Act No. 490 / 2009 Coll.
Law amending certain laws relating to the adoption of a Regulation of the European Parliament and of the Council laying down requirements on accreditation and market surveillance relating to the marketing of products
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Effective from 01.01.2010
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490
THE LAW
of 10 December 2009
amending certain laws relating to the adoption of a Regulation of the European Parliament and of the Council laying down requirements on accreditation and market surveillance relating to the marketing of products
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. 186 / 2006 Coll., Act No. 229 / 2006 Coll., Act No. 481 / 2008 Coll. and Act No. 281 / 2009 Coll., is amended as follows:
1. The heading of Part One reads: "TECHNICAL REQUIREMENTS FOR PRODUCTS AND ACCREDITATION OF CONFORMITY ASSESSMENT BODIES '.
2. In Paragraph 1, the current text becomes paragraph 1 and paragraph 2 is added, which includes footnote 1a:
"(2) This Act further regulates the accreditation of conformity assessment bodies (hereinafter referred to as" accreditation ') following the directly applicable regulation of the European Community1a.
(1a) Regulation (EC) No 765 / 2008 of the European Parliament and of the Council of 9 July 2008 laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339 / 93. "
Footnotes 1a and 1b to date shall be renumbered as footnotes 1b and 1c, including the footnotes.
3. In Article 2 (g), the words "conduct a subsequent business after the placing on the market (" distributes') 'are replaced by the words "supplies the products on the market; making the product available on the market is any subsequent transfer or transfer after its placing on the market (" distribution') '.
4. Paragraph 12 (6) reads as follows:
"(6) The Government shall, by regulation, determine the graphic form of the designation of the specified product, its design and its location on the product or in the accompanying documentation, unless the graphic form of the designation of the specified product is laid down in a directly applicable regulation of the European Communities. ';
5. The following title shall be inserted after Section 13b:
ACCREDITATION OF CONFORMITY ASSESSMENT BODIES '.
Title IV of Part One shall be renumbered Title V.
(6) Sections 14 to 16, including the headings, read:
Accreditation
The performance of the competence of the Czech Republic under the regulations of the European Community1a) for the field of accreditation is ensured and implemented by the Ministry.
Accreditation body
(1) The Ministry may delegate only one legal person (hereinafter referred to as the "accreditation body") to the decision to exercise the competence of the accreditation body (1a).
(2) The Ministry shall decide on a mandate to carry out accreditation at the request of a legal person. In the Decision, the Ministry shall define the scope of the implementation of the accreditation. It shall assess whether a legal person will be able to comply with the requirements of the accreditation body laid down by the directly applicable European Communities Regulation (1a).
(3) If the accreditation body fails to comply with the obligations or ceases to comply with the requirements laid down in the directly applicable Regulation of the European Communities (1a) or in a delegation decision, or if it so requests, the Ministry shall amend or revoke the delegation decision.
(4) The delegation decision for the implementation of accreditation and the decision to amend or repeal the decision will be published by the Ministry in the form of a communication in the Collection of Laws.
Accreditation certificate
(1) The accreditation body shall, at the request of a conformity assessment body, decide on the issue of an accreditation certificate (hereinafter referred to as "certificate") where that body complies with the requirements for carrying out a specific conformity assessment activity which lays down harmonised standards and, where appropriate, other conformity assessment documents (hereinafter referred to as "requirements"). The accreditation body shall take into account the certificates already issued for the same conformity assessment body when assessing the application. If the certificate referred to in the first sentence cannot be issued without delay, it shall be issued by the accreditation body no later than 120 days after the date of receipt of the application. In particular justified cases, the accreditation body may decide within a longer period but not more than five months.
(2) The application shall contain:
(a) the name, surname and address of the natural person or business name and registered office of the conformity assessment body;
(b) the subject matter and scope of the conformity assessment body's activities required.
The accreditation body may request further information or documents necessary to assess the required subject matter of the activities of the conformity assessment body.
(3) If the conformity assessment body does not meet the requirements, the accreditation body shall reject the application by decision of issuing the certificate.
(4) The conformity assessment body is obliged to pay the accreditation body the costs actually incurred in assessing its application; the amount of the costs shall be decided.
(5) The certificate shall contain the identification data of the accreditation body and the conformity assessment body and the definition of the subject, scope and conditions of operation of the conformity assessment body covered by this certificate and its duration. Notifications of certificates issued shall be published in the Official Journal of the Office and shall be published by the accreditation body in a way that allows remote access.
