RESTRICTED  WORLD TRADE  
ORGANIZATION  WT/ACC/UKR/151 
20 June 2007 
 
 (07-2620) 
Working Party on the 
Accession of Ukraine Original:   English 
 
 
 
ACCESSION OF UKRAINE 
 
Activity Licenses and Licenses to Engage in the Import and  
Export of Certain Products in Ukraine  
 
 
 The following submission, dated 18 June 2007, is  being circulated at the request of the 
Delegation of Ukraine.  
 
_______________ 
 WT/ACC/UKR/151 
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   Ukraine has both the system of business activ ities licensing and the system of licensing 
import and export operations. 
 The system of activities licensing shall confir m the right of a business agent to carry out 
activities indicated in its licence.  For example, th e following activities shall be subject to licensing: 
1. exploration of minerals; 
2. production of explosives and explosive mate rials (according to the List established by 
the Cabinet of Ministers of Ukraine); 
3. production of specifically da ngerous chemical substances; 
4. extraction and production of precious meta ls and stones, precious stones of organic 
formation and semiprecious stones; production of articles thereof; 
5. production of medicines, and whol esale and retail trade in medicines; 
6.  production of veterinary medicines and pr eparations, and wholesale and retail trade in 
veterinary medicines and preparations; 
7.  production of pesticides and agro-c hemicals (solely of phytohormones), and 
wholesale and retail trade in such pesticides and agro-chemicals (solely 
phytohormones); 
8. designing and production of special technical devices for recording of information 
from communication channels, and other devices of a secret receipt of information, and trade in special technical devi ces for recording of information from 
communication channels and other devices of a secret receipt of information; 
9. field of technical protection of information; 
10.  development, production, storage, tran sportation, purchase, conveyance, importation, 
exportation, sale and destruction of na rcotics, psychotropic substances and 
precursors; 
11. production of securities forms and the registered documents forms; 12.  medical practice; 
13.  veterinary practice; 
14.  services on transportation of passengers and cargo by aircraft; 15. services on transportation of passengers  and cargo by river and sea transport; 
16. services on transportation of passengers and cargo by motor transport; 17. services on transportation of passenge rs and cargo by railway transport; 
18. purchase, processing and metallurgical pr ocessing of non-ferrous and ferrous metals 
scrap; and 
19.  operations on import and export of spir its, alcoholic beverages and tobacco goods, 
and others. 
 In order to obtain the said li censes, an agent of entrepreneur ial activity shall apply to the 
licensing authority with an application of the establis hed form with the request to issue a licence.  The 
said application must contain the following information: 
- name; 
- location; 
- banking details and identifica tion code – for a legal entity; 
- surname, name, patronymic and passport deta ils (series, number, issuing authority, 
date of issuance and residence), and identifi cation number of a physical person who is 
the payer of taxes and other mandatory  payments – for  a physical person; 
- type of business activity for which an a pplicant intends to obtain a licence; and 
- copy of the certificate of state registration of the agent of entrepreneurial activity or 
copy of the certificate on its inclusion into the Unified State Register of Enterprises 
and Organizations of Ukraine certified by a notary or by the authority which issued 
the original document.  WT/ACC/UKR/151 
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   Upon submission of the especially authorized body on licensing issues, the Cabinet of 
Ministers of Ukraine shall establish the validity term  of a licence to carry out the certain type of 
business activity; however,  the said validity term shall not be less than three years.  Pursuant to the 
Resolution of the Cabinet of Ministers of Ukrain e, No. 1755, dated 29 November 2000, the validity 
term of a licence to carry out certain typ es of business activity shall be five years. 
 The Ministry of Economy or its authorized re gional authority shall establish the regime of 
individual licenses for export and import operations.  A licence for effectuation of export and import 
operations is the basis for passing of goods subject  to licensing regime through the customs border. 
 Concerning export and import of optical media equipment and discs , such operations are 
among activities subject to licensing.  The Cabinet of  Ministers of Ukraine (its Resolution "On the 
Approval of the List of Licensing Authorities," No. 1698, dated 14 November 2000) designated the 
Ministry of Economy   as the authority which effectuates licensing the activities of exporting and importing optical media equipment and discs. 
