ATT Nru. IV ta’ l-2006 ACT No. IV of 2006 ATT ma]ru[ b’li[i mill-Parlament ta’ AN ACT enacted by the Parliament of Malta.

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,907, 11 ta’ April, 2006

Taqsima A

MALTA

ATT Nru. IV ta’ l-2006

ACT No. IV of 2006

ATT ma]ru[ b’li[i mill-Parlament ta’

AN ACT enacted by the Parliament of

Malta.

Malta.

ATT biex jirregola t-te]id u l-e\ami ta’

AN ACT to regulate the collection and

demm uman u komponenti tad-demm

testing of human blood and blood

u biex jistabbilixxi livelli ta’ kwalità u

components and to establish standards

sigurezza g]at-tessut u `elloli umani

of quality and safety for human tissues

inti\i g]at-trapjanti fil-bniedem.

and cells intended for human

transplants.

I assent.

E DWARD F ENECH A DAMI

President

11th April, 2006

ACT No. IV of 2006

AN ACT to regulate the collection and testing of human blood and blood

components and to establish standards of quality and safety for

human tissues and cells intended for human transplants.

(1) The title of this Act is the Human Blood and Transplants

Act, 2006.

(2) This Act shall come into force on such date as the

Minister responsible for health may by notice in the Gazette establish,

and different dates may be so established for different provisions and

for different purposes of this Act.

