Legislative Alignment with the Old Approach Directives. Page 1 of 33

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1 Title /105/EEC 2001/83/EC 2004/27/EC 2001/20/EC 2004/24/EC Medicinal Products Medicinal products Act 124/11 45/09 71/07 Ministry of Health and Regulation (EC) No Ordinance on the criteria for wholesale pricing of 22/10 Act on Medicinal Products 124/11 141/2000 on orphan medicinal products and the methods for reporting 155/09 45/09 medicinal products wholesale prices 71/07 Ordinance establishing the criteria for inclusion of medicinal products in the basic and supplementary reimbursement lists of the Croatian Institute for Health Insurance 155/09 Ordinance on conditions for issuing marketing authorisation to specialised medicinal products retail shops Ordinance on the manner of advertising about medicinal products and homeopathic remedies 119/10 134/08 140/09 118/09 Ordinance on the quality control of medicinal products 56/05 Ordinance on pharmaco-vigilance 125/09 Ordinance on good practice in wholesale distribution of medicinal products Ordinance on the manner of monitoring irregularities in the medicinal products quality Ordinance on the procedure and method for granting marketing authorizations for medicinal products 29/05 36/05 155/09 113/08 Page 1 of 33

2 Ordinance on the conditions and issuing marketing authorisation procedure for conducting wholesale distribution of medicinal products and their import and export 29/05 Title Ordinance on the manufacturing conditions and distribution, and on the manner of quality control and the keeping of the homeopathic remedies register Ordinance on the type of information and the manner of preparing reports as regards the distribution of proprietary medicinal products 62/05 29/05 Ordinance on the manner of medicinal products classification, prescription and issuance of medicinal products Ordinance on special distribution conditions for proprietary medicinal products in the Republic of Croatia, distribution of which is approved in the EU states 82/10 10/08 Ordinance on clinical testing and good clinical practice Ordinance establishing the criteria and the procedure for ascertaining Good Manufacturing Practice and the procedure for granting the 127/10 14/10 74/09 Page 2 of 33

3 production permit and the certificate of implementation of Good Manufacturing Practice Title DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products, 2001/83/EC on the Community code relating to medicinal products for human use Ordinance on marketing, labelling and advertising of traditional herbal medicinal products 89/ /82/EEC 2004/28/EEC Veterinary medicinal products Act on veterinary-medicine products 84/08 Ministry of Agriculture Commission Regulation (EC) No 1950/2006 in accordance with 2001/82/EC Ordinance on the list of active substances necessary for the treatment of equidae 79/09 Act on veterinary-medicine products 84/ /82/EEC 2004/28/EC 2009/9/EC 2001/82/EC 2006/130/EC Ordinance on veterinary medicinal products Ordinance on veterinary medicinal products which are issued without a veterinary prescription and used on animals intended for human consumption 32/11 146/10 14/10 73/09 30/09 67/09 Page 3 of 33

4 1234/2008/EC Ordinance on amendments of marketing authorizations for veterinary medicinal products 122/10 Title Commission Regulation (EC) No 540/95 Regulation (EEC) No 2309/93 Ordinance on pharmacovigilance for veterinary medicinal products 79/ /28/EEC Ordinance on good laboratory practice and verification of its application in testing veterinary medical devices and veterinary medical devices 69/07 Act on Veterinary Medicinal Products and Veterinary Medical Devices 79/98 91/412/EEC Ordinance on principles and guidelines of good manufacturing practice for veterinary medicinal products 120/07 Ordinance on the procedure and method of issuing approval for market placement of proprietary veterinary medicinal products, medicinal additives and veterinary medical devices 109/08 142/03 Ordinance on the manner of prescribing and issuing medicinal products and preparations used in veterinary medicine Ordinance on conditions regarding retail sale and wholesale of proprietary medicinal products, medicinal additives and veterinary medical products carrying out by legal or natural persons 149/05 73/99 Page 4 of 33

5 Ordinance establishing principles of quality control of proprietary medicinal products, medicinal additives and veterinary medical products and of manner of keeping records 148/99 Title 3. 76/768/EEC Cosmetic products Ordinance on the health safety of mass consumption products 125/09 Common Use Items Act 43/10 75/09 85/06 Ministry of Health 2023/2006/EC Ordinance on specific requirements for manufacturing and placing on the market of general use items 82/10 Common Use Items Act 43/10 75/09 85/ /74/EC 97/37/EC 96/73/EC 73/44/EEC Textile Ordinance establishing the raw material composition and labeling of textile products Ordinance on the methods for the quantitative analysis of binary textile fibre mixtures 41/10 41/10 Act on Technical Requirements for Products and on Conformity Assessment 20/10 Ministry of Economy Ordinance on method of quantitative analysis of three-component textile fibre mixtures 41/ /11/EC Footwear Ordinance relating to labelling of the materials used in the main components of footwear for sale to the consumer 41/10 Page 5 of 33

