Key Benefits:
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Proposal for Law No 219 /XII
Exhibition of Motives
The Law No. 36/2013 of June 12 approves the quality assurance and security arrangements
of organs of human origin intended for transplantation in the human body, so as to
ensure a high level of protection of human health by transposing the Directive
n 2010 /53/UE, of the European Parliament and of the Council of July 7 on standards
of quality and safety of human organs intended for transplantation.
Article 13 (5) of Law No. 36/2013 of June 12, enshrines that in the event of
exchange of organs between member states, the transmission of the necessary data to
ensure traceability and information on the characterization of the same and the
donors, is done in accordance with the procedures set out in the terms of Article 29 of the
Directive No 2010 /53/UE, of the European Parliament and of the Council of July 7.
In the meantime, the Commission's Implementing Directive No 2012 /25/UE, of the Commission, has been adopted 9
October 2012, which establishes information procedures for the exchange, between
Member States, of human organs intended for transplantation.
In these terms, it matters to proceed to the amendment of Law No. 36/2013 of June 12 and transpose
for national legal planning a cited Enforcement Directive No 2012 /25/UE, of the
Commission, of October 9, 2012, being defined the procedures for the transmission
of data between Member States needed to ensure traceability, for the
notification of adverse reactions and incidents and for the transmission of information on the
characterization of organs and donors.
Attentive to matter, at the headquarters of the legislative process taking place in the Assembly of the Republic,
must be heard from the National Data Protection Commission and the National Council of
Ethics for the Sciences of Life.
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Thus:
Under the terms of the paragraph d ) of Article 197 (1) of the Constitution, the Government presents to the
Assembly of the Republic the following proposal for a law:
Article 1.
Object
This Law shall make the first amendment to the Act No 36/2013 of June 12 approving the
quality assurance and safety regime of organs of human origin intended for
transplantation in the human body, so as to ensure a high level of protection of the
human health, by transposing to the national legal order the Enforcement Directive n.
2012 /25/UE of the Commission of October 9, 2012 laying down procedures of
information for the exchange, between Member States, of human organs intended for
transplantation.
Article 2.
Amendment to Law No. 36/2013 of June 12
Articles 1, 2, 3, 6, 13, 14, 14, 14, and 21 of Law No. 36/2013 of June 12,
go on to have the following essay:
" Article 1.
[...]
1-[ Previous body of the article ].
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2-A present law also regulates the necessary information procedures
for the cross-border exchange of human organs intended for
transplantation in the European Union, establishing procedures of
transmission of information on the caraterization of donors and organs,
information transmission procedures necessary to ensure the
traceability of the organs and procedures aimed at ensuring the
notification of serious adverse reactions and adverse incidents, transposing to the
internal legal order the Enforcement Directive No 2012 /25/UE, da
Commission, of October 9, 2012.
Article 2.
[...]
1-[...].
2-The provisions of this Law shall also apply to the Exchange
cross border of human organs intended for transplantation in the Union
European, as well as with third countries with which Portugal has
established prior agreements.
3-[ Previous Article No 2 ].
Article 3.
[...]
[...]:
a) [...];
b) [...];
c) [...];
d) [...];
e) [...];
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f) [...];
g) [...];
h) [...];
i) "Delegated entity", the entity in which they are delegated
competencies in accordance with Article 5 (3), or the organization
european exchange of organs in which they are delegated
competencies under Article 20;
j) "Specification of the organ", anatomical description of an organ,
including:
i) The type;
ii) If applicable, your position in the body;
iii) Indication of full or partial use, mentioning the wolf or
segment;
k) "Member State of origin", the Member State in which the Member is harvested
organ intended for transplantation;
l) "Member State of destination", the Member State to which the Member is sent the
organ intended for transplantation;
m) [ Previous point (i) ];
n) [ Previous point j )];
o) "National identification number of donor or receiver", the code of
identification assigned to a donor or a recetor in compliance
with the identification system established under the terms of paragraph 2 of the
article 13;
p) [ Previous point (k) ] ;
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q) [ Previous point l) ] ;
r) [ Previous point (m) ] ;
s) [ Previous paragraph (n) ] ;
t) [ Previous point (o) ] ;
u) [ Previous paragraph (p) ] ;
v) [ Previous point (q) ] ;
w) [ Previous point r) ] ;
x) [ Previous point (s) ] ;
y) [ Previous point (t) ] .
Article 5.
[...]
1-A Directorate General of Health (DGS) is the competent authority, responsible
by the verification of compliance with the requirements set out in this Law in
the entire national territory, without prejudice to the articulation with the
Inspection-General of Activities in Health (IGAS), in subjects of
supervision and inspection, and of the competences of the IPST, in respect of
coordination of harvesting and transplantation activity, planning
strategic in response to national and authorization needs of the
import and export of organs.
2-[...]:
a) [...];
b) [...];
c) [...];
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d) [...];
e) Monitoring the information contained in the notification and management system
of serious adverse incidents and reactions, referred to in Article 6;
f) [...];
g) [...];
h) [...].
3-The powers provided for in the preceding paragraphs may be delegated,
upon dispatch of prior authorization from the member of the Government
responsible for the area of health.
Article 6.
[...]
1-[...].
2-RPT includes a component of notification and incident management and
serious adverse reactions and integrates the data referred to in articles 13, 14,
17. and 18.
3-[...].
4-[...].
5-The IPST guarantees DGS the alert and immediate access to the contained information
in the RPT, specifically when there are incidents and reactions
adversary, owing to DGS being informed of the respect of nature, cause,
adopted measures and consequences.
6-[...].
7-[...].
8-[...].
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Article 12.
[...]
1-The bodies, entities or companies involved in the transport of organs
establish operational procedures to ensure the integrity of the
organs during transport and a suitable transport time, according
with the system referred to in Article 9 para.
2-[...].
3-[...].
4-[...].
5-[...].
Article 13.
[...]
1-[...].
2-[...].
3-[...].
4-[...].
5-In the event of an exchange of organs with another Member State, the
transmission by the DGS to the competent authority or delegated entity of the
Member state of destination, of the data required for traceability and
of the information on the characterization of the same and the donors,
referred to in paragraph 3, ensures:
a) Specification of the organ;
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b) National identification number of the donor;
c) Date of harvest;
d) Name and contact data of the harvesting unit.
6-A DGS develops the necessary procedures to allow the
competent authority or delegated entity of the Member State of origin
be informed of the following:
a) National ID number of the receiver or, if the organ does not have
been transplanted, from its final use;
b) Date of transplantation, if applicable;
c) Name and contact data of the transplantation unit.
Article 14.
[...]