 The Order of the Ministry of Economy and on the Issues of European Integration of Ukraine, 
No. 244, dated 8 August 2002, registered with th e Ministry of Justice of Ukraine, Order 
No. 704/6992, dated 23 August 2002, approved the procedure for issuance of a licence for the above 
activities. 
 In order to obtain the said licence, it is necess ary to submit an application of the established 
form. The said application must contain the following information: 
- name of the legal entity with all its s ubsidiaries and branches, and its location; 
- surname, name, patronymic and passport deta ils (series, number, issuing authority, 
date of issuance and residence) – for a physical person; 
- contact telephone number; 
- organizational and legal form; 
- identification code for a legal entity (ide ntification number for a physical person); 
- banking details; 
- type of activity (export or import, optical media equipment or discs); 
- location of effectuation of the activity; and 
- obligations concerning the fulfilmen t of licensing terms and conditions. 
 At the same time, the following documentation must be attached to the application form: 
- copy of the certificate on state registration of  the agent of entrepreneurial activity or 
copy of the certificate on its inclusion into the Unified State Register of Enterprises 
and Organizations of Ukraine certified by a notary or by the authority which issued 
the original document; 
- list of the management of an agent of entr epreneurial activity (its head, deputy heads 
and chief accountant), including their surn ames, names and patronymics, positions 
and office telephone numbers signed by the head and duly stamped, as well as the 
reference concerning owners, signed by the head of a company and duly stamped; 
- duly certified copies of the founding documents (for a legal entity); 
- duly certified copies of the documents whic h confirm ownership rights or lease of 
storage facilities; 
- duly certified copies of the doc uments which confirm the in formation on the premises 
where wholesale and/or retail trade in optical media discs (for a licence to import 
discs) shall take place; 
- information on availability of optical medi a disc remainders as of 21 April 2002 (for 
export and import of optical media discs) – in case of such availability; and WT/ACC/UKR/151 
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  - list of main components for specialized equipment for production of optical media 
systems, export or import of which are subject to licensing pursuant to laws (for licenses on export and import of equipment). 
 A licence for activities of exporting and importing of optical media discs shall give the right 
to carry out export and import of discs only upon ava ilability of the special identification codes (CID-
codes) on such discs.  An agent of entrepreneuria l activity shall be obliged to export and import only 
those discs produced with the observance of intellectual property rights.  At the same time, an agent of 
entrepreneurial activity, which obtained a licence, sha ll be obliged to notify the Ministry of Economy   
on each allotment of optical media discs and/or subm it the list of equipment for production of optical 
media discs exported and/or imported.  Such notifica tion shall be effectuated by a letter which shall 
also contain the list of copyright and related right s objects (if applicable), number of cargo customs 
declaration and copy of cargo customs declaration for the given allotment, duly certified.  The said letter must be submitted within 15 days from the date of effectuation of export/import operation. 
 The following shall be the grounds  for refusal to issue a licence: 
- false information submitted by an applicant; and 
- discrepancy between the submitted documents and Licensing Terms and Conditions 
established for the given business activity. 
 In case of refusal to issue a licence on the b asis of discovered false information in the 
submitted documents, the new application shall be accepted not earlier that three months from the 
date of making decision to refuse a licence. 
 Licenses shall be issued for three years.  A fee in the amount of 340 Hryvnias (UAH) shall be 
charged.  This corresponds to expenses for processing of the said licence. 
 Concerning import of precious meta ls and precious stones into Ukraine
, such operations are 
not subject to licensing. 
 The activity of exporting the following precious  metals and precious stones from Ukraine 
shall be subject to licensing: 
- colloidal precious metals; inorganic or  organic compounds of precious metals, 
whether or not chemically defined; am algams of precious metals (code 2843); 
- diamonds, whether or not worked, but not mounted or set (code 7102); 
- precious stones (other than diamonds) and semi-precious stones, whether or not 
worked or graded but not strung, mounted or set; un-graded precious stones (other than diamonds) and semi-precious stones, temporarily strung for convenience of 
transport (code 7103); 
- silver (including silver plated with gol d or platinum), unwrought or in semi 
manufactured forms, or in powder form  (excluding banking metals (code 7106); 
- gold (including gold plated with platinum ), unwrought or in semi manufactured 
forms, or in powder form (exc luding banking metals (code 7108); 
- platinum, unwrought or in semi manufactured forms, or in powder form (excluding 
banking metals) (code 7110); and 
- waste and scrap of precious metal or of metal clad with precious metal (code 7112). 
