CROATIAN PARLIAMENT
1962
Pursuant to Article 89 of the Constitution of the Republic of Croatia, I hereby
DECISION
ON THE PROMOTION OF THE LAW ON MEDICAL ASSISTANCE
I hereby declare the Law on Medically Assisted Fertilization, adopted by the Croatian Parliament at its session on 13 July 2012.
years.
Class: 011-01 / 12-01 / 92 Reg. No: 71-05-03 / 1-12-2
Zagreb, 18 July 2012
President of the Republic of Croatia
LAW
Ivo Josipović, Ph.D. r.
ABOUT MEDICAL ASSISTANCE
I. GENERAL PROVISIONS
Content of the law
Article 1
(1) This Law regulates the conditions for exercising the right to medically assisted fertilization and
the rights, obligations and responsibilities of all participants in medically assisted fertility procedures.
(2) The terms used in this Law and the regulations made thereunder, which have a gender meaning, without
whether used in the masculine or feminine gender, they encompass male and female gender alike.
Article 2
This Act contains provisions which are in accordance with the following acts of the European Union:
- Directive 2004/23 / EC of the European Parliament and of the Council of 31 March 2004 setting standards
quality and safety for donation, procurement,
testing, treatment, storage, storage and distribution of tissues and cells of human origin (SL, L 102,
4/7/2004);
- Commission Directive 2006/17 / EC of 8 February 2006 implementing Directive 2004/23 / EC of the European Union
Parliament and the Council on certain technical requirements for tissue donation, procurement and testing
and cell of human origin (OJ L 38, 9.2.2006);
- Commission Directive 2006/86 / EC of 24 October 2006 implementing Directive 2004/23 / EC of the European Union
Parliament and Council with respect to monitoring requests, reporting of serious adverse reactions and occurrences, and
certain technical requirements related to the labeling, processing, storage, storage and distribution of human tissues and cells
of origin (OJ L 294, 25.10.2006).
Dignity protection and health standards
Article 3
(1) The application of medically assisted fertilization procedures shall protect the dignity and privacy of the persons involved
in the process of medically assisted fertilization, as well as people who donate germ cells or embryos.
(2) The procedures prescribed by this Law shall be carried out in order to achieve conception, pregnancy and the birth of a healthy child, in accordance with
the requirements of modern medical science and experience, with particular regard to the protection of women's health, impairment
treatment risks and well-being of offspring.
Reasons for carrying out the procedure of medically assisted fertilization
Article 4
(1) Medically assisted fertilization is a procedure carried out only when infertility treatment has been previously treated.
unsuccessfully or unsuccessfully, and to avoid the transmission of severe hereditary disease to the child at natural conception.
(2) The unsuccessful or unsuccessful treatment of infertility treatment shall be determined by a gynecology specialist
and obstetrics with a narrower specialization in human reproduction.
(3) The inevitability of the transmission of a serious hereditary disease to a child is determined by an expert in the field of human genetics who
identified a genetically inherited disease or diseases in one of the spouses.
The meaning of the term in this Act
Article 5
Some terms within the meaning of this Act have the following meaning:
1. Medically assisted fertilization is a medical procedure used in modern medicine
scientifically proven biomedical advances make it possible to connect the female and male sex cells to work
achieving pregnancy and childbirth, in a way different from intercourse.
2. The germ cells are the semen and ova that are intended to be used for the purpose of medically assisted fertilization.
3. An embryo is a fertilized egg (zygote) that by division attains multicellularity and can
reach the level of blastocyst development (5 -
6 days from fertilization).
4. Sexual tissues are the parts of the ovary and testes that contain the germ cells.
5. Homologous insemination is a medically assisted insemination using their own marital sex cells,
that is, extramarital partners.
6. Heterologous fertilization is a medically assisted fertilization using one's own sexual cells
the spouse and extramarital partner and the donor sex station.
7. A sex cell donor is a person who donates his own sex cells for the purpose of performing a heterologous procedure
medically assisted fertilization.
8. Embryo donors are spouses or extramarital partners who donate their embryos to another
infertile or extramarital couple to achieve pregnancy and childbirth.
9. Quality system means organizational structure, defined responsibilities, procedures,
the processes and resources needed to put in place a quality management system and its implementation, and that includes everything
activities that contribute directly or indirectly to quality.
10. Quality management is a coordinated activity of directing and supervising a health care institution in
in terms of quality.
11. Standard operating procedures (SOPs) are written instructions that describe all stages of a specific procedure,
including the materials and methods required and the expected end product.
12. Direct use means any process in which cells are donated and used without being stored in a bank
sex cells, sex tissues and embryos.
13. Taking is a process by which sex cells or tissues are reached.
14. Processing means all actions involved in the preparation, handling and storage of germ cells, germ tissues and
embryos.
15. Freezing means the use of chemical agents, changes in environmental conditions or other agents during the process
treatment to prevent or retard the biological or physical deterioration of germ cells, germ tissues, or
embryos.
16. Defrosting is the process of returning the germ cells, sex tissues or embryos to a condition similar to
medically assisted fertilization.
17. Distribution means the transportation and delivery of germ cells, sex tissues and embryos intended for procedures
medically assisted fertilization.
18. Transmission is the insertion of sexual cells or embryos into the sexual organs of a woman.
19. Storage covers the processing, storage and storage of germ cells, germ tissues and embryos.
20. A serious adverse event is any negative occurrence related to taking, testing, processing, storing and
the distribution of germ cells, sex tissues and embryos that can lead to the transmission of an infectious disease, death or
conditions of life-threatening, powerlessness and / or incapacity of the person, that is, which could result in the person
hospital treatment, pain, or prolong them.
21. A serious adverse reaction is an adverse reaction, including an infectious disease, of the donor or recipient
related to the procurement or administration of germ cells, sex tissues and death-causing embryos is a danger
life-threatening and / or incapacitated, resulting in hospital treatment, pain, or
extends.
22. The traceability of germ cells, sex tissues and embryos implies the ability to locate and identify them
sex cells at any stage of treatment, from collection, processing, testing and storage, to
applications, which also implies the ability to identify the donor and the station or institution where
the extraction, processing, storage and the ability to identify one or more recipients in
the health institution that uses the cells; traceability implies the ability to find and identify
any significant product and material information that comes in contact with these stations.
23. A fresh procedure is a procedure of medically assisted fertilization that is used to prepare, process and enter
non-frozen sex cells and embryos in the sexual organs of a woman.
24. Secondary procedure is a procedure of medically assisted fertilization with germ cells, reproductive tissues and embryos
after thawing them.
25. Human being "genetically identical" to another human being means a human being sharing the same set with another
cell nucleus genes.
