RESTRICTEDWORLD TRADE
ORGANIZATIONWT/ACC/UKR/89/Rev.1
11 April 2001
(01-1839)
Working Party on the
Accession of UkraineOriginal:  English
ACCESSION OF UKRAINE
Law Enforcement in High-Priority Areas of Trade-Related Legal Framework:
Customs Fees, Customs Valuation, Technical Barriers to Trade
and Sanitary and Phytosanitary Measures
Revision
The Governmental Commission on Ukraine's Accession to the WTO has submitted the
following information with the request that it be  circulated to members of the Working Party.
_______________WT/ACC/UKR/89/Rev.1
Page 2Laws and Regulations The assessment of compliance with GATT/ WTO agreements,
and proposed harmonization measures
Customs Fees
Resolution of the Cabinet of Ministers of Ukraine"On Customs Fee Rates" No. 65 dated22 January 1997Customs fee for customs clearance of goods and other
itemsCompliant.
Resolution of the Cabinet of Ministers of Ukraine
"On Regulation of the Customs Fees at the StateBorder Crossing Points" No. 1034 dated15 June 1999 Fee for services provided in relation to ecological,
veterinary, and phytosanitary control, and roads toll forvehicles and other self-propelled machinery for passingthrough Ukrainian roads (unified fee).Non-compliant.
Proposals on law harmonization:
The Ministry of Economy drafted a law "On Amendment ofthe Law of Ukraine "On the Introduction of the Unified Fee
Collected upon Crossing of the Ukrainian State Border"
No. 1212-XIV dated 4 November 1999".When approved (currently, the law is under consideration atthe Cabinet of Ministers of Ukraine), the law will repeal theresolution concerned, and the amount of the unified fee will be
determined in accordance with the law.
Customs valuation
Resolution of the Cabinet of Ministers of Ukraine"On Adopting the Procedure for Determining the
Customs Value of Goods and other ItemsCrossing the Customs Border of Ukraine"
No. 1598 dated 5 October 1
 998Methods of customs valuation are not clearly determined.
In the event the declared customs value of goods and
other items is obviously non-corresponding, or itscalculation is impossible, the customs authoritiessequentially determine the customs value on the basis ofvalue for identical goods and other items, or prices forsimilar goods.Customs valuation methods are not compliant with the GATT
1994, Article VII, and the Agreement on Application of
GATT Article VII.Proposals on law harmonization:
The draft Customs Code of Ukraine endorsed by the SupremeRada for the first reading on 16 December 1998, provides formethods of customs valuation that will be compliant with
binding rules and requirements of the GATT/ WTO
agreements.
                                                     
Note: Because of the need for greater detail, the areas of im port licensing and the enforcement of intellectual property rights  are dealt with in separate materials.WT/ACC/UKR/89/Rev.1
Page 3Laws and Regulations The assessment of compliance with GATT/ WTO agreements,
and proposed harmonization measures
Technical Barriers to Trade
Decree of the Cabinet of Ministers of Ukraine"On Standardization and Certification" No. 46-93
dated 10 May 1993Determines the principles of the standardization and
certification system in Ukraine (technical barriers to
trade)Non-compliant.
Proposals on laws harmonization (case-by-case):
Approval of the draft Law of Ukraine "On Standardization"Approval of the draft Law of Ukraine "On ConformityAssessment"Drafting and passing of the Resolution of the Cabinet ofMinisters of Ukraine "On Technical Regulations"
implementing requirements of the Agreement and Directives
98/34/EC, 98/48/EC providing for notification about changesin technical standards and regulations.Implementation of the Resolution of the Cabinet of Ministersof Ukraine "On Creation of the National Automated StandardsDatabase"  No. 84 dated 1 February 1995.
Drafting and implementation of the National Standard "Rules
of Notification to Other Members".Administrative Action to be Taken
Review of underlying standards of the state standardizationsystem.
Curtail list of goods subject to compulsory certification.
Development and enforcement of standards as follows:-"National Standardization System. Rules and Guidelines onAdoption and Enforcement of International Standards”;-" National Standardization System. Code of FixedStandardization Rules”.
