34/2006.



LAW



of 26 March. January 1, 2011,



amending Act No. 22/1997 Coll., on technical requirements for

products and amending and supplementing certain acts, as amended

the laws of the



Parliament has passed the following Act of the United States:



Article. (I)



Act No. 22/1997 Coll., on technical requirements for products and amending and

to certain laws, as amended by law No 71/2000 Coll., Act No.

102/2001 Coll., Act No. 204/2002 Coll., Act No. 228/2003 Coll., Act No.

277/2003 Coll., Act No. 186/2006 Coll., Act No. 229/2006 Coll., Act No.

481/2008 Coll., Act No. 281/2009 Coll., Act No. 490/2009 Coll. and act

No. 155/2010 Coll., shall be amended as follows:



1. In paragraph 2 (a). (b)), the words "the moment when the product is on the market of the European

for valuable consideration or free of charge for the first time, the community passed to or offered for

transfer for the purpose of distribution or use or when it for the first time

transferred ownership rights "shall be replaced by the words" the first delivery of the product to

the market as a commercial activity, which means the transfer or offer

to pass the product or transfer of title to the product for the purpose of

distribution, use or consumption in the market of the European Union ".



2. In paragraph 2 (d) at the end of the text), the words ", where appropriate,

trade mark; for the manufacturer, if so provided by the product or

product group, government regulation, is also considered a person who modifies the

the product already marketed in such a way that may affect its

compliance with the relevant technical requirements ".



3. In paragraph 2 (a). e), the words "the person who" shall be replaced by "person established in the

Member State of the European Union, "and the words" or the

product on the market provides "shall be deleted.



4. In paragraph 2 (a). g), the words "; the delivery of the product on the market, each other

his surrender or transfer after its placing on the market (hereinafter referred to as

"distribution") ' shall be deleted.



5. In paragraph 2, the period at the end of paragraph (i)) is replaced by a comma and the following

the letter j) is added:



"j) operator manufacturer, the importer, the distributor and the authorised

representative. ".



6. In article 7 (2). 7 (b). (b)) after the word "amendments" is inserted after the word ",

the suspension ".



7. In article 11 (1) 1, the third sentence is replaced by the phrases "in the case of a request for

authorization to assess conformity of products laid down in regulation of Government is

part of the request, the description of procedures and other activities in the conformity assessment.

The Office ensures compliance with the authorized persons in a single procedure

their activities ".



8. In section 11 (1) 4 the first sentence, the words "and the conditions laid down in the decision

about authorization ' shall be deleted.



9. in section 11 paragraph 5 is added:



"(5) if the notified body does the obligations laid down in this Act

or, on the basis of a change in the facts on the basis of

a decision on authorization lapses if the need for the existence of

an authorised person or authorised person so requests, the authority

shall decide on the



and suspension) certificate of authorization,



(b)) change the certificate of authorization, or



(c) cancel the certificate of authorization). ".



10. In article 11, paragraph 5, the following new paragraphs 6 and 7 are added:



"(6) in the decision to suspend the effectiveness of the certificate of authorization by

paragraph 5 (b). the Office shall specify a time limit) to rectify the situation. If the location

the notified body shall inform the redress without undue

delay of the Office. Where the Office finds sufficient redress cancels

the decision to suspend the effectiveness of the certificate of authorization. If

the authorized person fails to remedy within the prescribed period, the Office shall decide on the

change or cancellation of an authorization decision.



(7) in the case of cancellation of an authorization decision is authorized by the person

required after the legal force of the decision to pass the Office any

documents relating to the conformity assessment carried out by that person. In

event of a change or suspension of the certificate of authorization is effective

the authorized person shall after the legal force of such a decision

pass the documents under the first sentence of the Office if the Office so requests. ".



Paragraphs 6 to 8 shall be renumbered as paragraphs 8 to 10.



11. in section 11 paragraph 9 is added:



"(9) an authorized person shall become the notified persons notice

pursuant to § 7 para. 7 (b). (b)) or, in the cases provided for by regulation of the Government

the deadline of the notification if the European Commission or

the other Member States of the European Union raised objections within this period

against that notice, and may practise the notified body from the

date of receipt of communication from the Office that they have been notified. "



12. in section 11a. 2 (c)):



"(c)) in the cases and within the limits set by regulation of the Government



1. issue a certificate or other document, if you follow

the appropriate conformity assessment procedure has been demonstrated that the product complies with

the technical requirements laid down in the Decree of the Government under section 12

paragraph. 1 (b). (b)); the validity of this certificate or another document

an authorized person may restrict, suspend, or



2. calling the manufacturer to take appropriate corrective measures if

the authorized person in the course of the assessment of conformity or subsequently established that the

the products do not meet the technical requirements laid down in the relevant regulation

Government pursuant to § 12 para. 1 (b). (b)),



3. provide copies of certificates or other documents, including

related documents and information on the issue, refusal, amendment or

cancellation of certificates or other documents of the Office to the competent authority

surveillance, notified or to other persons whose activities are referred to

documents relating to the



4. inform the authority of any request of the supervisory authorities relating to the

conformity assessment activities,



5. inform the authority on request, assessment activities carried out by them

of conformity and any other activities, including

cross-border activities and subcontracting. ".