II. MEDICAL ASSISTANCE PROCEDURES
Method and purpose of medically assisted fertilization
Article 6
(1) Medically assisted fertilization is carried out using modern scientifically proven biomedical advances
which enable the fusion of the female and male sex cells to achieve pregnancy and childbirth, in a manner
different from intercourse.
(2) On the choice of the procedure of medically assisted fertilization (natural cycle, milder or standard ovulation stimulation)
the spouse or extramarital spouse or woman referred to in Article 10, paragraph 2 of this Act shall decide with
a specialist in gynecology and obstetrics with a narrow specialization in human reproduction.
(3) About appropriate methods of medically assisted fertilization Croatian Society of Gynecological Endocrinology and Human
Reproduction of the Croatian Medical Association will produce guidelines for the treatment of infertility.
Homologous fertilization
Article 7
(1) In methods of medically assisted fertilization, homologous fertilization is preferred using its own
sex cells of spouses or extramarital partners.
(2) Controlled ovulation stimulation in accordance with homologous extracorporeal fertilization may be used
with up-to-date biomedical knowledge to produce a maximum of twelve eggs. Of that number it can
fertilize all twelve eggs. In accordance with medical advances in the sexual organs of women allowed
is an entry of up to two embryos following the principle of traceability. The remaining embryos and / or ova are frozen.
(3) In women over 38 years of age, women with adverse ovarian reserve tests, repeated failure to
treatment, cancer patients and severe male infertility, allowed the introduction of three embryos in the genital organs
women.
(4) Spouses or extra-marital companions are obliged, before initiating the procedure of medically assisted fertilization, in
declare in writing whether they wish to fertilize up to two or more eggs.
(5) By way of derogation from paragraph 2 of this Article, if spouses or extramarital partners wish to fertilize up to two eggs, in
The sexual organs of a woman are fed the resulting number of embryos, and the excess eggs are frozen, following the principle of traceability.
(6) Remaining submissions not entered into the sexual organs of women shall be kept at the expense of the Croatian Bureau of
health insurance for up to five years. After the period of five years has elapsed, the donations shall be given with the consent of the donor for the sake of donation
pregnancy and childbirth entitlement to medically assisted fertilization who consents to such procedure. U
if spouses wish to extend embryo storage for a further five years, they are obliged to
bear the cost of safekeeping.
(7) The remaining ova shall be kept at the expense of the Croatian Health Insurance Institute for up to five years.
After the expiry of the term, the eggs are destroyed with the notification to spouses or extramarital partners. If
the woman wishes to donate the eggs, she is obliged to inform the health facility in accordance with the provisions of this
Of the law.
(8) The donation of embryos is allowed only for persons treated for infertility in the Republic of Croatia.
(9) All frozen frozen must be used before starting a fresh fresh extracorporeal procedure
embryos, followed by frozen eggs.
Heterologous fertilization
Article 8
(1) When it is not possible to use one's marital sex cells in the procedure of medically assisted fertilization,
or extramarital partners or when medically assisted fertilization is carried out for prevention
transmission of severe hereditary disease to the child, sexual assisted reproduction may be used in the procedure of medically assisted fertilization
donor cells for the purpose of performing the heterologous fertilization procedure.
(2) Exceptionally, under the conditions referred to in paragraph 1 of this Article, in the procedure of medically assisted fertilization
donated pronouns of spouses or extramarital spouses who are homologous may be used
fertilization, which is double,
that is, extramarital partners from whom they originate do not want to use for their own procreation, with their explicit written
consent.
(3) In heterologous fertilization, intrauterine insemination (IUI) procedures are preferred.
(4) In the case of heterologous fertilization, the provisions of Article 7, paragraphs 2 to 8, of this Regulation shall apply accordingly.
Of the law.
Types of medically assisted procedures
Article 9
(1) Medically assisted fertilization shall be carried out using the following procedures:
1. intrauterine insemination (IUI),
2. extracorporeal fertilization (IVF),
3. Intracytoplasmic sperm microinjection (ICSI),
4. freezing and thawing of germ cells, sex tissues and embryos
5. transfer of germ cells or embryos into the fallopian tube,
6. Preimplantation genetic diagnostics.
(2) The procedures referred to in paragraph 1, items 1, 2 and 3 of this Article may be homologous or heterologous.
III. USE OF THE RIGHT TO MEDICAL ASSISTED FERTILIZATION
Beneficiaries of medically assisted fertilization
Article 10
(1) The right to medically assisted fertilization under the conditions referred to in Article 4 of this Act shall be granted to adults and able to work
woman and man who are married or in extramarital union and who are of age and general age
a state of health capable of parental child care.
(2) The right to medically assisted fertilization is also granted to an adult, able-bodied woman who is not married, out of wedlock
or a same-sex community whose treatment of infertility has so far been unsuccessful or unprecedented and which
is capable of parental care for the child, given his or her age and general health.
(3) The right to medically assisted fertilization under the conditions referred to in Article 4 of this Law shall also be granted to a person who, by decision on deprivation
legal capacity is not limited in making statements regarding personal circumstances.
(4) The right to medically assisted fertilization at the expense of the Croatian Health Insurance Institute shall be vested in a woman
as a rule, until the age of 42. A doctor who performs a medically assisted fertilization procedure, in particular
justified health reasons may entitle a woman to medically assisted fertilization after the age of 42
of life.
(5) Treatment of infertility by medically assisted fertilization at the expense of the Croatian Institute for Health
insurance includes:
- four attempts at intrauterine insemination (IUI),
- six extracorporeal fertilization (IVF) attempts, with the obligation to make two attempts in the natural cycle.
(6) The right to medically assisted fertilization referred to in paragraphs 2 and 4 of this Article shall be granted to a woman who has been found to be hopeless
other forms of treatment.
(7) The reproductive capacity of a woman shall be determined by a specialist physician of gynecology and obstruction with a rope
specializing in human reproduction based on ovarian reserve tests. Women over the age of 42 or
women whose ovarian reserve tests are unfavorable, the doctor is obliged to warn of poor results
treatment, treatment and pregnancy risks, and risks for the baby.
Existence of marriage, ie extramarital union
Article 11
(1) Marriage or extramarital affairs must exist at the time of insertion of germ cells or embryos into the body
women.
(2) Spouses shall prove the existence of marriage by appropriate public documents.
(3) The existence of the extramarital union shall be proved by the extramarital partners by a statement certified by the public
notary.
(4) Before commencing the procedure of medically assisted fertilization, spouses or spouses are obliged to
to the health care institution where the medically assisted fertilization procedure will be carried out, submit the consent from
Article 14 of this Law.