Decree of the Cabinet of Ministers of Ukraine
“On State Monitoring of Compliance with
Standards, Rules and Regulations, and Liabilityfor Violations”Introduces government supervision over sustained
quality of the certified products, rules of test
performance.Will be revised upon passing of the Law of Ukraine “On
Conformity Assessment ”, “On Liability of Supplier for
Manufacturing and Distribution of Hazardous and LowQuality Products”
Resolution of the Cabinet of Ministers of Ukraine“On the Approval of the Procedure for CustomsClearance of Imported Goods (Products) Subjectto Compulsory Certification in Ukraine”
No. 1211 dated 4 November 1997Determines rules of customs clearance of foreign goods
(products) subject to mandatory certification.Resolution of the Cabinet of Ministers of Ukraine No. 1672
dated 8 November 2000 amends Paragraph 3 of the“Procedure of Customs Clearance of Imported Goods(Products) Subject to Compulsory Certification in Ukraine”.
Rules for Compulsory Certification of Domestic
Electric Appliances and Comparable Equipment
and PartsDetermine rules, sequence, and processes of certification. Non-compliant.
Will be revised upon approval of the Law of Ukraine “On
Conformity Assessment”, and new regulation compliant withthe New Approach EC Directives 73/23 ЕЕС , 89/336ЕЕС ,
93/68ЕЕС , 92/31ЕС.WT/ACC/UKR/89/Rev.1
Page 4Laws and Regulations The assessment of compliance with GATT/ WTO agreements,
and proposed harmonization measures
Rules of Compulsory Certification of Specific
Lines of Products.Determine rules, sequence, and processes of certification. Will be revised upon approval of the Law of Ukraine “On
Conformity Assessment”, and relevant regulations.
Rules for Performing Certification of ForeignGoods Manufactured as Serial ProductsThe Order of the State Committee for Standardization,
Metrology, and Certification No. 633 dated
18 August 1998, is designed to improve rules ofcertification of foreign products, in particular, rules ofapplications assessment, creation of commission, anddecision-making criteria. In terms of rules applicable to
conformance assessment process, the same are applied to
both domestically produced and foreign products. Therules of conformance assessment cover such issues asconformity to effective standards, sequence of tests,amount and type of fees charged, availability ofinformation, etc.Will be revised upon approval of the Law of Ukraine “On
Conformity Assessment”.
DSTU 3410-96 "UkrSEPRO Certification
Systems. Guidelines"The Standard determines underlying principles,
framework and rules of the national certification system.Will be revised upon approval of the Law of Ukraine "On
Conformity Assessment".
DSTU 3411-96 "UkrSEPRO Certification
Systems. Requirements for Certification Agencies
and Rules of Accreditation".Drafted in compliance with the requirements of Directive
ISO/IEC39, 56, 65, Directive ISO 27 and EN45011.Will be revised upon approval of the Laws of Ukraine "On
Accreditation of the Conformance Assurance Agencies",  "On
Conformity Assessment".
DSTU 3412-96 "UkrSEPRO CertificationSystems. Requirements for Test Labs and Rulesof Accreditation"Drafted in compliance with the requirements of the
Directives ISO/IEC25, and EN45001Will be revised upon approval of the Laws of Ukraine "On
Accreditation of the Conformance Assurance Agencies", "OnConformity Assessment".
DSTU 3413-96 "UkrSEPRO CertificationSystems. Certification procedures"Drafted in compliance with the requirements of the
Directives ISO/IEC7, 28, 60Will be revised upon approval of the Laws of Ukraine "On
Conformity Assessment".
Sanitary and Phytosanitary Measures
The Law of Ukraine "On Sanitary and EpidemicSafety of the Population" No. 4004-XII dated24 February 1994
The Law of Ukraine "On Quality and Safety of
Food Products and Food Raw Materials" No. 771dated 23 December 1997The Law of Ukraine "On the Protection of thePopulation from Infectious Diseases"No. 1645-14 dated 6 April 2000Article 16 of the Law of Ukraine "On Sanitary and
Epidemic Safety of the Population" No. 4004-XII dated24 February 1994 provides for rules of import,
distribution and consumption of products. Businesses,
organizations, and individuals have the right to bring in
raw materials and finished products (products,equipment, technological manufacturing equipment),distribute and consume/apply in Ukraine only if there is
data available about safety of such products to humans.