(6) The accreditation body may carry out a compliance check with the requirements of the conformity assessment body. Where the accreditation body finds that the conformity assessment body does not comply with the requirements on the basis of which it has been certified, it shall decide on the suspension of the validity of the certificate and shall set a time limit for redress. If the conformity assessment body fails to remedy it within the time limit set, the accreditation body shall decide to revoke the certificate.
(7) An appeal against an accreditation body's decision to refuse an application for a certificate, suspend the validity of the certificate or revoke the certificate shall be decided by the Ministry. The appeal has no suspensory effect.
(8) Where the accreditation body receives a complaint concerning the activities of a conformity assessment body to which it has issued a certificate, it shall examine it and report the outcome of the investigation to the complainant within 60 days of receipt of the complaint. If the complaint has been found to be justified, the accreditation body shall take the necessary measures to remedy it as referred to in paragraph 6 without delay. ';
7. Paragraph 18, including the title and footnotes Nos 4 to 4d, reads:
Supervision
(1) Supervision of whether the specified products are placed and made available on the market or put into service in accordance with the requirements laid down in this Act and whether the products are not unduly marked with the CE marking according to the directly applicable regulation of the European Communities (1a), or any other designated designation under this Act, is carried out by the Czech Trade Inspection4, or to the extent specified by specific legislation
(a) Czech Mining Authority (4a),
(b) Rail authorities (4b),
(c) where appropriate, another office, where the special law so provides
("supervisory authorities').
(2) In addition to the powers of the supervisory authorities under the Act on State Control or under special legislation4c)
(a) to take the necessary samples of products or samples from a series of products as a replacement from controlled persons to assess whether these products comply with the requirements of this Act, unless otherwise provided for in a separate law; for samples of products taken, a refund shall be granted to the person checked at the price at which the product is offered at the time of sampling; no refund shall be granted if the person checked renounces it; there is no entitlement to the refund in respect of a product which does not comply with the requirements laid down by this law or, where appropriate, with the provisions laid down for its implementation;
(b) carry out analyses or carry out analyses to verify that the products comply with the requirements of this law; Such analyses shall be carried out with the competent authorities or persons; where it has been established by analysis that the product does not comply with the requirements of this Act, the cost of the analysis shall be borne by the controlled person;
(c) require controlled persons to remedy the deficiencies identified, their causes and the harmful consequences within the time limit set, or to implement the necessary measures to remedy them without delay; Having regard to the seriousness of the risk identified, the supervisory authority may require such persons to inform the supervisory authority of the measures taken,
(d) require controlled persons to inform without delay of the danger of persons likely to be exposed to the risk arising from the product.
4) Act No. 64 / 1986 Coll., on Czech Trade Inspection, as amended.
4a) Act No. 61 / 1988 Coll., on Mining Activities, Explosives and State Mining Administration, as amended.
4b) Act No. 266 / 1994 Coll., on Railways, as amended.
4c) For example Act No. 64 / 1986 Coll., on Czech Trade Inspection, as amended.
4d) § 21 of Act No. 61 / 1988 Coll. '
8. After Paragraph 18, the following Sections 18a and 18b are inserted:
Safeguard measures
(1) Where the supervisory authority has reason to suspect that the product does not comply with the requirements of this Act, it shall prohibit the placing on the market or distribution of the product or series of products for the period necessary to carry out the inspection.
(2) The supervisory authority shall notify the orally controlled person of the imposition of the measures referred to in paragraph 1 and shall immediately record it in writing. If the person concerned does not agree to the action imposed, he may object to it, which shall be indicated in the alert, or may submit it in writing no later than 3 days after the date on which the person concerned has been informed of the alert. The supervisory authority shall decide without delay on the objections submitted. The written copy of the objection decision shall be served on the person checked. No appeal is admissible against a decision on objections.
(3) Where the supervisory authority finds that a product does not comply with the requirements of this Act or is an article which is unduly bearing the CE marking or other marking provided for in this Act, it shall decide to prohibit the placing on the market or distribution of such a product. If the reasons for imposing the prohibition are waived, the supervisory authority shall decide to amend or revoke it. An appeal against a decision under the first sentence shall not have suspensory effect.
(4) Where the supervisory authority finds that a product or series of products poses a threat to the legitimate interest, the supervisory authority shall decide to withdraw the product or series of products from the market or from distribution. At the same time, the supervisory authority may, if necessary, order the destruction of a product or a series of products or order another form of degradation. An appeal against a decision under the first sentence shall not have suspensory effect.