(5) For the purposes of this Act, an extramarital union shall consist of a woman and a man who are not married in the other
extramarital or same-sex union and who fulfill the prerequisites for a valid marriage.
Information on medically assisted fertilization
Article 12
(1) Spouses or extra-marital partners or women referred to in Article 10, paragraph 2 of this Act shall have the right to
information on possible forms of natural family planning, options for the treatment of infertility, and o
other ways of realizing parenting (such as adoption), and especially if they are both female and male
barren.
(2) Before carrying out all the procedures of medically assisted fertilization, a doctor, a master of biology or
other authorized health worker to spouses and extra-marital partners and the woman referred to in Article 10, paragraph 2.
of this Act is obliged to explain the details of the procedure, the prospects for success and the possible consequences and dangers of the proceedings
wife, man and child.
Legal and psychological counseling before medically assisted fertilization
Article 13
(1) Psychologically or spouses may be allowed to undergo psychological fertilization before conducting homologous insemination procedures.
or psychotherapy counseling.
(2) Legal and psychological or psychotherapy counseling must be carried out before the procedure of heterologous fertilization.
(3) The master of psychology or the specialist physician of psychiatry shall be obliged to be married, ie extra-marital
to acquaint the companions or women referred to in Article 10, paragraph 2 of this Law with the possible psychological consequences of the procedure
medically assisted fertilization. A psychologist or specialist doctor about the consultation
Psychiatry issues a written confirmation.
(4) The master of law of the health institution in which the procedure of heterologous fertilization is carried out is obligatory for the spouse or
to know extramarital spouses or women referred to in Article 10, paragraph 2 of this Act with the legal meaning and effects
consent to the planned procedure of medically assisted fertilization, family effects resulting from
certain medical procedures, and in particular the right of the child to know that he or she was conceived by medically assisted fertilization and
the child's right to know who his or her biological parents are. The Master of Law issues a written report on the consultation
confirmation.
(5) The health care institution where the medically assisted fertilization is carried out may itself ensure the implementation
legal and psychological or psychotherapy counseling, and if she cannot, she is obliged to refer spouses,
that is, spouses or women referred to in Article 10, paragraph 2 of this Act, at another health institution in
to whom such counseling is conducted or with persons authorized for psychological or psychotherapy counseling
and at the Master of Laws for legal advice.
Consent to medically assisted fertilization
Article 14
(1) The procedures of medically assisted fertilization regulated by this Law may be carried out only if they are married,
extramarital spouses, or women referred to in Article 10, paragraph 2 of this Act, to be acquainted with the details of the procedure
medically assisted fertilization in accordance with Article 12 and advised in accordance with Article 13 of this Law and, if so
the procedure gave their free consent in writing.
(2) The certified consent referred to in paragraph 1 of this Article shall be given for each procedure of medically assisted fertilization,
especially with regard to the type of procedure medically assisted fertilization and the origin of the germ cells or the embryo.
(3) Marital, extra-marital partners individually or together or by the woman referred to in the article
10, paragraph 2 of this Law may withdraw consent and withdraw from the procedure of medically assisted fertilization
until the semen or ova or embryos have been introduced into the female body. Procedure medical
assisted fertilization shall be terminated by a statement of withdrawal of the consent of one or both spouses or extramarital partners
the other or the women referred to in Article 10, paragraph 2 of this Act.
(4) After withdrawal of the consent referred to in paragraph 3 of this Article, the sexual cells shall be destroyed and the embryo stored.
for the purpose of giving the beneficiary the right to medically assisted fertilization.
(5) The statement of withdrawal of consent must be recorded by the health institution at the request of a woman or a man about it.
issue a written confirmation.
(6) Before entering semen, ova or embryos into a woman's body, the doctor is obliged to check whether
the consent referred to in paragraph 1 of this Article withdrawn.
The right of a person to access donor information
Article 15
(1) A person conceived and born with the help of medically assisted fertilization with a donated semen or a donated egg
cell or donated embryo, if she is 18 years old, has the right to see the conception record and
all information on their biological origin, including the identity of the seed donor
the cell or egg donor or embryo donor, as well as the identity of the persons referred to in Article 26.
of this Law, which is kept with the State Register of Medically Assisted Fertilization of the Ministry responsible for health
(hereinafter: the State Register).
(2) Parents are obliged to conceive and be born with the help of medically assisted fertilization with a donated semen
or by donating an egg or donated embryo, at the latest by the age of 18, to know that
conceived with the help of medically assisted fertilization.
(3) Insights into the information on the donor of the sexual cells or embryo shall be provided to the legal representative of the person referred to in the paragraph
1 of this Article or the person's doctor if at his / her request, for medically justified reasons and
well-being, previously approved by the National Commission for Medically Assisted Fertilization.
(4) Right to see the register and information about the person referred to in paragraph 1 of this Article and the donor of sex cells
has a court and a public administration body when necessary in connection with the application of this Act.
(5) The persons referred to in paragraphs 3 and 4 of this Article with the right of access to the register shall be obliged to provide information on the person referred to in paragraph 1.
of this article and the germ cell donor or embryo, as well as the information available in the register to be kept secret in
in accordance with special regulations.
The origin of the child
Article 16
(1) The origin of a child conceived in a medically assisted fertilization procedure shall be determined in accordance with family law regulations.
(2) If extramarital partners participate in the procedure of medically assisted fertilization, before the procedure
medically assisted fertilization a man is obliged to make a certified statement of acknowledgment of paternity of a child who will
be conceived in a medically assisted fertilization procedure, and the woman has a certified statement of consent to the paternity confession
child.
(3) The statements referred to in paragraph 3 of this Article shall be made in five copies, two of which shall be submitted by the woman
the health care facility where the medically assisted fertilization procedure will be performed, one copy
it is stored with a notary public, and one copy per person belongs to a woman or a man.
(4) The contestation of maternity and paternity of a child conceived in the procedure of medically assisted fertilization shall be regulated.
according to family law regulations.
IV. GENDER STATION AND JETTING DONORS
Gender Cell Donors
Article 17
(1) Gender donors may only be persons who are of legal age, age and ability and are healthy
agreed to donate semen or ova in accordance with the provisions of this Act.
(2) A donor of sex cells may be a person who is not restricted by a decision on deprivation of legal capacity
making statements concerning personal status and in accordance with the provisions of this Law and family law regulations
able to consent to the donation of semen or ova.
(3) An egg donor is a woman whose ova, with her certified consent, are used for
medically assisted fertilization of another woman. An egg donor may be a participating woman
a method of medically assisted fertilization in which an excess of oocytes was formed as well as a woman who donates an oocyte
without the intention of participating in the process of medically assisted fertilization alone.