 The term of a licence for carrying out the above business activity shall be three years.  Fee in 
the amount of UAH 340 shall be charged for the said licence.  WT/ACC/UKR/151 
 Page 5 
 
 
   Please see the answer to Question 47 of doc ument WT/ACC/UKR/110/Add.2 concerning the 
procedure for licensing. 
 Concerning the regime of import of narcotics , it is governed by the Law of Ukraine "On 
Turnover of Narcotics, Psychotropic Substances, Th eir Analogs and Precursors," No. 60/95-VR, dated 
15 February 1995, taking into account  international obligations of Ukraine.  The said Law provides 
that import or export of narcotics shall be carried  out by the authorized body of the Cabinet of 
Ministers of Ukraine according to a certificate (a separate permit) issued by the Committee on Control 
Over Narcotics attached to the Ministry of Health  Protection of Ukraine.  Issuance of the certificate 
shall be effectuated in agreement with the Secur ity Service of Ukraine (please see the answer to 
Question 46 of document WT/ACC/UKR/110/Add.2).  Th e Resolution of the Cabinet of Ministers of 
Ukraine "On the Approval of the Procedure for Issuan ce of Certificates to Import into Ukraine and to 
Export from Ukraine of Narcotics, Psychotropic Su bstances and Precursors," dated 3 February 1997, 
shall determine the procedure for issuance of the certificate and its sample. 
 In order to obtain the certificate to expor t/import narcotics, psychotropic substances and 
precursors, a company shall submit the following documents to the said Committee: 
 1. application on a company's letterhead addressed to the Head of the Committee.  The 
said application must contain the following information: 
- purpose of importation; 
- complete names, exact addresses and telephone (telexes) numbers of the 
importer (consignee) and exporter; 
- international non-proprietary name of th e imported produce, if such name is 
available, and/or the first name under which the said produce was issued, 
and/or the name under which it is ma nufactured in importing or exporting 
countries; 
- amount of narcotics, psychotropic substances and precursors subject to 
importation; 
- medical form of a narcotic, psyc hotropic substance and precursor; 
- name and amount of narcotics, psychot ropic substances and precursors which 
are imported under a contract and incl uded to the List of narcotics, 
psychotropic substances, their analogs a nd precursors that are subject to the 
special control pursuant to applicable  laws of Ukraine (hereinafter "those 
included to the list of controlled substances"); 
- name of the producer; 
- number of the contract for supply; 
- price (sum) of the contract for supply; 
- name and number of tare items - for narcotics, psychotropic substances and 
precursors in the form of substance used for production of medicines; 
- type of transport for supply; 
- delivery term for supply; and 
- name of the crossing point at state border of Ukraine through which 
importation shall be made. 
 2. invoice, cargo declaration, cargo, cu stoms and transportation documents which 
contain the information on the amount of na rcotics, psychotropic substances and 
precursors; 
 3. a company's Charter certified by a notary;  4. a copy of the contract, according to which importation of narcotics, psychotropic 
substances and precursors into Ukraine is  effectuated, certified by a notary; WT/ACC/UKR/151 
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   5. certificate of Medicines Registration Bureau of the Ministry of Health Protection of 
Ukraine on registration of medicines that are imported into Ukraine; 
 6. quality certificate of a narcotic or ps ychotropic substance with indication of its 
serviceable life (quality passport of the producer is attached as to precursors); 
 7. obligations of the company on use of narcotics, psychotropic substances and 
precursors only for the declared purposes (import); and 
 8. a license's copy for carrying out the given activity in the field of turnover of narcotics, 
psychotropic substances and precursors, certified by a notary. 
 The term of a licence for carrying out the above business activity shall be three years.  Fee in 
the amount of UAH 340 shall be charged for the said licence issuance. 
 Production of medicines, wholesale and retail trade in medicines
 is an activity that is subject 
to licensing according to the Law of Ukra ine "On Licensing Certain Business Activities," 
No. 1775-III, dated 1 June 2000.  The founding documents of an agent of business activity must 
indicate activities that are subject to licensing. 
