Act No. 526 / 2020 Coll.
Act amending Act No. 22 / 1997 Coll., on Technical Requirements for Products, and amending and supplementing certain acts, as amended, and Act No. 90 / 2016 Coll., on Conformity Assessment of Specified Products when Making Products Available, as amended
Valid
Law
Effective from 01.01.2021
Text versions:
01.01.2021
17.12.2020
526
THE LAW
of 12 November 2020
amending Act No 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain acts, as amended, and Act No 90 / 2016 Coll., on conformity assessment of specified products when making them available on the market, as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Act on Technical Requirements for Products
Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 205 / 2002 Coll., Act No. 226 / 2003 Coll., Act No. 277 / 2003 Coll., Act No. 155 / 2010 Coll., Act No. 34 / 2011 Coll., Act No. 100 / 2013 Coll., Act No. 64 / 2014 Coll., Act No. 91 / 2016 Coll., Act No. 183 / 2017 Coll., Act No. 265 / 2017 Coll., and Act No. 277 / 2019 Coll., is amended as follows:
1. In Paragraph 5 (2), the words "and maintains a database of Czech technical standards and other technical documents (hereinafter referred to as" databases ") shall be added at the end of the last sentence."
2. In Article 5, the following sentence is added at the end of paragraph 3: "The Agency is also the administrator of the fee for the provision of Czech technical standards and other technical documents, the fee for access to the database and the fee for sponsored access to Czech technical standards and other technical documents. The Agency's budget shall be a public budget for the purposes of managing such fees. ';
3. In Article 5 (6), the first sentence is added at the end of the text "except to allow sponsored access to Czech technical standards and other technical documents' and the second sentence is deleted.
4. In Article 5 (8), the words "and other technical documents' shall be inserted after the words" standards' and the words "the Office 'shall be replaced by the words" Agencies'.
5. In Article 5, the following paragraph 9 is added:
"(9) In order to issue the Decree implementing § 6a (4), § 6b (4) and § 6d (3), the Office shall submit to the Ministry of Industry and Trade (hereinafter referred to as" the Ministry ') a proposal for a fee rate pursuant to § 6a and a proposal for the amount of the fee pursuant to § 6b and 6d.'
6. After Paragraph 6, the following Sections 6a to 6d are inserted:
Fee for providing Czech technical standards and other technical documents
(1) The fee for providing Czech technical standards and other technical documents is payable by the applicant for the provision of Czech technical standard or other technical document included in the database.
(2) The subject of the fee for providing Czech technical standards and other technical documents is the provision of Czech technical standard or other technical document included in the database.
(3) The basis of the fee for providing Czech technical standards and other technical documents is the number of pages provided by Czech technical standards or other technical documents included in the database.
(4) The fee for providing Czech technical standards and other technical documents is no more than CZK 20 per page. The fee rate shall be determined by implementing legislation.
(5) The fee for providing Czech technical standards and other technical documents shall be payable within 14 days of the date of application for the provision of the Czech technical standard or other technical document included in the database. If the taxpayer does not pay the fee in time and at the correct amount, the administrator of the fee will not provide the Czech technical standard or any other technical document and the fee obligation will cease.
(6) The income from the fee for providing Czech technical standards and other technical documents is the income of the Agency's budget. If the Office is the administrator of the charge, the fee shall be the revenue of the state budget.
Fee for access to the database
(1) The fee for access to the database is payable by the applicant for access to the database or by the applicant for additional printing.
(2) The fee for access to the database shall be:
(a) the provision of access rights to the database without the possibility of printing for a maximum of 12 consecutive calendar months;
(b) the provision of access rights to a database with the possibility of printing for a maximum of 12 consecutive calendar months;
c) additional possibility of printing Czech technical standards and other technical documents from the database.
(3) The amount of the access fee to the database shall not exceed:
(a) 10 000 CZK for the fee referred to in paragraph 2 (a),
(b) the sum of the sum of CZK 10,000 and the sum of CZK 20 per party in the event of a fee as referred to in paragraph 2 (b),
(c) 20 CZK per page in the case of a fee as referred to in paragraph 2 (c).
(4) The amount of the fee for access to the database is laid down in the implementing legislation.
(5) The fee for access to the database shall be payable within 14 days of the date of application. If the fee is not paid in a timely and correct manner, the administrator of the fee shall not provide access rights to the database or supplementary printing option and the fee obligation shall cease.
(6) The revenue from the fee for access to the database is the revenue of the Agency's budget. If the Office is the administrator of the charge, the fee shall be the revenue of the state budget.
Sponsor access to Czech technical standards and other technical documents
(1) Sponsorized access to Czech technical standards and other technical documents means the free provision of access to the Czech technical standard or other technical document which, for the purposes of the specific legislation, is binding on end-users on the basis of registration in a way which allows remote access.
(2) Where the Czech technical standard or other technical document is binding for the purposes specified in the specific legislation, the Ministry or any other central administrative authority within the scope of this specific legislation shall ensure that the Agency is sponsored access to this Czech technical standard or other technical document.
(3) The Agency shall negotiate with the Ministry or any other central administration within whose jurisdiction the specific legislation referred to in paragraph 1 falls under the agreement on the sponsored access to the Czech technical standards and other technical documents.
Fee for sponsored access to Czech technical standards and other technical documents
(1) The fee for the fee for sponsored access to Czech technical standards and other technical documents is the Ministry or other central administrative office which provides sponsored access to Czech technical standards and other technical documents.