(4) A seed donor is a man whose semen cells with his consent are used for
medically assisted fertilization of a woman who is not his spouse or extramarital partner.
(5) The manner of giving consent and the identification of the donor shall be prescribed in an ordinance by the minister competent for health (u
hereinafter referred to as the Minister).
Embryo donors
Article 18
The embryo donors are spouses who have given up their own use of the embryo created
for their procreation, and both have at the same time certified their consent that their embryo be used to procreate others
spouses or spouses or women referred to in Article 10, paragraph 4 of this Law in accordance with the provisions of this Law
Of the law.
Consent to the gift and legal status of the donor
Article 19
(1) Donation and use of sexual cells to assist spouses and extramarital partners and women
referred to in Article 10, paragraph 2 of this Act according to the provisions of this Act can be implemented only on the basis of free
the consent of the donor or the donor in writing.
(2) The donation and use of an embryo in accordance with the provisions of this Act may only be carried out on a free basis
written consent of the woman and the man who originated the embryo and who gave up using the embryo for their own
procreation. The consent must be in writing and certified by a notary public.
(3) The consent referred to in paragraphs 1 and 2 of this Article must also include a statement from the donor that he / she is aware of the right
the child referred to in Article 15 of this Act.
(4) The donor and the donor of the sex cells or the embryo shall not have the right to know the identity of the woman and child for whose
medically assisted fertilization, or birth, their genetic material was used.
(5) The donor and the donor of the sex cells, or the embryo, have no family law or any other
obligations or rights to a child conceived with the use of their germ cells or embryos in procedures
medically assisted fertilization.
(6) The health institution in which the procedure of medically assisted fertilization is carried out is obliged to donors
germ cells or embryos in accordance with this Law, explain the details of the procedure in which they participate,
especially about the legal effects of using donated sex cells, or embryos.
(7) An egg donor or semen donor or embryo donor may withdraw
their consent to donate until the entry of the donated sex cells, or embryo into the sexual organs of a woman.
(8) The health institution is obliged to record the statement of withdrawal of consent and donated sex cells
destroyed and at the request of the donor or giver, issue a written confirmation thereof.
(9) Prior to the use of donated sex cells or embryos, the physician is obliged to check his consent
withdrawn.
Gift of embryos and germ cells for heterologous fertilization
Article 20
(1) The donors of embryos or germ cells may donate their embryo or their eggs or seeds
cells to only one of the health care institutions authorized to perform heterologous fertilization procedures.
(2) When donors of an embryo donate their embryo pursuant to Article 8, paragraph 2 and Article 18 of this Act, u
In one health institution, the health institution is obliged to inform the sex bank about the existence of the embryo
cells, sex tissues and embryos and the State Register.
(3) A health institution authorized to perform heterologous fertilization procedures is obligatory in the State Register
establish a system of checks on the donation of eggs or semen, that is, the embryos referred to in paragraph 1 of this Article.
Prohibition of monetary gain
Article 21
(1) It shall be prohibited to give or receive monetary compensation or any other benefit for the donation of sex cells
or embryos.
(2) Women and men who have donated their sex cells and / or embryos are entitled to reimbursement of necessary expenses.
(3) It is prohibited to conclude contracts, agreements or other forms of written or oral arrangement on donation
germ cells or embryos between the donor or donor of the sex cells, or the embryo and one or
both spouses and extramarital partners in the procedure of medically assisted fertilization.
(4) An agreement or agreement on the assignment of sex cells, ie embryos with financial compensation or other benefits is null and void.
Bank of germ cells, sex tissues and embryos
Article 22
(1) Gender banks may be established in clinical hospital centers carrying out medically assisted fertilization procedures
cells, sex tissues and embryos.
(2) The activity of the sexual cell bank, the sexual tissues and the embryos is to collect, process, freeze,
preservation and distribution of sex cells, sex tissues and embryos.
(3) The Minister shall issue an authorization for the operation of a bank of sexual cells, sex tissues and embryos.
(4) Minimum conditions regarding premises, workers and medical and technical equipment for carrying out the activity of the bank
sex cells, sex tissues and embryos shall be prescribed by ordinance by the Minister.
V. IMPLEMENTATION OF THE MEDICAL AID INFECTION PROCEDURE
Approval of the Commission for Heterologous Fertilization
Article 23
(1) The procedure of medically assisted heterologous fertilization shall be performed at the suggestion of a gynecology specialist and
obstetrics with a narrow specialization in human reproduction.
(2) The approval of the Medical Commission is required for the conduct of any heterologous fertilization procedure
assisted fertilization by a licensed health care facility (hereinafter referred to as the "Commission").
(3) The Commission shall consist of five members, of which at least:
- one specialist in gynecology and obstetrics with a narrow specialization in human reproduction,
- one Master of Biology,
- one Master of Laws.
(4) The Commission is obliged to establish and designate a health institution where the sex station bank is located,
sex tissues and embryos. The Commission may give the approvals referred to in paragraph 2 of this Article to other health authorities
facilities that carry out medical fertilization procedures.
(5) The commission shall be appointed by the director of the health institution with the consent of the minister. The term of office of the members of the Commission
is five years.
Health assumptions for the use of donated sex cells
Article 24
(1) The authorized health institution referred to in Article 38 of this Act shall be obliged before the selection and storage of seeds and
oocytes perform all necessary examinations and laboratory tests of the donor, as well as their sex
station.
(2) Procedures and criteria for the evaluation of a sex cell donor, procedures for taking sexual cells, procedures
their receipt and storage at the sex cell bank, as well as the mandatory laboratory tests referred to in paragraph 1.
the Minister shall prescribe this Rulebook.
(3) Donated sex cells may only be used for fertilization after they have been required
prescribed by the ordinance referred to in paragraph 2 of this Article, determined that they are suitable for fertilization and their use
it cannot cause adverse effects on the health of the woman or the expectant child.
Prohibition on the use of donated sex cells due to family law obstacles
Article 25
(1) Donated semen cells must not be used for fertilization if they are a donor and a woman receiving medical care
relatives by blood or law, and if there are other reasons why marriage is not allowed.
(2) Donated ova shall not be fertilized with the semen of a man to whom, due to blood or tazbin,
kinship or other reason would not be allowed to marry the donor.
(3) The donated embryo must not be used to procreate a woman who is in a blood or tazbin relationship with the donor
the semen cell from which the embryo was made, not even for the fertilization of a woman who is related to
the woman whose ovum originated.
Restrictions on the use of donated sex cells and embryos
Article 26
(1) The donated sex cells of one person may be used for the procedure of medically assisted fertilization until they occur.
up to the birth of up to three children in one or more different families.
