136/2017 Sb.
LAW
from day 4. April 2017,
amending Act 296/2008 Coll., on ensuring the quality and safety of
human tissues and cells intended for human applications, and of the change
related laws (Act on human tissues and cells), as amended by
amended
Parliament has passed the following Act of the United States:
Article. (I)
Act 296/2008 Coll., on ensuring 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. 41/2009 Coll.
Act No. 281/2009 Coll., Act No. 375/2011 Coll., Act No. 77/2012 Coll.
Act No. 64/2014 Coll., is amended as follows:
1. At the end of footnote No. 1, the following sentence
"The (EU) Commission Directive 2015/565 of 8 June. April 2015, amending
Directive 2006/86/EC as regards certain technical requirements for the
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 article 1, the following paragraph 3 is added:
"(3) if the human tissues and cells intended to be used in products for which
are subject to different legal regulations, this Act applies only to
the conditions for the
and) their donation, procurement and testing,
(b)) to ensure their traceability from the donor to the recipient and the recipient to
donors and
c) imports from third countries. '.
3. In paragraph 2 (a). (g)), paragraph 4, the words "in healthcare facilities"
replaced by the words "health service provider".
4. in paragraph 2 of the letter n) is:
"n) Member State means a Member State of the European Union and the Contracting State
The agreement on the European economic area ".
5. In paragraph 2, the following points about) to w) are added:
"o) a third country other than the Member State,
p) from a third country supplier tissue establishment or any other person established
in a third country, which provides export of tissues and cells and adds them to the
The European Union,
q) one-time imports imports of specific type of tissue or cells from the
a third country intended for use in a particular recipient or recipients
who are importing a tissue establishment and the supplier from a third country
known before their importation; for a one-time import does not constitute
imports from the same vendor from a third country that occurs regularly
or repeatedly,
r) code of the tissue establishment a unique identifier consisting of ISO
Code of the Czech Republic and the numbers of the tissue establishment referred to in the database
tissue establishments in the European Union,
with a unique number) unique number assigned to a specific donation
the donation of tissues and cells in accordance with the system for the allocation of these
numbers,
t) product code identifier of the specific type of tissues and cells,
consisting of the coding system of preparations concerning the
the coding system used by the tissue establishment and the number of
tissues and cells in the coding system for a type of preparation,
fraction number for) a number that distinguishes and unique way
identifies the tissue and cells that have the same number of donation, the same
the product code and come from the same tissue establishment
in) the European Union's information and coding platform technology platform
used by the European Commission (hereinafter referred to as "the Commission"), which is the operator of
a database of tissue establishments in the European Union, and the database of products from tissues
and cells, the European Union
w) release for free circulation or distribution to other tissue
device. ".
6. In section 3, paragraph 3. 3 (b). (b)), the number "3" by "4".
7. in section 4, paragraph 4. 2, § 7 (2). 2 and § 9 para. 2, the number "3" is replaced by
the number "5".
8. in § 5 para. 1 (b). (d)), the words "of the European Commission (hereinafter referred to as
"The Commission") ' shall be replaced by "the Commission".
9. in § 5 para. 1 (b). (e)) at the end of the text of point 1, the words ",
that is, if such an assignment required under this Act,
a single European code ".
10. In section 5, paragraph 1, the following paragraph 2 is added:
"(2) the tissue establishment shall ensure the identification and traceability of tissues and
cells referred to in paragraph 1 (b). e) points 1 and 2 by using the single
European code of collection to use in humans, or liquidation and
on the contrary. For tissues and cells used in the manufacture of medicinal products for
modern therapy ^ 2) traceability must be ensured, at least for producers
advanced therapy medicinal products. ".
Paragraphs 2 and 3 shall become paragraphs 3 and 4.
11. in § 5 para. 4 of the introductory part, the words ' the provisions of it imported from other
country other than the Member State (hereinafter referred to as ' third countries ') "shall be replaced by
"imported from a third country".
12. in § 5 para. 4 (b). and (3)) for the word "suppliers"
the words "from a third country".
