MARKETING AUTHORISATION (FEES) 
REGULATIONS
1st December, 2003
LEGAL NOTICE 372 of 2003.
Title.
Authorisation (Fees) Regulations.
Interpretation.
''complex application'' means an application for a marketing
authorisation, other than a major application, when it falls within
one or more of the following descriptions:
( a ) the application relates to a medicinal product which is
intended to be used in accordance with an indication
for use in respect of a new category of patients or as a
treatment for a new category of disease;
( b ) the application relates to a medicinal product
containing a new combination of active ingredients
that have not previously been included in that
combination in a medicinal product in respect of which
a marketing authorisation has previously been granted;
( c ) the application relates to a medicinal product
containing a new excipient;
( d ) the application relates to a medicinal product that is
intended to be administered by a route of
administration different from that used in the
administration of any medicinal product which
contains the same active ingredient as the product in
question and in respect of which a marketing
authorisation has previously been granted;
( e ) the application relates to a medicinal product
containing an active ingredient, the manufacture of
which involves a route of synthesis or, in the case of a
medicinal product not synthetically produced, a
method of manufacture, different from that used in the
manufacture of the active ingredient of any medicinal
product which contains the same active ingredient as
the product in question and in respect of which a
marketing authorisation has previously been granted;
( f ) the application related to a medicinal product which is
controlled release preparation and is not a simple
application;
( g ) the application relates to a sterile medicinal product
the manufacture of which involves a method of
sterilisation different from that used in the
manufacture of any medicinal product which contains
2 ġ S.L.458.29 MARKETING AUTHORISATION (FEES)
the same active ingredient as the product in question
and in respect of which a marketing authorisation has
previously been granted;
( h ) the application relates to a sterile medicinal product
the container of which is directly in contact with the
medicinal product and is made from different material
from the container of any medicinal product which
contains the same active ingredient as the product in
question and in respect of which a marketing
authorisation has previously been granted;
( i ) the application names as manufacturer of the active
ingredient of the medicinal product in question a
different manufacturer from the manufacturer of that
active ingredient included in a medicinal product in
respect of which a marketing authorisation has
previously been granted;
( j ) the application relates to a medicinal product which is
an influenza vaccine and in respect of which the
manufacturer or the manufacturing process is different
from that specified in any other marketing
authorisation which the applicant holds in respect of
that product;
( k ) the application is for the grant of a marketing
authorisation for a medicinal product which is an
influenza vaccine, except where it relates only to an
influenza vaccine containing a different strain or
strains from that specified in any other marketing
authorisation which the applicant holds;
( l ) the application is for the grant of a marketing
authorisation for a medicinal product which is to be
delivered by way of a metered dose inhaler;
( m ) the application is for the grant of a marketing
authorisation for a medicinal product which is in a
powdered form and is to be delivered by way of
inhalation;
( n ) the application relates to a medicinal product -
(i) which is administered to the site of action of
absorption by a method which has not
previously been authorised in relation to any
authorised medicinal product which contains the
same active ingredient as the product in question
and,
(ii) in respect of that other product, a marketing
authorisation had been previously granted;
''major application'' means an application submitted for a product
containing new chemical entities;
''market authorisation transfer'' is when a market authorisation is
transferred from the existing market authorisation holder to another
using a transfer procedure. A transfer may occur either before or
after authorisation;
MARKETING AUTHORISATION (FEES) ġ S.L.458.29 3
''simple application'' means:
( a ) an application for a marketing authorisation, or
( b ) an application other than one for a marketing
authorisation, for a medicinal product which is a new
strength or a product in respect of which a marketing
authorisation has been previously been granted; or
( c ) an application made no later than three months after
the expiry of a marketing authorisation, containing
identical provisions to those contained in the expired
authorisation and which is made by the same holder;
''standard application'' means any application for the grant of a
marketing authorisation other than a major application, a complex
application, a simple application, a marketing authorisation transfer
application or an application for a marketing authorisation in a
parallel import;
''Type I A and Type IB minor variation'' means a variation listed
in Annex I of 1084/2003 EC which fulfils the conditions set out
therein;
''Type II major variation'' means a variation which cannot be
deemed to be a minor variation or an extension of the marketing
authorisation;
''annual fee'' means a yearly fee, covering all aspects of routine
dossier management and maintenance from the date of the initial
authorisation.
Fees.
of an application for the issue, maintenence and variation of the
marketing authorisation shown under Column 1 of the Schedule, an
annual fee shown under Column 2 of the same Schedule.
4 ġ S.L.458.29 MARKETING AUTHORISATION (FEES)
SCHEDULE
Column 1 Column 2
Type Fee (Lm)
TRANSITION LIST
Centrally Authorised Products ................................................... No Fee
Products on the list which have an MA in compliance with the
Acquis communautaire  authorised in a country listed in the Second
Schedule of the Medicines Act ............................................................ 50 
Products on list not licensed in the EU
Major Application (New Chemical Entity) ....................................... 48,000
Complex Abridged (New product) ................................................... 15,000
Standard Abridged (Generics – Bioequivalence and Bibliographic
data required) ...................................................................................... 7,000
Simple Abridged (Innovator gives full access to data on its product) 2,500
Products NOT on the Transition List (New Applications)
Major Application (New Chemical Entity) ....................................... 48,000
Complex Abridged (New product) ................................................... 15,000
Standard Abridged (Generics – Bioequivalence and Bibliographic
data required) ...................................................................................... 7,000
Simple Abridged (Innovator gives full access to data on its product)  2,500
Incoming Mutual Recognition – Complex (After Accession i.e. 1st
May, 2004 ........................................................................................... 1,000
Incoming Mutual Recognition – Standard (After Accession i.e. 1st
May, 2004) ......................................................................................... 500
Minor Variation - National (Type IA) .............................................. 75
Minor Variation – National (Type IB) .............................................. 250 
Major Variation – National (Type II) ............................................... 500
Minor Variation – Mutual Recognition (Type IA) ............................ 75
Minor Variation – Mutual Recognition (Type IB) ............................ 200
Major Variation – Mutual Recognition (Type II) .............................. 300
Parallel Import Marketing Authorisation .......................................... 190
Market Authorisation Transfer (Change of Ownership) .................... 75
Annual fee (Post Licensing) ............................................................. 25