(2) Use of the sexual cells of one donor or one donor or embryos of marital or extra-marital status
a comrade was banned after it was determined that three children had been born.
(3) When the birth of three children is accomplished by donated sex cells, the remaining sex cells are destroyed.
(4) When the birth of three children is given by donated gifts, the remaining birth certificates shall not be donated.
(5) The authorized health institution is obliged to carry out a check before performing the heterologous fertilization
the use of donated sex cells or embryos in accordance with paragraphs 1 and 2 of this Article in the State Register.
Prohibition of gender selection
Article 27
(1) It is forbidden to use the procedure of medically assisted fertilization for the purpose of choosing the sex of the future child.
(2) By way of derogation from paragraph 1 of this Article, the sex of the child shall be allowed for the purpose of avoiding serious hereditary disease.
related to gender.
(3) The consent to the exemption referred to in paragraph 2 of this Article is given by the National Commission for Medically Assisted Fertilization.
Prohibition of the simultaneous introduction of semen and donated ova and the creation of embryos for donation
Article 28
It is forbidden to enter donated semen and donated ova and at the same time from donated sexes into the body of a woman
cell to create a donation embryo.
Prohibition of interference with sex cells
Article 29
In the procedure of medically assisted fertilization, it is forbidden to use mixtures of male or female sex
cells formed by the semen cells of two or more males or the ova of two or more females.
Prohibition of Trading and Public Advertising
Article 30
(1) It is prohibited to trade in sex cells, sex tissues and embryos.
(2) It is prohibited to advertise, advertise, solicit or offer sexual cells or embryos through all forms of public
communications or otherwise.
(3) By way of derogation from paragraph 1 of this Article, the bank of germ cells, germ tissues and embryos referred to in Article 22.
of this Act may, with the permission of the National Commission for Medically Assisted Fertilization, collect sexual
cells.
Prohibition of maternity leave
Article 31
(1) It is forbidden to advertise or otherwise offer or offer a birth service in public announcement
child for another (surrogate motherhood).
(2) It is forbidden to contract or carry out medically assisted fertilization for the birth of a child for others.
persons and surrender of a child born after medically assisted fertilization (surrogate motherhood).
(3) Contracts, agreements or other legal affairs concerning the birth of a child for another (surrogate motherhood) and o
surrenders of a child born after medically assisted fertilization, with or without financial compensation, are null and void.
Prohibition of cloning a human being
Article 32
Any procedure intended or likely to cause the creation of a human being or part is prohibited
a human being genetically identical to another human being, whether alive or dead.
VI. STORAGE OF OUTDOOR STATIONS, OUTDOOR TISSUES AND JUMP
Method and time limits for storage
Article 33
(1) Sex cells, sex tissues and embryos are taken with free certified written consent and stored and stored for
procedures of medically assisted fertilization for which the requirements laid down in this Act are fulfilled, u
to healthcare institutions authorized to store them.
(2) Stored germ cells, sex tissues and embryos are kept in line with modern achievements.
medical sciences, generally up to five years from the date of storage. With a written request from persons of whom
sex cells, sex tissues and embryos originate, the term of five years may be extended by another five years.
(3) In case of death of the person from which the sexual cells originate, that is, the sexual tissues which are stored
the healthcare facility is required to destroy the stored sex cells and sexual tissues within 30 days of the day
information on the death of a person from which the sex cells or germ tissues originate.
(4) In the event of the death of one or both of the persons originating from stored embryos, the embryos may be donated to another
the beneficiary of the right to medically assisted fertilization for childbirth and childbirth.
(5) In case the person from whom the germ cells originate, the embryos or sexual tissues are deprived of legal capacity,
sex cells, embryos, or sexual tissues, shall be kept in accordance with paragraph 2 of this Article.
(6) The health institution shall submit the data referred to in paragraphs 2, 3, 4 and 5 of this Article to the National Commission.
for medically assisted fertilization.
Storage
Article 34
(1) A man and a woman who, according to the knowledge of medical science, are in danger of being harmed
health reasons become infertile, can in authorized
Healthcare facility with free certified written consent to store your sex cells, sex tissues or embryos for
own use later.
(2) By way of derogation from paragraph 1 of this Article, the right to store sexual cells and sexual tissues shall also have the right
a minor who is at risk of becoming permanently infertile due to illness. Sexual cells and tissues
minors are kept until the age of 42 (women), or until the age of 50
(male).
(3) Stored germ cells, sex tissues and embryos referred to in paragraph 1 of this Article shall be kept as a rule up to five
years from the date of storage. Shelf life may be requested by persons of whom the sex cells, tissues, or embryos
are due to extend for another five years. Exceptionally, in particularly medically justified cases, and longer.
(4) In the case of death of a person from which the sexual cells and sexual tissues originate from health origin
the institution is obliged to destroy the stored sex cells and sexual tissues within 30 days from the date of finding out about
to donate stored embryos to another beneficiary of the right to medically assisted fertilization for fertilization and birth
child.
(5) The health institution shall submit the data referred to in paragraphs 2, 3 and 4 of this Article to the National
commission for medically assisted fertilization.
Transfer and use
Article 35
(1) Persons originating from stored sex cells, sexual tissues or embryos may be justified
reasons to request their transfer to another authorized healthcare facility for use in the procedure
medically assisted fertilization for their own medically assisted fertilization.
(2) The justification for the transfer of sexual cells, sex tissues or embryos to another authorized health institution
is decided by the National Commission for Medically Assisted Fertilization.
Embryo protection
Article 36
(1) The following shall be prohibited in the procedure of medically assisted fertilization:
1. enable the extracorporeal development of an embryo older than six days,
2. to fertilize a female ovum with a semen of any species other than the semen of man or
an animal egg with a human semen,
3. change the embryo by transplanting other human or animal embryos,
4. enter human sex cells or human embryo into an animal,
5. Enter animal sex cells or animal embryos into a woman.
(2) It is prohibited to create human embryos for scientific or research purposes.
(3) Scientific or research work on the embryo shall be prohibited.
New methods of medically assisted fertilization
Article 37
It is necessary for the introduction and use of new procedures of medically assisted fertilization in the Republic of Croatia
is the approval of the National Commission for Medically Assisted Fertilization.
VII. HEALTH INSTITUTIONS AUTHORIZED TO PERFORM MEDICAL PROCEDURES
Fertilization
Approval for medically assisted fertilization procedures
Article 38
(1) The procedures of medically assisted fertilization may be performed only by the health care institution to which he is
in accordance with the provisions of this Law, the approval of the Minister for carrying out the procedures of medically assisted fertilization (in
hereinafter referred to as "Authorized Healthcare Institution").
