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Changing The Implementation Decrees A Law On Human Tissues And Cells

Original Language Title: změna prováděcí vyhlášky k zákonu o lidských tkáních a buňkách

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167/2017 Sb.



DECREE



of 5 April 2004. June 2017,



amending Decree No. 422/2008 Coll. laying down detailed requirements

in order to ensure the quality and safety of human tissues and cells intended for

use in humans, as amended by Decree No. 339/2012 Coll. and Decree No.

45/2014 Sb.



The Ministry of health determined in accordance with section 29 of Act No. 296/2008 Coll.

ensure the quality and safety of human tissues and cells intended for

human applications and amending related laws (Act on human

tissues and cells), as amended by Act No. 77/2012 Coll. and Act No. 136/2017

Coll.:



Article. (I)



Decree 422/2008 Coll. laying down detailed requirements to ensure

the quality and safety of human tissues and cells intended for use in

man, as amended by Decree No. 339/2012 Coll. and Decree No. 45/2014 Coll.

is amended as follows:



1. in the introductory part of the provisions of paragraph 1, the words "European Community" ^ 1 ")"

replaced by the words "European Union" ^ 1 ")".



Footnote 1:



"1) European Parliament and Council Directive 2004/23/EC of 31 October. March

2004 establishing quality and safety standards for the donation, procurement,

testing, processing, preservation, storage and distribution of human

tissues and cells.



Commission Directive 2006/17/EC of 8 June 2004. February 2006 implementing

European Parliament and Council Directive 2004/23/EC, with regard to certain

technical requirements for the donation, procurement and testing of human

tissues and cells.



Commission Directive 2006/86/EC of 24 September 1998. October 2006 implementing

European Parliament and Council Directive 2004/23/EC, with regard to the requirements of the

traceability, notification of serious adverse reactions and events and

some of the technical requirements for the coding, processing, preservation,

storage and distribution of human tissues and cells.



Commission Directive (EU) 2015/565 of 8 June. April 2015, amending

Directive 2006/86/EC as regards certain technical requirements for

coding of human tissues and cells.



Commission Directive (EU) 2015/566 of 8 June. April 2015, which

Directive 2004/23/EC, as regards the procedures for verifying the equivalent

quality and safety standards for imported tissues and cells ".



2. In paragraph 1, at the end of paragraph (i)) dot replaced with a comma and the following

the letters j) to (l)), which read as follows:



"j) imports of tissues and cells and tissue establishments importing,



the scope of the information to be contained in) the certificate of authorisation of activities

the importing of the tissue establishment and



l) encoding the tissue and cell donation and allocation of unique numbers. ".



3. In paragraph 6, the words "and § 5 para. 2 (a). and) of the Act "shall be replaced by the words" and section

5 (3). 3 (b). and the law ").



4. In section 8 paragraph 1. 1 (b). (b)) (2) the word "identification" and "tissue and

the cells "are deleted.



5. In section 8 paragraph 1. 1 (b). (c)) item 1:



"1. the identification of the tissue establishment".



6. In section 8 paragraph 1. 1 (b). (c)) (2) the words "European Community",

replaced by the words "European Union".



7. In § 8 para. 1 (b). (d)), point 2, the words "medical devices"

replaced by the words "health service provider".



8. In paragraph 8, the dot at the end of paragraph 1 is replaced by a comma and the following

the letter e), which reads as follows:



"e) identify a single European code.".



9. In section 8 paragraph 1. 2 of the introductory part of the provisions, the word "operators"

replaced by the words "health service providers".



10. In § 8 para. 2 (a). (b)), the term "medical equipment" shall be replaced by

the words "health service provider".



11. In § 8 para. 2 (a). (e)), the word "and" shall be deleted.



12. in section 8 shall at the end of paragraph 2, the period is replaced by a comma and the following

the letter g) is added:



"(g)) the single European code.".



13. In the heading of section 9, for the text "to § 5 para. 1 (b). (e)) "text", §

20B paragraph 1. 3. "



14. in § 9 para. 1 (b). a), the words "identification number" shall be replaced by

the word "number".



15. in section 9, the following paragraph 4 is added:



"(4) the creation of a single European code structure, the requirements for its

use, the structure of the product code and the technical rules of the system

the allocation of unique numbers donation are set out in annex No 10 to

This Ordinance. ".



