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Notice Of Authorization To, Control Of And Reporting Of Serious Adverse Reactions And Serious Adverse Events In The Handling Of Human Tissues And Cells

Original Language Title: Bekendtgørelse om tilladelse til, kontrol med samt indberetning af alvorlige bivirkninger og alvorlige uønskede hændelser ved håndtering af humane væv og celler

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Table of Contents
Chapter 1 Definitions
Chapter 2 Conditions for obtaining authorization to handle tissues and cells
Chapter 3 The dispatches of the tagging
Chapter 4 Treatment of applications for the handling of tissues and cells from the medical management board
Chapter 5 Conditions governing possession of the authorization to handle human tissues and cells
Chapter 6 The control company of the medicinal mean management
Chapter 7 Notification of serious adverse reactions and serious adverse events
Chapter 8 Fees
Chapter 9 Punishment and entry into force
Appendix 1 Fees for the approval and control of tissue establishments, cf. § 19
Appendix 2 NOTIFICATION OF SERIOUS ADVERSE REACTIONS
Appendix 3 REPORTING OF SERIOUS ADVERSE EVENTS

Confescation of authorisation, control and report of serious adverse reactions and serious adverse incidents in the handling of human tissues and cells ; 1)

In accordance with section 6, section 13 (3). 6, section 14 (4). Three, section 18, paragraph. 2, section 20 (2). Paragraph 21 (1) and section 21 (1). Two, in Law No 273 of 1. April 2006 on the requirements for quality and safety in the handling of human tissues and cells (tissue slots) shall be determined as follows :

Chapter 1

Definitions

§ 1. For the purposes of this notice :

1) Processing : all activities related to the process of processing, handling, preservation and packaging of tissues or cells for use on humans.

2) " preservation " means the use of chemical agents (agents), changes in the environment or use of other means during processing in order to prevent or delay biological or physiological deterioration of tissues and cells.

3) Storage : storage of tissues and cells until distribution.

4) Distribution : transport and the delivery of tissues and cells in and between Denmark and another country within the European Union and the European Economic Area.

5) The import : transport and delivery of tissues and cells to Denmark from a country outside the European Union and the European Economic Area (non-member country).

6) Export : transport and delivery of tissues and cells to a country outside the European Union and the European Economic Area (non-member country) of Denmark.

7) Serious adverse reaction : an unintended complication, including a transmissible disease, donor or recipient in connection with the taking or use of human tissues and cells that are lethal, life-threatening or invalidity, resulting in incapacity or triggering or prolonging hospital or a disease.

8) Severe unwanted event : Any unintentional occurrence in relation to taking, testing, processing, preservation, storage and distribution of tissues and cells that could cause transfer of communicable diseases, death or life-threatening ; or invalidity or incapacity for patients or which may trigger or extend the hospital or sickness of any other disease.

9) tissue : tissue bank, hospital department, or other public or private unit in which testing, processing, preservation, preservation, distribution, or import or export of human tissues and cells are carried out.

10) The taking place : the hospital ward, health care centre, tissue centre or other public or private unit employed in the procurement of human tissues and cells.

11) Cells : Individual human cells or a collection of human cells when they are not kept together by any binding tissue of any kind.

12) Tissue : all the components of the human body, which are made out of cells.

Chapter 2

Conditions for obtaining authorization to handle tissues and cells

Permission to test, processing, preservation, storage, distribution, or export

§ 2. In order to obtain the consent of the Medicinal Products on the Clause Section 4 or 5 to perform the test, processing, preservation, storage, distribution or export of tissues and cells, the tissue centre shall comply with :

1) the requirements for the organisation, management, staff, equipment, premises, documentation, records and quality control, as shown in Appendix 1 to the Medicinal Order for the quality and safety of test, processing, preservation, storage and storage ; distribution and the import and export of human tissues and cells ; and

2) the requirements set out in Appendix 2 of the Order of the Medicinal Management Order for the quality and safety of test, processing, preservation, storage, distribution, import and export of human tissues and cells and related to the activities that are carried out ; The tissue is performing.