(2) The Minister shall grant the approval referred to in paragraph 1 of this Article for:
1. conducting homologous or heterologous intrauterine insemination (IUI),
2. carrying out homologous or heterologous extracorporeal fertilization (IVF),
3. conducting homologous or heterologous intracytoplasmic sperm microinjection (ICSI),
4. freezing and thawing of germ cells, sex tissues and embryos
5. transfer of germ cells or embryos into the fallopian tube,
6. preimplantation genetic diagnostics.
Working conditions
Article 39
(1) The Minister shall grant the approval referred to in Article 38 of this Act by a decision declaring that a health care
the institution is eligible to carry out the individual assisted fertilization procedure referred to in Article 38 (2).
of this Act with respect to space, workers, medical and technical equipment, quality system and other conditions.
(2) The Minister shall grant the approval referred to in paragraph 1 of this Article for a term of five years based on the previous one
opinions of the National Commission for Medically Assisted Fertilization.
(3) No appeal shall be allowed against the decision referred to in paragraph 1 of this Article, but an administrative dispute may be initiated.
(4) The conditions referred to in paragraph 1 of this Article shall apply to:
- minimal medical and technical equipment and space for performing each individual procedure in accordance with modern medical
cognitions,
- full-time employment obligation for at least one specialist in gynecology and obstetrics with narrowing
specializing in human reproduction, one master of biology and one nurse - to perform up to
250 medically assisted fertilization procedures per year,
- full time employment obligation at least: two gynecology specialists and obstetricians with
specializing in human reproduction, two masters of biology and one nurse - for
performing up to 500 medically assisted fertilization procedures per year,
- full time employment obligation at least: three gynecology specialists and obstetricians with
specializing in human reproduction, three masters of biology, two nurses and one
laboratory technician - for performing more than 500 medically assisted fertilization procedures per year.
(5) The health institution referred to in paragraph 1 of this Article shall be obliged to conclude a contract with the health institution of the same
substitution treatment activities in the event of special and unforeseen circumstances.
(6) The master of biology referred to in paragraph 4, subparagraphs 2, 3 and 4 of this Article must have at least two years of work
experience in the operations of medically assisted fertilization procedures.
(7) The conditions regarding space, medical and technical equipment and the quality system referred to in paragraph 1 of this Article, with
previously obtained opinion of the National Commission for Medically Assisted Fertilization and Croatian
of the Society for Gynecological Endocrinology and Human Reproduction of the Croatian Medical Association
the minister.
Applying
Article 40
(1) The health institution shall submit the request for approval from Article 38 of this Law to the Ministry
competent for health (hereinafter: the Ministry), and must contain:
1. name and headquarters of the health institution,
2. personal data of the responsible person,
3. a list of procedures for which approval is sought,
4. standard operating procedures for individual activities that provide insight into the medical procedures to date
assisted fertilization,
5. quality system manual,
6. proof that the procedures referred to in Article 39 of this Law have been fulfilled, for the procedures for which approval is sought;
7. report on compliance with the prescribed conditions,
8. Preliminary Opinion of the Croatian Society for Gynecological Endocrinology and Human Reproduction
of the Medical Association.
(2) The authorized health institution shall be obliged for any new information that affects the quality and safety
inform the ministry of the activity.
Renewal of approval
Article 41
The authorized health institution may, at the latest 90 days before the expiry of the authorization referred to in Article 38 of this Law
apply for renewal of approval.
Withdrawal of approval
Article 42
(1) The Minister shall issue a decision revoking the authorization referred to in Article 38 of this Act if he / she determines that the health institution:
1. no longer fulfills the conditions from Article 39 of this Law,
2. does not comply with the provisions of this Law.
(2) The proposal for revocation of the authorization referred to in paragraph 1 of this Article shall be submitted to the Minister by the National Commission for
medically assisted fertilization.
Professional workers participating in the procedure of medically assisted fertilization
Article 43
The following are involved in carrying out the procedures of medically assisted fertilization:
- specialist in gynecology and obstetrics with a narrow specialization in human reproduction,
- a specialist in urology,
- Master of Biology,
- if necessary, a histologic-embryologist with accreditation in andrology,
- nurse,
- a laboratory technician, in accordance with Article 39, paragraph 4, subparagraph 4 of this Act.
The call of conscience
Article 44
Healthcare professionals and non-health care professionals who should carry out or participate in the conduct of medical procedures
assisted insemination have the right to invoke the conscience because of their ethical, religious or moral views, or
convictions and refuse to participate in or participate in medically assisted fertilization.
A professional secret
Article 45
(1) All persons participating in the procedure of medically assisted fertilization shall be bound by professional secrecy.
information related to this procedure, and in particular the personal and health information about the woman or man to whom
medical assistance is provided to the child conceived in the procedure and to the donor of the germ cells or embryos.
(2) The court may, in particularly justified cases, release the person referred to in paragraph 1 of this Article from custody
professional secrets.
(3) The obligation of professional secrecy also applies to members of the National Medical Commission
assisted fertilization and to the members of the Commission, as well as to all other persons in the performance of their duties
have learned of the information referred to in paragraph 1 of this Article.
Records
Article 46
(1) Authorized health care institutions are obliged to conduct medically assisted fertilization procedures
records of:
1. the personal and health information of persons assisted with the procedures of medically assisted fertilization,
2. type of medically assisted fertilization procedures,
3. the personal and health information of the donor of the sex cells and embryos,
4. compulsory psychological, psychotherapy and legal counseling,
5. certified written consent to a specific procedure of medical fertilization under Article 14 of this Law,
6. Withdrawal of certified written consent,
7. information on the course and duration of the procedure, on important circumstances regarding pregnancy and childbirth,
8. health and non-health care workers who participated in the procedure of medically assisted fertilization,
9. stored sex cells, sex tissues and embryos,
10. the data necessary for the traceability of the germ cells, sex tissues and embryos, at all stages.
(2) The authorized health institution shall keep data from the records permanently.
Register of health institution
Article 47
(1) An authorized health institution shall be obliged to keep its own register of users of procedures
medically assisted fertilization and donors of germ cells and embryos under the provisions of this Act.
(2) The authorized health institution shall enter in the register referred to in paragraph 1 of this Article:
- the personal and health information of persons assisted with medically assisted fertilization procedures and information on the type
the procedure of medically assisted fertilization,
- information on medicines and medicinal products used in all medically assisted procedures
fertilization,
- personal and health information about the donor of the sex cells and embryos, including information about
donor parents,
- date of donation, storage and use of germ cells and embryos,
- date of storage and use of the sexual tissues,
- the results of the examination of the donor and the search of his sex cells,
- birth data of a child conceived with medically assisted fertilization with donated sex cells,
that is, a donated embryo,
- information on unsuccessful pregnancies.