16. In the heading of section 12 of the text "paragraph. 4 "shall be replaced with" paragraph 1. 6. "



17. in section 12a shall be inserted after section 12b and 12 c, which including the following titles:



"section 12b



Application for authorization of the activity of the tissue establishment



(Section 17, paragraphs 5 and 6 of the Act)



The scope and requirements of the documentation relating to the

tissue establishment and documentation relating to a supplier or suppliers

from third countries, at the request of the Institute and, if necessary, shall submit to the

the tissue establishment shall provide the importing of the Institute, are listed in the annex.

11 to this Decree.



§ 12 c



The certificate of authorisation of the activity of the tissue establishment



(For section 19, paragraph 5, of the Act)



The model for the issue of permits to the extent the activities of the tissue establishment

imports of tissues and cells from third countries are laid down in annex 12 to this

Ordinance. ".



18. in annex 2, part 7, at the end of paragraph (e)) dot replaced with a comma

and the following subparagraph (f)), which read as follows:



"f) donation identification sequences.".



19. in annex 2 section 7 of the final part of the provision, the words "to (e))"

replaced by the words "to (f))".



20. In annex 6, point 5.1 at the end of subparagraph (f)) dot is replaced by

the comma and the following of the letter g) is added:



"(g)) the single European code.".



21. in annex No 6 section 5.1 of the final part of the provision, the words "and (e))"

replaced by the words "e) and (g))" and the words "to (f))" shall be replaced by "up to

(g)). "



22. in annex 6, point 5.2, at the end of subparagraph (j)) dot is replaced by

the comma and the following letter to), which read as follows:



"k) tissues and cells for the imported country of collection and the exporting country,

If different from the country of collection ".



23. Appendix No. 7, including the title reads as follows:



' Annex # 7 to # 422/2008 Sb.



Announcements and messages

PART AND



NOTIFICATION



1. the model notification of serious adverse reactions or suspected

I----------------------------------------------------------------------------I

Even stating that the tissue establishment under section 7 of Decree No. 422/2008 Coll. (the name, and

I adresa) I

I----------------------------------------------------------------------------I

And the code of the tissue establishment and

I----------------------------------------------------------------------------I

(I) Identification and notification


I----------------------------------------------------------------------------I

(I) the date of notification (year/month/day)

I----------------------------------------------------------------------------I

I disabled person (the recipient or donor) and

I----------------------------------------------------------------------------I

The subscription date (year/month/day) and place of collection of tissues and cells, in the case of response and

I u dárce I

I----------------------------------------------------------------------------I

(I) filing date (year/month/day) and the site of the tissues and cells, in the case of response and

Even in a consumer and

I----------------------------------------------------------------------------I

And the unique number for the donation and

I----------------------------------------------------------------------------I

(I) date of serious adverse reaction/suspected (year/month/day)

I----------------------------------------------------------------------------I

(I) type of tissues and cells that are associated with the notification, and their single European and

I kód I

I----------------------------------------------------------------------------I

I kind of serious adverse reaction/suspected (Please describe)

I----------------------------------------------------------------------------I

And the responsible person of the tissue establishment (name, surname, title, phone, and I

I e-mail) I

I----------------------------------------------------------------------------I



2. the model notification of serious adverse events or suspected

I----------------------------------------------------------------------------I

Even stating that the tissue establishment under section 7 of Decree No. 422/2008 Coll. (the name, and

I adresa) I

I----------------------------------------------------------------------------I

And the code of the tissue establishment and

I----------------------------------------------------------------------------I

(I) Identification and notification

I----------------------------------------------------------------------------I

(I) the date of notification (year/month/day)

I----------------------------------------------------------------------------I

(I) date of serious adverse events/suspected (year/month/day)

I-------------------------I--------------------------------------------------I

(I) serious adverse and Specifications and

(I) the appointment or suspect I--------------I----------I---------I--------------I

Even on her, which may also Fail and tissue Failure Error as well as other (indicate the

And affect the quality and I and both cells and devices as well as man and announcing)

