Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
This law provides for the donation and testing of human blood and its parts, but not for blood and blood samples collected for scientific research. The law also provides for the processing, storage and distribution of blood and parts of blood intended for transfusion.
This law shall not apply to blood stem cells.
For the purposes of this law:
(1) By blood service activities The donation, testing, processing, storage, transport and distribution of blood and parts thereof;
(2) At the blood establishment A unit that collects and investigates human blood and its parts, processes, stores and distributes blood and parts thereof; and
(3) The blood centre The part of the healthcare unit that stores and distributes, and may continue to process blood and its components, and carry out suitable examinations for blood transfusion activities under the direction of the health care unit.
The donation of blood and parts shall be voluntary. Donor allowance shall not be given to the donor or any other comparable benefit.
Notwithstanding paragraph 1, travel expenses arising from donation may be reimbursed to the donor. In the case of donation, low-value catering and small gift items may also be provided.
The blood establishment shall be authorised by the Agency for the Safety and Development of Medicinal Products. The authorisation may attach conditions to the extent of the blood service activity. The blood establishment shall notify the Agency of the relevant changes to the Medical and Development Centre.
The Centre for the Safety and Development of Medicinal Products shall grant authorisation for a written application to the municipality, the municipality, association or any other entity entrusted with the fulfilment of the conditions laid down in this Law Quality and safety requirements for blood service activities. The application for authorisation shall include information on the personnel, premises, equipment and equipment of the establishment, and information on procedures relating to the donation, testing, processing, storage, transport, distribution and blood safety of the blood and its parts.
The Centre shall make a declaration of its activities and its essential changes to the Centre for Security and Development in the pharmaceutical sector.
The Regulation of the Ministry of Social Affairs and Health may provide for an application for authorisation of a blood establishment, notification of the operation of the blood centre, and the information required in the licence application and notification.
The blood establishment shall have a responsible person responsible for applying for the authorisation referred to in Article 4 and in Articles 6 to 17 on the implementation of the obligations imposed on the blood establishment.
The responsible person of the blood establishment shall meet the requirements of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001 /83/EU The qualifications required under Article 9 of Directive 2002/98/EC of the Parliament and of the Council.
The blood establishment shall inform the Centre for Security and Development of the Medical and Development Centre referred to in paragraph 1 and of his/her replacement. (16/10/2009)
The personnel of the blood establishment and the blood centre shall have appropriate qualifications and regular training for the staff.
The blood establishment and the blood centre shall include a documentation system, personnel and premises, as well as a quality system for blood donation. The Agency for Safety and Development in the pharmaceutical sector may provide more detailed provisions on the content and implementation of the quality system.
The blood establishment and the blood centre shall have a documentation system covering the instructions for the operation, the forms and documents in use and any other information necessary for the operation and its control.
The blood establishment and the health care unit shall have a system whereby all collected, examined, processed, preserved or fractions of blood and parts of blood can be traced from the donor to the recipient and vice versa. Details of the traceability data may be provided by a decree of the Ministry of Social Affairs and Health.
The blood establishment shall have the right, in particular circumstances, to obtain the information necessary to trace the donor in an individual case.
The blood establishment and the health care unit shall keep a list of all adverse events and reactions related to the blood or parts of the blood or parts thereof.
The blood establishment shall inform the Agency without delay of any serious adverse events related to the quality and safety of the blood or parts of the blood or parts thereof, as well as the blood or parts thereof. Any adverse effects observed during or after a transfusion due to a transfusion. (16/10/2009)
The health care unit shall report the events referred to in paragraph 2 to the blood establishment, which shall immediately transmit that information to the Agency for the Safety and Development of the Medicinal Products. (16/10/2009)
In addition, the health care unit may report any other adverse event related to blood or parts of blood or blood transfusions and adverse reactions to the blood establishment.
Blood and parts thereof referred to in paragraphs 2 or 3 shall not be used and such blood and part of it shall be removed from distribution. Such blood and part thereof may be introduced if, on the basis of a separate report, it can be demonstrated that it complies with the quality requirements of this law.
The Regulation of the Ministry of Social Affairs and Health may lay down provisions on the procedure for notification of adverse events and reactions and on the form to be used in the notification.