(3) The authorized health institution is obliged to submit all data from its register within three days at the latest.
To the State Register for permanent storage.
(4) All information from the State Register or the register of the health care institution is a professional secret.
Healthcare facility reports
Article 48
(1) Authorized health institutions are obliged to the National Commission for Medically Assisted Fertilization
to report on the number and type of procedures of medically assisted fertilization performed, their success and o
stored sex cells, sex tissues and embryos.
(2) The report referred to in paragraph 1 of this Article shall be submitted by authorized health institutions once a year for the previous one
calendar year, not later than February 15 of the current year, at the request of the National Commission for the
medically assisted fertilization before.
(3) The content and form of the report form referred to in paragraph 1 of this Article shall be prescribed by an ordinance by the Minister.
Serious adverse events and serious adverse reactions
Article 49
(1) Authorized healthcare institutions are obliged to establish an efficient and proven system for monitoring and reporting of serious
adverse events and serious adverse reactions; and
a system for withdrawal from the administration of germ cells, drugs, and medical products that have caused or can cause it
cause a serious adverse event or a serious adverse reaction.
(2) About any serious adverse event and serious adverse reaction of an authorized health care institution
they are obliged to notify the ministry in writing without delay.
(3) Ordinance on the manner of reporting serious adverse events and serious adverse reactions, and o
the manner of keeping records and the deadlines for reporting to the Ministry on serious adverse events and serious adverse events
reactions are made by the Minister.
(4) The register of serious adverse events and serious adverse reactions referred to in paragraph 2 of this Article shall be kept
ministry.
(5) Annual report on reported serious adverse events and serious adverse reactions
the ministry will submit it to the European Commission by 30 June for the previous year.
VIII. NATIONAL COMMISSION FOR MEDICAL ASSISTED INFUSION
Composition of the National Commission for Medically Assisted Fertilization
Article 50
(1) For the purpose of systematic monitoring of occurrences, consideration of issues and performance of other tasks related to the application of this
By law, the Minister establishes and appoints a National Commission for Medically Assisted Fertilization (hereinafter:
National Commission).
(2) The National Commission shall have nine members, consisting of:
- one representative of the Ministry,
- one expert in the field of law,
- one specialist in the field of psychology or psychiatry,
- one Master of Biology,
- three gynecology specialists with a narrow specialization in human reproduction,
- one representative of the National Bioethics Commission for Ethics Medicine,
- one representative of patient associations.
(3) The President and members of the National Commission shall be appointed by the Minister for a term of four years.
The affairs of the National Commission
Article 51
The National Commission performs the following tasks:
- gives a preliminary opinion to the Minister for granting or withdrawing approval to a health institution for
carrying out the procedure of medically assisted fertilization,
- approve access to the State Register according to Article 15 of this Law,
- agrees to the exemption from the prohibition on the use of medically assisted fertilization for the purpose
choosing the sex of the future child,
- decide on the justification for the transfer of stored germ cells, sex tissues and embryos pursuant to Article 35.
of this Law,
- gives or denies approval for the introduction and use of new procedures of medically assisted fertilization in
The Republic of Croatia,
- discuss the reports of health institutions submitted pursuant to Article 48 of this Law,
- monitor the progress of biomedical and other sciences in the field of medically assisted fertilization,
- provides recommendations, opinions and guidelines for amending existing regulations in this field,
- cooperates with the Commissions of authorized health institutions,
- performs other tasks in the field of medically assisted fertilization in accordance with this Law.
IX. STATE REGISTER ON MEDICAL ASSISTED INSURANCE
The contents of the registry
Article 52
(1) The state register shall contain data on users of medically assisted fertilization procedures, o
the birth of a baby conceived by medically assisted fertilization with donated sex cells and insects according to
the provisions of this Act and the birth of a child conceived by homologous fertilization.
(2) The State Register shall also contain information on donors of sex cells and submissions in accordance with the provisions of this Act.
(3) Beneficiaries and donors referred to in paragraphs 1 and 2 of this Article and any donation of germ cells and embryos
is assigned a unique identification number, which is entered in the State Register.
(4) The manner of operation of the State Register and the assignment of a unique identification number shall be prescribed by an ordinance
the minister.
(5) All data in the State Register shall be kept permanently.
Protection of personal data
Article 53
(1) Data from the State Register may be used only as aggregate statistical indicators and as
individual in the cases prescribed by this Act.
(2) The data in the State Register shall be confidential and only authorized persons who keep it shall have access to individual data
State Register, authorized persons employed in authorized health institutions and persons authorized for inspection
into the data in the State Register in accordance with Article 15 of this Law.
(3) Individual data, data protection measures and responsibility of persons having access to a single database
of the data of the State Register the regulations on protection of personal data apply.
Co-operation with European Union expert bodies
Article 54
The Ministry is obliged to provide expert information and treatment results on medically assisted fertilization
to submit to the representative of the Republic of Croatia in European professional societies (eg European society of
human reproduction and embryology).
X. SUPERVISION
Implementation of supervision
Article 55
(1) Supervision of the application and enforcement of this Act and regulations adopted pursuant to this Act, as well as
supervision of professional work in authorized health institutions referred to in Article 38 of this Law
the Ministry inspects.
(2) For the purpose of carrying out the supervision referred to in paragraph 1 of this Article, the Minister shall by decision appoint at least seven teams in
who, in addition to the representatives of the Ministry of Inspection, includes a representative of the profession - gynecology and obstetrics with
specialized in human reproduction and a representative of the profession - Master of Biology.
(3) The representatives of the profession referred to in paragraph 2 of this Article shall be appointed by the Minister from the list proposed by the Croatian Society for
gynecological endocrinology and human reproduction of the Croatian Medical Association.
(4) The supervision referred to in paragraph 1 of this Article shall be carried out at least once every two years.
(5) Supervision of the protection of personal data shall be carried out by the Personal Data Protection Agency.
