Content and objectives
section 1 of this Act contains provisions on the quality and
security standards for the handling of human tissues and cells
intended for human use or for the manufacture of
medicinal products for human use.
The purpose of the Act is to protect human health.
section 2 of this Act, the following definitions shall apply the following
"Serious adverse event" Event in conjunction with the
processing, storage and
distribution of tissues and
cells that can
1. lead to the transmission of a
contagious disease or to
2. be life-threatening, be
Disabling or cause
for the patient, or
3. cause or extend
illness or the need
Serious adverse reaction Such unintended response,
including infectious disease,
in donors or recipients in
When tissues and
cells are procured from donors
or used in the receiver, which
can cause death, life-threatening
or disabling condition
or that cause significant
disabilities or leads
to or extend disease
or need hospitalization.
Individual human cells
cells or a collection of human
cells, which are not bound by
any kind of connective tissue.
Body a differentiated and vital part
of the human body, formed by
different tissues, which
maintains its structure,
vascularisation, and capacity to
features with a significant
degree of autonomy.
exploiting a health care establishment, a Department
in a hospital or other
institution that promotes
human tissues or
cells, which do not need to have
permission to operate as a
Organisation responsible for
human a health care establishment, a Department
in a hospital or other
establishment which uses
human tissues and cells
Tissue all constituent parts of the
the human body consists of
Tissue establishment Establishment where physical or
legal entity engaged in
preservation, storage or
distribution of human
tissues or cells
for use on humans
or for the manufacture of
medicinal products intended for
use on humans.
Activities can also
the import or export of
human tissues or
Scope of application
section 3 of the Act applies to the activities of tissue establishments.
The provision on notification requirements in section 20 shall also apply
the activities of procurement organisations and
provisions on the obligation in paragraph 20 (b) and if
obligation in section 21A also apply to the activities of
organisations responsible for human application.
section 4 of the Act is not applicable to research involving human
tissues and cells used for purposes other than for the use
section 5 of the Act is not applicable.
1. When tissues and cells removed from and applied in the same
humans at the same surgical procedure, or
2. the bodies or parts of bodies, which will be used for the same
purposes as an entire organ in the human body.
The relationship to the provisions of any other law
section 6 of this Act does not apply when the Act (2006:496) on blood safety
section 7/expires U: 2016-01-01/
At the processing, preservation, storage and distribution
of human tissues and cells intended for human
for the production of medicines in lieu medicines Act
section 7/entry into force: 01/01/2016
At the processing, preservation, storage and distribution of human tissues and cells intended to be used for the production of medicines in lieu the medicines Act (2015:315). Law (2015:322).
section 8, unless otherwise provided for by this law or regulations
has been issued pursuant to the Act, the personal data Act
(1998:204), the processing of personal data.
Conditions and terms
§ 9 the activities of a tissue establishment may be carried out only by
the authorized. The authorization must be limited in time and
subject to conditions.
Authorization may be notified only if the business has a high
quality and safety.
The operator of a tissue establishment shall systematically and
continuously develop and secure operations.
10 § Government Announces rules on the
authorities ordering the State to pursue a
tissue establishment and the conditions that apply to
section 11 of the operator of a tissue establishment shall not undertake any
substantial changes to its activities without the
the licensing authority has previously submitted a written
approval of the change.
section 12 where a tissue establishment entrusts someone else to perform
some work for on behalf of the establishment, the establishment
draw up a written agreement with the contractor if there is
risk that the work could affect tissue and
cell quality and safety.
The contract shall state the obligations of the contractor
has relation to the Te.
13 § When a tissue establishment, there should be someone who responds
for operations (Operations Manager).
The operations manager should be a specially appointed officers
with adequate expertise and experience.
Operations Manager may instruct such officers in
activities that have sufficient expertise and experience to
perform certain management tasks.
Import and export
section 14 of the Only tissue establishments which have been granted an authorisation
to import or export under section 9 may import or
export of tissues and cells from or to third countries.
The Government, or Government authority determines,
provide for exemption from licensing
under the first subparagraph.
section 15 of the Government Announces rules on the
authorities exercising supervision over compliance with this Act
and of the regulations and conditions as given in
adherence to the law.
section 16 of a supervisory authority has the right to request the
information, documentation, samples and other materials as needed
for the purposes of supervision.
Have several regulatory agencies are appointed, they shall provide each other the
information they need supervision.
section 17 a supervisory authority shall regularly inspect and
check the tissue establishments. It may not go longer than
two years between inspections.
In addition, the supervisory authority shall, if necessary, inspect and
check the tissue establishments, if serious adverse reaction in
the donor or in the recipient incurred or severely abnormal
the event occurred.
The supervisory authority has the right of access to the areas,
premises and other facilities used in the business and, in
such spaces do surveys. The one whose activity
be inspected is obliged to provide the necessary assistance at
18 § a regulator may announce the injunctions
necessary for the conduct of supervision, inspections and
controls. An injunction may be subject to a penalty.
19 § inspection under this Act has the performing
the inspection has the right to get the help of the police authority
needed for the inspection to be carried out.
The request for assistance as referred to in the first subparagraph may only be made if
1. the particular circumstances give reason to suspect that
the operation cannot be carried out without a police man's special
powers under section 10 of the law on police (1984:387)
2. There are serious reasons.
Notification of serious adverse reactions and serious adverse
section 20 of the operations manager shall ensure that suspected or
observed serious adverse reactions and serious adverse
events notified to the supervisory authority without delay.
20 a of A "procurement organisation" shall, to the
tissue establishment have received tissues or cells
shall notify it without delay of any suspected or confirmed
a) serious adverse reaction in living donor which may affect
tissue or cell quality and safety, and
b) serious adverse event during procurement which may
affect human tissue or cell quality and
Security. Law (2008:1060).