6 6. 69/493/EEC Crystal glass Ordinance for crystal glass products 32/09 135/05 Title Act on Technical Requirements for Products and on Conformity Assessment 20/10 Consumers Protection Act 89/09 79/09 75/09 125/07 79/07 7. Chemicals Regulation (EC) No. 1907/2006 on the registration, evaluation, authorisation and restriction of chemicals Council 92/32 EEC of 30 April /121/EC REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing s 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 Chemicals Act 18/13 (49/11 53/08 63/07 150/05) Ministry of Health Page 6 of 33

7 Regulation (EC) No. 1272/2008 of the European Parliament and the Council of 16 December on classification, labeling and packaging of substances and mixtures Act on the Implementation of the Regulation (EC) 18/13 No. 1272/2008 of the European Parliament and 50/12 the Council of 16 December on classification, labeling and packaging of substances and mixtures, which is amending and repealing 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No. 1907/2006 Title Regulation (EC) No. 1907/2006 on the registration, Act on the Implementation of the Regulation (EC) evaluation, authorisation and restriction of chemicals No. 1907/2006 of the European Parliament and of the Council on the registration, evaluation, authorisation and restriction of chemicals 18/13 53/08 Regulation 689/2008/EC Act on the Implementation of Regulation (EC) No 689/2008 of the European Parliament and the Council on Export and Import of Dangerous Chemicals 25/13 139/ /10/EC COMMISSION REGULATION (EU) No 15/2010 COMMISSION REGULATION (EU) No 196/2010 of the 9 March 2010 Ordinance on good laboratory practice Ordinance on the import and export of hazardous chemicals 73/12 38/08 39/12 104/10 73/09 Chemicals Act 49/11 53/08 150/05 Page 7 of 33

8 Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Ordinance on conditions to be met by legal and natural persons providing service or agency activities during which they come in direct contact with hazardous chemicals 73/09 Title Ordinance on classification, packaging and labelling of hazardous chemicals List of hazardous chemicals the trade of which is prohibited or restricted 63/12 64/11 113/10 64/09 23/08 40/12 37/11 39/10 Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Ordinance on filling out the Safety Data Sheet 74/11 39/09 91/155/EEC defining and laying down the detailed Ordinance on keeping a register of hazardous arrangements for the system of specific information chemicals and on the method of and deadlines for relating to dangerous preparations in the deliver of data from the register implementation of Article 10 of 88/379/EEC (OJ, L76, 22/03/1991) 113/06 67/548/EEC classification, packaging and labelling of dangerous substances Odrinance on classification, labelling and packaging of dangerous Chemicals 63/12 64/11 113/10 64/09 23/08 Page 8 of 33

9 Title 1999/45/EC classification, packaging and labelling of dangerous preparations 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market The Chemicals Act 49/11 53/08 150/05 Odrinance on classification, labelling and packaging of dangerous Chemicals Act on Biocide Products Ordinance on amendments to the Ordinance on the list of existing active substances not permissible in biocidal products 71/12 64/11 113/10 64/09 23/08 56/10 35/08 63/07 18/13 39/12 31/11 36/10 28/09 90/08 The Chemicals Act 49/11 53/08 150/05 Act on Biocide Products 56/10 35/08 63/07 Ordinance on amendments to the Ordinance on the list of existing active substances permissible in biocidal products 26/13 32/12 31/11 36/10 28/09 90/08 Ordinance on the list of active substances in biocidal products 36/10 28/09 90/08 Page 9 of 33

10 Ordinance on the documentation for the evaluation of the active substances in biocidal products, and on the documentation for the evaluation of biocidal products, procedures for the evaluation of biocidal products and their use, and on the types of biocidal products with their descriptions and common principles for the evaluation of biocidal products 90/08 Title List of biocide products granted marketing authorisation in the Republic of Croatia 73/12 8. Regulation (EC) No Drug precursors The List of narcotic drugs, psychotropic substances 19/11 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors and plants from which drugs can be obtained and substances which can be used for the production of narcotic substances 2/10 50/09 Act on the Suppression of Narcotic Drugs Abuse 84/11 149/09 40/07 141/04 163/03 87/02 107/01 Ministry of Health Act on Suppression of Narcotic Substances Abuse 84/11 149/09 40/07 141/04 163/03 87/02 107/01 Page 10 of 33