 Production of medicines, wholesale and retail tr ade in medicines shall be effectuated on the 
basis of a licence for the given activity. 
 Documents for receipt of licenses on carrying out the given activities shall be submitted to the 
State Service of Medicines and Articles of Medical Purpose. 
 In order to obtain a licence, a business agent shall submit an application of the established 
form to the State Department for Control over Quality, Safety and Production of Medicines and 
Articles of Medical Purpose.  The said application must contain the following information: 
- name of the legal entity with all its s ubsidiaries and branches, and its location; 
- surname, name, patronymic and passport deta ils (series, number, issuing authority, 
date of issuance and residence) – for a physical person; 
- identification code for a legal entity (ide ntification number for a physical person); 
- type of activity; 
- location of effectuation of the activity; and 
- obligations concerning the fulfilmen t of licensing terms and conditions. 
 At the same time, a copy of the certificate of state registration of the agent of entrepreneurial 
activity or copy of the certificate of its inclusion into the Unified State Re gister of Enterprises and 
Organizations of Ukraine certified by a notary or by the authority which issued the original must be attached to the application form. 
 The following shall be the gr ounds for refusal of a licence: 
- false information submitted by an applicant; and 
- discrepancy between the submitted documents and Licensing Terms and Conditions 
established for the given business activity. 
 In case of refusal of a licence on the basis of  discovered false information in the submitted 
documents, a new application shall be accepted not ear lier that three months from the date of making 
decision on refusal in a licence issuance. 
 An agent of business activity, while carry ing out activities on production of medicines, 
wholesale and retail trade in such medicines, must ensure observance of consumer rights and  WT/ACC/UKR/151 
 Page 7 
 
 
  effectuate its activities in accordance with the La w of Ukraine "On Enterprises in Ukraine" and "On 
Ensuring of Sanitary and Epidemiological Well-being of Population." 
 Business agents may carry out production of  medicines, wholesale and retail trade in 
medicines on the basis of a licence on the given activity, if they meet qualifying, organizational and other special requirements as established by licensing terms and conditions. 
 Medicines may be produced after their registra tion.  Only medicines registered in Ukraine 
shall be allowed in wholesale and retail trade. Th ese medicines must also have a quality certificate 
issued by the producer.  Trade in medicines sha ll be carried out only through chemist's shops and 
pharmaceutical centres (warehouses) wh ich must pass state accreditation within a year from the date 
of a licence issuance. 
 Production of medicines shall be carried out following technical and technological regulations 
for production of medicines, and analytical no rmative documentation (pharmacopoeia article and 
technical terms and conditions) worked out in accordance with normative documents and standards 
applied in medical and microbiological industry. 
 Wholesale trade in medicines shall be eff ectuated only through pharmaceutical centres 
(warehouses).  It is mandatory for a pharmaceuti cal centre (warehouse) to have a valid State 
Pharmacopoeia, normative and techni cal and normative and legal doc uments, and special reference 
literature on the issues of dose, control over quality, storage, and procedure for distribution (shipment) 
of medicines. 
 Retail trade in medicines shall be effectuated only through chemis t's shops and their structural 
units (pharmaceutical points and pharmaceutical sta nds).  Chemist's shop fronts or their separate 
structural unit fronts should have the appropriate signboard, indicating the name of business agent and 
its owner or the owner's authorized body. 
 Individuals who are directly engaged in produc tion, wholesale and retail trade must have the 
relevant education and meet the unified qualifying requirements.  Such individuals must posses the 
following documents: 
(a) diploma of state standard on pharmaceutical education; and 
(b) certificate on awarding (acknowledgement) of pharmacist rank of  general type (for 
specialists graduated from academies (universities) after 1992).  
 Specialists who passed special training in educa tional institutions of foreign countries shall be 
allowed to carry out professional activities after examin ation of their qualification.  Specialists who do 
not work within three years on a specialty indicated  in their diplomas and certificates shall be allowed 
to carry out activities on production of medicines, wholesale and retail trade in medicine only after 
passing through retraining. 
 The term of a licence for carrying out the above business activity shall be five years. 