And safety of the tissues and I I I I I

Even cells in the context of I I I I I

And the difference of the: I I I I I

I-------------------------I--------------I----------I---------I--------------I

Even taking I I I I I

I-------------------------I--------------I----------I---------I--------------I

Even examination I I I I I

I-------------------------I--------------I----------I---------I--------------I

Even the transport I I I I I

I-------------------------I--------------I----------I---------I--------------I

And I I I I I

I-------------------------I--------------I----------I---------I--------------I

Storage of I I I I I

I-------------------------I--------------I----------I---------I--------------I

Even distribution of I I I I I

I-------------------------I--------------I----------I---------I--------------I

And materials (name, I I I I I

And the lot of the manufacturer) I I I I I

I-------------------------I--------------I----------I---------I--------------I

Other (enter the I I I I I

And that States) I I I I I

I-------------------------I--------------I----------I---------I--------------I

I Estimate the impact of the serious adverse events reported/suspected it

I----------------------------------------------------------------------------I

And the responsible person of the tissue establishment (name, surname, title, phone, and I

I e-mail) I

I----------------------------------------------------------------------------I



PART (B)



MESSAGES



1. the model of a serious adverse reaction reports

I----------------------------------------------------------------------------I

Even stating that the tissue establishment under section 7 of Decree No. 422/2008 Coll. (the name, and

I adresa) I

I----------------------------------------------------------------------------I

And the code of the tissue establishment and

I----------------------------------------------------------------------------I

(I) identification of the notification (in accordance with the notification of serious adverse reactions and

Reaction/suspected)

I----------------------------------------------------------------------------I

And the date of confirmation of serious adverse reaction (year/month/day)

I----------------------------------------------------------------------------I

And the date on which the assessment of serious adverse reactions closed

I (year/month/day)

I----------------------------------------------------------------------------I

Date of serious adverse reaction (year/month/day)

I----------------------------------------------------------------------------I

And the unique number for the donation and

I----------------------------------------------------------------------------I

(I) Confirmation of serious adverse reaction (yes/no)

I----------------------------------------------------------------------------I

A change in the type of serious adverse reaction (yes/no)

I----------------------------------------------------------------------------I

(I) If Yes, state change

I----------------------------------------------------------------------------I

Other changes from the data referred to in the notice serious adverse and

Reaction/suspected (If Yes, please indicate the changes)

I----------------------------------------------------------------------------I

The number of disabled beneficiaries, if it is a serious adverse reaction in a recipient and


I-------------------------------------I--------------------------------------I

And clinical outcome (if known) and a full recovery I

I I--------------------------------------I

Even slight consequences

I I--------------------------------------I

And even serious consequences

I I--------------------------------------I

I I úmrtí I

I-------------------------------------I--------------------------------------I

(I) type of tissues and cells associated with a confirmed serious adverse reactions and

And their single European code

I----------------------------------------------------------------------------I

The result of the evaluation of serious adverse reactions and the final conclusions and

I----------------------------------------------------------------------------I

And preventive and remedial measures

I----------------------------------------------------------------------------I

And the responsible person of the tissue establishment (name, surname, title, phone, and I

I e-mail) I

I----------------------------------------------------------------------------I

Message date (year/month/day)

I----------------------------------------------------------------------------I



2. the model reports of serious adverse events

I----------------------------------------------------------------------------I

Even stating that the tissue establishment under section 7 of Decree No. 422/2008 Coll. (the name, and

I adresa) I

I----------------------------------------------------------------------------I

And the code of the tissue establishment and

I----------------------------------------------------------------------------I

(I) identification of the notification (in accordance with the notification of serious adverse reactions and

Events/suspected)

I----------------------------------------------------------------------------I

And the date of confirmation of serious adverse events (year/month/day)

I----------------------------------------------------------------------------I

And the date on which the assessment of serious adverse event closed

I (year/month/day)

I----------------------------------------------------------------------------I

Serious adverse event date (year/month/day)

I----------------------------------------------------------------------------I

(I) analysis of the root causes and

I----------------------------------------------------------------------------I

And preventive and remedial measures

I----------------------------------------------------------------------------I

And the responsible person of the tissue establishment (name, last name, title, phone, and I

I e-mail) I

I----------------------------------------------------------------------------I

Message date (year/month/day)

I----------------------------------------------------------------------------I

".



24. After annex # 9 the following is added to annex No. 10 to 12, including

the headings are added:



' The annex to Decree No 10 No 422/2008 Sb.