The donor of the blood and its part shall, prior to donation, provide the necessary information relating to the donation and the (523/1999) Shall be kept informed of the confidentiality of the data. The donor shall be required to provide information on his individual, in the assessment of his/her medical condition and of the necessary information on the transferability of the donor, as well as the donor's or his or her hand-hand signature. Of the Law on electronic identification and electronic signatures (19/2009) An advanced electronic signature. The Agency for the Safety and Development of Medicinal Products may provide more detailed information on the information to be given to donors and their request.
The validity of the blood or part of the blood shall be subject to the condition that the donor's disease, medication or the risk of illness does not endanger the health of the donor or the safety of the donated blood or part thereof. Before blood donation, the healthcare professional of the blood establishment must determine that there is no impediment to the donation.
The Centre for the Safety and Development of Medicinal Products may provide more detailed provisions on the clearance of the donation and on the grounds on which blood cannot be released on a permanent or temporary basis. (16/10/2009)
The doctor of the blood establishment may, for a specific reason, derogate from the conditions of release. The blood establishment must record these cases.
The blood establishment shall examine each donation of blood or part of the blood to ensure safety. The Centre for the Safety and Development of Medicine may provide more detailed provisions for the studies required and for their satisfactory results.
The blood establishment must record the blood donor's name, the identity number and the necessary contact details for the purpose of tracing the blood donor and his consent for blood donation. In addition, the records of the donor required for the donation of blood and the results of blood tests shall be recorded in the register.
A person who has not been accepted as a donor may be entered in the register with the name, identification number, contact details and the general grounds for the waiver. This information shall be deleted immediately after the processing of such data is no longer justified.
The records of the registries and other donors of blood services, as well as the documents, are kept secret.
In addition, the collection, use and storage of data in the register shall be taken into account, where appropriate, in the archive (181/1994) And the Personal Data Act.
The blood establishment, the blood centre and the health care unit shall retain the data relating to traceability under Article 9 for 30 years. The blood establishment shall keep the information referred to in Articles 11 (1) and 11 (1) and Articles 12 to 14 for 15 years.
The Agency for Safety and Development in the pharmaceutical sector may provide more detailed provisions on the retention of the information referred to in Article 11. (16/10/2009)
The preservation of documents is provided for in the Archives Act.
The blood establishment and the blood centre shall ensure that the conditions of storage, transport and distribution of blood and parts thereof are appropriate. The Agency for Safety and Development in the pharmaceutical sector may provide more detailed provisions on the storage conditions and the storage period, as well as transport and distribution conditions.
The blood establishment shall ensure that the quality and safety of the blood and its components are appropriate. The Agency for Safety and Development in the pharmaceutical sector may provide more detailed provisions on quality and safety requirements.
The control and supervision of blood service activities, under the Ministry of Social Affairs and Health, belongs to the Agency for Safety and Development in the pharmaceutical sector. (16/10/2009)
The Decree of the Ministry of Social Affairs and Health lays down provisions on the fees to be charged, taking into account the provisions of the State Payment Act (150/1992) Or is provided for or prescribed.
The control and supervision of the Centre is in force, as is the case in the Public Health Act. (186/1972) , special care law, (18/02/1989) , the Law on Private Health (152/1990) And the Law on the health professionals (559/1994) Provides.
The Agency should check the blood establishment at regular intervals, but at least every two years. (16/10/2009)
In addition, the Centre for the Safety and Development of Medicine may, where appropriate, check the blood establishment where it is found to have a serious or serious adverse reaction to the quality and safety of blood or parts of the blood or parts thereof, or if suspected, That something like that happened. (16/10/2009)
The inspector shall be admitted to all premises of the blood establishment. The inspection shall contain, notwithstanding the confidentiality provisions, all documents requested by the inspector necessary for the purpose of carrying out the inspection. The inspector shall be given, free of charge, copies of the documents necessary for the examination of the inspection and samples of the substances and preparations in the office for further examination. For specific reasons, the inspector shall be entitled, notwithstanding the provisions of confidentiality, to obtain the information contained in the blood donation register mentioned in Article 14. The inspector also has the right to take photographs during the inspection.