(5) In the event of the imposition of the measures referred to in paragraph 3 or 4, the supervisory authority shall at all times state in the reasons for the decision the specific reasons for the imposition of the measures defined for the specified product by the Government Regulation.
Notification obligation
(1) The supervisory authorities are required to notify the Ministry of Justice of the adoption of measures concerning a product or a series of products where the product presents a serious risk (4e). This shall also apply in the case of a measure taken by the supervised entity on its own initiative and the supervisory authority shall receive information on that measure.
(2) The information provided to the Ministry shall contain all available details, in particular the data necessary for the identification of the product, its origin, the supply chain, the threat posed by the product, the nature and duration of the measure taken by the supervisory authority and, where appropriate, information on the voluntary measure taken by the controlled person.
(3) If the threat referred to in paragraph 1 exceeds the territory of the Czech Republic, the Ministry shall immediately inform the Commission of the European Communities of the presence of such product.
(4) If the Ministry receives information from the Commission of the European Communities on the adoption of measures against a product or a series of products presenting a serious risk, it shall forward that information to the supervisory authorities without undue delay for further action.
(5) In order to ensure the functioning of the information exchange system referred to in paragraphs 1 to 3, specific legislation governing procedures, content and form of information on the occurrence of hazardous non-food products4f shall apply mutatis mutandis.
(6) The staff of the relevant ministries and supervisory authorities shall be required to maintain confidentiality regarding information concerning products and obtained within their scope, with the exception of information which must be published in order to protect the health and safety of consumers and to ensure effective control of the market and the activities of the supervisory authorities.
4e) Article 20 of Regulation (EC) No 765 / 2008 of the European Parliament and of the Council.
(f) Government Regulation No 396 / 2004 Coll., on procedures, content and form of information on the occurrence of dangerous non-food products. '
9.
"Administrative offences
Transfers
(1) A natural person commits an offence by:
(a) misuse of the CE marking or other designated marking, certificate or other document under this law, or of the certificate or other document under this law falsifies or modifies,
(b) in contravention of Article 4 (2), the document shall mark the CSN mark; or
(c) multiply or extend the Czech technical standard or part thereof in contravention of § 5 (8).
(2) A fine of up to CZK 20 000 000 may be imposed for the offence referred to in paragraph 1 (a) and a fine of up to CZK 1 000 000 for the offence referred to in paragraph 1 (b) or (c). "
10. After Paragraph 19, the following Sections 19a and 19b are inserted:
Administrative offences of legal and business natural persons
(1) A natural person, whether legal or legal, commits an administrative offence by:
(a) misuse of the CE marking or other designated marking, certificate or other document under this law, or of the certificate or other document under this law falsifies or modifies,
(b) in contravention of Article 4 (2), the document shall mark the CSN mark;
(c) multiply or extend the Czech technical standard or part thereof in contravention of § 5 (8);
(d) carry out a conformity assessment activity reserved for the purposes of this Act to an authorized person without authorisation pursuant to Article 11 (1); or
(e) carry out a conformity assessment activity reserved for the purposes of this Act to an accredited person without a certificate pursuant to Article 16 (1).
(2) An authorised person commits an administrative offence by failing to fulfil one of the obligations under Paragraph 11a (2).
(3) The manufacturer, importer, authorised representative or distributor commits an administrative offence by placing on the market or putting into service or distributing specified products
(a) without the CE marking or any other marking or document provided for by a government regulation;
(b) with a designation or document contrary to Article 13;
(c) fails to comply with a safeguard measure granted under Paragraph 18a (2), (4) or (5); or
(d) fails to fulfil the obligation imposed by the supervisory authority pursuant to Article 18 (2) (c) or (d).
(4) A fine shall be imposed for the administrative offence:
(a) 50 000 000 CZK if it is an administrative offence pursuant to paragraph 3;
(b) 20 000 000 CZK if it is an administrative offence referred to in paragraph 1 (a), (d) or (e);
(c) 1 000 000 CZK if it is an administrative offence referred to in paragraph 1 (b) or (c) or paragraph 2.
Common provisions on administrative offences
(1) The legal person shall not be liable for an administrative offence if he proves that he has made every effort to prevent an infringement.
(2) The determination of the amount of the fine shall take into account the seriousness of the administrative offence, in particular the manner in which it was committed and the consequences thereof and the circumstances in which it was committed.