 The Law of Ukraine "On State Regulation of the Production and Trade in Ethyl, Cognac and 
Fruit Spirits, Alcoholic Beverages and Tobacco Goods (with changes and amendments)," No. 493, 
dated 19 December 1995, and the Resolution of the Cabinet of Ministers of Ukraine "On Provisional 
Procedure for Issuance of Licenses to Import and E xport Ethyl, Cognac and Fruit Spirits, Alcoholic 
Beverages and Tobacco Goods," No. 493, dated 13  May 1996, shall govern licensing to import and 
export spirits, alcoholic beverages and tobacco goods . WT/ACC/UKR/151 
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   Licenses to import and export ethyl and fruit spir its, distilled grape ethyl spirits and distilled 
fruit ethyl spirits shall be issued only to the st ate-owned enterprises and organizations specifically 
authorized for such purposes by the Cabinet of Mini sters of Ukraine.  Licenses to import and export 
cognac spirits shall be issued only to the specialized cognac enterprises.  The Cabinet of Ministers of 
Ukraine shall approve the list of  the said specialized enterprises. 
 The Ministry of Economy upon consent of State Department on the Issues of Excise Duty 
Administration and Control over Production and turnover Excise Goods of the State Tax Administration of Ukraine shall issue the said licenses separately for importing and exporting. 
 In case the Cabinet of Ministers of Ukraine sh all entrust the enterprises which produce ethyl, 
cognac and fruit spirits, distilled grape ethyl spirits  and distilled fruit ethyl spirits with powers to 
export such spirits or sell such spirits through wholesale trade to Ukrainian consumers, the said 
enterprises shall be exempted from a fee on the li cence to export such spirits within the amounts of 
their own production. 
 In order to obtain a licence, the fo llowing documents must be submitted: 
- an application form to obtain a licence to  import and export ethyl, cognac and fruit 
spirits, distilled grape ethyl spirits, distille d fruit ethyl spirits, alcoholic beverages and 
tobacco goods; 
- copy of the certificate on state registration of the agent of entrepreneurial activity, 
certified by a notary or by the authority which issued the original document; and 
- copy of the document which confirms the special authorities granted by the Cabinet 
of Ministers of Ukraine to the state-owned enterprise or organization to carry out 
import and export of ethyl, cognac and fruit spirits, distilled grape ethyl spirits and 
distilled fruit ethyl spirits, certified by the head's signature and stamped with a company's seal (in case of submission of the documents for receipt of a licence to carry out the given operations). 
 Processing and issuance of a licence shall be eff ectuated on the basis of a copy of the payment 
order (with the bank's mark) submitte d by an applicant which confirms transfer of the annual fee for a 
licence to the State budget of Ukraine, as well as on the basis of a reference of the relevant financial 
authority regarding actual receipt of the funds by the State budget of Ukraine.  Issuance of a licence shall be effectuated upon availability of the duly made  power of attorney for receipt of such licence 
and a document which identifies the person. 
 Decision to refuse a licence will be made when: 
- discrepancy between the submitted documents  and applicable laws of Ukraine; 
- applicant's violation of Ukrainian laws in  the field of foreign economic activity; and 
- non-receipt of consent on issuance of a li cence from State Department on the Issues 
of Excise Duty Administration and Control over Production and turnover Excise Goods of the State Tax Administration of Ukraine. 
 In case of refusal to issue a licence, the period for review of the documents shall suspend until 
the applicant submits the reviewed and improved documents or the appropr iate substantiation. 
 Licenses shall be issued for five years.  A li cence fee shall be charged annually.  The amount 
of a licence fee shall be UAH 170,000.  In case of late payment of th e regular fee, a licence shall be 
suspended.  WT/ACC/UKR/151 
 Page 9 
 
 
   Business activities related to production of pesticides and agro-chemicals (solely 
phytohormones), wholesale and retail trade in such products  is activities subject to licensing.  The 
Law of Ukraine "On Pesticides and Agro-Chemical s," No. 86-95/VR, dated 2 March 1995, and the 
joint Order of State Committee of Ukraine for the Issues of Regulator Policy and Entrepreneurship 
and Ministry of the Industrial Policy of Ukraine "On the Approval of Licensing Terms and Conditions 
for Carrying out Business Activities on Production of Pesticides and Agro-Chemicals, Wholesale and 
Retail Trade in Pesticides and Agro-Chemicals,"  No. 40/70, dated 22 February 2001, shall govern 
licensing terms and conditions of the said activities. 
