![]() |
Home
| Databases
| WorldLII
| Search
| Feedback
Maltese Laws |
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
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 | Lm |
Qualified licence (Receipt and validation of application) …… | 50 |
Issue of licence ……………………………………………… | 150 |
Notification of approved variation ………………………… | 10 |
Annual renewal of licence ………………………………… | 50 |
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
Prezz 8ç – Price 8c
WorldLII:
Copyright Policy
|
Disclaimers
|
Privacy Policy
|
Feedback
URL: http://www.worldlii.org/mt/legis/laws/ma2003io2003mar200626o2006588