PART I

PRELIMINARY

In this Act, unless the context otherwise requires –

“allogenic use” means cells or tissues removed from one

person and applied to another<

“autologous transfusion” means transfusion in which the

donor and the recipient are the same person and in which pre-

deposited blood and blood components are used<

“autologous use” means cells or tissues removed from and

applied in the same person<

“blood” means whole blood collected from a donor and

processed either for transfusion or for further manufacturing<

“blood component” means a therapeutic constituent of blood

(red cells, white cells, platelets, plasma) that can be prepared by

various methods<

“blood component release” means a process which enables a

blood component to be released from a quarantine status by the

use of systems and procedures to ensure that the finished product

meets its release specification<

“blood establishment” means any structure or body that is

responsible for any aspect of the collection and testing of human

blood or blood components, whatever their intended purpose, and

their processing, storage and distribution when intended for

transfusion, but does not include a hospital blood bank<

“blood product” means any therapeutic product derived from

human blood or plasma<

“cells” means individual human cells or a collection of human

cells when not bound by any form of connective tissue<

“the Commission” means the European Commission<

“deferral” means suspension of the eligibility of an individual

to donate blood or blood components, such suspension being either

permanent or temporary<

“Directive 2004#23#EC” means the Commission Directive

2004#23#EC of the European Parliament and of the Council of 31

March, 2004 on setting standards of quality and safety for the

donation, procurement, testing, processing, preservation, storage

and distribution of human tissues and cells<

“Directive 2004#33#EC” means the Commission Directive

2004#33#EC of 22 March, 2004 implementing Directive

2002#98#EC of the European Parliament and of the Council as

regards certain technical requirements for blood and blood

components<

“distribution” means in the case of blood and blood

components, the act of delivery of blood and blood components to

other blood establishments, hospital blood banks and manufacturers

of blood and plasma derived products. It does not include the

issuing of blood or blood components for transfusions. In the case

of human tissues and cells “distribution” means transportation and

delivery of tissues or cells intended for human application<

“donor” means every human source, whether living or

deceased, of human cells or tissues<

“donation” means donating human tissues or cells intended

for human applications<

“establishment” includes a blood establishment and a tissues

and cells establishment<

“haemovigilance” means a set of organised surveillance

procedures relating to serious adverse or unexpected events or

reactions in donors or recipients, and the epidemiological follow-

up of donors<

“hospital blood bank” means a hospital unit which stores and

distributes and may perform compatibility tests on blood and blood

components exclusively for use within hospital facilities, including

hospital based transfusion activities<

“human application” means the use of tissues or cells on or in

a human recipient and extracorporal applications<

“inspection” means formal and objective control to identify

problems in accordance with standards adopted to assess

compliance with these regulations<

“the Licensing Authority” means the Superintendent of Public

Health as established in article 3 (1) of this Act<

“the Medicines Authority” means the Licensing Authority

established under the Medicines Act<

“organ” means a differentiated and vital part of the human

body, formed by different tissues, that maintains its structure,

vascularisation and capacity to develop physiological functions

with an important level of autonomy<

“processing” means all operations involved in the preparation,

manipulation, preservation and packaging of tissues or cells

intended for human applications<

“procurement” means a process by which tissues or cells are

made available<

“preservation” means the use of chemical agents, alterations

in environmental conditions or other means during processing to

prevent or retard biological or physical deterioration of cells or

tissues<

“quarantine” means the status of retrieved tissues or cells, or

tissue isolated physically or by other effective means, whilst

awaiting a decision on their acceptance or rejection<

“serious adverse event” means in the case of blood and blood

components, any untoward occurrence associated with the

collection, testing, processing, storage, and distribution, of blood

and blood components that might lead to death or life-threatening,

disabling or incapacitating conditions for patients or which results

in, or prolongs, hospitalisation or morbidity< and in the case of

tissues and cells means any untoward occurrence associated with

the procurement, testing, processing, storage and distribution of

tissues and cells that might lead to the transmission of a

communicable disease, to death or life-threatening, disabling or

incapacitating conditions for patients or which might result in, or

prolong, hospitalisation or morbidity<

“serious adverse reaction” in the case of blood and blood

components means an unintended response in donor or in patient

associated with the collection or transfusion of blood and blood

components that is fatal, life-threatening, disabling, incapacitating,

or which results in, or prolongs, hospitalisation or morbidity< in

the case of tissues and cells it means an unintended response,

including a communicable disease, in the donor or in the recipient

associated with the procurement or human application of tissues

and cells that is fatal, life-threatening, disabling, incapacitating or

which results in, or prolongs, hospitalisation or morbidity<

“storage” means maintaining the product under appropriate

controlled conditions until distribution<

“tissue” means all constituent parts of the human body formed

by cells<

“tissues and cells establishment” means a tissue bank or a

unit of a hospital or another body where activities of processing,

preservation, storage or distribution of human tissues and cells are

undertaken. It may also be responsible for procurement or testing

of tissues and cells<

“qualified health professional” includes a doctor, nurse and

any health professional regulated by the Health Care Professions Cap. 464.

Act.

PART II

THE LICENSING AUTHORITY

(1) The Superintendent of Public Health shall be the

Licensing Authority for the purposes of this Act.

(2) The Licensing Authority, hereinafter referred to as the

Licensing Authority, shall have the following functions>

(a) to verify that the establishments are in compliance with

the requirements set out under this Act and any regulations made

thereunder<

(b) to indicate to the establishment which activities it may

undertake<

(c)

to establish conditions applicable to establishments<

(d) to issue, renew, amend, vary, suspend or revoke any

licence that may be required by or under this Act<

(e) to carry out inspections of establishments and organize

control measures in such establishments regularly and in any case

not less than once every two years<

(f) to conduct such additional inspections of establishments

as it considers necessary for the purpose of ensuring compliance

with the requirements of this Act and any regulations made

thereunder<

(g) to inspect hospital blood banks to ensure that such banks

and persons responsible for the management of such banks comply

with the requirements of this Act and any regulations made

thereunder<

(h) to organize, in the event of any serious adverse event or

reaction or suspicion thereof, inspections and other control

measures<

(i) to establish guidelines concerning the conditions of the

inspections and control measures, and on the training and

qualification of the officials involved in order to reach a consistent

level of competence and performance<

(j) to establish and maintain a publicly accessible register

of tissue establishments specifying the activities for which they

have been licensed<

(k) to do all such things as may be necessary for the purpose

of ensuring compliance with any of the provisions of this Act or

regulations made thereunder.