11 9. Regulation (EC) No 648/2004 of the European Parliament and of the Council of 13 March 2004 relating to detergents Detergents Act on the implementation of Regulation (EC) No 648/2004 of the European Parliament and the Council of 31 March 2004 on detergents Ordinance on safety of detergents 25/13 34/12 1/11 Title Act on General Purpose Goods 43/10 75/09 85/06 Ministry of Health REGULATION (EC) No 1336/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 amending Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures /324/EEC 2008/47/EC Aerosol dispensers Ordinance on aerosol dispensers 83/10 Act on Technical Requirements for Products and on Conformity Assessment 20/10 Ministry of Economy 11. Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers Fertilisers Act on Fertilisers and Soil Improvers 40/07 163/03 Ministry of Agriculture Page 11 of 33

12 The Act on Fertilisers and Soil Improvers (OG 163/03, 40/07) has been aligned with Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers, in the part relating to the competent inspection service for the control of fertilisers provided for in the said Regulation. Title Ordinance on good agricultural practice in utilisation of fertilisers 56/08 Act on Fertilisers and Soil Improvers 40/07 163/03 Ordinance on mineral fertilizers 60/07 Ordinance on the conditions to be met by authorised laboratories for testing the quality of fertilisers and soil enhancers 99/10 80/ /317/EEC Old Approach s in the field of metrology Ordinance on the metrological and technical requirements for 5 to 50 kilogramme medium accuracy rectangular bar weights and 1 to 10 kilogramme medium accuracy cylindrical weights 2/07 The Metrology Act 111/07 194/03 163/03 State Office for Metrology 71/347/EEC Ordinance on metrological and technical requirements for measuring of the standard mass per storage volume of grain 2/07 71/349/EEC Ordinance on metrological and technical requirements for the tanks of vessels 2/07 Page 12 of 33

13 Title 74/148/EEC Ordinance on metrological and technical requirements for weights from 1 mg to 50 kg of above-medium accuracy 2/07 76/765/EEC Ordinance on metrological and technical requirements for alcoholmeters and alcohol hydrometers 118/09 2/07 86/217/EEC Ordinance on metrological and technical requirements for tyre pressure gauges for motor 2/ /106/EEC 76/211/EEC 75/107/EEC 80/232/EEC Pre-packaged products and bottles used as measuring containers Ordinance on metrological requirements for prepackaged products and bottles used as measuring containers 35/09 32/06 90/ /181/EEC Units of measurement Ordinance on units of measurement 145/ Motor ; two- or three-wheel motor ; wheeled agricultural or forestry Page 13 of 33

14 /156/EEC as last 2001/116/EC type-approval of motor and their trailers Title Ordinance on type-approval of motor 115/04 Act on Technical Requirements for Products and on Conformity Assessment 20/10 70/156/EEC as last 2007/37/EC Ordinance on the type-approval of motor (issue 01) 64/09 16/09 Road Traffic Safety Act 74/11 67/ /46/EC as amended by 1060/2008/EC, 385/2009/EC, 371/2010/EC and 2010/19/EC type-approval and individual approval of motor Ordinance on the type-approval and individual approval of motor (issue 00) 66/12 74/11 56/11 9/ /157/EEC as last 2007/34/EC permissible sound level and the exhaust system of motor Ordinance on the type-approval of motor relating to the permissible sound level and the exhaust system of motor Vehicle ordinance /09 67/ /220/EEC as last 2003/76/EC Measures to be taken against air pollution by gases from positive-ignition engines of motor Ordinance relating to measures to be taken against air pollution by gases from positive-ignition engines of motor Vehicle Ordinance * (102.01) 74/12 121/11 6/11 17/ /221/EEC as last 2000/08/EC (2006/20/EC) liquid fuel tanks and rear protective devices for motor and their trailers Ordinance on technical requirements and typeapproval procedure relating to liquid fuel tanks and rear protective devices for motor and their trailers Vehicle ordinance 103 (103.01) 42/08 Page 14 of 33