The inspection shall be maintained. In particular, the examination of the matters to be taken into account, the precise content of the verification procedure and the Protocol, its retention period and its notification may be laid down by a regulation of the Ministry of Social Affairs and Health.
The inspector may lay down provisions to remedy any identified deficiencies. As a result of a provision which may have been issued, it is necessary to take the necessary measures without delay.
The Centre for Security and Development in the pharmaceutical sector may suspend or revoke the authorisation of a blood establishment or place a threat to the fine as in the (1113/1990) Shall be provided if:
(1) the conditions for authorisation are no longer met;
(2) the blood establishment has substantially acted in breach of the terms of this law or authorisation or otherwise seriously jeopardises the safety of the blood or its parts; or
3) No action has been taken under the provisions of Article 20.
The blood establishment may import blood or parts thereof from a Member State of the European Union in accordance with the terms of this law and the authorisation of the blood establishment.
The import of blood or parts from third countries into Finland requires the authorisation of the Agency for Security and Development in the pharmaceutical sector. The authorisation may be granted to a blood establishment if it shows that the batch of the product, blood or parts of it meets the quality, safety and traceability requirements laid down in this law. (16/10/2009)
The decision referred to in Article 4 and Article 22 (2) of this Law and the order referred to in Article 20 may require an adjustment from the Agency for the Safety and Development of Medicinal Products, in the same way as in the administrative law (2003) Provides. The requirement of correction within the meaning of Article 20 of this Act shall be made within 30 days of the end of the inspection. Measures shall be taken in the light of an appeal.
The decision taken under this law and the decision on the request for review may be appealed against by the administrative court, as in the case of administrative law (18/06/1996) Provides.
In the case of withdrawal of authorisation, the decision on the withdrawal of authorisation shall be subject to appeal as laid down by the Law on Administrative Law. An appeal against any other decision of the administrative court may be lodged only if the Supreme Administrative Court grants an appeal.
L to 104/2015 Article 23 shall enter into force on 1 January 2016. The previous wording reads:
The order referred to in Article 20 of this Law shall not be challenged. The dissatisfaction of the order shall be the right to make a request to the Medical and Development Centre for the correction of the decision. The order shall be accompanied by instructions to refer it to the Agency for Safety and Development in the pharmaceutical sector. Despite the need for a correction, measures must be taken in accordance with the provisions. (16/10/2009)
The objection referred to in paragraph 1 shall be filed in writing within 30 days of the end of the inspection and shall indicate:
(1) the name of the complainant;
(2) an order for which an adjustment is sought;
(3) to what extent an adjustment is sought and an adjustment required for it; and
4) the grounds for the appeal.
The adjustment requirement shall be signed by the author or by the author.
The request for adjustment shall be accompanied by evidence to which the complainant wishes to rely and which have not been submitted earlier.
§ 24 has been repealed by L 7.8.2015/1044 , which enters into force on 1 January 2016. The previous wording reads:
In the light of Articles 4 and 21 to 23 of the Agency for Safety and Development in the pharmaceutical sector, an appeal is sought in the form of a change in the administrative law (18/06/1996) Provides.
This Act shall enter into force on 1 November 2005.
This law repeals the Law of 4 November 1994 on blood services (18/04/1994) .
Before the law enters into force, action can be taken to enforce the law.
By 31 May 2005, the Finnish Red Cross shall inform the Medical Service that its blood service activities are in conformity with this law and the provisions of the Ministry of Social Affairs and Health respectively and the provisions of the Medical Service. By 31 October 2005, the medicinal product shall be subject to authorisation.
THEY 251/2004 , StVM 3/2005, EV 11/2005This Act shall enter into force on 1 September 2009.
THEY 36/2009 , LiVM 12/2009, EV 90/2009
This Act shall enter into force on 1 November 2009.
Before the law enters into force, measures may be taken to implement the law.
THEY 166/2009 , StVM 28/2009, EV 122/2009
This Act shall enter into force on 1 January 2016.
In the case of appeals before the entry into force of this Act, the provisions in force at the time of entry into force of this Act shall apply.
THEY 230/2014 , LaVM 26/2014, EV 319/2014