1-The harvesting units and transplantation units, the GCCT and the CST
use a notification system, in accordance with the one established by the IPST
in accordance with Article 6, intended for immediate communication, research,
registration and transmission of the information on:
a) Serious adverse incidents susceptible to influencing quality and
safety of organs and which can be attributed to the donation, harvesting,
characterization, analysis, preservation and transport of the organs;
b) Any serious adverse reaction, observed during or after the
transplantation, which may be related to harvesting, analysis,
characterization, preservation, transport and transplantation of the organs.
2-IPST provides for operational procedures for alert and notification
immediate to the DGS of the reactions and serious adverse incidents.
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3-IPST monitors and effectuates the management of the notifications referred to in the number
previous and issue the necessary alerts, in order to be taken the measures
suitable.
4-The notification system referred to in paragraph 1 shall be interconnected with the
notification system provided for in Article 11 of Law No 12/2009 of 26 of
March, amended by Law n [Reg. PL 112/2014], and may both be
integrated into a single system.
5-In the event of an exchange of organs between Member States, the notification
of the reactions and serious adverse incidents is done in accordance with the
following procedures:
a) When DGS is notified of an adverse reaction or incident
grave that you suspect to be related to one organ received from another
Member State, immediately informs the competent authority or
delegated entity of the Member State-Member of origin and transmits it a
initial report with the information shown in Annex III to the present
law, of which it is an integral part, if such information is
available;
b) DGS immediately informs the competent authorities or
delegated entities of each Member State of destination and transmits, the
each, an initial report with the information stated in the Annex
III to this Law, whenever it is notified of a reaction or
serious adverse incident that suspect to be related to an organ
that sent from a donor whose organs were similarly sent
for other Member States;
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c) When it disposes of further information subsequent to the
initial report, the DGS shall transmit them immediately;
d) Unless a reasoned reason, within three months, from the
transmission of the initial report in accordance with the points a ) or
b ), DGS transmits to the competent authorities or entities
delegated from all target Member States, a report
common final with the information set out in Annex IV to the present
law, of which it is an integral part, giving notice of the same to
IPST;
e) The final report, with the information set out in Annex IV to the
present law, it shall be drawn up after the collection of the information
relevant to all the Member States in question.
Article 21.
[...]
1-[...].
2-[...].
3-[...]:
a) [...];
b) [...];
c) The failure to comply with Article 14 (2) and 5 (5);
d) [...];
e) [...];
f) Failure to comply with Article 18 (1), 2 and 3 of Article 18;
g) The failure to comply with Articles 19-and 19-B;
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h) [ Previous point f )];
i) [ Previous point g )];
j) [ Previous paragraph h )].
4-[...]:
a) [...];
b) [...];
c) [...];
d) [...];
e) [...];
f) [...];
g) [...];
h) [...];
i) [...];
j) [...];
k) [...];
l) The failure to comply with Article 18 (4);
m) [ Previous point l )];
n) [ Previous point m )];
o) [ Previous Article para. )].
5-[...]. "
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Article 3.
Addition to Law No. 36/2013 of June 12
They are deferred to Law No. 36/2013 of June 12, Articles 18, 19-A, 19.-B and 24.-A,
with the following essay:
" Article 18.
Common procedural rules
1-The information transmitted pursuant to this Law, between authorities
competent or delegated entities, comply with the following rules:
a) Transmission in writing, either electronically or by fax;
b) Use of language of mutual understanding between sender and
recipient or, in the case of their non-existence, in a language
mutually agreed upon or, if not exist, in English;
c) Immediate transmission;
d) Registration and possible provision on request;
e) Indication of the date and time of the transmission;
f) Inclusion of the contact data of the transmission officer;
g) Contain the following warning: " Contains personal data. Protect against
disclosure or unauthorized access. ".
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2-In case of urgency, the information can be exchanged verbally, in
special in the exchanges provided for in Article 14 (5) and in the article
19.-A, following the transmission in writing, in accordance with the
referred to articles.
3-A the receiving of the information transmitted in accordance with the provisions of
in the present law is confirmed to the sender, in accordance with the
requirements set out in paragraph 1.
4-The entities referred to in paragraph 1 are permanently available for
situations of urgency and guarantee the exchange of information pursuant to the
present law, without unwarranted delay.
Article 19-The
Information on the characterization of organs and donors
1-The IPST ensures that in the case of exchange of organs between states-
Members, are transmitted, prior to the exchange of the organ, the information
obtained to characterize the donor and the harvested organs, as
specified in Article 11, the competent authorities or the entities
delegated from the possible target Member States.
2-The IPST ensures that, when part of the information to be transmitted in
compliance with paragraph 1 is not available, at the time of transmission
initial, and become available later, this information is transmitted from
prompt, to allow themselves to take the necessary medical decisions.
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3-For the purposes of the forecast in the preceding paragraphs, the GCCT is the
responsible for the direct and immediate transmission to the transplantation centre
of the required information.
4-From the transmission referred to in the preceding paragraph is given immediate knowledge
to DGS, which communicates to the competent authority or delegated entity of the
Member State of destination.
Article 19-B
Interconnection between Member States
1-A DGS, as a competent authority, communicates to the Commission the
necessary contact details, for which they must be transmitted the
relevant information for the purposes of the provisions of Article 13 (5) and (6),
in Article 14 (5) and in Article 19, which shall include the name, the
telephone number, the electrochemical address, the number of fax and the
postal address of the organism.
2-A DGS keeps updated the information included in the list that the
Commission places at the disposal of the Member States, with an indication of
all competent authorities or delegated entities designated by the
Member States in accordance with paragraph 1.
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Article 24-The
Fees
1-Are due fees for the appreciation of the applications for authorization of the activities
of harvesting and transplantation of organs effected by hospitals and
health establishments, public and private, to settle and charge us
terms defined by the porterie of the members of the Government responsible for the
areas of finance and health.
2-A The revenue affectation is defined by the porterie referred to in the preceding paragraph,
endo to the Directorate General of Health the minimum amount of 60% of the product
of the recipes. "
Article 4.
Addition of Annexes III and IV to Law No 36/2013 of June 12
They are deferred to Law No 36/2013 of June 12, Annexes III and IV, with the essay
constant in Annex I to this Law, of which it is an integral part.
Article 5.
Republication
It is republished, in Annex II to this Law, of which it is an integral part, the Act No. 36/2013, of
June 12, with the current essay.
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Article 6.
Entry into force
This Law shall come into force on the 1's working day of the month following that of its publication.