(3) The liability of a legal person for an administrative offence shall cease if the administrative authority has not initiated proceedings against him within 3 years of the date on which he became aware of him, but not later than 5 years from the date on which he was committed.
(4) Administrative offences referred to in Articles 19 (1) (b) and (c), 19a (1) (b), (c), (d) and (e) and 19a (2) at first instance shall be dealt with by the Office, administrative offences referred to in Articles 19 (1) (a) and 19a (1) (a) and 19a (3) at first instance shall be dealt with by the supervisory authority.
(5) The provisions of this Act on liability and sanctions of a legal person shall apply to liability for acts which have taken place in or directly related to the business of a natural person. ';
Transitional provisions
1. The accredited person responsible for carrying out accreditation of conformity assessment bodies under existing legislation shall be considered an accreditation body under Act No. 22 / 1997 Coll., as effective from the date of entry into force of this Act, until a new decision to delegate the accreditation body has been taken, but no more than 2 years from the date of entry into force of this Act.
2. The Accreditation Person shall issue an Accreditation Certificate pursuant to Act No. 22 / 1997 Coll., as effective by the date of entry into force of this Act.
3. An accreditation certificate issued under the existing legislation shall be considered an accreditation certificate under Act No. 22 / 1997 Coll., as effective from the date of entry into force of this Act, only for the period for which it was issued, but not until 31 December 2014 at the latest.
4. The proceedings for fines initiated before the date of entry into force of this law shall be completed in accordance with the existing rules.
Repeal
Government Decree No 291 / 2000 Coll., laying down the graphic form of the CE marking, is hereby repealed.
Amendment to the Plant Health Act
Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Acts, as amended by Act No. 626 / 2004 Coll., Act No. 444 / 2005 Coll., Act No. 131 / 2006 Coll., Act No. 189 / 2008 Coll., Act No. 249 / 2008 Coll., Act No. 227 / 2009 Coll. and Act No. 281 / 2009 Coll., is amended as follows:
1. Paragraph 39, including the title, reads:
Information on adverse effects of preparations and exchange of information
(1) The holder of a decision granted under Sections 34 to 38, 53 or 54 must immediately notify the phytosanitary authorities in writing of new information on the potential and identified dangerous effects of the product or other means of human, animal or environmental health, including residues of the active substance. The plant health administration shall immediately forward the information to the other Member States of the European Union and to the Commission.
(2) The Plant Health Administration shall publish in the Bulletin information on decisions taken pursuant to Articles 34 to 38, 53 or 54, indicating at least:
(a) the name or name or business name of the holder of the decision;
(b) the trade name of the preparation or other device,
(c) the type of formulation of the preparation or other device,
(d) the name and quantity of active substance contained in the preparation or active ingredient contained in another device;
(e) the uses for which the preparation or other device is intended,
(f) maximum residue limits, unless the provisions of the European Communities have already been established (1),
(g) the data necessary for the evaluation of the MRLs established;
(h) the reasons for the revocation of the decision, including the identified dangerous effects of the preparation or other device.
The plant health service shall also inform the other Member States of the European Union and the Commission in writing of the marketing authorisations issued and of the withdrawal of the marketing authorisation no later than 1 month after the end of each calendar quarter, giving the information referred to in the first sentence.
(3) The plant health administration will publish annually in the Bulletin a list of products and other resources authorised in the Czech Republic pursuant to Sections 34 to 38, 53 or 54. The plant health service shall also forward annually the list referred to in the first sentence to the other Member States of the European Union and to the Commission.
(4) The plant health administration is authorised to inform the public, through the media, of the potential and identified dangerous effects of the preparation or of any other device on human, animal and environmental health, including residues of the active substance, to the extent specified in paragraph 2 (a) to (h). "
2. in Paragraph 42 (1) (r):
"(r) the expiry date clearly and clearly stated, corresponding to the expiry date specified in the Marketing Authorisation."
3. Paragraph 43, including the title, reads:
Control of preparations and other means
(1) Control of preparations and other means is meant to check compliance with the conditions, requirements and obligations laid down in this Act, its implementing legislation and decisions or authorisations pursuant to § 53 or 54 of the plant health administration to natural and legal persons and concerning preparations or other products such as products, their placing on the market, storage, storage within the framework of distribution and use.
