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Medicines Act, 2003 (Actno. Iii Of 2003) Medicines Authority (Fees) Regulations, 2006 (L.N.26 Of 2006 )

B 693
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. (1) The title of these regulations is the Medicines Authority
(Fees) Regulations, 2006.
2. For the purposes of these regulations –
“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<
3. There shall be paid to the Medicines Authority, in respect of a 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.

Title.

Interpretation.

Fees.

B 694
SCHEDULE

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

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

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