Seen and approved in Council of Ministers of March 27, 2014
The Prime Minister
The Minister of the Presidency and Parliamentary Affairs
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ANNEX I
(referred to in Article 4)
" ANNEX III
(referred to in point a ) of Article 14 (5))
Initial report of suspected reactions or serious adverse incidents
1-Member State Rapporteur
2-Number of identification of the report: country number (ISO) /national
3-Contact data of the rapporteur (competent authority or delegated entity of the
Reporter Member State): telephone, electro mail and, if available, fax
4-Centre / rapporteur body
5-Contact data of the coordinator / person to be contacted (centre of
transplantation / harvesting of the Member State-rapporteur): telephone, electro mail
and, if available, telecopy
6-Date and time of communication (aaaa/mm/dd/hh/mm)
7-State-Member of origin
8-Number of national identification of the donor, as communicated under the
article 6 para.
9-All Member States of destination (if known)
10-Number of national identification of the receiver, as communicated under the
article 6 para.
11-Date and time of the start of the reaction or serious adverse incident
(aaaa/mm/dd/hh/mm)
12-Date and time of detetion of the reaction or serious adverse incident
(aaaa/mm/dd/hh/mm)
13-Description of the reaction or serious adverse incident
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14-Measures immediately taken
ANNEX IV
(referred to in point d ) of Article 14 (5))
Final report of reactions or serious adverse events
1-Member State Rapporteur
2-Number of identification of the report: country number (ISO) /national
3-Rapporteur's contact data: telephone, electro mail and, if available,
telecopy
4-Date and time of communication (aaaa/mm/dd/hh/mm)
5-Number of identification of initial reports (Annex I)
6-Description of the case
7-Member States concerned
8-Result of research and final conclusions
9-preventive and corrective actions taken
10-Conclusion or follow-up, depending on applicable. "
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ANNEX II
( referred to in Article 5)
Republication of Law No. 36/2013 of June 12
CHAPTER I
General provisions
Article 1.
Object
1-A present law establishes standards that aim to ensure the quality and safety of organs
of human origin intended for transplantation in the human body, so as to ensure
a high level of protection of human health, by transposing into the legal order
internal to Directive No 2010 /53/UE, of the European Parliament and of the Council, of 7 of
July.
2-A This Law also regulates the necessary information procedures for the
cross-border exchange of human organs intended for transplantation in the Union
European, establishing procedures for the transmission of information on the
caraterization of donors and organs, procedures for transmitting information
necessary to ensure the traceability of the organs and procedures aimed at
ensure notification of serious adverse reactions and adverse incidents, transposing to the
internal legal order to the Commission Implementing Directive No 2012 /25/UE of the Commission, 9 of
October 2012.
Article 2.
Scope of application
1-The provisions of this Law shall apply to the donation, harvesting, characterization, analysis,
preservation, transport and implantation of organs of human origin intended for
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transplantation in the human body.
2-The provisions of this Law shall also apply to the cross-border exchange of
human organs intended for transplantation in the European Union, as well as with
third countries with which Portugal has established prior agreements.
3-The provisions of this Law shall not apply to the use of organs for the purposes of research,
except if the same ones are intended for transplantation in the human body.
Article 3.
Definitions
For the purposes of this Act, it shall be understood by:
a) "Characterization of the donor" the collection of relevant information on the
characteristics of the donor, necessary to assess their suitability for the gift of
organs, effecters an appropriate risk assessment and minimise the risks to the
receiver, as well as to optimize organ allocation;
b) "Characterization of the organ" the collection of relevant information on the
characteristics of the organ required to assess compliance and suitability and
minimize the risks to the receiver and optimize the allocation of organs;
c) "Centres of blood and transplantation" services territorially
de-concentrates of the Portuguese Institute of Blood and Transplantation, I. P. (IPST),
to which it competes, in the area of transplantation, specifically:
i) Ensure the laboratory study of donors and candidate patients to
organ transplantation;
ii) Ensure the maintenance of the necessary conditions for the choice of the pair
donor / recetor in renal transplantation;
iii) Accompany the transplantation of organs;
d) "Harvest" the process by means of which the donated organs are made available;
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e) "Donor hospital coordinator" the physician with specific training for the
detetion and evaluation of potential donor organs and tissues for transplantation,
that integrates the National Network for Coordination of Harvest and Transplantation;
f) "Dádiva" the donation of organs for transplantation;
g) "Dador" the person who makes gift of one or several organs, wants the gift to occur in
life, either after death;
h) "Disposal" the final destination given to an organ when this is not used for
transplantation;
i) "Delegated entity", the entity in which competences are delegated to the terms
of Article 5 (3), or the European organisation for organ exchange in which
are delegated competences pursuant to Art. 20;
j) "Specification of the organ", anatomical description of an organ, including:
i) The type;
ii) If applicable, your position in the body;
iii) Indication of full or partial use, mentioning the wolf or segment;
k) "State-Member State of origin", the Member State in which the organ is harvested
intended for transplantation;
l) "State-Member of destination", the Member State to which the organ is sent
intended for transplantation;
m) "Offices harvesting and transplantation coordinators" the autonomous structures
endowed with specialized human resources in the area of harvesting coordination and
transplantation, and of pluridisciplinary teams for the realization of the harvest of
organs, tissues and cells in the identified donors, which integrate the National Network
of Coordination of Harvest and Transplantation;
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n) "Serious adverse incident" an undesirable and unexpected occurrence associated with
any stage of the process, from the donation to the transplantation, susceptible to
lead to the transmission of an infective disease, to death or to situations of danger of
life, disability or inability of the donor or the patient or to provoke or
extend to your hospitalization or morbidity;
o) "Number of national donor identification or recetor", the identification code
assigned to a donor or to a receiver in compliance with the system of
identification set out in accordance with Article 13 (2);
p) "European Organisation for organ exchange" a non-purpose organisation
lucrative, public or private, dedicated to national exchange or
cross-border of organs, whose member countries are majority-states
members;
q) "Organ" a differentiated part of the human body, consisting of various tissues,
which maintains, in a significantly autonomous way, its structure,
vascularization and ability to develop physiological functions, including the
parts of organs that have as a function to be used to serve the same
goal that the entire organ in the human body, maintaining the conditions of
structure and vascularization;
r) "Preservation" the use of chemical agents, the change of conditions
environmental or other means intended to prevent or retard deterioration
biological or physical organs of human organs, from the harvest to the transplantation;
s) "Operational procedures" the written instructions that describe the steps of a
specific process, including the materials and methods to be used and the final result
expected;
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t) "Traceability" the ability to locate and identify the organ at each step of the
process, from the donation to the transplantation or disposal, including the
ability to:
i) Identify the donor and the harvesting body;
ii) Identify the receiver and the transplantation centre; and
iii) Find and identify all relevant non-personal information,
related to the products and materials that come into contact with the
organ;
u) "Serious adverse reaction" an undesirable and unexpected response, including a
infective disease, from the living donor or from the receiver, who may be associated with
any stage of the process, from the donation to the transplantation, which causes the
death or put life in danger, lead to a disability, disability,
internment, prolongation of hospitalization or morbidity;
v) "Receiver" the person who receives the transplantation of an organ;
w) "Transplantation" the process intended for the restoration of certain functions of the
human organism, upon the transfer of an organ from a donor to a
receiver;
x) "Harvesting unit" the units in which the harvesting activity is authorized
organs of human origin for the purpose of transplantation;
y) "Transplantation unit" an establishment of health care, a
team or a unit of a hospital or other body that will proceed to
organ transplantation and that is authorized to do so.