13. In Article 11a the following paragraph 4 is added:



"(4) If the authorized person receives a complaint pursuant to § 18 para. 3, is

to re-examine the certificate or other document issued under section 11a

paragraph. 2 (a). c) point 1 and of the outcome of the review to submit to the supervisory authority

message. ".



14. in section 13 paragraph 1 reads:



"(1) provided for the product may be placed on the market or, for products

laid down by regulation of the Government, put into operation only, provided that the

It meets the technical requirements laid down pursuant to § 12 para. 1 (b). (b)),

conformity assessment procedure referred to under § 12 para. 3 and if they are

compliance with the conditions referred to in paragraph 2. If the importer prior to launch

established product on the market and only considers or has reason to believe that

This product does not meet the technical requirements laid down pursuant to § 12 para.

1 (b). (b)) and, moreover, threatens the health, informs you of products

laid down by regulation of the Government of the competent supervisory authority and the manufacturer. ".



15. In § 13 para. 2, after the word "marking" the words ", other

the descriptions ".



16. in § 13 para. 8, the word "States" shall be replaced by the word "supplied".



17. in article 13, paragraph 9 is added:



"(9) the Distributor is obliged to act to prevent the distribution of

provided for products that clearly do not meet the requirements of the Act, in particular

products which do not bear the designation laid down and other

markings. For products set by regulation of the Government, distributor shall not

placing on the market provided for the product with which it considers or has reason to

believe that does not meet the technical requirements laid down pursuant to § 12 para. 1

(a). (b) in addition, the set). If a product endangers health, shall inform the

the distributor of the competent supervisory authority, the manufacturer and the importer. ".



18. in section 13 shall be inserted after paragraph 9, paragraphs 10 to 13 of that

shall be added:



"(10) the manufacturer or the importer of the products shall be laid down by regulation of the Government and

having regard to their nature and the risks that these products represent,

measures to protect the health and safety of persons.



(11) the manufacturer, importer or distributor, who believes or has reason to

to believe that provided for the product, which he introduced on the market or supplied,

does not meet the requirements of this Act or the regulations issued by the Government to its

the implementation is required to for the products laid down in regulation the Government do

the necessary measures to bring that product into conformity with these

requirements, download the product from the market or recall the product set,

that has already been delivered to the user; In addition, if established by a product endangers

health, the manufacturer, importer or distributor shall immediately inform the

the competent supervisory authority.



(12) the manufacturer, importer, distributor or authorised representative must keep

for products set by regulation of the Government data necessary to identify the

of all the economic operators who have submitted to him as determined by product and

that handed the set product.



(13) an importer or distributor shall ensure that the products set out in the regulation

Government storage and transport conditions which do not pose compliance

provided for the product, which intends to bring or ship on the market with the requirements of

This Act. ".



The present paragraph 10 shall be renumbered as paragraph 14.



19. in article 18, the following paragraph 3 is added:



"(3) the supervisory authorities can, if they have a reasonable doubt, that provided for

the product does not meet the technical requirements laid down in the relevant regulation

Government pursuant to § 12 para. 1 (b). (b)), to give an incentive to the notified body


review the certificate issued under section 11a. 2 (a). (c)), point 1. In

the case that proves that the product does not meet the requirements laid down by

the first sentence, the supervisory authorities may impose an authorized person to

the certificate has been removed. ".



20. in paragraph § 18a. 1, after the words "placing on the market", the words ",

entry into service ".



21. in paragraph § 18a. 3, after the words "placing on the market", the words ",

entry into service ".



22. in section 19(a)(1). 2, after the words "in accordance with" the words "§ 11 (1) 7

or ".



23. in section 19(a)(1). 3 (b). (c)), the words "paragraph § 18a. 2, 4 or 5 "

replaced by the words "§ 18a para. 1, 3 or 4 ".



24. In article 19a, paragraph 3, the following paragraph 4 is added:



"(4) a legal entity or individual entrepreneur is committed by the administrative

tort as



the importer fails to comply with an obligation) in accordance with § 13 para. 1 the second sentence,



(b) fails to comply with any of the) distributor obligations pursuant to § 13 para. 9,



(c) the manufacturer or importer fails to comply with) any of the requirements pursuant to § 13 para.

10,



(d)) the manufacturer, importer or distributor fails to fulfil any of the obligations

According to § 13 para. 11,



(e)) the manufacturer, importer, distributor or authorised representative fails to comply with

the obligation pursuant to § 13 para. 12, or



f) fails to comply with the obligation of importer or distributor pursuant to § 13 para. 13. ".



The current paragraph 4 shall become paragraph 5.



25. In section 19(a)(1). 5 at the end of subparagraph (c)) is replaced by a comma and dot

the following point (d)), which read as follows:



"d) 500 000 CZK in the case of an administrative offence referred to in paragraph 4.".



26. in section 19b paragraph 2. 4, after the words "§ 19 para. 3 "the words" and 4 ".



27. in paragraph 22, the words "§ 11 (1) 1 and 2 "shall be replaced by the words" § 11 (1) 1, 2

and 9 "and the words" and 13 "are replaced by the words" § 1 and § 18 para. 3. "



Article. (II)



This law shall enter into force on 20 March 2004. July 2011.



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