15 /222/EEC space for mounting and the fixing of rear registration plates on motor and their trailers Ordinance on technical requirements for relating to the space for registration plate Vehicle ordinance /04 Title /311/EEC steering equipment for motor and their trailers Ordinance on technical requirements and the approval procedure for relating to the steering equipment Vehicle ordinance / /387/EEC doors of motor and their trailers Ordinance on the technical requirements and procedure for type-approval for of categories M and N relating to their doors Vehicle ordinance / /388/EEC audible warning devices for Ordinance on the technical requirements and typeapproval 7/07 motor procedure for audible warning devices 131/04 for motor Vehicle ordinance /97/EC as last 2005/27/EC /320/EEC as last 2002/78/EC devices for indirect vision Ordinance relating to the type-approval of devices for indirect vision and of equipped with these devices Vehicle ordinance braking devices of certain Ordinance on type approval procedure relating to categories of motor the braking devices of certain category of motor and of their trailers and of their trailers Vehicle ordinance /12 79/09 67/08 19/07 Page 15 of 33

16 /245/EEC as last 95/54/EC (2006/28/EC) suppression of radio interference produced by spark-ignition engines fitted to motor Ordinance on technical requirements and typeapproval of motor relating to the suppression of electromagnetic interference (electromagnetic compatibility) Vehicle ordinance 110 (110.02) Title 33/11 (67/08) /306/EEC as last 97/20/EC (2005/21/EC) measures to be taken against the emission of pollutants from diesel engines for use in Ordinance on technical requirements and typeapproval procedure relating to the measures to be taken against the emission of pollutants from diesel engines for use in Vehicle ordinance / /60/EEC as last 2000/4/EC interior fittings of motor (interior parts of the passenger compartment other than the interior rear-view mirrors, layout of controls, the roof or sliding roof, the backrest and rear part of the seats) Ordinance on technical requirements and typeapproval procedure relating to the interior fittings of motor Vehicle ordinance / /61/EEC as last 95/56/EC devices to prevent the unauthorized use of motor Ordinance on technical requirements and typeapproval procedure relating to devices to prevent the unauthorized use of motor Vehicle ordinance 113 7/07 176/04 Page 16 of 33

17 /297/EEC as last 91/662/EC interior fittings of motor (the behaviour of the steering mechanism in the event of an impact) Ordinance on technical requirements and typeapproval procedure of with regard to the behaviour of the steering mechanism Vehicle Ordinance /04 Title /408/EEC as last 96/37/EC (2005/39/EC) interior fittings of motor (strength of seats and of their anchorages) Ordinance on technical requirements and procedure for vehicle type-approval relating to the strength of seats, their anchorages and their head restraints Vehicle Ordinance /08 66/ /483/EEC as last 87/354/EC (2007/15/EC) external projections of motor Ordinance on technical requirements and typeapproval of motor in respect of external projections Vehicle Ordinance /08 (67/08) /443/EEC as last 97/39/EC reverse and speedometer equipment of motor Ordinance on technical requirements and procedure for M and N category of motor relating to the reverse and speedometer equipment Vehicle Ordinance / /114/EEC as last 87/345/EC statutory plates and inscriptions for motor and their trailers, and their location and method of attachment Ordinance on the technical requirements and 131/04 procedure for type-approval of concerning statutory plates and inscriptions Vehicle Ordinance 118 Page 17 of 33

18 /115/EEC as last 96/308/EEC (2005/41/EC) anchorages for motorvehicle safety belts Ordinance on technical requirements and typeapproval procedure for motor relating to the anchorages for safety belts Vehicle ordinance (119.01) 100/08 71/08 Title (67/08) /756/EEC as last 97/28/EC (2007/35/EC) installation of lighting and light-signalling devices on motor and their trailers Ordinance on the technical requirements and procedure for type-approval relating to the installation of lighting and light-signalling devices on motor and their trailers Vehicle ordinance /12 74/11 48/10 67/ /757/EEC as last 97/29/EC reflex reflectors for motor and their trailers Ordinance on the technical requirements and typeapproval procedure relating to retro reflectors for motor and their trailers, Vehicle ordinance 121 7/07 132/ /758/EEC as last 97/30/EC end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps for motor and their trailers Ordinance on the technical requirements and typeapproval procedure for end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps for motor and their trailers, Vehicle ordinance / /759/EEC as last 1999/15/EC direction indicator lamps for motor and their trailers Ordinance on the technical requirements and the process of type-approval of direction indicator lamps for motor and their trailers Vehicle ordinance 123 7/07 142/04 Page 18 of 33