13. in section 6 (1). 3 (b). g), the words "§ 5 para. 3 "shall be replaced by ' paragraph 5
paragraph. 4. "
14. in section 7 (2). 1 (b). (c)) the final part of the provisions of the
"governing the implementation of transplantation", the words "; in the case of
collection of tissues and cells that is deceased donors made teams of two or
tissue establishments shall ensure that more sampling device, the appropriate system
traceability of all such subscriptions ".
15. the Group heading above section 11 is added:
"Imports of tissues and cells from third countries".
16. in paragraph 11 (1) 1 introductory part of the provisions, the words "shall be authorised to
ensure "shall be replaced by" ensure ".
17. in paragraph 11 (1) 1 (b). (b)) after the word "activities", the words "in the
the extent of imports of tissues and cells ", the words" with permission to lay off workers and
distribute "shall be replaced by the words" relating to ", and the words", where appropriate,
comparable type of tissues and cells, "shall be deleted.
18. In paragraph 11 (1) 1 (d)) to f) are added:
"d) imported tissues and cells comply with the requirements on quality and safety
equivalent to the requirements under this Act and can be traced from the donor to the
from the recipient to the recipients and donors,
e) each package of tissues and cells contain data on the packaging and instructions
According to § 5 para. 3 (b). (d)) that are listed in the Czech language and
(f)) has an a written contract with the supplier from a third country under section 11a
paragraph. 1 with the exception of the cases referred to in § 11a. 2 (hereinafter referred to as
"importing a tissue establishment"). ".
19. in article 11, paragraph 2 shall be deleted.
Paragraphs 3 and 4 shall become paragraphs 2 and 3.
20. In paragraph 11 (1) 2, after the word "cell", the words "from third
countries ".
21. in article 11, paragraph 3 shall be deleted.
22. in article 11, the following new sections 11a and 11b, which including the following title:
"§ 11a
(1) the tissue establishments shall with the supplier from a third country with a written
the contract, if at least one of the activities of the donation, procurement,
testing, processing, storage or imports into the European Union of tissues
and cells to be imported into the European Union, takes place outside the EU; in
a written contract must be
and) requirements the quality and safety of tissues and cells, which
by meeting the ensures the equivalence of the requirements on quality and safety
imported tissues and cells with the requirements laid down in this Act,
(b)) agreed agree that the Institute can perform control activities
vendor from a third country, including its equipment, for a period of validity of the
This agreement and for a period of 24 months from the date of its expiry,
and the corresponding obligation of the Contracting Parties to enable the Institute to carry out this
control,
(c)) for detailed information about the requirements of the tissue establishment
to ensure that the requirements on quality and safety
imported tissues and cells laid down the law and mutually agreed roles
and obligations of both parties in ensuring the equivalence of the requirements of the
the quality and safety of imported tissues and cells,
d) arrangements to ensure that the supplier in the third country has provided the
importing a tissue establishment, documentation relating to the activities of the
This vendor from a third country, containing at least the following information:
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 or not
voluntary and unpaid donation
2. detailed information on the diagnostic laboratory or other similar
workplace, which the supplier from a third country used for testing of tissues and
cells, and on tests that when this investigation is being carried out
3. detailed information on the procedures used during the processing of tissues
and cells, including details of the validation procedure, processing,
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 from a third country,
6. details of any subcontractors used by the supplier of the
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 of the third country, including the date, the type of inspection and the main
the conclusions,
8. a summary of the most recent audit carried out at the supplier from a third country
importing tissue establishment or on its behalf,
9. all the competent national or international accreditation,
e) arrangements to ensure that the third country supplier informed
importing tissue establishment of any serious adverse event or
reaction or suspicion on them, which may influence the quality and safety of
tissues and cells that have been or are to be imported by the importing of tissue
the device,
f) arrangements with the aim of ensuring that the supplier from a third country has informed the