Permission to Import

§ 3. In order to obtain the medicinal product of the medicinal product after the tissue slots section 5 to import tissues and cells, the tissue centre shall ensure that the imported tissues and cells are :

1) can be traced from donor to recipient (recipient) and inverse in accordance with the requirements for traceability of the Clause 12 and the requirements of section 15 of the Medicinal Management Order for the quality and safety of test, processing, preservation, the storage, distribution, import and export of human tissues and cells ; and

2) meet quality and safety standards equivalent to those laid down in the Notice of the quality and safety of the Board of Health for the donation, procurement and testing (human tissues and cells) and in the Medicinal Medieval Order on Quality, and security of test, processing, preservation, storage, distribution, import and export of human tissues and cells.

Requirements for the submission of applications for the handling of tissues and cells

§ 4. The submission of an application or a reapply for the consent of the Medicinal Medium Management Board of the Clause Section 4 or 5 for handling human tissues and cells must be carried out on a specific schema which can be obtained from the place of the Medicinal Management Board or by the following : communication to the Management Board. The application shall be provided with evidence that the tissue centre meets the requirements of sections 2 or 3.

Chapter 3

The dispatches of the tagging

§ 5. In connection with the application, the place of extraction shall communicate the name of the medical board of the person responsible for the name and the types of human tissues and cells to be taken into consideration in the application.

Paragraph 2. The notification must be made on a special schema that can be retrieved from the network of the Medicinal Management Board or by contacting the Board.

Paragraph 3. Changes in the provisions referred to in paragraph 1. 1 information provided must be communicated immediately to the Medicinal Board of Directes.

Chapter 4

Treatment of applications for the handling of tissues and cells from the medical management board

§ 6. The governing board shall examine an application or a re-application for authorization following the sections 4 or 5 of the tissue slots within 90 days of the submission of a full application.

§ 7. The governing board may require a tissue establishment to provide further information on the conditions laid down for the application, cf. § § 2 and 3.

Paragraph 2. In the event of further information provided in accordance with paragraph 1, the Agency for the Medicinal Products Agency shall be provided. 1, suspend the time limit in section 6 until such information is provided by the tissue centre.

§ 8. The governing board shall not authorize, after the Board of Governing, the Board of Directs, 4 and 5, after the Management Board has checked that the tissue meeting meets the requirements of sections 2 or 3.

§ 9. The governing board shall specify the activities of the tissue centre to carry out the activities of the tissue in accordance with the authorization.

Paragraph 2. The Mediation Board may assign special conditions to the permit. The governing board may, in addition, time limit to the authorisation.

Chapter 5

Conditions governing possession of the authorization to handle human tissues and cells

§ 10. The tissue centre must continuously comply with the requirements of the tissue centre in accordance with the requirements of the tissue centre. sections 2 and 3, as well as the individual terms and conditions which may be associated with the authorization in accordance with section 9 (4). 2. A tissue establishment authorised to carry out testing, processing, preservation, storage, distribution, import and / or export of tissues and cells must also continue to meet the requirements of the Medicinal Management Order for quality ; and security of testing, processing, preservation, storage and distribution, and the import and export of human tissues and cells related to the activities carried out by the tissue establishment.

§ 11. The Centre shall not make any significant changes in the activities of the Movement of the Movement without having obtained the written approval of the Medicines Management Board without prejudice to any such measures.

Chapter 6

The control company of the medicinal mean management

§ 12. The governing board controls at regular inspections and other control measures, whether tissue establishments and sampling points meet the conditions laid down in the tissue slots and rules laid down in pursuance of the limit of tissue. The interval between two inspections shall not exceed two years.

Paragraph 2. In addition to the one in paragraph 1. 1 the inspection activities referred to above shall be carried out by the medical board inspections and carry out appropriate control measures if a serious adverse reaction or a serious unwanted event is taken. Whereas the Management Board shall also undertake such inspections and control measures if a reasoned request is made by the competent authorities of a country within the European Union and the European Economic Community ; Area of cooperation.