20 b of An organisation responsible for human application
going to the tissue establishment who have deployed the tissues
or cells shall notify it without delay of any suspected or
a) serious adverse reaction observed during or after the
clinical use and that can be attributed to tissue
or cell quality and safety, and
b) "serious adverse event" that could affect the tissue
or cell quality and safety. Law (2008:1060).
section 21 of The authorized to engage in a tissue establishment shall
keep a record of
1. its activities;
2. the donor and recipient of human tissues and cells, and
3. checks carried out by human tissues and cells.
The registry may have intended only to ensure the traceability
of human tissues and cells in order to prevent the transmission
of diseases. The registry may be proved by means of automated
The register may, in the case of personal data include information
only if the
1. the donor's identity,
2. the donor's medical history, quintiles
3. the results of surveys on the sensor and the control of
human tissues and cells, and
4. the recipient's identity.
The information in the registry to screen 30 years after the introduction.
Anyone who has permission to conduct a tissue establishment is
responsible for the register. Law (2008:1060).
section 21A of The organisation responsible for human application
to provide information about the recipient's identity to the
tissue establishment who have deployed the tissues or
the cells. Law (2008:1060).
section 22 of the Government, or the Government authority determines,
may provide for the information in the registry
specified in section 21 shall be kept for a longer period of time than what is being said
section 23 of the Inspectorate for health and social care, with the help of
automated treatment, keep a record of those who have
permit to conduct a tissue establishment. The registry has to
purpose to give publicity to the tissue establishments
authorized and for which activities these are granted
The registry may also be used for surveillance, research and
The register may, in the case of personal data include information
only if it is authorized to carry on a
tissue establishment and if the Operations Manager.
Inspectorate for health and long-term care is responsible for
the registry. Law (2012:953).
24 § Government Announces rules on which authority
the information to the Inspectorate for health and social care
necessary for inspection to keep records
According to section 23.
Government Announces rules on which authorities may
have direct access to the data in the inspection for health and
care records. Law (2012:953).
section 25 of the Government, or the Government authority determines,
Announcing the details of the data tables in the 21
and 23 sections should contain.
section 26 of the provisions of the personal data Act (1998:204) about
rectification and Indemnity apply to the processing of
personal information under this Act.
section 27 of The belonging to or belonged to staff in a
individual's tissue establishment where there is
procurement and testing of human tissues and cells
for use in the manufacture of medicinal products intended for
human use, must not improperly disclose what he
or she's in business have been told about a single donor
health or other personal circumstances. As
disclosure is not considered that any fulfills
obligation imposed by law or regulation.
In the activities of the individual health care applied
the provisions of Chapter 6. 12 § the patient safety Act (2010:659).
Of the public business, the provisions of
public access to information and secrecy (2009:400).
section 28 of the applicant for a permit referred to in section 9 shall pay
application fee. As long as a permit shall also
the annual fee is paid.
The Government may provide for fees.
Revocation of permits, etc.
section 29 If a supervisor becomes aware that any broken
with a provision that applies to activities that are under the
the Authority's supervision according to this law, it shall take
measures to win redress.
section 30 where a supervisory authority finds that a tissue establishment
does not comply with the requirements under this Act or the regulations
issued pursuant to the Act, the Agency may submit to the
the tissue establishment to remedy abuses.
The order may be subject to a penalty.
An injunction under the first subparagraph shall include information
If the measures the regulator believes should be taken to
the alleged irregularities to be remedied.
section 31 If a notice under section 30 is not complied with and if the
the abuses are serious, the supervisory authority may
withdraw the authorization to conduct a tissue establishment.
If there is probable cause that a condition will be
be revoked pursuant to the first subparagraph, such a decision cannot
seriously, the supervisory authority may decide on the withdrawal of
the State until further notice, pending the final decision.
Decision under the second subparagraph in a maximum of six months. If the
There are serious reasons, the period of validity may be extended
with no more than six months.
32 § if there is danger to human life or health,
the supervisory authority without prior order recall
the authorization to conduct a tissue establishment.
section 33 A regulatory authority becomes aware that the activity
carried out without authorization under section 9 shall notify the
The police authority or to the public prosecutor's Office if there are
suspicion of a crime. Law (2014:767).
34 § whoever knowingly engages in a tissue establishment without
permit referred to in section 9 shall be liable to a fine or imprisonment of up to one
year. In minor cases should not be tried for responsibility.
35 § human tissues or cells that have been the subject of
offence under this Act or the value thereof, and exchange of such
crimes shall be declared forfeited, unless it is clear
The first paragraph also applies to vessels or equipment where human
tissues or cells were stored.
36 § A decision under this Act may be appealed to the
General Administrative Court, if the decision concerns
1. authorization or withdrawal of authorization under 9, 31 or
section 32, or
2. notice under section 18 or 30.
Leave to appeal is required for an appeal to the administrative court.
37 section Decision as an authorisation or regulatory authority,
administrative law or Chamber right under this law Announces
effective immediately, unless otherwise specified in the decision.
38 § Government, or Government authority determines,
may announce additional regulations on tissue establishments and
management of human tissues and cells that are needed to
the protection of life or health.
1. this law shall enter into force on 1 July 2008.
2. A tissue establishment established before the law
entry into force, may continue to operate, if
Operations Manager by 1 december 2008 applies for
condition is stated in section 9. Activities, such
the application continue pending the licensing authority, or
1. this law shall enter into force on 1 June 2013.
2. for the purposes of the administrative judicial procedure Act, section 7 a
(1971:291), the Inspectorate for health care be the
individual counterparty, if the inspection after the entry into force is
jurisdiction to deal with the kind of question that is the subject of