(3) The Licensing Authority may by rules delegate any of

the functions referred to in sub-article (2) hereof to the Medicines

Authority, or any other authority or institution it deems competent.

(4) The Licensing Authority shall levy such fees as may be

prescribed for the purpose of this Act.

PART III

BLOOD ESTABLISHMENTS AND HOSPITAL BLOOD BANKS

(1) The inspections and control measures of blood Inspections and

control measures.

establishments and hospital blood banks shall be carried out by any

person duly authorized in writing by the Licensing Authority and shall,

on production of this authorization, have a right to>

(a)

inspect at any reasonable hour>

(i) any premises owned or managed by a blood

establishment or person responsible for management of a

hospital blood bank, or at which the blood establishment or

person responsible for management of a hospital blood bank

carries out any of this Activities referred to in this Part of this

Act<

(ii) any premises of any person who carries out any of

this Activities referred to in this Part of this Act on behalf of,

and pursuant to a contractual arrangement with, a blood

establishment or a person responsible for management of a

hospital blood bank< and

(iii) where any facilities for donor evaluation and

testing are in the premises of any person other than a blood

establishment or hospital blood bank, those facilities in that

person’s premises<

(b) to require the production of, and inspect any article or

substance at the premises<

(c) to require the production of, inspect and take copies of,

or extracts from, any book, document, data or record, in whatever

form held at the premises, or any computer data or records which

are accessible thereat<

(d) to take possession of any samples for examination and

analysis and any other article, substance, book, document, data,

record in whatever form held at the premises, or any computer

data or records which are accessible thereat<

(e) to question any person whom he finds at the premises

and whom he has reasonable cause to believe is able to give him

relevant information<

(f) to require any person to afford him such assistance as he

considers necessary with respect to any matter within that person’s

control, or in relation to which that person has responsibilities<

(g) to require, as he considers necessary, any person to afford

him such facilities as he may reasonably require that person to

afford him<

(h) carry out any activity he may deem appropriate for the

proper execution of his duties and responsibilities as provided by

this Act and any regulations made thereunder.

(1) It shall not be lawful for any person to carry out any

activity listed in sub-article (2) other than in accordance with a licence

issued under article 3 of this Act.

(2) The activities referred to in sub-article (1) hereof are>

(a) the collection of human blood components, whatever

their intended purpose< and

(b) the testing of human blood components, whatever their

intended purpose< and

(c) their preparation, storage and distribution when intended

for transfusion, unless any such activity is undertaken in a blood

establishment licensed for that purpose by the Licensing Authority.

(3) A licence shall not be required for –

(a) the storage and distribution of, and the performance of

compatibility tests on, blood and blood components exclusively

for use within hospital facilities, including transfusion activities

where such activities are performed by a hospital blood bank< or

(b) any person carrying out any of the activities referred to

in sub-article (2) where that person carries out that activity on behalf

of, and pursuant to, a contractual arrangement with –

(i) a blood establishment which is licenced under this

Part to carry out the activity in question< or

(ii) a person responsible for the management of a

hospital blood bank.

(4) The application for the grant of a licence shall be made

to the Licensing Authority and shall be accompanied by the prescribed

(5) The application shall contain the information as may

be prescribed and shall be submitted in the form and in the manner as

may by rules be laid down by the Licensing Authority.

(6) Where an application is received by the Licensing

Authority, it may –

(a)

grant or refuse any application<

(b) grant such licence in respect of particular sites or

activities only<

(c)

grant such licence subject to conditions<

(d) refuse to process the application if such application has

not been submitted in accordance with this Act and regulations

made thereunder<

(e) request the applicant to furnish it with additional

information as it may deem necessary.

(7) When the Licensing Authority grants a licence following

an application, it shall give notice in writing to the blood establishment

specifying –

(a) the activities which the blood establishment may

undertake under this Act and regulations made thereunder at each

site in respect of which licence is granted< and

(b) the conditions which apply to the undertaking of those

activities.