importing a tissue establishment of any substantial changes in its
activities, including the total or partial cancellation or suspension
authorised for exports of tissues and cells, or other such decisions
the competent authority of the third country relating to the failure to fulfil the conditions to
may influence the quality and safety of tissues and cells that have been or are
be imported importing tissue establishment,
g) negotiated agreement that the Institute can carry out inspection activities
vendor from a third country, including on-site inspections, should it Institute
He would proceed under the inspection of the importing of the tissue establishment
h) a clause guaranteeing the right to make importing tissue establishment;
regular audit of the supplier from a third country,
even) the terms upon which the parties have agreed and which must be fulfilled in the
transporting of tissues and cells between the supplier from a third country and importing
tissue establishment,
j) arrangements in order to ensure that donor records relating to
imported tissues and cells are kept by the supplier from a third country or
its sub-contractor, in accordance with the law on the protection of personal
data for a period of 30 years starting from the date of implementation of collection of tissues or cells and to
ensure their retention in the event that the supplier of the
third country has stopped,
to) the provisions on regular review and, where necessary, on the amendment
This written contract, including adjustments to reflect any changes in the
requirements for the quality and safety of tissues and cells laid down by law,
l) a list of all standard operating procedures the supplier from a third
the country related to the quality and safety of imported tissues and cells and
an obligation to provide, on request of the Institute or of the importing tissue
device description these standard operating procedures.
(2) the tissue establishment in the case of urgent needs in accordance with § 13 para. 1
or one-off imports is not obliged to
and conclude with the supplier) from a third country a written contract in accordance with paragraph
1 if the
1. ensure traceability from donor to recipient, and the recipient to
donors and
2. imported tissues and cells shall be used only for recipients for whom
specifically, it imported, were
(b)) to provide the information and documentation provided for the Institute by the implementing
legal regulation according to § 17 para. 5 If the conditions are met according to the
(a)) points 1 and 2.
One-off imports for a particular recipient can the tissue establishment
take place only once.
section 11b
Exports of tissues and cells to third countries
(1) exports of tissues and cells to third countries for their use in the treatment of
the recipient ensures a tissue establishment if it released the tissue and
cells for use to treat the beneficiary if
and) exported tissues and cells comply with the requirements of this Act and the requirements of the
the legislation of the third country; meet the requirements of the legislation of the third
the country shows a tissue establishment export is conducted, proof
issued by the competent authority of the third country; does not issue such a document if,
You can certify this fact to the Declaration of the tissue establishment
(b) the holder of the authorization) is the activity with permission to distribute tissue and type
cells, or comparable type of tissues and cells that are the subject of
export; the tissue establishment can arrange distribution of tissues and cells to
a third country by a person to be tissue and cells in the third
the country shipped or her in writing to the responsible person on the condition that it is
distribution of tissues and cells under the legislation of the State in which they have
tissues and cells to be exported, and
(c)) the conditions for export under the law governing the implementation of the
transplantation of ^ 3), even in the case when tissues and cells are not exported
intended for transplantation.
(2) the export of tissues and cells to third countries for their use in the manufacture of
medicinal products may be made subject to the
and) conditions referred to in paragraph 1 (b). (c)), and
(b)) the requirements under this Act to the donation, procurement, testing, and
release of tissues and cells for use in the manufacture of medicinal products
and the requirements of the legislation of the third country; compliance with the requirements of the laws,
the laws of a third country, demonstrating a tissue establishment of release these tissue
and cells for the export document issued by the competent authority of the third country;
does not issue to such a document, you can certify this fact to the Declaration
tissue establishment. ".
