Human Blood and Transplants (Fees) Regulations, 2016

L.N. 385 of 2016

HUMAN BLOOD AND TRANSPLANTS ACT

(Cap. 483)

Human Blood and Transplants (Fees) Regulations, 2016

IN exercise of the powers conferred by article 16 of the Human

Blood and Transplants Act, the Minister for Health, after consultation

with the Minister for Finance, has made the following regulations

The title of these Regulations is Human Blood and Citation.

Transplants (Fees) Regulations, 2016.

(Regulation 3)

License and Inspection Fees

Type of Application

Type of

Fee for the issue of a

Fee for the annual

(involving an inspection in

Facility

licence

renewal of a licence

Malta or within the

European Union/European

Economic Area)

Micro (0-9)

(Includes all the

personnel

employed within

the facility)

€5,000

€3,000

Small (10 to 49

employees

(Includes all the

Application for the issuance

personnel

of a licence to carry out any

employed within

activity in connection with

the facility)

€7,000

€5,000

testing, processing,

Medium (50 to

preservation, storage or

249 employees)

distribution of human tissue

(Includes all the

and cells intended for human

personnel

applications

employed within

the facility)

€10,000

€7,000

Large (more than

250 employees)

(Includes all the

personnel

employed within

the facility)

€15,000

€10,000

Variation - Application for approval to make an

administrative/ non technical office based change

in activities

€300

Variation - Application for approval to make a

substantial change in activities

€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

€15,000 plus €1,000 per day per Inspector

in connection with testing, processing, preservation,

(including days spent for actual inspection and

storage or distribution of human tissue and cells

intended for human applications

for travel)

Requirement for additional inspection

€5,000 plus €1,000 per day per Inspector

(including days spent for actual inspection and

for travel)

B

Annual fee (if applicable in case of issuance of €5,000 plus €1,000 per day per Inspector

license and/ or certificate and/ or equivalent

(including days spent for actual inspection and

for travel) if applicable

Application for an inspection related to any activity

€15,000 plus €1,000 per day per Inspector

in connection with testing, processing, preservation,

(including days spent for actual inspection and

storage or distribution of human tissue and cells

intended for human applications

for travel)

Consultation (per man hour)

€50

€0.36

In these Regulations, unless the context otherwise requires: Interpretation.

"Act" means the Human Blood and Transplants Act;

"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.

(1) There shall be paid to the Licensing Authority the Levy of fees.

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

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 sub-

Regulation shall be provided for in writing to the applicant.