(8) The Licensing Authority may at any time remove or

vary any of the licence conditions, or may impose additional conditions.

(9) When the Licensing Authority removes or varies any

condition or imposes any additional condition the Licensing Authority

shall inform in writing the blood establishment in question giving reasons

for its decision.

(10) A blood establishment may not make any substantial

change in the activities which it undertakes without the prior written

approval of the Licensing Authority.

(11) Any application for approval to make a substantial

change in its activities shall be made in writing to the Licensing

Authority, and shall be accompanied by the prescribed fee.

(12) For the purpose of this article, a substantial change in

a blood establishment’s activities is any change -

(a) to the sites from which the blood establishment operates

or to the activities to be carried out at each site<

(b) which would result in breach of this Act or regulations

made thereunder or of any condition specified by the Licensing

Authority< or

(c) to the quality system which is likely to have a substantial

impact on the conduct of, or might compromise the safety of, any

of those activities which the blood establishment has been licensed

to undertake.

(1) The Licensing Authority may suspend or revoke the

licence of a blood establishment on one or more of the following

grounds -

(a) that the blood establishment has failed, in any material

respect, to comply with the requirements of this Act or regulations

made thereunder<

(b) that the collection, testing, processing, storage or

distribution of blood or blood components by the blood

establishment cannot be carried out safely<

(c) that any blood or blood components cannot be supplied

to hospital blood banks in such a state that they could be safely

administered for transfusion< or

(d) that the information given by the blood establishment

was false or incomplete in any material respect.

(2) Prior to suspending or revoking the licence of a blood

establishment, the Licensing Authority shall serve a notice on the blood

establishment stating that it intends to suspend or revoke its licence

with effect from the date specified in the notice, giving reasons for such

decision>

Provided that a suspension or revocation shall take effect

immediately when the Licensing Authority considers that it is necessary

in the interests of safety.

(3) In those cases where -

(a) the blood establishment has failed, in any material

respect, to comply with the requirements of this Act or regulations

made thereunder< or

(b) the information given by the blood establishment was

false or incomplete in any material respect, and the Licensing

Authority considers that the failure in question is not sufficiently

serious to warrant suspension or revocation of the licence of the

blood establishment in the first instance, the Licensing Authority

may serve a notice on the responsible person of the blood

establishment>

(i) identifying the requirements of which the blood

establishment is in breach or, in the case of false and

incomplete information, the further information which is

required<

(ii) identifying the action which the blood

establishment is required to take< and

(iii) giving the timescale within which the blood

establishment shall take the action identified in the preceeding

sub-paragraph.

(4) If the blood establishment fails to comply with the

requirements set out in the notice within the specified timescale, the

Licensing Authority may, by a notice served on the blood establishment,

suspend or revoke the licence of the blood establishment.

(5) Any suspension shall be for such period as the Licensing

Authority shall consider necessary having regard to the reasons for the

suspension.

(6) The suspension or revocation of an licence may be total,

or limited to a particular activity or to one or more activities carried out

at a particular site or sites, or to a particular blood component.

(1) If the Licensing Authority is of the opinion that -

(a) the person responsible for management of a hospital

blood bank has failed, in any material respect, to comply with the

requirements of these articles< or

(b) the testing, storage or distribution of blood or blood

components by the hospital blood bank is such that any blood or

blood components cannot be safely administered for transfusion<

or

(c) the information given by the person responsible for

management of a hospital blood bank was false or incomplete in

any material respect, the Licensing Authority may serve a notice

on the person responsible for management of the hospital bank

requiring that the hospital ceases to conduct any of this Activities

specified in the notice, or refrains from administering to patients

any blood or blood components specified in the notice, until the

conditions set out in the notice are complied with.

(2) Any notice served by the Licensing Authority pursuant

to sub-article (1) shall specify the date from which the prohibition

specified in the notice shall take effect, which shall be not less than

seven days from the date on which the notice is served>

Provided that where the Licensing Authority considers that it

is necessary in the interests of safety, it may specify in the notice that

the prohibition takes immediate effect.