19 /760/EEC as last 97/31/EC rear registration plate lamps for motor and their trailers Ordinance on the technical requirements and typeapproval procedure for rear registration plate lamps for motor and their trailers Vehicle ordinance /04 Title /761/EEC as last 1999/17/EC motor-vehicle headlamps which function as mainbeam and/or dipped-beam headlamps and to incandescent electric filament lamps for such headlamps Ordinance on the type-approval procedure for motor-vehicle headlamps which function as mainbeam and/or dipped-beam headlamps and to incandescent electric filament lamps for such headlamps, Vehicle ordinance / /762/EEC as last 1999/18/EC front fog lamps for motor Ordinance on the technical requirements and typeapproval procedure of front fog lamps for motor and filament lamps for such lamps and their trailers, Vehicle ordinance / /389/EEC as last 96/64/EC relating to motor-vehicle towing-devices Ordinance on the technical requirements and the approval procedure for motor of categories M and N with respect to the towing devices Vehicle ordinance / /538/EEC as last 1999/14/EC rear fog lamps for motor and their trailers Ordinance on the technical requirements and the approval procedure for rear fog lamps for motor and their trailers Vehicle ordinance /04 Page 19 of 33

20 /539/EEC as last 97/32/EC reversing lamps for motor and their trailers Ordinance on the technical requirements and approval procedure for the reversing lamps for motor and their trailers, Vehicle ordinance 129 7/07 169/04 Title /540/EEC as last 99/16/EC parking lamps for motor Ordinance on the technical requirements and the approval procedure for parking lamps for motor Vehicle ordinance / /541/EEC amended last by 2000/3/EC ( 2005/40/EC) safety belts and restraint systems of motor Ordinance on the type-approval procedure relating to safety belts and restraint systems of motor Vehicle ordinance 131 (Amended) 104/08 71/08 7/07 87/05 (67/08) /649/EEC as last 90/630/EC field of vision of motor vehicle drivers Ordinance on technical requirements and typeapproval procedure for M1 category motor relating to the driver's field of vision Vehicle Ordinance / /316/EEC as last 94/53/EC) interior fittings of motor (identification of controls, tell-tales and indicators) Ordinance on the type-approval procedure relating to controls, tell-tales and indicators Vehicle ordinance / /317/EEC defrosting and demisting systems of glazed surfaces of motor Ordinance on technical requirements and typeapproval procedure for M1 category motor relating to the defrosting and demisting systems of glazed surfaces Vehicle Ordinance /04 Page 20 of 33

21 /318/EEC as last 94/68/EC wiper and washer systems of motor Ordinance on the technical requirements and typeapproval procedure for of category M1 relating to their wiper and washer systems Vehicle ordinance /04 Title /56/EC as last 2006/119/EC heating systems for motor and their trailers Ordinance on the type-approval procedure for heating systems for motor and their trailers Vehicle Ordinance /08 67/ /549/EEC as last 94/78/EC wheel guards of motor Ordinance on the technical requirements and the type-approval procedure of motor in M1 category relating to the wheel guards Vehicle ordinance 137 7/07 132/ /932/EEC head restraints of seats of motor Ordinance on the technical requirements and the type-approval procedure for head restraints of seats of motor Vehicle ordinance / /1268/EEC as last 1999/100 EC (2004/3/EC) fuel consumption of motor Ordinance on technical requirements and typeapproval procedure relating to the carbon dioxide emission and fuel consumption of motor Vehicle ordinance /08 (67/08) /1269/EEC as last 1999/99/EC engine power of motor Ordinance on technical requirements and typeapproval procedure relating to the engine power of motor Vehicle ordinance /04 Page 21 of 33

22 /77/EEC as last 2001/27/EC measures to be taken against the emission of gaseous pollutants from diesel engines for use in Ordinance on type approval procedure relating to 12/09 the emission of pollutants from diesel engines for 19/07 use in and positive-ignition engines fuelled with natural or liquefied petroleum gas for use in Vehicle Ordinance 141 (valid only Article 7.(2)) Title /55/EC as last 2005/78/EC measures to be taken against the emission of gaseous pollutants from diesel engines for use in Ordinance on type approval procedure relating to the emission of pollutants from diesel engines for use in and positive-ignition engines fuelled with natural or liquefied petroleum gas for use in Vehicle Ordinance /11 58/11 18/10 67/ /297/EEC lateral protection (side guards) of certain motor and their trailers Ordinance on the technical requirements and the type-approval procedure of relating to the lateral protection Vehicle ordinance / /226/EEC as last 95/48/EC spray-suppression systems of certain categories of motor and their trailers Ordinance on the technical requirements and the type-approval procedure relating to the spraysuppression systems of motor and their trailers, Vehicle ordinance / /21/EEC masses and dimensions of motor of category M1 Ordinance on the technical requirements and the type-approval procedure relating to the masses and dimensions of motor Vehicle ordinance /04 Page 22 of 33