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CHAPTER II
Principles governing the donation of organs
Article 4.
Principles applicable
1-A organ donation is voluntary and unpaid, without prejudice to the provisions of the
the following numbers and in Article 5 (3) of Law No 12/93 of April 22, amended and
republished by Law No. 22/2007 of June 29.
2-Living donors are entitled to receive strictly limited compensation to be covered
the expenses incurred and the loss of donations related to the donation, not
may that constitute an incentive or financial benefit for organ donation.
3-The conditions under which the compensation provided for in the preceding paragraph may be granted
are defined by dispatching from the member of the Government responsible for the area of health.
4-The living donor is always entitled to be indemnified for damages arising from the
process of donation and harvesting, regardless of fault, pursuant to Art. 9 para.
Law No. 12/93 of April 22, amended and Republicated by Law No. 22/2007, 29 of
June.
5-A The activity developed by the harvesting units cannot have lucrative character.
6-It is prohibited advertising on the need for organs or on their availability,
when it is intended to offer or seek to obtain financial profits or advantages
equivalents.
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CHAPTER III
Competent authority
Article 5.
Designation and functions of the competent authority
1-A Directorate General of Health (DGS) is the competent authority, responsible for
verification of compliance with the requirements set out in this Law throughout the territory
national, without prejudice to the articulation with the Inspectorate-General of Activities in Health
(IGAS), in matters of surveillance and inspection, and of the competences of the IPST, in matter
of coordination of harvesting and transplantation activity, of strategic planning of
response to national and authorization needs of import and export of
organs.
2-Compete to DGS, namely:
a) Establish and keep up to date a system for the quality and safety that
cover all steps of the process, from the donation to the transplantation or
elimination of the organ;
b) Authorize the harvesting units and transplantation units, according to
the present law, upon an assent of the IPST, as a responsible entity
by strategic planning of response to national needs;
c) Ensure that the harvesting units and transplantation units, the offices
harvesting and transplantation coordinators (GCCT) and the centres of blood and of the
transplantation (CST), be subjected to control measures or audits
regular in order to check the fulfilment of the requirements, guidelines or
guidelines issued by DGS and IPST, pursuant to this Act;
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d) Suspend or revoke the authorisations granted to the harvesting units and to the
transplantation units, should the control measures demonstrate that not
comply with the requirements set out in this Law;
e) Monitor the information contained in the notification and incident management system and
serious adverse reactions, referred to in Article 6;
f) Issue guidelines intended for harvesting units and transplantation units,
to the health professionals and other people involved in all the steps of the
process of transplantation, from the donation to the transplantation or disposal of
organs, including guidelines for the collection of pre- and post-transplant information
relevant to assess the quality and safety of transplanted organs;
g) Participate in the network of competent authorities of the European Union, whose creation if
finds provided for in Article 19 (1) of Directive No 2010 /53/UE, of the
European Parliament and of the Council of July 7;
h) Scrutinizing the exchange of organs with other member states and with countries
third parties, pursuant to this Law.
3-The powers provided for in the preceding paragraphs may be delegated, by
dispatch of prior authorization from the member of the Government responsible for the area of health.
Article 6.
Records and reports of the harvesting units and transplantation units
1-The IPST is the entity responsible for ensuring the operation of a system of
unique and integrated information in the field of harvesting and transplantation, designated by
Portuguese Registration of Transplantation (RPT).
2-RPT includes a component of notification and management of incidents and adverse reactions
serious and integrates the data referred to in articles 13, 14, 17 and 18.
3-The RPT further integrates data relating to the activities of the harvesting units and the
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transplantation units, specifically aggregated data on the number of
donors, as well as the type and quantity of organs harvested and transplanted or
eliminated, in accordance with the applicable data protection provisions
personal and statistical secret.
4-RPT allows IPST the management of the waiting list of candidate patients to
transplantation, the selection of the donor / receiver pair in transplantation and the traceability, in the
terms of the provisions of paragraph the ) of Article 3 (2) of the Decree-Law No 39/2012 of 16
of February.
5-The IPST guarantees DGS the alert and immediate access to the information contained in the RPT,
specifically when there are adverse incidents and reactions, owing to DGS
be informed of the respect of nature, cause, adopted measures and consequences.
6-RPT access levels are defined in articulation between the IPST and the DGS and
subjected to authorisation pursuant to Law No 67/98 of October 26.
7-A DGS and the IPST annually draw up reports on transplantation activity,
that will be submitted to the Assembly of the Republic and to the Government.
8-Whenever requested by the European Commission or by another member state, the IPST and
the DGS provide information on the record of the harvesting units and the units
of transplantation.
Article 7.
Authorization
1-The harvesting and transplantation activities of organs can only be authorized in the
units that meet the requirements set out by the member of the Government member
responsible for the area of health, to which to provide for the tramway and enunciate all the
elements that must instruct the applications for permission for the said activities.
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2-All establishments that have ventilatory support care are
required to, within 60 days of the entry into force of this Law or of the
creation of the unit, communicate to IPST, for the purposes of appearing before, its immediate
availability for the realization of organ harvesting.
3-The opinion of the IPST, when favourable, is remitted to DGS, at the end of the harvesting activity
of organs being authorized.
4-A DGS proceeds to the issuance of the authorization, indicating the authorized activities.
5-Harvesting units and transplantation units may not proceed to any
alteration of its activities without the prior approval of DGS.
6-The minimum number of transplants to be carried out in the transplantation units is defined
by DGS, taking into account the European and international standards of quality and
security that the evidence recommends.
7-An authorization granted for the exercise of the organ harvesting activities for
transplantation purposes can be revoked whenever public health reasons, from
medical or ethical deontology advises him, or if for three consecutive years no
are achieved the targets set in quantity for the type of transplant-type respect,
in the terms set out in paragraph 6.
