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).