The office of the Chief Sanitary Doctor of Ukraineidentifies the list and content of such data.In the event safety data is not readily available, import,distribution and consumption of foreign products is
allowed if positive assurance of the state sanitary expert
commission is obtained.Non-compliant.Proposals on law harmonization:
To supplement Article 16 and other provisions stipulating that
the security data (for products, raw materials, equipment, etc.)
for the people’s health and sanitary measures on prevention(elimination) of the negative in fluence thereof, are established
by the State Chief Sanitary Officer of Ukraine, taking intoaccount the International standards, instructions andrecommendations.
To adopt the draft Law of Ukraine "On State Sanitary-
Hygienic Expert Examination".WT/ACC/UKR/89/Rev.1
Page 5Laws and Regulations The assessment of compliance with GATT/ WTO agreements,
and proposed harmonization measures
Order of the Ministry of Health Protection "On
performing State Sanitary Expert Examination of
Design, Manufacturing and Consumption ofPotentially Harmful Products" No. 190 dated20 October 1995The Order determines rules of performing expert
examinations, and list of food products subject to
mandatory tests to be performed at the state sanitaryagencies.Compliant.
Order of the Ministry of Health Protection "On
fees charged for services rendered by the statesanitary agencies to organizations, private and
public businesses"
Resolution of the Cabinet of Ministers of Ukraine"On the Approval of the List of ServicesRendered by the State Health Protection Agenciesand Higher Education Medical Institutions"No. 1138 dated 17 September 1996
Resolution of the Cabinet of Ministers of Ukraine
"On Amendment of the Resolution of the Cabinetof Ministers of Ukraine No. 1138 dated17 September 1996" No. 449 dated 12 May 1997These regulations determine fees for performing sanitary
tests and issuance of respective documents.Compliant
The Law of Ukraine "On Veterinary Medicine"
No. 567/96- ВР dated 5 December 1996The State Department for Veterinary Medicine under
Ministry of Agrarian Policy of Ukraine is authorized bythe Ukrainian Government to exercise veterinary control.
Movement across customs border of Ukraine of
shipments falling under jurisdiction of state veterinary
authorities, including items and materials potentiallybearing pathogenic organisms harmful to animals, issubject to compulsory veterinary control.
Customs clearance is considered completed upon
completion of veterinary control check, performed by
experts of relevant regional branch veterinary agencies,and experts of customs office and customs check points.Import, export and transit through the territory ofUkraine of shipments falling under jurisdiction of stateveterinary authorities, entry of vehicles subject to
compulsory veterinary control, are subject to
presentation of relevant documents as required byinternational agreements, and compliance with veterinarycontrol requirements.Compliant.WT/ACC/UKR/89/Rev.1
Page 6Laws and Regulations The assessment of compliance with GATT/ WTO agreements,
and proposed harmonization measures
Resolution of the Cabinet of Ministers of Ukraine
"Regulation on the Regional Service of State
Veterinary Control at the State Border and onTransport of the State Department of VeterinaryMedicine of the Ministry of Agriculture ofUkraine" No. 264 dated 2 March 1998Regional agencies of the State Veterinary Control at the
State Ukrainian Border and Transport are appointed to
enforce compliance with the requirements of stateveterinary control during international and nationalconveyance of all class of animals, products andmaterials of animal origin , biological, microbe, virus
strands and fungus, items of collection of animal origin,
veterinary medicines, and products and materials
potentially bearing pathogenic organisms harmful toanimals, and other shipments subject to veterinarycontrol.In addition, regional agencies of the state veterinarycontrol perform check of veterinary compliance
documents, clinic examination of animals, veterinary
expert examination of materials and products of animaland vegetative origin, feeding stuffs, substances designedfor veterinary medicine, during their import, export, andtransit through the territory of Ukraine.Compliant.
The Law of Ukraine "On Plant Quarantine"
No. 3348-XII dated 30 June 1993.Plant quarantine requirements are designed to safeguard
the territory of Ukraine from import and dissemination of
pests, pathogenic organisms, and weed non-existent in
Ukraine.Central State Inspection for Plant Quarantine underMinistry of Agrarian Policy of Ukraine is authorized bythe Ukrainian Government to exercise veterinary control.All materials and items subject to plant quarantine,
which are moved beyond the State Ukrainian Border and
boundaries of special quarantine zones, are subject tophytosanitary control.Materials subject to plant quarantine can be brought intoUkraine subject to:
- Phytosanitary certificate issued by the government 
agencies enforcing quarantine and plants protection of the exporting country;Compliant.
