Key Benefits:
See the copyright notice Conditions of use .
According to the decision of the Ministry of Social Affairs and Health, the Law of 2 February 2001 on the medical use of human organs, tissues and cells (101/2001) , as amended by Law 547/2007:
This Regulation lays down:
1. On the medical use of human organs, tissues and cells (101/2001, hereafter referred to as Tissue law ) The labelling of the tissue establishment register referred to in Article 20i (5);
(2) the essential changes to the operation which require a modification of the authorisation granted by the Agency for the Safety and Development of the Pharmaceutics;
(3) information which, according to Article 20s (3) of the tissue law on all organ donors and organs, must at least be available;
(4) the traceability of organs, tissues and cells;
(5) the forms used for the reporting and reporting of serious adverse events and incidents;
(6) exceptional situations where the pharmaceutical safety and development centre may authorise the import or export of certain tissues or cells;
(7) Checks carried out by the Agency for the safety and development of the pharmaceutical sector, in particular on the matters to be taken into account, on the precise content of the inspection procedure and on the Protocol, its storage period and its notification.
For the purposes of this Regulation:
(1) Procurement organisation A healthcare facility, a hospital unit or any other facility that carries out the procurement of human tissues and cells to a tissue establishment and which has not been granted the authorisation of the Agency for the Safety and Development of Medicare;
(2) An organisation responsible for use The health care unit or any other entity in which the use of human tissues and cells in humans takes place;
(3) Member State of origin The Member State of the European Union in which the body is recovered for transplantation;
(4) Member State of destination The Member State of the European Union to which the body is imported or exported for transplantation;
(5) Body specification, The anatomical description of the body, where appropriate its location on the left or right body, and whether it is a whole body or part of the body and which body or body of the body is involved;
(6) Authorised body Body entrusted with delegated tasks in accordance with Article 17 (1) of Directive 2010 /53/EU of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation A transplant organisation which has been delegated in accordance with Article 21 of that Directive.
The tissue establishment register held by the Centre for the Safety and Development of Medicine shall include the identification and contact details of the tissue establishment, the contact details of the persons responsible and their alternates, as well as the branch of the tissue establishment.
The essential changes to the activities referred to in Article 20b of the Tudoslaw, which must be notified to the Centre for the Safety and Development of the Medical Service, are changes in the activity or location of the tissue establishment, the change of responsibilities and the operation of Closure. Where the notified amendment requires a change of authorisation, the tissue establishment shall submit an application for this to the Medical and Development Centre.
If the body is brought to Finland or exported from Finland to a Member State of the European Union or to a State belonging to the European Economic Area, information transmitted between States:
(1) shall be provided in writing, either by electronic means or by fax;
(2) be written in a language which is understood by both the sender and the recipient, or, failing that, in a language agreed between them, or, if not, in English;
(3) provide without undue delay;
4) shall be recorded and made available upon request.
The information referred to in paragraph 1 shall also include:
(1) the date and time of delivery;
(2) the contact details of the person responsible for the transmission;
3) the following reminder: " Includes personal data. Protect from unauthorised disclosure and access."
In urgent cases, the information may be exchanged orally. After oral contact, the information shall be provided in writing. Reception of the data submitted shall be confirmed to the sender.
The transplantation centre shall always be available for urgent situations and receive and transfer the information provided for in this Regulation without undue delay.
All organ donors and organs shall contain the information set out in Annex 4.
When designing a body to be exported from Finland, the transplant centre shall provide a description of the organ and donor characteristics before the body is exported to the competent authorities of the Member States of destination or to the authorised bodies.
Where information on the description of the organ or donor characterisation is not available, when the information referred to in paragraph 1 is provided, but shall be made available later, it shall be provided as soon as possible in accordance with Possible.
Where the body is exported from Finland to a Member State of the European Union or to a State belonging to the European Economic Area, the transplant centre shall inform the competent authority or authority of the Member State of destination of the following information:
1) the specification of the body;
2) the national donor identification number;
3) the date of recovery;
4) the name and contact details of the donor hospital.