23 /22/EEC as last 2001/92/EC safety glazing and glazing Ordinance on the type-approval procedure for materials on motor safety glazing and glazing materials on motor and their trailers and their trailers Vehicle ordinance /05 Title /23/EEC ( 2005/11/EC) tyres for motor and their trailers and to their fitting Ordinance on the technical requirements and the type-approval procedure relating to tyres for motor and their trailers and to their fitting Vehicle ordinance 146 (Amended) 120/10 100/08 90/08 132/04 (67/08) /24/EEC (as last 2004/11/EC) speed limitation devices or similar speed limitation onboard systems of certain categories of motor Ordinance on the technical requirements and the type-approval procedure for speed limitation devices or similar speed limitation on- board systems of certain categories of motor Vehicle ordinance / /27/EC as last 2003/19/EC masses and dimensions of certain categories of motor and their trailers (Text with EEA relevance) Ordinance on the type-approval procedure relating to the masses and dimensions of certain categories of motor Vehicle ordinance /09 34/08 39/ /114/EEC external projections forward of the cab's rear panel of motor of category N Ordinance on the technical requirements and the type-approval procedure for motor of category N relating to the external projections forward of the cab's rear panel Vehicle ordinance /04 Page 23 of 33

24 /20/EC mechanical coupling devices of motor and their trailers and their attachment to those Ordinance on the technical requirements and typeapproval procedure of the mechanical coupling devices of motor and their trailers and their attachment to those Vehicle ordinance /04 Title /28/EC burning behaviour of materials used in the interior construction of certain categories of motor Ordinance on the technical requirements and the type-approval procedure relating to the burning behaviour of materials used in the interior construction of certain categories of motor vehicle Vehicle ordinance / /85/EC special provisions for used for the carriage of passengers Ordinance on the type-approval procedure of used for the carriage of passengers comprising more than eight seats in addition to the 15/06 comprising more than eight driver s seat seats in addition to the Vehicle ordinance 152 driver's seat /79/EC as last 1999/98/EC protection of occupants of motor in the event of a frontal impact Ordinance on the type-approval procedure relating 117/05 to the protection of occupants of motor in the event of a frontal impact, Vehicle ordinance /27/EC protection of occupants of motor in the event of a side impact and amending Ordinance on the type-approval procedure relating 7/07 to the protection of occupants of motor in 152/05 the event of a side impact, Vehicle ordinance 154 Page 24 of 33

25 /91/EC motor and their trailers intended for the transport of dangerous goods by road Ordinance on the technical requirements and the process of approval of motor and their trailers intended for the transport of dangerous goods Vehicle ordinance /04 Title /40/EC front under run protection of motor Ordinance on the type-approval procedure relating 114/05 to the front under run protection of motor Vehicle ordinance Regulation (EC) no. 78/2009 as last Regulation (EC) no. 631/2009 type-approval procedure for motor with regard to the protection of pedestrians and other vulnerable road users Ordinance on the type-approval procedure for motor with regard to the protection of pedestrians and other vulnerable road users TPV /12 1/11 74/11 48/10 67/ /64/EC type-approval procedure for motor relating to their reusability, recyclability and recoverability Ordinance on the type-approval procedure for motor relating to their reusability, recyclability and recoverability, Vehicle Ordinance /11 16/ /40/EC as (EC)706/2007 emissions from airconditioning systems in motor Ordinance on the type-approval procedure for motor relating to emission from their air conditioning systems, Vehicle Ordinance / (EC) No 79/2009 type-approval procedure for hydrogen-powered motor Ordinance on type-approval procedure of hydrogen-powered motor Vehicle Ordinance /11 115/10 Page 25 of 33