(2) The control of preparations and other means also means their laboratory tests to verify that the composition of the preparation, its chemical, physical and technical properties, and, where appropriate, the biological properties, if any, of the product containing micro-organisms, comply with the conditions laid down in the decision or authorisation, including the particulars on the basis of which it was issued.
(3) The use of the product and other means shall mean all activities directly directed towards its application, in particular hand or temporary storage outside distribution, immediate handling, dilution, mixing and application by means of the application device itself.
(4) The production, re-packaging and re-labelling of preparations or other means are also subject to control where this activity is intended for marketing.
(5) In order to identify deficiencies, plant health authorities may impose measures in accordance with Article 75 or Article 76 (1) (f) or (g).
(6) The product or other device presents a serious risk in particular if its effects have not been assessed in the decision-making process.
(7) Samples of consumer packaging with the product or other means of laboratory testing are taken by the phytosanitary service
(a) the place where distribution, sale or storage takes place after notification to the holder of the decision or to the holder of an authorisation pursuant to § 53 or 54; or
(b) even without notification to the holder of the decision or to the holder of the authorisation pursuant to Article 53 or 54, where this is expedient in relation to a controlled product or other device and circumstances.
A certificate shall be drawn up for sampling, including the price of the sample taken at which the sample was taken by its owner.
(8) The holder of a marketing authorisation or authorisation pursuant to § 53 or 54 is required to deliver for his own cargo at the request of the phytosanitary service
(a) the analytical standard of the active substance contained, where appropriate, of the active ingredients accompanied by an analytical certificate;
(b) analytical standards of toxicological or ecotoxicological impurities;
(c) a sample in intact sales packaging corresponding to the manufacturing number (s) of the product or other device placed on the market in the Czech Republic, in the quantities strictly necessary for carrying out the control analyses and within the time limit and place specified by the plant health authority.
(9) The marketing authorisation holder or the authorisation holder referred to in Article 53 or 54 shall, in the case of sampling as referred to in paragraph 7 (a) or (b), pay the owner the price at which the sample was taken by the owner as indicated in the certificate referred to in paragraph 7.
(10) Where the plant health authority finds that the sample taken pursuant to paragraph 7 complies with the law and implementing rules, it shall provide the marketing authorisation holder or the authorisation holder with a refund of the price paid pursuant to paragraph 9, which shall not exceed the normal price, provided that the marketing authorisation holder or the authorisation referred to in Article 53 or 54 applies for the refund within a period of 2 months from the date of notification of the result of the laboratory examination; the entitlement to compensation shall cease in vain by the expiry of that period. Replacement shall be granted by the plant health service no later than 30 days from the date on which the marketing authorisation holder or the authorisation holder has applied for it pursuant to § 53 or 54.
(11) The person responsible for distributing the product or other device referred to in § 46a shall provide synergies under the procedure referred to in paragraph 7 and shall suffer the presence of the marketing authorisation holder or authorisation holder pursuant to § 53 or 54 when sampling. ';
4. The following Section 46a is inserted after Section 46, including the title and footnote 35a:
Distribution of products
(1) The distributor is any natural or legal person who places the products on the market.
(2) The places on which the business activity 35a) is handled by products or other means of distribution must meet the criteria laid down in the implementing legislation.
(3) The control of the distribution of preparations and other products is carried out by the plant health authority.
(4) A natural or legal person is obliged to:
(a) to supply products or other means only in intact sales packages;
(b) inform their customers immediately of any defects or adverse effects of the product or other device identified;
(c) keep documentation on the distribution of products or other means and on the origin of the products or other means distributed and ensure the availability of such documentation to the phytosanitary authorities for at least 5 years;
(d) provide the phytosanitary service on request with information on the types and quantities of products or other means it has supplied in the distribution;
(e) comply with the principles of good distribution practice;
(f) inform the phytosanitary service, upon request, of the places of storage of the products or other means.
(5) The implementing act provides for:
(a) principles of good distribution practice;
(b) the extent and manner of storage of documentation and records of the distribution of products or other products and their origin.
35a) Act No. 513 / 1991 Coll., Commercial Code, as amended. Act No. 455 / 1991 Coll., on Business Business (Trade Act), as amended. Act No. 252 / 1997 Coll., on Agriculture, as amended. '
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Regulation Information
| Citation | Act No. 490 / 2009 Coll., amending certain laws concerning the adoption of a Regulation of the European Parliament and of the Council laying down requirements on accreditation and market surveillance relating to the marketing of products |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.2009 |
|---|---|
| Effective from | 01.01.2010 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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