Where a body is imported from a Member State of the European Union or a State belonging to the European Economic Area, the transplant centre shall inform the competent authority or the authorised body of the Member State of origin of the following information:
(1) the national consignee identification number, or, if the body has not been used for transplantation, its final use;
(2) where applicable, the date of transplantation;
3) Name and contact details of the transplantation centre.
The tissue establishment shall have the following information to ensure the traceability of tissues and cells:
(1) identification of the donor;
(2) identification of the donation, containing at least the identification of the tissue establishment or the procurement organisation, the unique identification number of the donation, the date of purchase, the purchase date and the type of delivery;
(3) the identity of the product containing at least the identification of the tissue establishment, the tissue and cell or the type of the product, the type number (if several items are assembled), the number (if divided into sublots), the expiry date, The status of tissue or cell status, the description and origin of the products, including the treatment steps taken and the materials and additives coming into contact with tissues and cells, which affect their quality and/or safety, and Identification of the body responsible for the final labelling; and
(4) identification of human use, containing at least the date of distribution and destruction and the identity of the end-user.
The information referred to in paragraph 1 shall be obtained and maintained for the importation of tissues or cells from third countries.
In order to ensure the traceability of tissues and cells, the following information shall be available to ensure the traceability of tissues and cells:
(1) identification of the body which supplied the tissue or cells;
(2) identification of the end-user or installation;
3) the type of tissues and cells;
(4) identification of the product;
(5) identification of the recipient; and
6) Date of use.
The transplantation centre shall immediately report any serious incident or adverse reaction that it has suspected of being associated with another Member State of the European Union or a body which is a member of the European Economic Area, or The donor who has been sent to other Member States of the European Union or to countries belonging to the European Economic Area, to the competent authority of the Member State of origin or the Member State of destination or to the authorised body. In addition, it shall provide, without undue delay, the original report containing the information set out in Annex 5 if this information is available.
If additional information becomes available following the submission of the original report, they shall be provided without undue delay.
As regards the body exported from Finland, the Agency shall, within three months of the date of the initial report submitted in accordance with paragraphs 1 and 2, submit to the competent authorities of all the Member States: Or authorised entities, a joint final report containing the information set out in Annex 6.
The final report shall be drawn up following the collection of the necessary information from all relevant Member States of the European Union and the countries belonging to the European Economic Area. For the body imported into Finland, the Centre and the Agency for Safety and Development in the pharmaceutical sector shall provide the relevant information within a reasonable period of time to the competent authority of the Member State of origin or to the authorised body.
The tissue establishment shall assess serious adverse events or serious adverse events affecting the quality and safety of tissues and cells, as well as planning and implementing appropriate corrective measures.
The tissue establishment shall ensure that the procurement organisation and the relevant organisation have procedures in order to preserve the data and to inform the tissue establishment without delay of any serious adverse reactions or Incidents that may affect the quality and safety of tissues and cells.
The tissue establishment shall inform the Agency of the safety and development centre in accordance with Annexes 1 and 2 without delay of its activities:
(1) serious adverse reactions which may be due to the quality of the tissues or cells; and
(2) serious adverse events which may affect the quality and safety of tissues or cells.
The tissue establishment shall submit a yearly summary of serious adverse events and incidents to the Agency by 30 March of the following year by means of a form in accordance with Annex 3.
The notification requirement referred to in paragraph 1 shall also apply to serious adverse events and incidents related to tissues and cells exported to Finland from third countries and exported from Finland to third countries.
The formulae for the notification of serious adverse reactions and serious adverse events shall be aligned with the Annexes to this Regulation (Annexes 1 to 3).
The retrospective weightings in the form of the formula shall be permitted.
The Ministry's confirmation clause can only be attached to a formula using an electronic or other form designed for an electronic or other form of the formula.
In accordance with Article 23 (a) of the Tudoslaw, a situation in which the Centre for the Safety and Development of the Medicinal Products may grant an authorisation shall mean a situation in which:
(1) as an importer or country exporter of tissues or cells, the other health care unit is the tissue establishment;
(2) tissue establishments bring tissues or cells which do not comply with the quality, safety and traceability requirements laid down in the law.