(3) The notice shall be withdrawn if>

(a) the person responsible for management of the hospital

blood bank is no longer in breach of the requirements of these

articles<

(b) the hospital blood bank is able to show that the activity

or product referred to in the notice given pursuant to sub-article

(1)(b) may be safely carried out or, as the case may be,

administered< or

(c) all necessary information has been supplied to the

Licensing Authority.

(1) Every licence granted under this Act shall, unless Validity of licence.

previously revoked or renewed, expire at the end of its period of validity.

(2) Every licence shall, unless previously revoked, be

renewable upon application by the holder made at least three months

before the expiry of the period of validity.

No person shall import into Malta any blood or blood Importation.

components, including blood or blood components intended for use as

a starting material or raw material in the manufacture of medicinal

products, from a country or territory outside the European Community

which does not meet standards of quality and safety equivalent to those

laid down in Annex V of Directive 2004#33#EC and any amendments

thereto.

(1) Where the Licensing Authority is aware of a specific Specific

epidemiological situation, such as an outbreak of a disease, which may epidemiological

situations.

affect the safety of blood donations, and as a result of which it considers

that specific deferral criteria for the collection of blood donations should

be adopted, it shall notify>

(a) the blood establishments that those criteria must be

adopted< and

(b) the Commission of the epidemiological situation and

the additional deferral criteria which blood establishments are

required to adopt in relation to it pursuant to paragraph (a) hereof.

(2) A blood establishment shall adopt and comply with any

criteria for additional tests notified to them by the Licensing Authority

pursuant to sub-article (1) hereof.

PART IV

TISSUES AND CELLS ESTABLISHMENTS

(1) The inspections and control measures of tissues and Inspection and

control measures.

cells establishments shall be carried out by any person duly authorized

in writing by the Licensing Authority and such person shall, on

production of his authorization, have a right to>

(a)

inspect at any reasonable hour>

(i) any premises owned or managed by a tissues and

cells establishment, or at which the tissues and cells

establishment carries out any of its activities in relation to the

procurement of human tissues and cells<

(ii) any premises of any person who carries out any of

the activities referred to above on behalf of, and pursuant to a

contractual arrangement with, a tissues and cells

establishment< and

(iii) where any facilities for donor evaluation and

testing are in the premises of any person other than a tissues

and cells establishment, those facilities in that person’s

premises<

(b) to require the production of and inspect any article or

substance at the premises<

(c) to require the production of, inspect and take copies of,

or extracts from, any book, document, data or record, in whatever

form it is held at the premises, or any computer data or records

accessible thereat<

(d) to take possession of any samples for examination and

analysis and any other article, substance, book, document, data,

record, in whatever form they are held at the premises, or any

computer data or records accessible thereat<

(e) to question any person whom he finds at the premises

and whom he has reasonable cause to believe is able to give him

relevant information<

(f) to require any person to afford him such assistance as he

considers necessary with respect to any matter within that person’s

control, or in relation to which that person has responsibilities<

(g) to require, as he considers necessary, any person to afford

him such facilities as he may reasonably require that person to

afford him<

(h) to evaluate and verify the procedures and the activities

carried out in tissues and cells establishments and the facilities of

third parties that are relevant to the requirements of this Act and

regulations made thereunder<

(i) carry out any activity he may deem appropriate for the

proper execution of his duties and responsibilities as provided by

this Act and regulations made thereunder.

(1) It shall not be lawful for any person to carry out any Supervision

licensing.

activity in connection with testing, processing, preservation, storage or

distribution of human tissue and cells intended for human applications

otherwise than in accordance with a licence issued under article 3 of

this Act.

