HUMAN BLOOD AND TRANSPANTS (FEES) REGULATIONS

HUMAN BLOOD AND TRANSPLANTS (FEES)

SUBSIDIARY LEGISLATION 483.09

HUMAN BLOOD AND TRANSPANTS

(FEES) REGULATIONS

22nd November, 2016

LEGAL NOTICE 385 of 2016.

The title of these regulations is the Human Blood and

Transplants (Fees) Regulations.

(Regulation 3)

License and Inspection Fees

Type of Application

Fee for the

Fee for the

(involving an inspection in

issue of a

annual

Malta or within the

Type of Facility

licence and/

renewal of a

European Union/European

or initial

licence

Economic Area)

inspection

Micro (0-9 employees)

(Includes all the

personnel employed

within the facility)

€5,000

€3,000

S

m

a

l

l

(

t

o

Application for the issuance

of a licence to carry out any employees) (Includes all

activity in connection with the personnel employed

p r o c e s s i n g , within the facility)

€7,000

€5,000

testing,

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

€7,000

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

€10,000

Variation - Application for approval to make an

administrative/ non technical office based change in

activities

€300

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

€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

connection with testing, processing, preservation, d a y p e r

Inspector

storage or distribution of human tissue and cells (including days spent for

intended for human applications

actual inspection and for

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

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

In these regulations, unless the context otherwise requires

"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 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

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.

HUMAN BLOOD AND TRANSPLANTS (FEES)