8-The harvesting units and transplantation units present to the DGS, up to the
last day of the month following the year to which they respect, an annual report of its
activities, which is an integral part of the assessment necessary to the maintenance of the
authorization of exercise of activity.
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Article 8.
Measures of control
1-A DGS ensures, in articulation with IGAS, the carrying out of audits, inspections or
other control measures appropriate to the harvesting units and to the units of
transplantation, the GCCT and CST:
a) Of a periodic nature, in order to ensure compliance with the provisions of the present
law;
b) In the event of adverse reactions or serious or suspected incidents of them;
c) At the request of the competent authorities of another member state, provided that
justified.
2-A DGS notifies in writing the responsible of the services referred to in the preceding paragraph
of the result of the audits and inspections effectuated.
3-A DGS, in articulation with the IGAS, sets out the guidelines regarding the conditions of
audit, inspection or other control measures, as well as training and qualification
of the professionals involved, in order to guarantee high competence and performance.
4-Whenever requested by another member state or by the European Commission, the DGS
provides information on the results of inspections and control measures
related to the requirements set out in this Law.
CHAPTER IV
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Quality and safety of organs
Article 9.
Regime for quality and safety
1-Harvesting units and transplantation units, the GCCT and the CST shall, in the
scope of your area of acting, implement and keep up to date a system for the
quality and safety, in accordance with the system established at the national level by DGS,
referred to in para. a ) of Article 5 (2), including the application of procedures
operational to:
a) Check the identity of the donor;
b) Please confirm the information regarding consent, authorization or non-existence
of objections from the donor or his family, in accordance with the one established in law, in the
place where the donation and harvesting took place;
c) Check that the characterization of organs and donors was carried out, such as
provided for in Article 11;
d) The harvesting, preservation, packaging and labeling of organs, according to the
articles 10 and 12;
e) The transport of human organs, as provided for in Article 12;
f) The exact, quick and verifiable notification of serious adverse reactions and adverse incidents, such
as provided for in Article 14 and in Article 17 (5);
g) The management of serious adverse reactions and adverse incidents, as provided for in paragraph 2 of the
article 14;
h) Ensure traceability, from the donor to the recetor and vice versa, on the terms
of Article 13;
i) Ensuring the safety and confidentiality of personal data relating to donors
and receivers, pursuant to Art. 18 para.
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2-The operating procedures referred to in points f ), g ), h ) and i ) of the previous number
specify, inter alia, the responsibilities of the harvesting units, the units
of transplantation and the European organ exchange organisations.
3-Harvest units and transplantation units, the GCCT and CST adopt the
necessary measures to ensure that the documentation relating to procedures
operational referred to in the preceding paragraphs is available at the
audits, inspections or other control measures carried out within the framework of this Law.
Article 10.
Harvesting of organs
1-Harvesting units ensure that, in the case of dador corpse, selection and
evaluation of donors are effectuated under the advice and guidance of the
hospital coordinator of donation.
2-A organ harvesting is carried out in operating rooms designed, built, maintained and
managed in accordance with applicable law and with the standards of good clinical practice, of
mode to ensure the quality and safety of the harvested organs.
3-The materials and equipment used in the harvest are treated in accordance with
applicable legislation on sterilization of medical devices.
Article 11.
Characterization of organs and donors
1-The donor organs and respects are characterized prior to transplantation, upon
the collection of the set of data set out in Part A of Annex I to this Law, of which
is an integral part.
2-In addition to the minimum set of data referred to in the preceding paragraph, the medical team,
where necessary and taking into account the availability of the information and the
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particular circumstances of each case, proceeds to the collection of the information provided in the
part B of Annex I to this Law.
3-In the emergency situations, duly substantiated from the clinical point of view, in
that the expected benefits for the recetor outweigh the risks arising from data
incomplete, can be considered for transplantation the organs in relation to which
are not available all the minimum data referred to in Part A of Annex I to
present law.
4-To comply with the quality and safety requirements provided for in this Law, the team
medical:
a) Obtains, from the living donors, all the necessary data, supplying them, for the
effect, the information that they need to understand the consequences of
dondiva;
b) It seeks to obtain information from the relatives of the donor or other persons, in the
case of the post-mortem donors, where possible and appropriate;
c) Sensitize all the people to whom information is requested for the importance of the
quick transmission of the same.
5-Laboratory tests required for organ transplantation are carried out by
laboratories of the IPST or its service, which have facilities and equipment and
appropriate operational procedures to ensure that the information regarding the
characterization of organs and donors are transmitted to the transplantation units in
useful time.
6-Transplantation units check, before they proceed to the same, if the
characterization of the organ and the donor was carried out and registered, pursuant to this Law.
Article 12.
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Transport of organs
1-The bodies, entities or companies involved in the transport of organs establish
operating procedures to ensure the integrity of organs during transport
and a suitable transport time, in accordance with the system referred to in Article 9.
2-The containers used for the transport of organs are labeled with the following
information:
a) Identification of the harvesting unit and the health unit where it was carried out,
including date and time, the respected addresses and telephone numbers;
b) Identification of the target transplantation unit, including health unit
where it is found installed, address and telephone number;
c) Indication that the packaging contains an organ, specifying the type of organ and,
where appropriate, your location on the left or the right, and include the sentence
"Handle with care";
d) The appropriate conditions of transport, in such a way as to maintain the integrity of the organ.
3-The transported organs are accompanied by the characterization report of the organ and
of the donor.
4-The provisions of the b ) of paragraph 2 is not chargeable in case of transport of organs within
of the same establishment.
5-Transplantation units check, before they proceed to transplantation, if the
conditions of preservation and transport of the received organs have been fulfilled.
Article 13.
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Traceability
1-The organs harvested and transplanted into the national territory shall be able to be traced,
from the donor to the recetor and vice versa, in order to protect the health of donors and the
receivers.
2-For the purposes of the provisions of the preceding paragraph, the harvesting units and the units of
transplantation, the GCCT and the CST dispose, within the scope of the respective area of acting, of
a system for identification of donors and receivers, integrated into the RPT, which allows
identify each donation and each of the organs associated with it, according to the forecast
in Article 18 para.
3-The information system referred to in the preceding paragraph includes the data required for
ensure traceability at all stages of the process and the information on the
characterization of organs and donors set out in Annexes I and II to this Law.
4-The data required to ensure traceability are retained during the
minus 30 years after the donation, regardless of the type of support and since
safeguarded to respect confidentiality and destroyed as soon as they are not required
to the effect.