23. § 12 including the title reads as follows:
"section 12
Distribution of tissues and cells between the Czech Republic and the other Member State
Distribution of tissues and cells between the Czech Republic and the other Member State
provides a tissue establishment if
a) tissues and cells comply with the requirements on quality and safety equivalent to the
the requirements laid down in this Act,
(b) the holder of the authorization) is the activity with permission to lay off workers and
distribute the given type of tissues and cells, or comparable type of tissues and
cells, and
(c)) the conditions for importation or exportation under the law governing
implementation of the transplantation ^ 3), even in the case when tissues and cells are not
intended for transplantation. "
24. in section 13 paragraph 1 reads:
"(1) the distribution of the Member State, or importation from a third country in the case of
urgent needs of the tissues and cells for use in treating a specific
the recipient ensures a tissue establishment which is the holder of the authorisation
activities with permission to lay off workers and distribute that type of tissues and cells,
where appropriate, a comparable type of tissues and cells. An import permit from a Member
State, or importation from a third country in the case of urgent needs of issues
The Ministry of health under the law governing the implementation of the
transplantation. In the case of urgent needs for the use of tissues and cells
in the treatment of a particular recipient, the requirements for quality assurance and
the safety of tissues and cells and coding requirements for tissues and cells
imported tissues and cells would not apply. Urgent need for means
any unexpected situation, for which there is no other solution than
without delay, deliver or distribute tissue and cells for immediate use
for a particular recipient or recipients whose health would be without such a
importation or distribution was seriously endangered. ".
25. in article 13, paragraph 3 is deleted.
Paragraph 4 becomes paragraph 3.
26. in § 13 para. 3, after the words "to make" the words "distribution
or "and after the word" provided ", the words" or "distribution.
27. in section 15, at the end of paragraph 2, the period is replaced by a comma and the following
the letter e), which reads as follows:
' e) on the basis of reasonable grounds for the request of the competent authority of another Member
the State, which are then distributed to tissues and cells to be imported into
The United States from a third country, the conduct of inspections
1. the tissue establishments and in the importing
2. the supplier from a third country which has concluded a contract under section 11a.
1. ".
28. the following shall be added in article 15, paragraphs 3 and 4 are added:
"(3) in the area of tissues and cells, encoding the Institute ensures activities referred to
in § 20 c.
(4) the Institute shall notify the
and) to the competent authority of another Member State, the finding that
1. the tissue establishments in the database of the European Union are maintained incorrect
information about the other Member State, or
2. serious violations of the provisions related to the single
the European code, which relates to that other Member State,
(b)) the Commission and the competent authority of another Member State, the finding that it is
need to update the database of the tissues and cells of the European Union. ".
29. in paragraph 17, the following new paragraph 3, paragraphs 4 and 5 are added:
"(4) an application for authorization of the activity of the tissue establishment to the extent of imports
tissues and cells from third countries containing the information and documentation referred to in paragraphs
1 to 3 and in addition to the General requirements under the administrative code
and) information about importing tissue establishment,
1. the name of the site in which the tissue establishment performs its operation,
2. address of the health care facility in which the tissue establishment shall exercise
its activities,
3. the address of the place where the intake of imports, and
4. status of the tissue establishment; the status means information, whether it is
the applicant is already the holder of the authorization of the activity of the tissue
the device, whether the newly requested permission of the activity or whether the requests a change in the
the existing authorization of the activity,
(b) the contact details of the applicant),
1. email address, telephone number and fax number,
2. the name of the person authorized to act on behalf of the applicant, in the case of legal
person, and the name of the responsible person referred to in section 6 (1). 2,
3. Internet address of the site of the tissue establishment if
exists, and
4. mailing address, if different from the registered office of the tissue establishment or
the addresses listed under (a)) points 2 and 3,
c) details of tissues and cells to be imported,
1. a list of the types of tissues and cells to be imported,
2. the name of the supplier from a third country for each type of tissue and cells that
to be imported,
(d) activities by type) specifications for tissues and cells and individuals that is
be carried out,
1. indicating for each kind of tissues or cells from the activities
the donation, procurement, testing, processing, preservation and storage
carried out prior to import from a third country supplier or subcontractor from a third
country,
2. enumeration of all activities that importing a tissue establishment after importation
be carried out for each type of tissues or cells, and
3. for each type of tissue or cell names of third countries where
activities prior to import,
e) information about the suppliers from third countries with which the tissue establishment has
a written agreement under section 11a. 1, and it
1. the name of the vendor from a third country,
2. the name of the person authorized to act on behalf of the supplier from a third country,
3. the address of the registered office of the supplier from a third country,
4. postal address of the supplier from a third country, if different from the registered office
vendor from a third country, and
5. email address and telephone number of the supplier from a third country,
f) documentation, which must be attached to the request,
1. a copy of the written agreement with the supplier or the supplier from a third country,
2. detailed description of the flow of imported tissues and cells from their procurement to
After the adoption in importing tissue establishment and
3. a copy of the certificate of an export permit or a vendor from a third country,
If no specific export authorisation certificate is not issued,
a certificate from the competent authority or authorities of a third country to allow
the activities of the supplier from a third country in the tissues and cells, including
export. This documentation must also contain the contact details of the
the competent authority or authorities in the third country. In the case of third countries, where
This documentation is not available, you must provide other documents,
showing permissions vendor from a third country for export under the
legislation of that third country, such as in particular audit reports
a vendor from a third country.
