HUMAN BLOOD AND TRANSPLANTS (FEES) [ S.L.483.09 SUBSIDIARY LEGISLATION 483.09 HUMAN BLOOD AND TRANSPANTS (FEES) REGULATIONS 22nd November, 2016 LEGAL NOTICE 385 of
- The title of these regulations is the Human Blood and Transplants (Fees) Regulations.
- In these regulations, unless the context otherwise requires: "Act" means the Human Blood and Transplants Act; Citation. Interpretation. Cap.
- "applicant" means the person who submitted an application as required in the Act; "blood component" shall have the same meaning assigned to it in article 2 of the Act; "cells" shall have the same meaning assigned to it in article 2 of the Act; "human application" shall have the same meaning assigned to it in article 2 of the Act; "licence" means the licence to carry out any activity listed in article 12 of the Act; "Licensing Authority" means the Superintendent of Public Health as established in article 3
(1)of the Act; "substantial change" shall have the same meaning assigned to it in article 12 of the Act; "tissue" shall have the same meaning assigned to it in article 2 of the Act. 3.
(1)There shall be paid to the Licensing Authority the fees specified in the Schedule in respect of the issuance of, renewal of and, or the substantial change to a license as provided for in the Act.
(2)No fee under the provisions of these regulations shall exempt the charge of any other fees payable to other competent authorities with regards to any licence, permit or authority imposed by any other regulation or other law.
(3)Any additional expenses incurred by the Licensing Authority shall be charged separately, which additional expenses may include inspections in third countries tissues establishments.
(4)For applications involving an inspection in a third country outside the European Union the applicant has to additionally cover for the cost of the flight, all the accommodation expenses of the inspectors, all visa costs which may be incurred, any immunisations which may be necessary, transport costs and any other expenses which may be reasonably incurred.
(5)In exceptional circumstances and, or at the discretion of the Levy of fees. 1 2 [ S.L.483.09 HUMAN BLOOD AND TRANSPLANTS (FEES) Licensing Authority, waivers for and, or reduction in fees due under these regulations may be granted.
(6)Fees for academic research without support from industry shall benefit from a fee waiver of 70% of the full fee. The exemption shall be at the discretion of the Licensing Authority.
(7)The waivers and, or reduction referred to in this regulation shall be provided for in writing to the applicant. [ S.L.483.09 HUMAN BLOOD AND TRANSPLANTS (FEES) 3 SCHEDULE (Regulation 3) License and Inspection Fees Type of Application (involving an inspection in Malta or within the European Union/European Economic Area) Type of Facility Fee for the Fee for the issue of a annual licence and/ renewal of a or initial licence inspection Micro (0-9 employees) (Includes all the personnel employed within the facility) €5,000 S m a l l ( 1 0 t o 4 9 Application for the issuance of a licence to carry out any employees) (Includes all activity in connection with the personnel employed €7,000 testing, p r o c e s s i n g , within the facility) preservation, storage or Mediu m (50 to 24 9 distribution of human tissue employees) (Includes all and cells intended for human the personnel employed applications within the facility) €10,000 L a rg e ( m o r e t h a n 2 5 0 employees) (Includes all the personnel employed within the facility) €15,000 Variation - Application for approval to make an administrative/ non technical office based change in activities Va r i a t i o n - A p p l i c a t i o n f o r a p p r o v a l t o m a k e a substantial change in activities €3,000 €5,000 €7,000 €10,000 €300 €2,500 Type of Application Fee in € (Involving an inspection in a third country outside the European Union/ European Economic Area) Application for an inspection related to any activity in € 15,000 plus €1,000 per Inspector connection with testing, processing, preservation, d a y p e r storage or distribution of human tissue and cells (including days spent for actual inspection and for intended for human applications travel) Requirement for additional inspection €5,000 plus €1,000 per day per Inspector (including days spent for actual inspection and for travel) Annual fee (if applicable in case of issuance of license €5,000 plus €1,000 per day and/or certificate and/ or equivalent per Inspector (including days spent for actual inspection and for travel) if applicable 4 [ S.L.483.09 HUMAN BLOOD AND TRANSPLANTS (FEES) Application for an inspection related to any activity in €15,000 plus €1,000 per connection with testing, processing, preservation, d a y per Inspector storage or distribution of human tissue and cells (including days spent for intended for human applications actual inspection and for travel) Consultation (per man hour) €50