Paragraph 3. After each inspection, the Evaluation Board shall prepare a report on the extent to which the tissue establishment or set-aside place complies with the requirements of the tissue slots and rules issued in accordance with the loom of the tissue. The content of these reports shall be notified by the inspection visit, the set-aside or tissue establishment.

§ 13. The governing board shall communicate at the request of the European Commission or to the competent authorities of a country within the European Union or the European Economic Area of information on the results of inspections carried out ; and control measures referred to in section 12 (3). One and two.

Chapter 7

Notification of serious adverse reactions and serious adverse events

§ 14. Healthcare workers who use tissues and cells as part of a patient treatment or in connection with clinical trials on human beings must immediately alert the centre to report serious adverse reactions which may be related to tissue and security, and which : is observed in the consigs of this.

Paragraph 2. The tissue centre shall be notified immediately on the basis of paragraph 1. 1 received reports to the Medicinal Products Agency.

Paragraph 3. The Centre for the Centre shall report in accordance with paragraph 1. 2 must be carried out on a special schema with the content given in Annex 2, Parts A and B, to this notice. The schema could be retrieved at the location of the Medical Board or by contacting the Medicinal Board.

§ 15. Recipients of tissues and cells and their families can report serious adverse reactions during or after the clinical use of tissues and cells.

Paragraph 2. The report must be carried out on a specific scheme, which can be obtained from the place of the Medicinal Management Board or by contacting the Medicinal Products Agency.

§ 16. The extraction point shall be immediately reported to the tissue centre immediately reporting serious adverse reactions to the donor and serious adverse events which may affect tissues and cells, quality and safety, and taken in the case of the taking of tissues and cells.

Paragraph 2. The tissue centre shall forthwith disclose the Centre pursuant to paragraph 1. 1 received report to the Medicinal Products Agency.

Paragraph 3. The report by the tissue centre in accordance with paragraph 1. 2 shall be carried out in particular schemas containing the contents of Annex 2, Part A and B of Annex 3, and Annex 3, part A and B, to this notice. The Schema may be retrieved at the place of the Medicinal Management Board or by contacting the Medicinal Products Agency.

§ 17. The Centre shall immediately report serious adverse events for testing, processing, preservation, storage, distribution, import or export of tissues and cells.

Paragraph 2. The Centre for the Centre shall report in accordance with paragraph 1. 1 must be carried out on a special schema with the content given in Annex 3, part A and B, to this notice. The schema could be retrieved at the location of the Medical Board or by contacting the Medicinal Board.

Dissemination of information on serious adverse reactions and serious adverse events

§ 18. The governing board shall immediately inform the competent authorities of the competent authorities of the competent authorities of other countries concerned immediately after receiving reports of serious adverse reactions and serious adverse events.

Chapter 8

Fees

§ 19. In the case of the following benefits from the Medicinal Products Agency for the approval and control of tissue establishments, the fee shall be paid :

1) Treatment of the application for an application for tissue slots, sections 4 and 5 to handle tissues and cells at one geographic location.

2) Ongoing control activities pursuant to section 14 (4) of the VA. One and two.

Paragraph 2. The fees for the services referred to in paragraph 1. 1 is given in Appendix 1 to this notice.

Paragraph 3. In exceptional cases, the medical management board may, in exceptional cases, be exempt from payment of the fee.

Paragraph 4. By way of derogation from the date of the year a permit to perform testing, processing, preservation, storage, distribution, import or export of tissues and cells cease, full fee shall be paid for the year in question.

Paragraph 5. A tissue establishment at the beginning of the year in possession of a permit for the sections 4 and 5 of the Vacation of the VA shall pay the full annual charge for the year in question.