(5) the importing tissue establishment shall submit at the request of the Institute, and in the case of
the needs of the Institute shall provide documentation on importing tissue
equipment and documentation relating to the vendor or vendors of the
third countries. '.
The current paragraph 4 shall become paragraph 6.
30. In § 17 paragraph 2. 6 is the number "3" is replaced by "5".
31. in section 19 para. 2, the first sentence is inserted after the sentence "Department in the decision
enabling activities of the tissue establishment to the extent of imports of tissues and cells of
a third country shall enter the type imported tissues and cells and a vendor from a third
country. "and at the end of the paragraph, the following sentence" If the decision
be authorised by the activity of the tissue establishment to the extent of imports of tissues and cells of
a third country, may Institute such a decision to further restrict the types of tissues and
the cells, which can be imported, or the vendor of the third-country
may be used. ".
32. In paragraph 19, the following paragraphs 3 to 5 shall be added:
"(3) the Institute following the entry into legal force of the decision to allow the activities of the
the tissue establishment to the extent of imports of tissues and cells from third countries shall issue
tissue establishment certificate of issue of the permit activity of tissue
the device in the range of imports of tissues and cells from third countries.
(4) a certificate of authorisation of tissue establishments in the scope of activities
imports of tissues and cells from third countries released by the Institute includes the following
requirements:
and the name of the tissue establishment),
(b) tissue establishments database) code of the European Union,
(c) the contact details of the importing) of the tissue establishment
(d)) kind of imported tissues and cells,
e) activities of the importing tissue establishments in third countries,
(f) the conditions laid down for imports),
g) information about suppliers from third countries,
(h) the date of the grant of certificates of) the issue of permits the activity of tissue
the device in the range of imports of tissues and cells from third countries and
I) expiry date of the certificate of authorisation of activities
the tissue establishment to the extent of imports of tissues and cells from third countries.
(5) the model of the certificate of issue of the permit activity in the tissue establishment
the extent of imports of tissues and cells from third countries lays down detailed legal
prescription. ".
33. In article 20 (2). 1, the third and fourth sentence are deleted.
34. In article 20, paragraph 1, the following new paragraphs 2 and 3 shall be added:
"(2) Importing the tissue establishment is in the case of the proposed substantive changes
their activities required in advance to request a change to enable
the extent of imports of tissues and cells from third countries. Such changes are
considered, in particular the species imported tissues and cells, activities
carried out in third countries, which can affect the quality and
the safety of imported tissues and cells, or suppliers from third countries.
If importing a tissue establishment performs a one-time import of tissues
or cells originating from a third country supplier, which is
It does not apply to activities in the scope of the authorisation of imports of tissues and cells
from a third country, it is not considered a substantial change in imports, if the
importing a tissue establishment permission to imports of the same type of tissues
or cells from another supplier or suppliers from third countries. The request of the
the amendment of the authorisation of activities must contain information about a requested change in
extent provided in section 17.
(3) the Institute about the request under paragraph 1 or 2 shall have 30 days from the date of
its delivery, and shall proceed pursuant to section 18 and 19 shall apply mutatis mutandis. If they are
The Institute's new fact known, may initiate the procedure for amendment of the authorisation
action ex officio and shall have 30 days from the date of initiation of the proceeding,
with the procedure referred to in section 18 and 19 apply mutatis mutandis. In the case where it is needed
an investigation on the spot, extend the period referred to in the first sentence and
the second 90 days. ".