(2) A licence shall not be required for –

(a) the storage and distribution of, and the performance of

compatibility tests on, tissues and cells exclusively for use within

hospital facilities< or

(b) any person carrying out any of these activities referred

to in sub-article (1) hereof, where that person carries out that activity

on behalf of, and pursuant to a contractual arrangement with a

tissues and cells establishment which is licenced under this Part to

carry out the activity in question<

(c) the direct distribution of specified tissues and cells for

immediate transplantation to the recipient as long as the supplier

is licensed for such activity.

(3) The application for the grant of a licence shall be made

to the Licensing Authority and shall be accompanied by the prescribed

(4) The application shall contain the information as may

be prescribed and shall be submitted in the form and in the manner as

may by rules be laid down by the Licensing Authority.

(5) Where an application is received by the Licensing

Authority, it may –

(a)

grant or refuse any application<

(b) grant such licence in respect of particular sites or

activities only<

(c)

grant such licence subject to conditions<

(d) refuse to process the application if such application has

not been filed in accordance with this Act and regulations made

thereunder<

(e) request the applicant to furnish it with additional

information as it may deem necessary.

(6) When the Licensing Authority grants an application

for licence, it shall give notice in writing to the tissues and cells

establishment specifying –

(a) the activities which the establishment may undertake

under this Act and regulations made thereunder at each site in

respect of which a licence is granted<

(b) the conditions which apply to the undertaking of those

activities< and

(c) the tissues and cells preparation processes which the

establishment may carry out.

(7) The Licensing Authority may at any time remove or

vary any of the licence conditions, or may impose additional conditions.

(8) When the Licensing Authority removes or varies any

condition or imposes any additional condition, it shall inform in writing

the establishment in question giving reasons for its decision.

(9) A tissues and cells establishment may not make any

substantial change in the activities which it undertakes without the prior

written approval of the Licensing Authority.

(10) Any application for approval to make a substantial

change in the activities of the tissues and cells establishment shall be

made in writing to the Licensing Authority, and shall be accompanied

by the prescribed fee.

(11) For the purposes of this article, a substantial change in

a tissues and cells establishment’s activities is any change -

(a) to the sites from which the establishment operates or to

the activities to be carried out at each site<

(b) which would result in breach of this Act or regulations

made thereunder or of any condition specified by the Licensing

Authority< or

(c) to the quality system which is likely to have a substantial

impact on the conduct of, or might compromise the safety of, any

of the activities which the establishment has been licensed to

undertake.

(12) The Licensing Authority shall suspend or revoke the

licence of a tissues amd cells establishment or of a tissue or cell

preparation process if inspections or control measures demonstrate that

such an establishment or process does not comply with the requirements

of this Act and regulations made thereunder.

(1) (a) The Licensing Authority may suspend or revoke Revocation or

the licence of a tissues and cells establishment on one or more of the suspension

licence.

following grounds -

(i) that the establishment has failed, in any material respect,

to comply with the requirements of this Act or regulations made

thereunder<

(ii) that the information given by the blood establishment

was false or incomplete in any material respect.

(b) In addition the Licensing Authority shall suspend

or revoke the licence of a tissues and cells establishment or of a tissues

or cells preparation process if inspections or control measures

demonstrate that such an establishment or process does not comply with

the requirements of this Act and regulations made thereunder.

(2) Prior to suspending or revoking the licence of a blood

establishment, the Licensing Authority shall serve a notice on the blood

establishment stating that it intends to suspend or revoke its licence

with effect from the date specified in the notice, giving reasons for such

decision>

Provided that such suspension or revocation shall take effect

immediately when the Licensing Authority considers that it is necessary

in the interests of safety.

(3) In those cases where -

(a) the establishment has failed, in any material respect, to

comply with the requirements of this Act or regulations made

thereunder< or

(b) the information given by the establishment was false or

incomplete in any material respect, and the Licensing Authority

considers that the failure in question is not sufficiently serious to

warrant suspension or revocation of the licence of the establishment

in the first instance, the Licensing Authority may serve a notice on

the responsible person of the establishment>

(i) identifying the requirements of which the

establishment is in breach or, in the case of false and

incomplete information, the further information which is

required<

(ii) identifying the action which the establishment is

required to take< and

(iii) giving the timescale within which the blood

establishment shall take the action identified in sub-paragraph

(ii) hereof.