5-In case of exchange of organs with another Member State, transmission by DGS
to the competent authority or delegated entity of the Member State of destination, of the
data necessary for the traceability and information on the characterization of the
same and of the donors, referred to in paragraph 3, assures:
a) Specification of the organ;
b) National identification number of the donor;
c) Date of harvest;
d) Name and contact data of the harvesting unit.
6-A DGS develops the necessary procedures to allow the authority to
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competent or delegated entity of the Member State of origin be informed of the
next:
a) National identification number of the recetor or, if the organ has not been
transplanted, from its final use;
b) Date of transplantation, if applicable;
c) Name and contact data of the transplantation unit.
Article 14.
Systems for notification and management of serious adverse reactions and adverse events
1-Harvesting units and transplantation units, the GCCT and the CST use
a notification system, in accordance with the one established by the IPST pursuant to the
article 6, intended for the immediate communication, research, registration and transmission of the
information about:
a) Serious adverse events susceptible to influencing the quality and safety of the
organs and which can be attributed to the donation, harvesting, characterization, analysis,
preservation and transport of the organs;
b) Any serious adverse reaction, observed during or after the transplantation, which
may be related to the harvesting, analysis, characterization, preservation,
transport and transplantation of the organs.
2-IPST provides for operational procedures for alerting and immediate notification to DGS
of the reactions and serious adverse incidents.
3-The IPST monitors and effectuates the management of the notifications referred to in the preceding paragraph and
issues the necessary alerts in order to be taken the appropriate measures.
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4-The notification system referred to in paragraph 1 shall be interconnected with the system of
notification provided for in Article 11 of Law No 12/2009 of March 26, amended by the Law
n. [Reg. PL 112/2014], and may both be integrated into a single system.
5-In case of exchange of organs between Member States, notification of reactions and
serious adverse incidents is done in accordance with the following procedures:
a) When DGS is notified of a reaction or serious adverse incident that
suspect to be related to an organ received from another Member State,
immediately informs the competent authority or delegated entity of the State-
Member of origin and transmits you an initial report with the information
set out in Annex III to this Law, of which it is an integral part, if those
information is available;
b) DGS immediately informs the competent authorities or entities
delegated from each Member State of destination and transmits, to each, a
initial report with the information set out in Annex III to this Law, always
that is notified of a reaction or serious adverse incident that it suspects to be
related to an organ that sent from a donor whose organs were
also sent to other Member States;
c) When additional information is available after the initial report, the
DGS must transmit them immediately;
d) Unless a reasoned reason, within three months, from the transmission of the
initial report in accordance with the points a ) or b ), the DGS transmits to the
competent authorities or delegated entities of all Member States
of destination, a joint final report with the information set out in Annex IV to the
present law, of which it is an integral part, giving knowledge of the same to
IPST;
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e) The final report, with the information set out in Annex IV to this Law, shall be
drawn up after the collection of the relevant information from all the States-
Members in question.
Article 15.
Qualified professionals
1-The professionals of the harvesting and transplantation units dispose of descriptions of
updated tasks that clearly establish the respective missions and responsibilities,
being an object of initial and continuous training appropriate to the respective tasks.
2-Harvesting units and transplantation units assign the responsibility
by the management of respect activities and quality assurance to different persons and
independent of each other.
3-It is mandatory for the existence of records of the training provided, which must include
modules referring to good practices.
4-The content of training programmes and the specific competence of professionals are
periodically assessed by the responsible persons of the respective units.
CHAPTER V
Protection of donor and receiver and donor selection and evaluation
Article 16.
Consent
1-A organ harvesting in living donors can only be effected after they have been met
the requirements relating to the information and consent provided for in Articles 7 and 8 of the
Law No. 12/93 of April 22, amended and Republicated by Law No. 22/2007, 29 of
June.
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2-A harvest post mortem of organs can only be carried out after verification of non-opposition
or non-existence of restrictions to the donation, through consultation of the National Register of no
Donors (RENNDA), pursuant to Article 15 of the Decree-Law No. 244/94, of 26 of
September.
3-The consent of the receiver is provided and obtained in accordance with that provided for in Article 7.
and No. 1 and 2 of Article 8 of Law No 12/93 of April 22, amended and Republicated by the Law
n. 22/2007, of June 29.
4-Addressing minor payers, consent is provided by parents, provided that
not inhibited from the exercise of parental power, or, in the event of inhibition or lack of both,
upon judicial authorization.
5-A organ transplantation in minors with an ability to understand and to
manifestation of will lacks, too, of the concordance of these.
6-A organ transplantation in larger receivers, unable for reasons of anomaly
psychic, can only be done by judicial authorization.
7-The consent of the receiver or of whom lawfully the represent is always provided by
written, being freely revocable.
Article 17.
Quality and aspets related to the safety of the living donor
1-A donation and the harvesting of organs in life for therapeutic or transplantation purposes only
may be carried out in the terms and conditions of Article 6 of Law No 12/93 of April 22,
amended and republished by Law No. 22/2007 of June 29.
2-Living donors are selected on the basis of their state of health and clinical history,
by a multidisciplinary team of the transplantation unit, the
record of the decision, in support of integrating the RPT.
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3-A The assessment referred to in the preceding paragraph implies the exclusion of persons whose gift
may constitute an unacceptable risk to health.
4-Transplantation units have and keep up to date a donor register
living, integrated in the RPT, in accordance with that provided for in Article 18.
5-Transplantation units guarantee the follow up of the living donor after the process
of donations and harvesting, and they have a notification system, according to the defined
by the letter and ) of Art. 5 (2), including the registration of any event
potentially related to the quality and safety of the donated organ and,
consequently, with the safety of the recetor and any serious adverse reaction,
observed in the living donor, which may result from the donation.
6-Applies to the notification of the reactions and serious adverse incidents referred to in the number
previous, to their research and their respective results, the one provided for in Article 14 (2).
Article 18.
Protection, confidentiality and security of personal data
1-The personal data relating to donors and receivers, their treatment and interconnection,
are subject to professional secrecy and appropriate safety measures and
confidentiality of information, in the strict respect for the conditions set out in the Act
of Protection of Personal Data, approved by Law No. 67/98, of October 26.
2-To the donor and receiver is guaranteed the confidentiality of all related information
with your health, with the results of the analyses of your donations and with the traceability
of your gift.
3-In the donation post mortem and in the cross-renal donation, the donor or his relatives do not
you may know the identity of the receiver, nor the receiver or your relatives to
identity of the donor, owing to the respected data being the object of encryption or other
means appropriate to ensure the non-intersecting of information.
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4-Are expressly prohibited aditations, suppressions or unauthorized changes of the
constant data from donor sheets or exclusion registers, as well as the
unauthorized transfer of information when they fail to comply with the provision in Law No.