Paragraphs 2 to 4 shall become paragraphs 4 to 6.
35. In section 20 (2). 5, the words "§ 22 para. 3 "shall be replaced by ' section 22 para.
2. "
36. in the first section of his head in the following title VI, including the
Title:
' TITLE VI
THE ENCODING OF THE TISSUES AND CELLS
section 20b
(1) the single European code shall be distributed to all tissues and
cells that are put into circulation for use in humans. The single
European code is a unique identifier that consists of
and sequence identification of donation); donation identification sequence
It consists of a tissue establishment and the unique code number of the donation and
(b) the identification of sequences); identification of the sequence of
It consists of the product code numbers, fractions, and the end date of the period
usability.
In cases other than those referred to in the first sentence, if it is not stipulated
otherwise, it must be used at least in literature, at least
donation identification sequence.
(2) a single European Code referred to in paragraph 1 shall not apply in the case of
and) the donation of reproductive cells between husband and wife, who together make up the
infertile couple and are undergoing infertility treatment together,
b) tissues and cells, if they stay within one of the tissue establishment and in
one medical facility,
c) tissues and cells imported from a third country, if they stay away from imports to the
human applications under one of the tissue establishment and in one
a medical facility.
(3) 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 lays down detailed legal
prescription.
(4) the tissue establishment shall ensure
and the allocation of a single European code) to all tissues and cells, for which
This code must be used no later than prior to their distribution to the
human applications,
(b) donation identification sequence) to allocate tissues and cells after collection
or when the imports of tissues and cells from third countries; in the case of collections
the final product shall assign a new identification number for donation, and
traceability to ensure that each donation of tissue
the device in which the collection is carried out; means the physical collections
contact or mixing of tissues and cells from one or more subscriptions from
the same donors or from two or more donors in one container; sequence
donation identification after the allocation cannot be changed, except when the
needed to correct an error caused by incorrect entries, and any
fix must be properly documented,
c) using one of the used coding schemes and products
the corresponding numbers of the tissues and cells contained in the database
of tissues and cells, the European Union, and at the latest before their
distribution for human applications,
(d) the numbers of the fraction) and the date of expiration;
in the case of tissues and cells, for which there was no end date period
date end date must be a date which is indicated
the number of "00000000", and at the latest before their distribution to use in
man,
e) placing single European code on the label of the affected tissues and cells
an indelible and enduring form and putting it in the accompanying
documentation before the distribution of tissues and cells for use in
man; the tissue establishment may be entrusted to another product marking
providers that treated with tissues and cells, provided that it is
to ensure consistency with this Act, and in particular, with regard to the uniqueness of the
code; If the location of a single European code on the label prevents
the size of the label, the code must be clearly associated with tissues and cells,
on the packaging label is given, through the
supporting documentation, and
f) take the necessary measures in the event of an incorrect location
single European code on the label.
(5) the tissue establishment shall, without delay, but no later than 10 working days
the date on which the fact in question has been identified, inform the Department of, if
and) information in the database of the European Union of tissue establishments
require updating or repair,
(b)) the database of tissues and cells, the European Union requires
Update, or
(c)) notes that serious violations of the requirements in connection with the
the single European code relating to tissues and cells obtained from
other establishments in the European Union.
