Regulation (2008:414) On Standards Of Quality And Safety For Human Tissues And Cells

Original Language Title: Förordning (2008:414) om kvalitets- och säkerhetsnormer vid hantering av mänskliga vävnader och celler

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2008:414

Introductory provision



paragraph 1 of this regulation are given supplementary regulations to the

Act (2008:286) on quality and safety standards for

management of human tissues and cells. The expression and

terms used in the Act have the same meaning in this

Regulation.



Licensing and supervision



section 2 of the health and social care Inspectorate examines issues of

permission to carry out activities at the tissue establishment

relating to the management of human tissues or cells intended for

use on humans. The inspection also decides on the

conditions in the individual case shall apply to such

activity.



Health and social care Inspectorate supervises

activities referred to in the first subparagraph.



Inspectorate for health and social care, at the request of the European

the Commission or a competent authority in another

Member State may submit information to the Commission or the

requesting authority of the results of the inspections referred to

in the second paragraph. Regulation (2013:189).



section 3 of the FDA decides whether permission to conduct

activities at a tissue establishment relating to the management of

human tissues or cells intended for the manufacture of

medicinal products for human use.

The MPA also decides on the conditions in the

individual case shall apply to such activities.



The FDA oversees activities set out in

the first paragraph.



Agency shall, at the request of the European Commission

or a competent authority in another Member State

information to the Commission or the requesting authority

If the results of the inspections referred to in the second subparagraph.

Regulation (2013:189).



section 4 of the application for a licence to operate a

tissue establishment under section 9 Act (2008:286) on quality

and safety standards when handling human tissues and

cells shall include information on



1. Te name and address,



2. the purpose of the tissue establishment;



3. the activities or the activities

the tissue establishment shall include,



4. the extent to which activities at the tissue establishment

referred to get,



5. the name of the program under section 13 of the Act shall be responsible for

operations (Operations Manager), and his address, and



6. the name or the names of the executives who

referred to be instructed to perform some management tasks.



The application must be made before the activity at the tissue establishment

begins. If any circumstance covered by a previous

application is amended, shall immediately be notified to the supervisory authority

for health and long-term care and the medical products agency. Inspection

for health and social care, and national agency shall, if necessary,

interact with each other. Regulation (2013:189).



§ 5 Inspection for health and long-term care and the medical products agency,

interact with each other on the supervision referred to in paragraphs 15 to 18

Act (2008:286) on quality and safety standards for

management of human tissues and cells pipe inspection and

inspection of tissue establishments, as well as for questions about the rectification,

withdrawal of authorisation and notification of the offence under

29 to 33 of the same Act. Regulation (2013:189).



Import and export



section 6 of the exemption from the requirement of paragraph 14, first subparagraph, the law

(2008:286) on quality and safety standards for the handling of

human tissues and cells must be notified only if

sufficient safety and quality standards may be considered

met.



The National Board of health shall notify the details of the exception

from licensing in 14 of the law on

quality and safety standards for the handling of human

tissues and cells in relation to the activities referred to in

2 §.



Agency may announce details relating to exceptions

from licensing in 14 of the law on

quality and safety standards for the handling of human

tissues and cells in relation to the activities referred to in

section 3. Regulation (2013:189).



Register



section 7 of the Inspectorate for health care may provide closer

rules about what information the records referred to in

section 21 of the Act (2008:286) on quality and safety standards for

management of human tissues and cells should contain in the

regarding the activities referred to in paragraph 2.



Agency may announce details relating to the

tasks such records referred to in section 21 of the law on

quality and safety standards for the handling of human

tissues and cells shall include, in respect of those activities

referred to in paragraph 3. Regulation (2013:189).



§ 8 Inspection for health and long-term care may provide

If the data in the register provided for in section 21 of the Act

(2008:286) on quality and safety standards for the handling of

human tissues and cells should be preserved for longer than

that said, in respect of the activities referred to in paragraph 2.



Agency may provide that the information

in the register provided for in section 21 of the law on the quality and

safety standards when handling human tissues and

cells shall be kept for longer than is being said where in question

If the operations referred to in paragraph 3. Regulation (2013:189).



§ 9 Inspectorate for health and social care register pursuant to section 23 of the

Act (2008:286) on quality and safety standards for

management of human tissues and cells should contain

data on



1. Te name and address,



2. Director's name and address,



3. the purpose of the business and its scope, and



4. the activities or the activities

the tissue establishment shall include. Regulation (2013:189).



section 10 of the MPA, to the Inspectorate for health and

care shall provide the information necessary to

the inspection should be able to bring its register pursuant to section 23 of the Act

(2008:286) on quality and safety standards for the handling of

human tissues and cells.



The FDA and the National Board of health shall have direct access

to the Inspectorate for health and social care register.

Regulation (2013:189).



Fees



section 11 of the applicant for a permit to conduct a

tissue establishment under section 9 Act (2008:286) on quality

and safety standards when handling human tissues and

cells should pay the application fee of $200. Annual fee

for such a condition is imposed by the licensing authority with

18 000 SEK.



Inspectorate for health care may provide additional

regulations on charges not related to the fees in

regarding the activities referred to in paragraph 2.



Agency may announce further provisions concerning

charges not related to the fees in respect of such

activities referred to in paragraph 3. Regulation (2013:189).



Additional regulations



section 12 of the National Board may announce further provisions concerning

tissue establishments and the handling of human tissues and

cells that are necessary for the protection of life and health

the activities referred to in paragraph 2.



Agency may announce further provisions concerning

tissue establishments and the handling of human tissues and

cells that are necessary for the protection of life and health of such

activities referred to in paragraph 3. Regulation (2013:189).



paragraph 13 of the Inspectorate for health care may provide additional

regulations for the application procedure under article 9 of the law

(2008:286) on standards of quality and safety of human

tissues and cells, and rules relating to notification procedure

under paragraph 4, second subparagraph this regulation, in the case of such

activities referred to in paragraph 2.



Agency may announce further provisions concerning

the application procedure under article 9 of the law on the quality and

safety of human tissues and cells and

rules on the notification procedure provided for in paragraph 4 of the second

subparagraph this regulation, in respect of such activities as

referred to in paragraph 3. Regulation (2013:189).