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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Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=122815

Overview (table of contents) Chapter 1 Definitions

Chapter 2 Conditions for obtaining authorization for the handling of tissues and cells

Chapter 3 Procurement site's reporting duty

Chapter 4 the Danish Medicines Agency's processing of applications for permission for the handling of tissues and cells

Chapter 5 conditions for the possession of an authorization for the handling of tissues and cells

Chapter 6 the Danish Medicines Agency's control activities

Chapter 7 reporting of serious adverse reactions and serious adverse events

Chapter 8 Fees

Chapter 9 Penalties and entry into force

Annex 1

Annex 2

Annex 3 The full text of the Ordinance for authorization to, control and reporting of serious adverse reactions and serious adverse events in the handling of human tissue and cells 1)

Under section 6, section 13, paragraph 6, article 14, paragraph 3, article 18, paragraph 2, article 20, paragraph 1, and article 21, paragraph 2, of law No. 273 of 1. April 2006 about the quality and safety requirements for the handling of human tissues and cells (tissue Act) shall be determined:

Chapter 1

Definitions

§ 1. In this notice, the term:





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.





Chapter 2

Conditions for obtaining authorization for the handling of tissues and cells

Permission for testing, processing, preservation, storage, distribution or export

§ 2. In order to achieve the Danish Medicines Agency's permission after tissue § § 4 or 5 to perform the testing, processing, preservation, storage, distribution or export of tissues and cells to the tissue establishment comply with:





1) requirements for organization, management, personnel, equipment, facilities, documentation, records and quality control, as set out in annex 1 to 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, and

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.





Permission to import

§ 3. In order to achieve the Danish Medicines Agency's permission after tissue section 5 to import the tissues and cells to the tissue establishment ensure that imported tissues and cells:





1) can be traced from the donor to the recipient (recipient) and vice versa in accordance with the requirements for traceability in tissue section 12 and the requirements set out in section 15 of 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

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.





Form requirements upon application for permission for the handling of 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.

Chapter 3

The sampling site reporting duty

§ 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.

Chapter 4

The Danish Medicines Agency's processing of applications for permission for the handling of tissues and cells

§ 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.

Chapter 5

Conditions for the possession of an authorization for the handling of tissues and cells

§ 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.

Chapter 6

The Danish Medicines Agency's control activities

§ 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.

Chapter 7

Reporting of serious adverse reactions and serious adverse events

§ 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.

Disclosure of information about serious adverse events and serious adverse events

§ 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.

Chapter 8

Fees

§ 19. For the following services from the Danish Medicines Agency relating to the approval and inspection of tissue establishments paid fee:





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.

Chapter 9

Punishment and entry into force

§ 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.

(2). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.

§ 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.
The Ministry of health and prevention, the 15. December 2008 Jakob Axel Nielsen/Nina Moss Annex 1

Fees for the approval and inspection of tissue establishments, without prejudice. § 19







 



2009-2010





2011-





 



Application-

fee





Control-

fee/year





Application fee





Inspection fee/year







TES 21,402 kr.





27,823 kr.





21,402 us $.





us $ 19,259.







Tissue establishments alone performs the insemination and in this connection only performs processing ' swim-up ' method.





617 kr.





617 kr.





617 kr.





617 kr.







Annex 2

REPORTING OF SERIOUS ADVERSE REACTIONS

A. Quick reporting of suspected serious adverse reactions









Tissue center

 







Transmission identification

 







Reporting date (year/month/day)

 







Interested person (the recipient or donor)

 







Date and place of the taking or use on people (year/month/day)

 







Unique donation identification number

 







Date for the serious side effect that is suspected (year/month/day) Tissue-/celletype, which is involved in the serious side effect, there is a suspicion of

 

 

 

 







Type of serious adverse reaction/suspected serious adverse reactions

 

 

 

 









B. conclusion on the investigation of serious side effects









Tissue center

 







Transmission identification

 







Confirmation date (year/month/day) date of serious adverse reaction (year/month/day) the Unique donation identification number Confirmation of serious adverse reaction (yes/no) modification of serious adverse reaction (yes/no)

 

 

If Yes, please specify

 

 

 







Clinical outcome (if known): complete cure

 

Facilitate sequelae

 

Serious sequelae

 

Deaths

 







Findings and conclusions

 

 

 







Recommendations on preventive and corrective measures

 

 

 







Annex 3

REPORTING OF SERIOUS ADVERSE EVENTS


A. Quick reporting of suspected serious adverse events









Tissue center

 







Transmission identification

 







Reporting date (year/month/day) date of the serious adverse event (year/month/day) Any tissue-/celletyper involved in the serious adverse event

 

 

 







Serious adverse event that may affect the quality and safety of tissues and cells as a result of a deviation in connection with: Specification

 

 







Tissue-and

cellefejl





Fejl ved

udstyret





Menneskelig fejl





Andet

(specify)













Sampling

 



 

 

 

 





Testing

 



 

 

 

 





Processing

 



 

 

 

 





Preservation

 



 

 

 

 





Storage

 



 

 

 

 





Distribution

 



 

 

 

 





Materials

 



 

 

 

 





Other (specify)

 



 

 

 

 







B. conclusion on the investigation of serious adverse events









Tissue center

 







Transmission identification

 







Confirmation date (year/month/day) date of the serious adverse event (year/month/day) Analysis of the root cause (particulars) which corrected measures have been taken (details)

 

 

 







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).