(2) The subject of the fee for sponsored access to Czech technical standards and other technical documents is to allow sponsored access to Czech technical standards and other technical documents.
(3) The amount of the fee for sponsored access to Czech technical standards and other technical documents amounts to a maximum of CZK 23 000 000 per 12 consecutive calendar months based on the number of pages of the Czech technical standard or other technical document made available and the expected number of end users. The amount of the fee shall be determined by implementing legislation.
(4) The fee for sponsored access to Czech technical standards and other technical documents shall be payable within 30 days of the date of application of the agreement on sponsored access to Czech technical standards and other technical documents between the taxpayer and the administrator of the fee. If the taxpayer does not pay the fee in time and at the right amount, the fee manager sponsored access to Czech technical standards and other technical documents will not allow and the fee obligation will cease.
(5) The income from the fee for sponsored access to Czech technical standards and other technical documents is the income of the Agency's budget. "
7. In the second sentence of Article 7 (8), "Ministry 'is replaced by" Ministry'.
8. In Article 7 (9), "Ministry 'is replaced by" Ministry'.
9. In Article 15, the following paragraph 5 is added:
"(5) The Ministry is the competent administrative body of the accreditation body."
10.Paragraph 16 (8) reads as follows:
"(8) The appeal against the decision of the accreditation body shall be decided by its statutory body. The appeal has no suspensory effect. The proposal for a decision on appeal shall be submitted to the statutory body of the Commission set up for that purpose. This committee shall have at least five members. The President and the other members of the Commission shall be appointed by the statutory body. The members of the panel shall be experts who do not otherwise participate in the performance of the accreditation body. ';
11. The following Paragraph 19c is inserted after Paragraph 19b, which includes the title:
Official Journal
The Office publishes the Bulletin of the Office, which is a publication collection in the field of technical standardisation, metrology and state testing. In particular, important notices concerning the creation and publication of Czech technical standards and other technical documents are published in the Office Bulletin, notifications concerning notified persons in the field of state testing, notifications concerning authorised persons in the field of metrology and the Agency price list. The Office shall publish the Bulletin of the Office in a manner that allows remote access. ';
12. In Paragraph 22, the present text becomes paragraph 1 and the following paragraph 2 is added:
"(2) The Ministry shall issue a decree for the implementation of Sections 6a (4), 6b (4) and 6d (3)."
Transitional provision
Proceedings which were not final before the date of entry into force of this Act shall be completed in accordance with Act No. 22 / 1997 Coll., as effective before the date of entry into force of this Act.
Amendment of the Act on conformity assessment of specified products when making them available on the market
Act No. 90 / 2016 Coll., on the conformity assessment of specified products when making them available on the market, as amended by Act No. 183 / 2017 Coll. and Act No. 265 / 2017 Coll., is amended as follows:
1. in Article 2 (1) and (2), "23" is replaced by "17."
2. In Part Two, Title I, the following sections 4 and 5 are inserted after Section 3, including the headings and footnotes 14 to 17:
Medical devices
(1) In the Czech Republic, the Authority is the body responsible for notified bodies under the directly applicable European Union law in the field of medical devices (14).
(2) Where a directly applicable European Union regulation in the field of medical devices refers to a language designated or requested by a Member State for documents submitted by an authority referred to in paragraph 1 for the purpose of appointing conformity assessment bodies, that language shall be Czech in the Czech Republic.
(3) In the notification procedure, the period referred to in Article 19 (2) shall be extended by the time limits laid down in the directly applicable European Union law in the field of medical devices (15).
In vitro diagnostic medical devices
(1) In the Czech Republic, the Authority is the authority responsible for notified bodies under the directly applicable European Union Regulation on diagnostic medical devices in vitro16).
(2) Where the directly applicable European Union Regulation in the field of in vitro diagnostic medical devices refers to a language designated or requested by a Member State for the documents submitted by an authority referred to in paragraph 1 for the purpose of designating conformity assessment bodies, that language shall be the Czech language in the Czech Republic.
(3) In the notification procedure, the period referred to in Article 19 (2) shall be extended by the time limits laid down in the directly applicable European Union law in the field of diagnostic medical devices in vitro17).
(14) Regulation (EU) 2017 / 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 / 83 / EC, Regulation (EC) No 178 / 2002 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90 / 385 / EEC and 93 / 42 / EEC.
15) Article 39 of Regulation (EU) 2017 / 745 of the European Parliament and of the Council.
16) Regulation (EU) 2017 / 746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98 / 79 / EC and Commission Decision 2010 / 227 / EU.
17) Article 35 of Regulation (EU) 2017 / 746 of the European Parliament and of the Council. '
3. in Article 54 (2) (a), the word "or" shall be deleted;
4. In Article 54, at the end of paragraph 2, the dot is replaced by "or 'and the following point (c) is added:
"(c) fails to fulfil one of the obligations of the notified body under the directly applicable European Union Regulation referred to in paragraphs 27 to 27d. ';
5. In Article 54 (5), the words "or (c) 'shall be added at the end of the text of point (c).
EFFECTIVE
This Act shall take effect on the 15th day following its publication.
Vondracek v. r.
Zeman v. r.
Babiš v. r.
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Regulation Information
| Citation | Act No. 526 / 2020 Coll., amending Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain acts, as amended, and Act No. 90 / 2016 Coll., on conformity assessment of specified products when making them available on the market, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.12.2020 |
|---|---|
| Effective from | 01.01.2021 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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