26 /24/EC as last 2006/120/EC /14/EEC (as last 2006/27/EC) type-approval of two or Ordinance on the type-approval of two- or threewheel three-wheel motor motor vehicle (issue 01) braking of two or threewheel motor Ordinance on type-approval procedure relating to the braking of two- or three-wheel motor Vehicle Ordinance /09 Title 104/08 (67/08) /80/EEC identification of controls, tell-tales and indicators for two-or three-wheel motor Ordinance on the type-approval procedure relating to the identification of controls, tell tales and indicators for two or three-wheel motor Vehicle ordinance /10 67/ /30/EEC audible warning devices for two-or three-wheel motor Ordinance on the type-approval procedure relating to audible warning devices for two- or three-wheel motor, Vehicle ordinance / /78/EEC stands for two-wheel motor Ordinance on the type-approval procedure relating to stands for two- or three-wheel motor Vehicle ordinance /10 67/ /32/EEC (2009/79/EC) passenger hand-holds on two-wheel motor Ordinance on the type-approval procedure relating to passenger hand-holds on two- or three-wheel motor, Vehicle ordinance /10 (67/08) Page 26 of 33

27 /33/EEC protective devices intended to prevent the unauthorized use of twoor three-wheel motor Ordinance on the type-approval procedure for protective devices intended to prevent the unauthorized use of two- or three-wheel motor, Vehicle ordinance 206 Title 114/ /34/EECas last 2006/27/EC statutory markings for twoor three-wheel motor Ordinance on the type-approval procedure for twoor three-wheel motor relating to the statutory markings for two- or three-wheel motor Vehicle Ordinance /12 74/11 48/10 67/ /92/EEC as last 2000/73/EC installation of lighting and light-signalling devices on two or three-wheel motor Ordinance on the technical requirements and the type-approval procedure for two or three-wheel motor in respect of the installation of lighting and light-signalling devices Vehicle ordinance / /93/EEC (as last 2004/86/EC) masses and dimensions of two or three-wheel motor Ordinance on the type-approval procedure relating to the masses and dimensions of two or threewheel motor Vehicle ordinance /08 90/08 (67/08) /94/EEC as last 1999/26/EC (2009/62/EC) space for mounting the rear registration plate of two or three-wheel motor Ordinance on the type-approval procedure relating to the space for mounting the rear registration plate of two or thee-wheel motor Vehicle ordinance /10 Page 27 of 33

28 /1/EC as last 2002/41/EC (2006/27/EC) maximum design speed, maximum torque and maximum net engine power of two or threewheel motor Ordinance on the type-approval procedure relating to the maximum design speed, maximum torque and maximum net engine power of two or threewheel motor Vehicle ordinance /08 Title /24/EC as last 2002/51/EC certain components and characteristics of two or three-wheel motor Ordinance on certain components and characteristics of two- or three-wheel motor Vehicle ordinance (Part 2,6,8,10) 12/07, 12/09 (Part 2) /24/EC as last 2006/120/EC Ordinance on the type-approval procedure for certain components and characteristics of two- or three-wheel motor Vehicle Ordinance 212 (01) (Part 1, 3, 5, 4, 7, 9, 11 and 12) 4/09 (Parts 1 & 3), 16/09 (Part 4,5,7,9,11 & 12), 111/10 (Part 5 i 9), 95/10 (Part 9) 67/ /150EEC as last 2001/3/EC (2003/37/EC as last 2005/96/EC) type-approval of agricultural or forestry, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units Ordinance on the type-approval for agricultural and forestry (issue 01) 109/11 83/11 16/09 Page 28 of 33

29 /63/EC Certain parts and characteristics of wheeled agricultural or forestry Ordinance on the type-approval of agricultural and 40/10 forestry in view of the maximum permissible mass, position and affixing of rear registration plates, fuel tanks, additional weights, audio warning devices, permissible noise levels and the exhaust system and solid harmful substances from the engine Vehicle Ordinance Title /60/EC Maximum design speed of and load platforms for wheeled agricultural or forestry Ordinance relating to the maximum design speed of and load platforms for wheeled agricultural or forestry Vehicle Ordinance /11 32/ /346/EEC as last 98/40/EC (2009/59/EC) Rear-view mirrors for wheeled agricultural or forestry Ordinance relating to rear-view mirrors for wheeled agricultural or forestry Vehicle Ordinance /10 (67/08) /2/EC Field of vision and windscreen wipers for wheeled agricultural or forestry Ordinance on the type-approval of agricultural and 53/09 forestry in view of the field of vision and windscreen wipers Vehicle Ordinance / /66/EC Steering equipment of wheeled agricultural or forestry Ordinance relating to the steering equipment of wheeled agricultural or forestry Vehicle Ordinance /10 Page 29 of 33