A draft law "On amendment of the Law of Ukraine "On Plant
Quarantine" is being prepared, in which the European Council
Directives No. 79/93 of 1998 are taken into account.WT/ACC/UKR/89/Rev.1
Page 7Laws and Regulations The assessment of compliance with GATT/ WTO agreements,
and proposed harmonization measures
- Quarantine import license issued by the Central State 
Inspection for Plant Quarantine of Ukraine.
Customs clearance of shipments is performed uponcompletion of phytosanitary control.Specimen of the phytosanitary certificate and rules of thecertificate issuance are identified by the Central StateInspection for Plant Quarantine of Ukraine, in
compliance with the requirements of international
conventions.Specimen of the quarantine import license and rules ofthe license issuance are identified by the Central StateInspection for Plant Quarantine of Ukraine.
Resolution of the Cabinet of Ministers of Ukraine"On Fees Charged for Inspection of Materials
Subject to Quarantine, and Services Provided to
Businesses, Organizations, and Individuals"No. 953 dated 24 November 1993.Fee for inspection of materials under quarantine. Compliant.
Resolution "On Charter of the State Office of
Plant Quarantine of Ukraine" No. 892 dated28 October 1993List of goods subject to quarantine control: seeds and
sowing materials, agricultural, forestry and decorativeplants and their parts (sprouts, bulbs, foetus), and othervegetative products which may potentially bear pests,
plant plague and weed seeds, spores and fungus; viruses,
hook-warms, ticks, insects, collections, herbariums,specimens, agricultural tools, cultivation machinery,speciality industrial products, packaging and goodsmanufactured from materials of vegetative origin whichmay potentially bear pests, plants plagues and weed
seeds, monoliths and soil samples, and vehicles arriving
from foreign countries and Ukrainian regions underspecial quarantine regime.Compliant.
Moreover, the respective amendments will be introduced afterthe adoption of the Law of Ukraine "On Amendment of theLaw of Ukraine "On Plant Quarantine".
Order of the Ministry of Health No. 55 dated17 March 2000 "Maximum Fee Rates for theSpecialized Assessment and Expertise ofMaterials for the State Registration (Re-
registration) of Medicines at the State Scientific
and Expert Center of Medicines of the Ministry ofHealth of Ukraine".The order approves fee rates without discriminating
among residents and non-residents for the specializedassessment and expertise of medicines at the StateScientific and Expert Center of Medicines of the
Ministry of Health of Ukraine.Compliant.WT/ACC/UKR/89/Rev.1
Page 8Laws and Regulations The assessment of compliance with GATT/ WTO agreements,
and proposed harmonization measures
Resolution of the Cabinet of Ministers of Ukraine
"On the Approval of the Procedure of State
Registration (Re-registration) of Medicines"The fee rates for the registration (re-registration) of
medicines are uniform for residents.
Three main GATT/WTO and EU requirements weretaken into consideration:- The registration certificate is issued to the applicant for
the registration of the medicine, the applicant being alegal entity responsible for the production, quality,
effectiveness and safety of the medicine.
- Re-registration is only required where the registrationcertificate has expired.- The validity of the old registration certificate must beextended where the applicant timely submits materialsfor the re-registration of the medicine.Compliant.
Instruction "On the Procedures for Clinical Tests
of Medicines and Expertise of Materials of
Clinical Tests"In the development of the instruction the 1964 Helsinki
Declaration, EU directives and rules applied in
international practice (ICH rules, GCP - Good ClinicalPractice) were taken into consideration.Compliant.
Sample Regulation "On the Commission on
Ethics"In the development of the regulation the 1964 Helsinki
Declaration, EU directives and rules applied ininternational practice (ICH rules, GCP - Good ClinicalPractice) were taken into consideration.Compliant.
Instruction "On the Surveillance of Side
Reactions and/or Effects of Medicines"In the development of the instruction rules applied in the
international practice (ICH rules) and EU directive on
pharmacological supervision were taken into
consideration.Compliant.
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