§ 20 c
The Institute in the field of encoding of the tissues and cells shall ensure:
and after the issue of the permit activity) under this Act, the data were entered into
a database of tissue establishments in the European Union; These data include
1. the name of the tissue establishment
2. the tissue establishment
3. address of the tissue establishment, where appropriate, the address of the workplace
the provider, which is a tissue establishment,
4. the contact details of which are electronic address, telephone number, and
the fax number,
5. the name of the authority which issued the authorisation of activities
6. the name of the authority responsible for the maintenance and updating of the data in the database
tissue establishments in the European Union,
7. management of tissues and cells, for which authorisation was granted, activity
8. putting the activities for which the authorisation was granted, and activities
9. data concerning any conditions or exceptions provided for in
enabling activities
(b) the allocation of unique numbers) of the tissue establishments all tissue
devices that have been granted permission to operate under this Act;
If the tissue establishment used for the allocation of unique numbers
donating more systems coding, allocates to each encoding system
a separate unique number
(c) the allocation of unique numbers) donation by implementing the rule
the regulation referred to in section 20b paragraph 1. 3, which is compatible with the common
the European code and
(d) data validation) tissue establishments registered in the database of tissue
the equipment of the European Union, and without undue delay, to update them, and
it if
1. is the new tissue establishment authorised activities,
2. details of the changes to the tissue establishment referred to in the database of tissue
the equipment of the European Union, or if information is not properly recorded,
3. changes to data that is the content of the enabling activities of the tissue
equipment, including authorization for the new kind of cells or tissues, enabling for
a new activity, conditions or exceptions in the authorization of the activity, or
4. for a partial or full suspension of the authorisation to a certain
activity or kind of tissues or cells, partial or full cancellation of the
the authorization of the activity of the tissue establishment or termination of the authorisation of activities
tissue establishment. ".
The former title VI to IX are referred to as title VII to X.
37. under article 21, the following new section 21a is inserted:
"§ 21a
The Institute also performs checks on suppliers from third countries who
concluded the contract pursuant to § 11a. 1 if it is necessary to verify whether the
to meet the quality and safety of imported tissues and cells
comparable with the requirements under this Act. Of any measures
to be adopted, the Institute shall decide, on the basis of consultations with the
the competent authority of the Member State which has submitted a request to conduct a
inspection. ".
38. In article 23, the following paragraphs 3 and 4 are added:
"(3) inspectors, who are charged with monitoring activities at suppliers of
third countries who contracted pursuant to § 11a. 1,
and evaluate and verify the procedures) and the activities carried out in the establishments
suppliers from third countries, which are important for equivalence
requirements for the quality and safety of tissues and cells that are or are to be
imported, with the requirements laid down in this Act,
(b) examine any documents or) records that are referred to
evaluation and verification of the material.
(4) a professional prerequisite for the performance of the functions of the Inspector is duly completed
University studies in the field of pharmacy or general medicine ^ 7),
biochemistry or biology and at least 3 years of professional experience in such
activity that is related to the area in which the control officer
activity. ".
39. In § 25 para. 3, the first sentence shall be deleted.
40. In § 25 para. 4 (b). (c)), the word "or" is deleted.
41. In § 25 para. 4 at the end of subparagraph (d)) shall be replaced by "dot,
or ' and the following point (e)), which read as follows:
"e) contrary to section 20 (2). 1 be treated with tissues and cells without decision
The Institute for change enabling activities or changing the persons responsible or change
or part of the activities provided by the contract. ".
42. In § 25 para. 6 c) and (d)):
"(c)) does not ensure compliance with the rules of good distribution practice in the
distribution of tissues and cells referred to in § 5 para. 1 (b). k),
(d)) shall ensure imports of tissues and cells from third countries in violation of § 11 (1)
1. "
43. In § 25 para. 6 the following is added to point (e))) are added:
"e) shall ensure that the export of tissues and cells to third countries in violation of § 11B(2).
1,
f) ensure distribution of tissues and cells between the Czech Republic and other
a Member State in breach of section 12,
g) in violation of § 13 para. 1 ensure the distribution of the Member State or
imports from third countries in the case of the urgent needs of the tissues and cells without
the appropriate permissions
(h) fails to comply with the notification obligation) in accordance with § 13 para. 2,
I) contrary to section 20 (2). 2 be treated with tissues and cells without decision
The Institute for change activities within the scope of imports of tissues and cells of
a third country,
j) does not ensure compliance with the obligations in the area of tissues and cells referred to in encoding
section 20b paragraph 1. 4, or
k) fails to comply with information requirements under section 20b paragraph 1. 5. ".
