Source: https://www.global-regulation.com/translation/denmark/609703/notice-of-authorization-to%252c-control-of-and-reporting-of-serious-adverse-reactions-and-serious-adverse-events-in-the-handling-of-human-tissues-and-ce.html
Timestamp: 2019-04-25 01:52:05+00:00

Document:
1) Processing: all activities connected with the processing, handling, preservation and packaging of tissues or cells intended for human beings.
2) Preservation means the use of chemical substances (agents), changes in the surrounding environment or the use of other means during processing to prevent or retard biological or physiological degradation of tissues and cells.
3) storage: storage of tissues and cells until distribution.
4) Distribution: transportation and delivery of tissues and cells in and between Denmark and another country within the European Union and the European economic area.
5) Import: transportation and delivery of tissues and cells to Denmark from a country outside the European Union and the European economic area (third country).
6) Exports: transportation and delivery of tissues and cells to a country outside the European Union and the European economic area (third country) from Denmark.
7) serious adverse reaction: an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or illness.
8) serious adverse event: any untoward occurrence associated with the procurement, testing, processing, preservation, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, or incapacitating conditions for patients or which might trigger or prolong, hospitalisation or morbidity;.
9) tissue establishment: a tissue bank or a unit of a hospital or other public or private entity, which carried out the testing, processing, preservation, storage or distribution or made the import or export of tissues and cells.
10) procurement organisation: hospital, health care institution, the tissue center or other public or private entity that is involved in the procurement of human tissues and cells.
11) Cells: individual human cells or a collection of human cells when not bound by any form of connective tissue the same.
12) Tissue: all constituent parts of the human body formed by cells.
2) the requirements set out in annex 2 to the Danish Medicines Agency's announcement about the quality and safety of the testing, processing, preservation, storage, distribution, import and export of human tissues and cells and which relate to the activities that the establishment carries out.
2) meet quality and safety standards equivalent to those laid down in the National Board of Health's Decree on quality and safety for the donation, procurement and testing (human tissues and cells) and in the Danish Medicines Agency's announcement about the quality and safety of the testing, processing, preservation, storage, distribution, import and export of human tissues and cells.
§ 4. The submission of an application or reapplication of the Danish Medicines Agency's permission after tissue § § 4 or 5 for the handling of tissues and cells shall be carried out in a special form, which can be downloaded from the website of the Danish Medicines Agency or please contact the Agency. The application must be provided with evidence that the tissue establishment complies with the requirements of sections 2 or 3.
§ 5. The procurement organisation, in connection with the application must give the Danish Medicines Agency notice of its geographical location, whether the responsible doctor's name and on what types of human tissues and cells that are procured.
(2). The notification must be made on a special form, which can be downloaded from the website of the Danish Medicines Agency or please contact the Agency.
(3). Changes in the information provided under paragraph 1 shall immediately be notified to the Danish Medicines Agency.
§ 6. The Danish Medicines Agency deals with an application or reapplication for a licence after tissue § § 4 or 5 within 90 days from the submission of a complete application.
§ 7. The Danish Medicines Agency may require a tissue establishment provides further information on the facts underlying the application, see. sections 2 and 3.
(2). If the Danish Medicines Agency has demanded further information provided pursuant to paragraph 1, the period laid down in paragraph 6 shall be suspended until that information has been provided by the Te.
§ 8. The Danish Medicines Agency issues first permission after tissue Act sections 4 and 5, after the Agency has verified that the tissue establishment complies with the requirements of sections 2 or 3.
§ 9. The Danish Medicines Agency stated in the permit, which activities the tissue establishment shall perform pursuant to the permit.
(2). The Danish Medicines Agency may attach specific conditions to the permit. The Danish Medicines Agency may further limit the authorization.
§ 10. The tissue establishment must continuously comply with the requirements, which are the basis for the Te permission, see. sections 2 and 3, as well as the individual conditions that may be attached to the permit in accordance with section 9, paragraph 2. A tissue establishment authorised to carry out the testing, processing, preservation, storage, distribution, import and/or export of tissues and cells, in addition to continuously meet the demands of the Danish Medicines Agency's announcement about the quality and safety of the testing, processing, preservation, storage and distribution as well as import and export of human tissues and cells, which relates to the activities that the establishment carries out.
§ 11. Tissue establishment shall not undertake any substantial changes in the activities of the tissue establishment authorised to carry out, without first having obtained the written approval of the Danish Medicines Agency.
§ 12. The Danish Medicines Agency checks by regular inspections and other control measures of tissue establishments and tissue procurement organisations fulfilling the conditions laid down in the law and the rules laid down in accordance with the Danish tissue Act. The interval between two inspections shall not exceed two years.
(2). In addition to the inspections referred to in paragraph 1 shall carry out the Danish Medicines Agency inspections and carry out control measures as appropriate, if there occurs a serious adverse reaction or serious adverse event. The Danish Medicines Agency also carries out such inspections and control measures, if put forward a reasoned request from the competent authority or authorities in a country within the European Union and the European economic area.