The application for derogation referred to in paragraph 1 (1) shall be accompanied by a medical examination by the doctor responsible for the care of the patient for the specific therapeutic reasons for which authorisation is sought and an explanation of how the tissues and The quality and safety of cells is ensured.
The Agency for the Safety and Development of the Medicinal Products may grant the authorisation referred to in paragraph 1 (2) on a temporary basis. The tissue establishment shall include in its application for derogation the risk assessment of the person responsible for the import of tissues and cells.
In the context of the checks referred to in Article 20j of the tissue law, the Agency shall draw attention to the fact that: (22.10.2009)
(1) the donation, procurement, testing, processing, preservation, preservation, distribution and distribution of tissues and cells correspond to authorisations granted on the basis of tissue law and acts adopted pursuant to it, and that the tissue establishment meets the requirements of: The authorisation has been granted;
(2) the staff of the tissue establishment have adequate training and familiarisation with their duties and staff are adequate to the extent of the activity;
(3) the facilities of the tissue establishment are suitable for operation;
(4) the tissue establishment is equipped with appropriate equipment, equipment and materials;
(5) the documentation conforming to the required quality system has been properly prepared;
(6) the registry of the tissue establishment has been drawn up and maintained;
(7) the traceability of tissues and cells is carried out in accordance with the provisions and regulations; and
(8) The procedures for the treatment of adverse events and incidents have been instructed and the events are duly recorded.
The Agency shall prepare a protocol for the inspection, which shall be submitted to the responsible person of the tissue establishment within 30 days. (22.10.2009)
The copy of the protocol on the inspection shall be kept for 10 years from the inspection.
The inspection shall be deemed to have been completed once the copy of the inspection protocol has been served on the tissue establishment concerned and any deficiencies identified during the inspection have been corrected.
This Regulation shall enter into force on 28 December 2007. Before the entry into force of the regulation, measures may be adopted for the implementation of the Regulation.
Annex 4 (27/04/2013)
Description of body and donor characteristics
All organ donors and organs shall have the following information:
1) Surrender hospital where recovery takes place, and other general information
2) Type of donor
3) Blood type
4) Gender
5) Cause of death
6) Date of death
7) Date of birth or estimated age
8) Weight
9) Length
(10) Current or earlier use of narcotic drugs
11) Current or previous malignant neoplasms
(12) Current other diseases that may be transmitted
13) HIV, HCV, HBV tests
14) Basic information necessary for the evaluation of the activities of the donated organ.
Annex 5 (27/04/2013)
Original report on suspected serious adverse events or reactions
1) Reporting Member State
2) Identification number of the report: country (ISO) /national number
(3) Contact details of the reporting entity (competent authority or delegated authority of the reporting Member State): telephone, e-mail and fax, if any
4) Reporting centre/organisation
5) Contact details of the coordinator/contact person (organ transplant centre/donor hospital in the reporting Member State): telephone, e-mail and fax, if any.
6) Date and time of report (yyyy/mm/dd/mm/mm)
(7) Member State of origin
(8) National donor identification number, as notified under Article 4d
9) All Member States of destination (if known)
(10) National examiners' identification numbers, as notified under Article 4d
(11) Date and time of serious adverse event or adverse reaction (yyyy/mm/pp/mm)
12) Date and time of serious adverse event or adverse reaction (yyyy/mm/pp/tt/mm)
(13) Description of serious adverse event or adverse reaction
14) Immediate measures taken/proposed
Annex 6 (27/04/2013)
Final report of serious adverse events or reactions
1) Reporting Member State
2) Identification number of the report: country (ISO) /national number
3) Contact details of the reporting entity: telephone, e-mail and fax, if any
4) Date and time of report (yyyy/mm/dd/mm/mm)
5) Identification number (s) of the original report (s) (Annex 4)
6) Description of the case
7) Member States relating to the case
8) Results of the investigation and final conclusions
(9) Preventive and corrective actions implemented
(10) Conclusions/Follow-up if necessary
This Regulation shall enter into force on 1 November 2009.
Before the entry into force of the regulation, measures may be taken to implement the Regulation.
This Regulation shall enter into force on 10 April 2014.