44. In § 25 para. 7 (b). ) to c), the number "2" is replaced by "3".
45. In § 25 para. 8, the words "paragraph. 3 "shall be replaced by" paragraph. 4. "
46. In § 25 para. 10, the words "in violation of § 4 para. 2 comply with the requirements
on the preservation of documentation or traceability or availability
the stored tissues and cells for the purpose of use "is replaced by" meet the
documentation retention requirements, traceability, or availability
the stored tissues and cells for the purpose of use in accordance with § 4 para. 2. "
47. In paragraph 25, after paragraph 10, insert a new paragraph 11 is added:
"(11) the provider is guilty of an administrative offense that does not ensure
compliance with the written instructions of the tissue establishment pursuant to § 3 (2). 5. ".
The present paragraph 11 shall become paragraph 12.
48. In § 25 para. 12 (a). and) (a) after the words ". (b)) "the words" and
(e)) "and the words" and (d)) "shall be replaced by" e) to) ".
49. In § 25 para. 12 (a). (b)), after the words "paragraph 6 (a). (b)) "
the words "and (d))" and the words "and to paragraph 10" shall be replaced by the words "up to 11".
50. in section 26 para. 4, the words "§ 11 (1) 1 (b). (c)), section 11 (1) 2 (a).
(c)), section 11 (1) 3 or section 11 para. 4 (b). a) "is replaced by" section 11
paragraph. 2, section 11B(2). 2 and § 12 ".
51. In article 29, the words "§ 5 para. 2 "shall be replaced by the words" § 5 para. 3 ", the words
"§ 17 para. 4 "shall be replaced by the words" § 17 para. 6, § 19 para. 5 "and
the words "section 20a para. 2 "with the words" section 20b paragraph 1. 3. "
Article II
Transitional provisions
1. For tissues and cells that are stored on the day 29. October 2016 according to the
Act No. 296/2008 Coll., in the version in force before the date of entry into force of
This Act shall not apply to obligations relating to the single
the European code under this Act, if
and) these tissues and cells will be put into circulation in the Member States
The European Union or in a Contracting State to the agreement on the European economic
space to 29 April. October 2021 and
(b) ensuring full traceability) of these tissues and cells in other
resources.
2. For tissues and cells, which will be put into circulation after the date of 29. October
2021 and to which it is not possible to place a single European code, in particular,
that the tissue and cells are within the storage of deep-frozen,
tissue establishments shall apply the procedures set out in section 20b paragraph 1. 4 (b). (e))
Act No. 296/2008 Coll., in the version in force from the date of entry into force of
of this Act.
3. enabling activities, including enabling activities with permission to lay off workers
and distribute tissues and cells that are being exported to another
State other than the Member State of the European Union or a State party to the agreement on
The European economic area, or of the distribution between the Czech Republic
and another Member State of the European Union or in a Contracting State to the agreement on
European economic area issued under Act No. 296/2008 Coll., in
the version in force before the date of entry into force of this law, shall be construed as
permit activity issued under Act No. 296/2008 Coll., in the version in force
from the date of entry into force of this Act.
4. tissue establishments, which carry out imports of tissues and cells from another
State other than the Member State of the European Union or a State party to the agreement on
The European economic area, on the basis of enabling activities with
permission to lay off workers and distribute tissue and cell type, which is
the subject of imports, issued pursuant to Act No. 296/2008 Coll., as amended by
effective before the date of entry into force of this Act shall submit to the
Institute for drug control application for authorization of the activity of the tissue establishment
the extent of imports of tissues and cells from third countries pursuant to § 17 para. 4 of the law
No. 296/2008 Coll., in the version in force from the date of entry into force of this
the Act, until 31 December 2006. August 2017. The tissue establishment may import of tissues and
cells from third countries on the basis of the authorization of the activity referred to in the sentence
first take place not later than 31 December 2006. December 2017.
Article. (III)
The effectiveness of the
This Act shall take effect on the 15th day following its publication.
Hamáček in r.
Zeman in r.
Sobotka in r.
