Medicines Authority (Fees) Regulations, 2006

L.N. 26 of 2006

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Medicines Authority (Fees) Regulations, 2006

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

Act, 2003, the Minister of Health, Elderly and Community Care after

consultation with the Licensing Authority and with the concurrence of

the Prime Minister and Minister of Finance, has made the following

regulations>–

(1) The title of these regulations is the Medicines Authority Title.

(Fees) Regulations, 2006.

Interpretation.

For the purposes of these regulations –

Licence for placing on the market of products without a

marketing authorisation (Qualified Licence) per product (Article

126(a) of Directive 2001#83#EC) per pharmaceutical form#strength

Qualified licence (Receipt and validation of application) ……

Issue of licence ………………………………………………

Notification of approved variation …………………………

Annual renewal of licence …………………………………

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

“Directive 2001#83#EC” shall mean 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, and its amendments as amended by Directive 2004#27#EC

and Directive 2004#24#EC<

“qualified licence” is a licence granted to a product to be

placed on the market without a marketing authorisation as specified

in the Medicines Act, 2003 and any regulations made thereunder<

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

qualified licence and related activities, fees as specified in the Schedule

to these regulations>

Provided that these fees do not include any fees charged by other

competent authorities in relation to any documentation and, or, reports

required by the Medicines Authority for final issue licences or decisions.

Such additional expenses incurred by the Medicines Authority shall be

charged separately.