HUMAN BLOOD AND TRANSPLANTS ACT

HUMAN BLOOD AND TRANSPLANTS

CHAPTER 483

HUMAN BLOOD AND TRANSPLANTS 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.

15th September, 2006

ACT IV of 2006 , as amended by Legal Notice 427 of 2007 .

The short title of this Act is the Human Blood and

Transplants 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,

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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;

" h a e m o v i g i l a n c e " m e a n s a s e t o f o rg a n i s e d s u r v e i l l a n c e

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);

"the Medicines Authority" means the Licensing Authority

established under the Medicines Act;

"organ" means a differentiated and vital part of the human body,

f o r m e d b y d i ff e r e n t t i s s u e s , t h a t m a i n t a i n s i t s s t r u c t u r e ,

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

HUMAN BLOOD AND TRANSPLANTS

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

c o m p o n e n t s , a n y u n t o w a r d o c c u r r e n c e a s s o c i a t e d wi t h t h e

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 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;

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(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 subarticle (2) 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

The inspections and control measures of blood

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

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bank carries out any of the activities referred to

in this Part of this Act;

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

of the 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 subarticle (2) other than in accordance with a

licence issued under article 3.

(2)

he activities referred to in sub-article (1) 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.

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(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 subarticle (2) where that person carries out that

activity on behalf of, and pursuant to, a contractual

arrangement with -

(i) a blood establishment which is licensed 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 fee.

(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

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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

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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 preceding subparagraph.

(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

subarticle (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.

HUMAN BLOOD AND TRANSPLANTS

(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

subarticle (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

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

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

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

may 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).

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

criteria for additional tests notified to them by the Licensing

Authority pursuant to subarticle (1).

PART IV

TISSUES AND CELLS ESTABLISHMENTS

The inspections and control measures of tissues and 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

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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

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.

(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

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

to in subarticle (1), where that person carries out that

activity on behalf of, and pursuant to a contractual

arrangement with a tissues and cells establishment

which is licensed 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 fee.

(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

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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 and 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.

13.(1)(a) The Licensing Authority may suspend or revoke the

licence of a tissues and cells establishment on one or

more of the 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

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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

subparagraph (ii).

(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

(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 Directive 2004/23/EC.

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

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

cells establishment;

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(b) such exports to third countries complies with the

requirements of Directive 2004/23/EC.

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

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

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

Authority, by regulations provide for -

(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

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 eleven thousand and six hundred and forty-six euro and

eighty-seven cents (11,646.87).

(1) Notwithstanding any other law providing for the trial

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

eleven thousand and six hundred and forty-six euro and eighty-

seven cents (11,646.87).

(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

HUMAN BLOOD AND TRANSPLANTS

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 subarticle

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

referred to in subarticle (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.