The formation and structure of a single European code requirements for its

use, the structure of the product code and the technical rules of the system

the allocation of unique numbers donation



I. the Creation and structure of the single European code

Explanatory notes:



*) The ISO code of the Czech Republic (CZ).

**) Number of the tissue establishment is allocated to each tissue establishment;

and published in a database of tissue establishments of the European Union.

) and the Expiration Date) shall be entered in the order year, month, day

(YYYYMMDD).

(b)) in the case of tissues and cells, for which there was no end date

date shall be indicated instead of the data "00000000" (8 numeric characters as

for the expiration date).



II. requirements for the use of a single European code



The tissue establishment shall open a single European code in a format readable by simply

eye, before the code States the abbreviation "SEC", signifying a single European code.

Donation identification sequence and sequence identification of needs

be separated by a space or 1 must be placed on the two

consecutive lines.



III. structure of the product code



The product code is folded



and) from one letter character identifying the coding system allowed

The European Union, that the tissue establishment's chosen, namely:



1. the "E" for the EUTC,



2. "and" for the ISBT128,



3. "B" to Eurocode, and



(b)) of the number of (7 alphanumeric characters) that the chosen encoding

the system provides for different types of tissues and cells.



IV. the technical rules of the system of allocation of unique numbers for donation



and a unique number, donation) that is assigned to a specific donation

tissues and cells shall be provided in the form of 13 alphanumeric characters, in order:



1. the indication of the date of the subscription in the order of the last two digits of the year, month, day

(YYMMDD)



2. the donor's initials in the order first name, surname,



3. the registration number of the subscription.



If the sum of the alphanumeric characters referred to in points 1 to 3

not exhausted the number of 13 alphanumeric characters, at the end of the required

the number of zeros to the number 13 alphanumeric characters.



b) tissue establishments may use different technical rules of

the allocation of unique numbers donation than those referred to in (b)), if

guarantee the unambiguous identification of a specific donation of tissues and cells and

thus allocated a unique number the donation contains 13 alphanumeric

characters.



Annex # 11 to # 422/2008 Sb.



The scope and requirements documentation at the request of the Institute

submit and if necessary provide the importing a tissue establishment

Of the Institute



A. documentation relating to the importing of the tissue establishment includes:



1. Responsibilities of the responsible person, and details about her qualifications and

education pursuant to § 6 of the Act, if the activities of the importing tissue

the device will be appointed by another responsible person than for other activities

the tissue establishment.



2. a copy of the label of the primary container, the label of the new packaging, outer packaging

and transport container.



3. A list of current versions of standard operating procedures for

activities in the area of imports of tissues and cells from third countries including


procedures for the implementation of the single European code, adoption and

storage of imported tissues and cells in a tissue establishment, importing

procedures for adverse events and reactions, the download of

distribution and traceability from the donor to the recipient.



B. documentation relating to a supplier or suppliers from third countries

contains:



1. A detailed description of the criteria used for identifying and evaluating

the donor, information provided to the donor or his family, the way it is

obtained the consent of the donor or his family and whether the donation was voluntary and

unpaid or not.



2. Detailed information on the diagnostic laboratory or other similar

the workplace is being used, the supplier from a third country and the tests referred to

the workplace is carried out.



3. Detailed information on the procedures used during the processing of tissues

and cells, including details of the validation process.



4. for each activity carried out by the supplier from a third country, a detailed description of the

space, critical equipment and materials and the criteria used

for quality control and control of the environment.



5. Detailed information on the conditions for release of tissues and cells

by the supplier or the supplier from a third country.



6. Details of any subcontractors used by suppliers of

third countries, including the name, location and your work.



7. A summary of the most recent inspection of the supplier from a third country

the competent authority or authorities of a third country, including the date, the type of inspection and

the main conclusions.



8. a summary of the most recent audit carried out at the supplier from a third country

importing tissue establishment or on his behalf.



9. all the competent national or international accreditation.



Appendix 12 to the notice No. 422/2008 Coll.



The model for the issue of permits to the extent the activities of the tissue establishment

imports of tissues and cells from third countries

Explanatory notes:

DTZ-importing a tissue establishment

AFTER-competent authority (eg. The State Institute for drug control) ".



Article II



The effectiveness of the



This Decree shall take effect on the 15th day following its publication.



Minister:



JUDr. Ing. Louis, MBA, in r.