(4) If the establishment fails to comply with the requirements

set out in the notice within the specified timescale, the Licensing

Authority may, by a notice served on the establishment, suspend or

revoke the licence of the establishment.

(5) Any suspension shall be for such period as the Licensing

Authority shall consider necessary having regard to the reasons for the

suspension.

(6) The suspension or revocation of an licence may be total,

or limited to a particular activity or to one or more activities carried out

at a particular site or sites, or to a particular tissue and cell.

(1) Every licence granted under this Act shall, unless

previously revoked or renewed, expire at the end of its period of validity.

(2) Every licence may, unless previously revoked, be

renewed upon application by the holder made at least three months

before the expiry of the period of validity.

(1) No person shall import tissues and cells from third

countries unless>

(a) such an activity is undertaken by a licensed tissues and

cells establishment<

(b) the imported tissues and cells can be traced from the

donor to the recipient and vice versa in accordance with the

procedures established by regulations under this Act<

(c) the tissues and cells establishments that receive such

imports from third countries ensures that they meet standards of

quality and safety equivalent to the ones laid down in

Directive2004#23#EC.

(2) No person shall export tissues and cells to third countries

(a) such activity is undertaken by a licensed tissues and cells

establishment<

(b) such exports to third countries complies with the

requirements of Directive 2004#23EC.

(3) The Licensing Authority may, after ensuring that the

that imports and exports of tissues and cells referred to in subarticle (2)

hereof meet quality and safety standards equivalent to those laid down

in Directive 2004#23#EC, directly authorise>

(a) the import or export of tissues and cells referred to in

article 12(2)(c)<

(b) the import or export of certain tissues and cells in case

of emergency.

PART V

MISCELLANEOUS

The Minister may, after consultation with the Licensing Power of the

Minister to make

Authority, by regulations provide for –

regulations.

(a) the requirements to be satisfied by blood and tissues and

cells establishments<

(b) standards of good practice in manufacture<

(c) the requirements to be satisfied by hospital blood banks<

(d) the requirements to establish an effective system of

haemovigilance<

(e) prescription of the fee to be paid for the issue of a licence<

(f) any other matter to better put into effect the provisions

of this Act.

Any person who fails to comply with any of the provisions Offences and

penalties.

of this Act or any regulations or rules made thereunder, shall be guilty

of an offence and shall, on conviction, be liable a fine not exceeding

five thousand liri.

(1) Notwithstanding any other law providing for the trial Special procedure.

of offences, where the Authority believes that a person has committed

an offence against this Act or any regulations made thereunder, the

Licensing Authority shall give notice in writing to such person describing

the offence of which the person is accused, indicating the steps to be

taken to remedy the offence and the penalty he is required to pay in

respect of that offence.

(2) The Minister shall prescribe the penalties that may

be demanded by the Licensing Authority in relation to any specified

offence>

Provided that such penalty shall not exceed the amount of

five thousand Malta liri.

(3) Where a notice under this article has been given, the

person named in the notice may, within twenty-one days of the service

of the notice, accept responsibility for the offence specified in the notice

and within the same period pay the penalty indicated in the notice, and

comply with the relative provision of this Act, or of the regulations or

rules made thereunder and no further proceedings may be taken under

this Act in respect of such offence.

(4) Where the person to whom notice is given under sub-

article (1) has not paid the penalty within the twenty-one day period

referred to in sub-article (3) and has not, within the time specified,

complied with the requirements of this Act, criminal proceedings may

be taken against him in accordance with the provisions of the Criminal

Code, of this Act and of any other law applicable to the offence.

Passed by the House of Representatives at Sitting No. 374 of the 4th April,

2006. A NTON T ABONE

Speaker

R ICHARD J. C AUCHI

Clerk to the House of Representatives