30 /322/EEC as last 2001/3/EC Suppression of radio interference produced by spark-ignition engines fitted to wheeled agricultural or forestry Ordinance relating to the suppression of radio interference produced by spark ignition engines fitted to wheeled agricultural or forestry Vehicle Ordinance /12 37/07 Title /432/EEC as last 97/54/EC Braking devices of wheeled agricultural or forestry Ordinance relating to the braking devices of wheeled agricultural or forestry Vehicle Ordinance / /763/EEC as last 1999/86/EC Passenger seats for wheeled agricultural or forestry Ordinance relating to passenger seats for wheeled agricultural or forestry Vehicle Ordinance 308 (valid to ) 24/11 100/ /76 Driver-perceived noise level of wheeled agricultural or forestry Ordinance on the type-approval of agricultural and forestry in view of the noise level perceivedexperienced by the tractor driver Vehicle Ordinance /10 67/ /536/EEC as last 1999/55/EC (2009/57) Roll-over protection structures of wheeled agricultural or forestry Ordinance relating to the roll-over protection structures of wheeled agricultural or forestry Vehicle Ordinance /10 (67/08) Page 30 of 33

31 /537/EEC as last 97/54/EC Measures to be taken against the emission of pollutants from diesel engines for use in wheeled agricultural or forestry Ordinance relating to the measures to be taken against the emission of pollutants from diesel engines for use in wheeled agricultural or forestry Vehicle Ordinance /07 Title /764/EEC as last 1999/57/EC Driver s seat on wheeled agricultural or forestry Ordinance relating to the driver s seat on wheeled agricultural or forestry Vehicle Ordinance / /61/EC Installation of lighting and light-signalling devices on wheeled agricultural and forestry Ordinance on the type-approval of agricultural and forestry in terms of installation of lighting devices and light signalisation Vehicle Ordinance /10 67/ /532/EEC as last 97/54/EC (2009/68) Component type approval of lighting and lightsignalling devices on wheeled agricultural or forestry Ordinance relating to the component typeapproval of lighting and light signalling devices on wheeled agricultural or forestry Vehicle Ordinance / /58/EC Coupling device and the reverse of wheeled agricultural or forestry Ordinance relating to the coupling device and the reverse of wheeled agricultural or forestry Vehicle Ordinance /10 67/08 Page 31 of 33

32 /75/EZ Roll-over protection structures of wheeled agricultural or forestry (static testing) Ordinance on the type-aproval procedure of rollover protection structures of wheeled agricultural or forestry (static testing) TPV Title 124/10 67/ /720/EEC as last 2010/62/EC roll-over protection structures of wheeled agricultural or forestry Ordinance on type-approval on roll-over protection structures of wheeled agricultural or forestry Vehicle Ordinance / /297/EEC as last 2010/62/EC roll-over protection structures of wheeled agricultural or forestry Ordinance on type-approval on roll-over protection structures of wheeled agricultural or forestry Vehicle Ordinance / /298/EEC as last 2010/22/EC rear roll-over protection structures of narrow wheeled agricultural or forestry Ordinance on type-approval on rear roll-over protection structures of narrow wheeled agricultural or forestry Vehicle Ordinance / /415/EEC as last 97/54/EC /402/EEC as last 2005/67/EC Installation, location, operation and identification of the controls of wheeled agricultural or forestry Certain components and characteristics of wheeled agricultural and forestry Ordinance on the installation, location, operation and identification of the controls of wheeled agricultural or forestry Vehicle Ordinance Ordinance relating to certain components and characteristics of wheeled agricultural and forestry Vehicle Ordinance /11 95/11 Page 32 of 33

33 /173/EEC as last 2006/26/EC Certain parts and characteristics of wheeled agricultural or forestry Ordinance on certain component parts and features of wheeled agricultural and forestry Vehicle Ordinance (02) 145/11 42/09 Title 67/ /25/EEC as last 2005/13/EC agricultural or forestry, emissions of gaseous and particulate pollutants by their engines Ordinance on the type-approval procedure for agricultural or forestry relating to the emissions of gaseous and particulate pollutants by their engines Vehicle Ordinance /13 14/13 107/12 112/11 105/10 16/ /68/EC as last 2004/ 26/EC Emission of pollutants from engines installed in non-road mobile machinery Ordinance on measures for the prevention of emission of gaseous pollutants and pollutants in the form of particles from internal combustion engines installed in non-road mobile machinery Vehicle Ordinance 401 (issue 00) 41/12 105/10 64/09 16/09 Made in by: Ministry of Economy Republic of Croatia Page 33 of 33