Paragraph 6. Permission granted under Clause 2, 3 and 4 of the first 9 months of the year shall be paid full annual tax for the current year. Permission granted in the last three months of the year, the annual charge will be payable only the following year after year.

20. The FDA shall notify the procedure for the payment of fees.

Paragraph 2. Fees for the services referred to in section 19 (1). 1, shall be paid to the Medicinal Products Management Board no later than one month after commend;

Chapter 9

Punishment and entry into force

§ 21. Unless higher penalties have been imposed on other legislation, penalty shall be penalised by the penalty which is in breach of section 5 (5). Paragraph 1 or paragraph 1. 3, or section 11.

Paragraph 2. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

§ 22. The announcement shall enter into force on 1. January 2012.

Paragraph 2. At the same time, notice No 1427 of 14. In December 2010, on the authorisation, control and report of serious adverse reactions and serious adverse reactions in the handling of human tissues and cells.

The Ministry of Health and Prevention, the 14th. December 2011

Astrid Krag

/ Nina Moss


Appendix 1

Fees for the approval and control of tissue establishments, cf. § 19

Application fee
Control Fee / Year
Varenr. 50125
Varenr. 50126
Tissue establishments
$22.379.
8:138.
Varenr. 50127
Varenr. 50128
Tissue establishments that carry out insemination alone and in this context only carry out the processing by the "swim up" method.
$646.
$646.

Appendix 2

NOTIFICATION OF SERIOUS ADVERSE REACTIONS

A. Rapid reporting of serious adverse reactions

VvvCenter
Preparation identification
Prepared Date (year/month / day)
Affected Person (recipient or donor)
Date and place of taking or using people (year/month / day)
Unique donation identification number
Date of the severe side effect that is suspected of (year/month / day)
The tissue / cell type that is involved in the severe side effect that is suspected of
Type of serious adverse reaction / serious adverse reactions that are suspected

B. Conclusion on investigation of serious side effects

VvvCenter
Preparation identification
Acknowledgment date (year/month / day)
Date of severe side effect (year/month / day)
Unique donation identification number
Confirmation of serious side effect (yes/no)
Change of serious side effect (yes / no)
If yes, please specify
Clinical result (if known) :
Complete recovery
Lette sequelae
Serious sequenelae
Deaths
Survey Results and Final Conclusions
Recommendations for preventive and corrective measures

Appendix 3

REPORTING OF SERIOUS ADVERSE EVENTS

A. Fast report of suspected of serious adverse events

VvvCenter
Preparation identification
Report date (year/month / day)
Date of the grave unwanted event (year/month / day)
Any tissues / cell types involved in the serious unwanted event
Spec
Severe unwanted event which may affect the quality and safety of tissues and quality as a result of a deviation in connection with :
Liquid and cell errors
Equipment error
Human error
Other
(specify)
Sampling
Test Testing
Processing
Preservation
Retention
Distribution
Materials
Other
(specify)

B. Conclusion on investigation of serious adverse events

VvvCenter
Preparation identification
Acknowledgment date (year/month / day)
Date of the serious unwanted event (year/month / day)
Analyzing the root cause (details)
What corrective measures have been taken (detailed information)
Official notes

1) The announcement contains provisions which implement parts of Directive 2004 /23/EC of the European Parliament and of the Council of 31. March 2004 laying down standards for the quality and safety of donation, procurement, testing, treatment, preservation, storage and distribution of human tissues and cells (EU Official Journal 2004, nr. L 102, s. EUR 48), parts of Commission Directive 2006 /17/EC of 8. February 2006, on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council with regard to certain technical requirements for the donation, procurement and testing of human tissues and cells (EU Official Journal (EU Official Journal). L 38, s. EUR 40) and parts of Commission Directive 2006 /86/EC of 24. In October 2006, on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council with regard to requirements for traceability, the reporting of serious adverse reactions and undesirable occurrences and certain technical requirements for coding, processing, praisedation, the storage and distribution of human tissues and cells (EU Official Journal 2006, nr. L 294, s. THIRTY-TWO.