67/98, of October 26.
5-The information systems provided for in this Law guarantee the security of data.
6-The rights of access and opposition of the data holders to the information contained in us
systems for registration of donations and donors exercise in the terms and conditions referred to
in Articles 11 and ( a ) of Article 12 of Law No 67/98 of October 26.
Article 18-The
Common procedural rules
1-Information transmitted pursuant to this Law, between competent authorities
or delegated entities, comply with the following rules:
a) Transmission in writing, either electronically or by fax;
b) Use of language of mutual understanding between sender and recipient or, in the
case of its non-existence, in a mutually agreed language or, if it does not exist,
in English;
c) Immediate transmission;
d) Registration and possible provision on request;
e) Indication of the date and time of the transmission;
f) Inclusion of the contact data of the transmission officer;
g) Contain the following warning: " Contains personal data. Protect against disclosure or
unauthorized access. ".
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2-In the event of an urgency, the information can be exchanged verbally, in particular in the
exchanges provided for in Article 14 (5) and Article 19, A, following
transmission in writing, in accordance with the said articles.
3-A the receiving of the information transmitted in accordance with the provisions of the present
law is confirmed to the sender, in accordance with the requirements set out in paragraph 1.
4-The entities referred to in paragraph 1 are permanently available for situations of
urgency and guarantee the exchange of information pursuant to this Law, without delay
unjustified.
CHAPTER VI
Exchange of European bodies and organizations of organ exchange
Article 19.
Exchange of organs
1-The exchange of human organs with third countries is subject to permission from the
IPST, upon advice favourable from DGS on quality and safety, only
may be authorized when the following circumstances are checked:
a) The organs can be traced from the donor to the recetor and vice-versa;
b) The organs comply with the quality and safety requirements provided for in the present
law or, in the case of third countries, equivalent standards.
2-A DGS guarantees the surveillance of organ exchange with other member states and
with third countries, in accordance with the quality and safety requirements
provided for in this Law.
3-For the purposes of the provisions of the preceding paragraph, DGS may enter into agreements with the
competent authorities counterparts in other member states and third countries,
provided that the said authorities ensure compliance with the equivalent requirements
to those provided for in this Law.
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Article 19-The
Information on the characterization of organs and donors
1-The IPST ensures that in the case of exchange of bodies between Member States, they are
transmitted, prior to the exchange of the organ, the information obtained to characterize the
donor and the organs harvested, as specified in Article 11, to the authorities
competent or to the delegated entities of the possible target Member States.
2-The IPST ensures that, when part of the information to be transmitted in compliance with
o n. 1 is not available, at the time of the initial transmission, and staying available
subsequently, such information is transmitted immediately, to allow them to take place
the necessary medical decisions.
3-For the purpose of the forecast in the preceding paragraphs, the GCCT shall be those responsible for
direct and immediate transmission to the transplantation center of the required information.
4-From the transmission referred to in the preceding paragraph is given immediate knowledge to DGS, which
communicates to the competent authority or delegated entity of the Member State of
destination.
Article 19-B
Interconnection between Member States
1-A DGS, as a competent authority, communicates to the Commission the data of
necessary contact, for which the relevant information must be transmitted
for the purposes of the provisions of Article 13 (5) and (6), Article 14 (5) and in the article
19.-A, which shall include the name, the telephone number, the electrochemical address, the
telecopy number and the postal address of the body.
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2-A DGS keeps updated the information included in the list that the Commission places on
provision of Member States, with an indication of all the competent authorities
or delegated entities designated by the Member States in accordance with the
n. 1.
Article 20.
European organ exchange organisations
DGS can enter into agreements with officially recognised organisations at the European level
of organ exchange, provided that the said organizations ensure compliance
of the requirements set out in this Law, in order to delegate to the said organizations,
particularly:
a) The exercise of the activities provided for in the scheme for quality and safety;
b) Specific functions related to the exchange of organs with other States
members and with third countries;
c) The surveillance of the exchange of organs with other member states and with countries
third parties.
CHAPTER VII
Infractions and sanctions
Article 21.
Counterorders
1-To the infractions in the protection of personal data, confidentiality and security
of the processing of data is applicable the regime of counterordinations provided for in the Act
n. 67/98, of October 26.
2-Constitutions lightweight counterorders:
a) The failure to comply with Article 7 (2) and (8);
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b) The failure to comply with Article 10 (1);
c) The failure to comply with Article 11 (2);
d) Failure to comply with Article 15 (1), 3 and 4 of Article 15
3-Constituts serious counterordinations:
a) The failure to comply with points f ) a i ) of paragraph 1 and paragraph 3 of Article 9;
b) The failure to comply with the points a ) and b ) of Article 11 (4);
c) The failure to comply with Article 14 (2) and 5 (5);
d) The failure to comply with Article 15 (2);
e) The failure to comply with Article 16 (7);
f) Failure to comply with Article 18 (1), 2 and 3 of Article 18;
g) The failure to comply with Articles 19-and 19-B;
h) The failure to comply with Article 17 (2) and (6);
i) The infractions that have served to facilitate or cover up light infractions;
j) The recidivism in the practice of light infractions in the last six months.
4-Constitutions very serious counterordinations:
a) The failure to comply with paragraphs 1, 2, 4, 5 and 6 of Article 4;
b) The operation of harvesting units and transplantation units without the
authorization of the DGS, pursuant to Article 7 (1) and (5);
c) The failure to comply with points a ) a and ) of Article 9 (1);
d) The failure to comply with Article 10 (2) and (3).
e) The failure to comply with Article 11 (1);
f) The absence of the statement of reasons provided for in Article 11 (3);
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g) The failure to comply with Article 11 (5) and (6);
h) The failure to comply with Articles 12 and 13;
i) The failure to comply with Article 14 (1);
j) Failure to comply with the provisions of Article 16 (1 a) (6);
k) The failure to comply with Article 17 (3), 4 and 5 of the Article 17;
l) The failure to comply with Article 18 (4);
m) The failure to comply with Article 19 (1);
n) The infractions that have served to facilitate or cover up serious infractions or
very serious;
o) The recidivism in the practice of serious infractions in the last five years.
5-In the counter-ordinations provided for in the preceding paragraphs are punishable by negligence and the
attempt, being the amounts of the fines referred to in the following article reduced to
half.
Article 22.
Fines
The counterordinations provided for in the previous article are punishable with fines according to the
next graduation:
a) Lightweight counterorders are punishable with fines up to (euro) 750;
b) Serious counterorders are punishable with fines since (euro) 750 until
(euro) 10000, for natural persons, and up to (euro) 22500, for collective persons;
c) Very serious counterorders are punishable with fines since (euro) 22500 until
(euro) 35000, for natural persons, and up to (euro) 66000, for collective persons.