XI. INFRINGEMENTAL PROVISIONS
Article 56
(1) A legal person shall be fined between HRK 70,000.00 and HRK 250,000.00 for a misdemeanor if:
1. perform a procedure of medically assisted fertilization contrary to the provisions of Article 7 of this Law,
2. if he acts contrary to the principle of traceability in accordance with Article 7, paragraph 5 and Article
46, paragraph 1, item 10 of this Law,
3. perform the procedure of heterologous fertilization contrary to Article 8 of this Law,
4. perform the procedure of medically assisted fertilization without prescribed legal, psychological or psychotherapy
consultation (Article 13, paragraph 2),
5. perform the procedure of medically assisted fertilization without the prescribed written consent (Article 14, paragraph 2)
1 and 2 and Article 17),
6. fails to record the statement of withdrawal of the certified consent and / or fails to issue a confirmation thereof (Article 14, paragraphs 3 and 5; and
Article 19, paragraph 8),
7. act contrary to the provisions of Article 15, paragraphs 1, 3, 4, and 5 of this Law,
8. perform the procedure of heterologous fertilization without the free certified consent of the donor in writing
(Article 19 (1) and (2))
9. perform the procedure of medically assisted fertilization without the consent of the Commission of the authorized health institution
(Article 23, paragraph 2),
10. act contrary to the provisions of Article 24 of this Law,
11. perform the procedure of medically assisted fertilization contrary to the provisions of the article
25 of this Law,
12. uses donated sex cells for the birth of more than three children (Article 26),
13. fails to carry out a check in the State Register before performing heterologous fertilization (Article 26, paragraph 5),
14. perform a procedure of medically assisted fertilization for the purpose of selecting the sex of the unborn child contrary to Article 27 of this
The law,
15. perform a procedure of medically assisted fertilization contrary to Article 28 of this Law;
16. perform a procedure of medically assisted fertilization with a germ cell mixture (Article 29),
17. trade, advertise, advertise or search for, or offer sex cells, sex tissues and embryos (Article 30),
18. Seeks or offers the service of giving birth to a child for another or contracting or conducting medically assisted care
fertilization for the birth of a child for others and delivery of a child born after medically assisted fertilization
(Article 31),
19. performs a process intended to create a human being or part of a human being genetically identical to another
to a human being, whether alive or dead (Article 32),
20. stores and treats sexual cells, sexual tissues and embryos contrary to Article 33 of this Law,
21. act contrary to Article 34 of this Law,
22. act contrary to Article 36 of this Law,
23. perform the procedure of medically assisted fertilization without the Minister's approval (Article 38),
24. allow the carrying out of medically assisted fertilization procedures to persons who do not fulfill the conditions laid down in Article 43.
of this Act.
(2) A fine of HRK 7,000.00 to HRK 25,000.00 for the misdemeanor referred to in paragraph 1 of this Article shall also be imposed on a fine.
responsible person in a legal entity.
(3) A fine of HRK 7,000.00 to HRK 25,000.00 for the misdemeanor referred to in paragraph 1 of this Article shall also be imposed on a fine.
the immediate perpetrator.
(4) For attempting an offense referred to in paragraph 1, points 1 to 5, 7 to 9, 11, 12 and 14 to 24 of this Article, the following shall be punished:
the offender.
Article 57
(1) A legal person shall be fined between HRK 50,000.00 and HRK 100,000.00 for a misdemeanor if:
1. does not keep records and keep data (Article 46),
2. does not maintain its own register of beneficiaries of medically assisted fertilization procedures for donors
sex cells, sex tissues and embryos (Article 47 (1)),
3. fails to submit the records and data from his own donor register to the State Register (Article 47, paragraph 2);
3.),
4. fails to report within the prescribed period the National Commission (Article 48 (2)).
(2) A fine of HRK 10,000.00 to HRK 15,000.00 for the misdemeanor referred to in paragraph 1 of this Article shall also be imposed on a fine.
the responsible person in the legal entity and the immediate perpetrator.
XII. TRANSITIONAL AND FINAL PROVISIONS
Article 58
The Ministry is obliged to establish a State Register within six months from the day this Law enters into force.
Article 59
The Minister will appoint the National Commission for Medically Assisted Fertilization within 30 days of the date
the entry into force of this Act.
Article 60
(1) The consent forms, the statement and the certificate referred to in Article 14 (1) and (5), Article 17 (1), Article 18,
Article 19, paragraph 8 and Article 33, paragraph 1 of this Act
the ordinance shall be prescribed by the Minister within two months from the day this Law enters into force.
(2) The Minister for which the adoption is authorized by this Law shall pass the Minister within two months from the day
the entry into force of this Act.
Article 61
Pending the entry into force of the implementing regulations referred to in Article 60 of this Act, they shall remain in force, unless they are contrary to this
By law:
1. Ordinance on the conditions in respect of premises, professionals, medical and technical equipment, quality systems and
other conditions for carrying out fertilization procedures (Official Gazette 110/09 and 38/10),
2. Rulebook on the manner of reporting and on the manner of keeping records and deadlines for reporting serious
adverse events and serious adverse reactions (Official Gazette 110/09),
3. Ordinance on the method of giving consent for the collection, storage and storage of semen and ova
station (Official Gazette 110/09),
4. Ordinance on the method of consenting and identification of donors of sex cells (Official Gazette 110/09),
5. Rulebook on Procedures and Criteria for the Evaluation of Gender Cell Donors and Receipt Procedures i
storage of sex cells (Official Gazette 110/09),
6. Rulebook on the method of giving consent of spouses or extra-marital companions for conducting medical procedures
fertilization (Official Gazette 110/09),
7. Ordinance on the method of giving consent of a spouse or extramarital spouse for donation of sex cells (»Narodne
Gazette «, no. 110/09.),
8. Ordinance on the Form of the Certificate of Destruction of the Sexual Cells after withdrawal of the consent of the donor (»Narodne
Gazette «, no. 127/09.),
9. Ordinance on the Form of the Declaration on Extra-marital Community (Official Gazette 156/09),
10. Ordinance on the mode of operation of the State Register of Medical Fertilization and Allocation of Unique
identification number (Official Gazette 33/10),
11. Rulebook on the content and form of the report form on the number and type of medical procedures performed
fertilization, their success and stored sex cells (Official Gazette 33/10).
Article 62
(1) All duly recorded procedures of medically assisted fertilization effective on the day this enters into force
The law is in the process of being drafted or already started, it will be completed according to the medical method which provides that
be made if the party so requests.
(2) The procedures of medically assisted fertilization carried out up to the date of entry into force of this Act shall not count
in the total number of proceedings referred to in Article 10, paragraph 5 of this Act.
Article 63
On the day this Act enters into force, the Law on Medical Fertilization (Official Gazette, no.
88/09., 137/09. and 124/11).
Article 64
This Law shall enter into force on the eighth day after its publication in the Official Gazette, with the exception of the provision of Article 49, paragraph 5.
which shall enter into force on the date of accession of the Republic of Croatia to the European Union.
Class: 543-01 / 12-01 / 01
Zagreb, 13 July 2012
CROATIAN PARLIAMENT
Josip Leko, Vice-President of the Croatian Parliament, v. r.