Law (2008:286) On Standards Of Quality And Safety For Human Tissues And Cells

Original Language Title: Lag (2008:286) om kvalitets- och säkerhetsnormer vid hantering av mänskliga vävnader och celler

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2008:286

General provisions



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.



Definitions



section 2 of this Act, the following definitions shall apply the following

importance.



"Serious adverse event" Event in conjunction with the

procurement, testing,

processing, storage and

distribution of tissues and

cells that can



1. lead to the transmission of a

contagious disease or to

death,



2. be life-threatening, be

Disabling or cause

significant disabilities

for the patient, or



3. cause or extend

illness or the need

hospital care.



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

develop physiological

features with a significant

degree of autonomy.

Organization for

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

tissue establishment.



Organisation responsible for

human a health care establishment, a Department

in a hospital or other

establishment which uses

human tissues and cells

in humans.



Tissue all constituent parts of the

the human body consists of

cells.



Tissue establishment Establishment where physical or

legal entity engaged in

activities involving

testing, processing,

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

include procurement,

the import or export of

human tissues or

cells.

Law (2008:1060).



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.

Law (2008:1060).



section 4 of the Act is not applicable to research involving human

tissues and cells used for purposes other than for the use

on people.



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

is applicable.



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

(1992:859).



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

the business.



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.



Supervision, etc.



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

the inspection.



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)

used, or



2. There are serious reasons.

Law (2014:767).



Notification of serious adverse reactions and serious adverse

events



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

confirmed



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).



Register



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

treatment.



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

there.



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

State.



The registry may also be used for surveillance, research and

stats.



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.



Professional secrecy



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).

Law (2010:676).



Fees



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).



Liability, etc.



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

unfair.



The first paragraph also applies to vessels or equipment where human

tissues or cells were stored.



Appeal, etc.



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.

Law (2009:855).



Additional authorization



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.



Transitional provisions



2008:286



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

Court orders.



2012:953



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

trial.