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Article 23.
Supervision, instruction and application of fines
1-Compete to IGAS to ensure the monitoring of compliance with the constant provisions
of this Law and the application of the penalties provided for in this Chapter.
2-A IGAS is the competent entity to instruct the counterordinance processes whose
introduction has been determined by DGS or IPST.
Article 24.
Target of the product of the fines
The product of the fines provided for in this Law reverses:
a) In 60% for the State;
b) In 30% for the DGS;
c) In 10% for IGAS.
Article 24-The
Fees
1-Are due fees for the assessment of applications for permission of the harvesting activities and
transplantation of organs effected by hospitals and health establishments, public
and private, to settle and charge in the terms defined by the porterie of the members of the
Government responsible for the areas of finance and health.
2-A The revenue affectation is defined by the porterium referred to in the preceding paragraph, by the
Directorate General of Health the minimum amount of 60% of the proceeds of the proceeds.
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CHAPTER VIII
Transitional and final provisions
Article 25.
Transient standard
3-Harvesting units and transplantation units already in operation have
of a period of 12 months, counted as from the date of the publication of this Law, to
adapt to the requirements set out in it.
4-After the period referred to in the preceding paragraph the health units where they are located
installed the harvesting units and the transplantation units have one
maximum period of 30 working days to apply for DGS, pursuant to Article 7, to
renewal of the application for the authorization of the activities in accordance with the schedule in
present law.
5-The provisions of the preceding paragraphs shall not preclude the harvesting units and centres
of transplantation already in operation may apply for renewal of the authorisation
before the adjustment period provided for in paragraph 1, if they meet the requirements
provided for in this Law.
Article 26.
Abrogation standard
The paragraphs 3 and 4 of Article 3 of Law No 12/93 of April 22, amended and are repealed.
republished by Law No. 22/2007 of June 29, and Portaria No. 31/2002 of January 8.
Article 27.
Regulation
The regulation provided for in this Act is approved within 120 days of its
entry into force.
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ANNEX I
(referred to in Article 11)
Characterization of organs and donors
PART A
Minimum set of data to be collected
Minimum set of data-information aimed at the characterization of organs and donors to
collect for each donation, as required in Article 11 (1) and without prejudice to the
provisions of Article 11 (2)
Minimum set of data:
Establishment where the harvest and other general character data has been carried out;
Date and time of the harvest for each organ;
Type of donor;
Blood group;
Sex;
Cause of death;
Date of death;
Date of birth or estimated age;
Weight;
Height;
History present or past of drug use by intravenous (IV);
History present or past of malignated disease;
Present history of other communicable diseases;
Tests of HIV, VHC, VHB;
Basic information to evaluate the function of the donated organ.
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PART B
Complementary set of data
Complementary set of data-information aimed at the characterization of organs and
donors to be collected in addition to the minimum set of data specified in Part A, with
basis in the decision of the medical team, taking into account the availability of the information and the
particular circumstances of the case, pursuant to Art. 11 (2)
Complementary set of data:
General data-information concerning the contact of the body / establishment
where the necessary harvest was carried out for the coordination, allocation and traceability of the
organs from donors to receivers and vice-versa;
Data relating to the donor-demographic and anthropometric data required for
guarantee an appropriate compatibility between organ / donor and receiver;
Clinical history of the donor-clinical history of the donor, in particular of pathologies that
may affect the suitability of organs for transplantation and imply the risk of
transmission of diseases;
Physical and clinical data-data from the clinical examination required for the evaluation of the
physiological maintenance of the potential donor, as well as any finding that
reveal illnesses not detached during the analysis of the clinical history of the donor and that
may affect the suitability of the organs for transplantation or imply the risk of
transmission of diseases;
Laboratory parameters-data required for the evaluation of functional characterization
of the organs and the dethetion of potentially communicable diseases and possible
contraindications to the donation of organs;
Imaging examinations-imaging examinations required for the assessment of the state
anatomical of the organs for transplantation;
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Therapeutics-treatments administered to the donor and relevant to the evaluation of the
functional status of organs and suitability for organ donation, in particular the use of
antibiotics, inotropic support substances or therapeutic transfusion.
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ANNEX II
(referred to in Article 13)
Information on the minimum data about the donor / receiver to be kept
A-Pelas organ harvesting units
Identification of the donor.
Identification of the donation that will include at least:
Identification of the harvesting body;
Code of harvest;
Date of harvest;
Location of the harvest;
Type of donation (for example, an organ or various organs; living donors or donors
corpse);
Date of distribution or disposal;
Identification of the transplantation center to which the organs were distributed.
B-Pelos organ transplantation centres
Identification of the receiver.
Identification of the harvesting unit of supplier organs.
Date of distribution or disposal.
Identification of the clinker or end user / installation.
Type of organ.
Date of transplantation or deletion.
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ANNEX III
(referred to in point (a) of Article 14 (5))
Initial report of suspected reactions or serious adverse incidents
1-Member State Rapporteur
2-Number of identification of the report: country number (ISO) /national
3-Contact data of the rapporteur (competent authority or delegated entity of the State-
Reporter Member): telephone, electro mail and, if available, fax
4-Centre / rapporteur body
5-Contact data of the coordinator / person to be contacted (centre of
transplantation / harvesting of the Member State-rapporteur): telephone, electro-mail and, if
available, fax
6-Date and time of communication (aaaa/mm/dd/hh/mm)
7-State-Member of origin
8-Number of national identification of the donor, as communicated under the article
6.
9-All Member States of destination (if known)
10-Number of national identification of the receiver, as communicated under the article
6.
11-Date and time of the start of the reaction or severe adverse incident (aaaa/mm/dd/hh/mm)
12-Date and time of the detetion of the reaction or serious adverse incident (aaaa/mm/dd/hh/mm)
13-Description of the reaction or serious adverse incident
14-Measures immediately taken
CHAIR OF THE COUNCIL OF MINISTERS
53
ANNEX IV
(referred to in point (d) of Article 14 (5))
Final report of reactions or serious adverse events
1-Member State Rapporteur
2-Number of identification of the report: country number (ISO) /national
3-Rapporteur's contact data: telephone, electro mail and, if available, fax
4-Date and time of communication (aaaa/mm/dd/hh/mm)
5-Number of identification of initial reports (Annex I)
6-Description of the case
7-Member States concerned
8-Result of research and final conclusions
9-preventive and corrective actions taken
10-Conclusion or follow-up, depending on applicable.