(3). After every inspection shall draw up a report on the Danish Medicines Agency whether the tissue establishment or procurement organisation complies with the requirements of the Danish tissue Act and in regulations issued pursuant to the Danish tissue Act. The content of such reports shall be communicated to it of the inspection concerned procurement organisation or tissue establishment.
§ 13. The Danish Medicines Agency disclose upon request from the European Commission or by the competent authority or authorities in a country within the European Union or the European economic area, information on the results of inspections and control measures referred to in article 12, paragraphs 1 and 2.
§ 14. Health-care professionals, using tissues and cells as part of patient care or in connection with clinical trials on humans, must immediately report any serious side effects to the Te that may be connected with safety of tissues and cells, and which are observed in the recipient associated with it.
(2). The tissue establishment shall immediately report the on the basis of paragraph 1 received reports to the Danish Medicines Agency.
(3). The Te reported in accordance with paragraph 2 shall take place on a special table with the content that has been reprinted as annex 2, part A and B to this order. The form can be downloaded from the Danish Medicines Agency's website or by contacting the Danish Medicines Agency.
§ 15. Recipients of tissues and cells and their relatives to the Danish Medicines Agency can report information about serious adverse reactions occurred during or after the clinical use of tissues and cells.
(2). Notification must be made on a special form, which can be downloaded from the Danish Medicines Agency's nedsted or by contacting the Danish Medicines Agency.
§ 16. Procurement organisation shall immediately report any serious side effects to the Te in the donor and serious adverse events, which may have an impact on the quality and safety of tissues and cells and which occurred in connection with the procurement of tissues and cells.
(2). The tissue establishment shall immediately disclose it pursuant to paragraph 1 received reporting to the Danish Medicines Agency.
(3). The Te reports in accordance with paragraph 2 shall be carried out in special schemas with the content that has been reprinted as annex 2, sections A and B, and annex 3, part A and B to this order. Forms can be downloaded on the website of the Danish Medicines Agency or by contacting the Danish Medicines Agency.
§ 17. The tissue establishment shall immediately report to the Danish Medicines Agency serious adverse events associated with the testing, processing, preservation, storage, distribution, import or export of tissues and cells.
(2). The Te reported in accordance with paragraph 1 shall be carried out in a special table with the content that has been reprinted as annex 3, part A and B to this order. The form can be downloaded from the Danish Medicines Agency's website or by contacting the Danish Medicines Agency.
§ 18. The Danish Medicines Agency disclose immediately after receipt of reports of serious adverse reactions and serious adverse events information, when it is relevant to safety, to the other competent authorities of the countries concerned.
1) Processing of application for authorisation in accordance with § § 4 and 5 tissue to deal with tissues and cells at one geographic location.
2) continuous control business pursuant to § 14 tissue, paragraphs 1 and 2.
(2). Fee rates for the services, as referred to in paragraph 1 are listed in annex 1 to this notice.
(3). The Danish Medicines Agency may in exceptional cases be wholly or partly exempt from payment of the fee.
(4). Regardless of when in the year a permission to perform testing, processing, preservation, storage, distribution, import or export of tissues and cells ceases to be paid full fee for that year.
(5). A tissue establishment which at the end of the startup is in possession of a permit after tissue Act §§ 4 and 5, pay the full annual fee for the year in question.
(6). Authorisation shall be issued in accordance with sections 2, 3 and 4 in the year's first nine months, paid full fee exemption for the current year. Authorisation shall be issued in the year 3 last months, paid the annual fee first year after.
§ 20. The Danish Medicines Agency notifies the procedure for payment of fees.
(2). Fees for the services, as referred to in section 19, paragraph 1, shall be paid to the Danish Medicines Agency within one month of the order.
§ 21. Unless a higher penalty is inflicted for other legislation, is punishable by a fine anyone who violates section 5 (1) or (3) or section 11.
§ 22. The notice shall enter into force on the 1. January 2009.
(2). Executive Order No. 289 of 26. March 2007 for permission to, control and reporting of serious adverse reactions and serious adverse events in the handling of human tissue and cells shall be repealed.
Tissue establishments alone performs the insemination and in this connection only performs processing ' swim-up ' method.
Official notes 1) Ordinance contains provisions implementing parts of the European Parliament and of the Council Directive 2004/23/EC of 31. Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (the official journal of the European Union 2004, nr. L 102, p. 48), parts of Commission Directive 2006/17/EC of 8. February 2006 on the implementation of European Parliament and Council Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (the official journal of the European Union, no. L 38, p. 40) and parts of Commission Directive 2006/86/EC of 24. October 2006 on the implementation of European Parliament and Council Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (the official journal of the European Union 2006, nr. L 294, p. 32).

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