Marketing Authorisation (Fees) Regulations, 2003

L.N. 372 of 2003

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Marketing Authorisation (Fees) Regulations, 2003

IN exercise of the powers conferred by article 106 of the Medicines

Act, 2003, the Minister of Health, with the concurrence of the Minister

of Finance and Economic Affairs, has made the following regulations>-

(1) The title of these regulations is the Marketing Title and

commencement.

Authorisation (Fees) Regulations, 2003.

(2) These regulations shall come into force on the 1st

December, 2003.

For the purposes of these regulations -

Column 1

Type

TRANSITION LIST

Centrally Authorised Products ………………………………

Products on the list which have an MA in compliance with

the Acquis communitaire authorised in a country listed in Schedule

2 of the Medicines Act ……………………………………………

Products on list not licensed in the EU

Major Application (New Chemical Entity) …………………

Complex Abridged (New product) …………………………

Standard Abridged (Generics – Bioequivalence and

Bibliographic data required) ………………………………………

Simple Abridged (Innovator gives full access to data on its

product) …………………………………………………………

Products NOT on the Transition List (New Applications)

Major Application (New Chemical Entity) …………………

Complex Abridged (New product) …………………………

Standard Abridged (Generics – Bioequivalence and

Bibliographic data required) ………………………………………

Simple Abridged (Innovator gives full access to data on its

product) …………………………………………………………

Incoming Mutual Recognition – Complex (After Accession

i.e. 1st May, 2004 ………………………………………………

Incoming Mutual Recognition – Standard (After Accession

i.e. 1st May, 2004) ………………………………………………

Minor Variation - National (Type IA) ………………………

Minor Variation – National (Type IB) ………………………

Major Variation – National (Type II) ………………………

Minor Variation – Mutual Recognition (Type IA) …………

Minor Variation – Mutual Recognition (Type IB) …………

Major Variation – Mutual Recognition (Type II) ……………

Parallel Import Marketing Authorisation ……………………

Market Authorisation Transfer (Change of Ownership) ……

Annual fee (Post Licensing) …………………………………

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

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 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<

“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.

2. There shall be paid to the Medicines Authority, in respect of

an application for the issue, maintenence and variation of the marketing

authorisation shown under Column 1 of the Schedule to these

regulations, an annual fee shown under Column 2 of the same Schedule.