 Pesticides and agro-chemicals of domestic pr oduction, as well as foreign ones, imported for 
use into Ukraine must meet the following requirements: 
- high biological effectiveness as to designated purposes; 
- safety for human health and the environment of regulations for their use are observed; 
and 
- conformity to state standards, sanita ry norms and other normative documents. 
 It is prohibited to import into the customs terr itory of Ukraine, produce, sell, use and advertise 
pesticides and agro-chemicals prior to their state re gistration.  State Interdepartmental Commission of 
Ukraine on the Issues of Testing and Registration of Plant Protection Means and Growth Regulators 
shall issue a permit to import and use unregistered p esticides and agro-chemicals, if such pesticides 
and agro-chemicals meet the following requirements: 
- they are considered as customs cargo and are under customs control; 
- they are used for scientific and research purposes; 
- they are imported during rise of a threat of mass seats for reproduction of dangerous 
organisms; 
- they are designated for combating plant micr o-organisms within the closed areas or 
pipeline systems on enterprises and institu tions of mining, nuclear and medical 
industries; and 
- they are imported together with seeds which were treated with protective and 
stimulant substances that pursuant to their chemical content and action methods meet 
analogs registered in Ukraine. 
 In order to import and use pesticides and ag ro-chemicals, unregistered in Ukraine, for the 
above purposes, it is mandatory to present documentary  confirmation of their use in the country where 
they are produced. 
 Entrepreneurial activity in the field of produc tion, wholesale and retail trade in pesticides and 
agro-chemicals shall be carried out on the basis of  a licence.  The Ministry of Industrial Policy of 
Ukraine shall issue a licence fo r production, wholesale and retail trade in pesticides and agro-
chemicals. 
 In order to obtain a licence, a business agent shall submit an application of the established 
form.  The said application must contain the following information: 
- name of the legal entity with all its s ubsidiaries and branches, and its location; 
- surname, name, patronymic and passport deta ils (series, number, issuing authority, 
date of issuance and residence) – for a physical person; 
- identification code for a legal entity (ide ntification number for a physical person); 
- type of activity; 
- location of effectuation of the activity; and 
- obligations concerning the fulfilmen t of licensing terms and conditions. WT/ACC/UKR/151 
Page 10  
 
   At the same time, a copy of the certificate of state registration of the agent of entrepreneurial 
activity or copy of the certificate of its inclusion into the Unified State Re gister of Enterprises and 
Organizations of Ukraine certified by a notary or by the authority which issued the original must be attached to the application form. 
 The following shall be the grounds  for refusal to issue a licence: 
- false information submitted by an applicant; and 
- discrepancy between the submitted documents and Licensing Terms and Conditions 
established for the given business activity. 
 In case of refusal of a licence on the basis of  discovered false information in the submitted 
documents, the new application sh all be accepted not earlier that three months from the date of 
making the decision on refusal of the licence. 
 In order to carry out business activities on pr oduction of pesticides and agro-chemicals, a 
business agent must ensure mandatory observance of  the requirements of technological regulations 
and rules.  In order to produce pesticides a nd agro-chemicals, business agent must posses the 
following documentation: 
- normative documents of standardization (GOST [State Standards of the former Soviet 
Union, which still apply in Ukraine], TU  [Technical Terms and Conditions], DSTU 
[State Standards of Ukraine]) for produc tion of goods of the given quality; 
- technological regulations; 
- positive conclusions of sanitary and epidemiological service; 
- permit to commence work; 
- permit to produce testing groups of domes tic pesticides and agro-chemicals; and 
- rules, drafted and approved by busin ess agent on the basis of the approved 
technological regulations. 
 In order to carry out business activities on whol esale and retail trade in pesticides and agro-
chemicals, a business agent must posses the following: 
- storing facilities for storage of pesticides a nd agro-chemicals.  Such storing facilities 
must meet sanitary and hygienic requirements and safety engineering rules, as well as to have sanitary passports; 
- quality certificates for pesticides and agro-chemicals; 
- regulations to carry out trade operations; 
- rules on labour protection, production sanitation and fire safety; 
- duties regulation; and 
- positive conclusions of sanitary and epidemiological service. 
 A business agent must sell pesticides and agro -chemicals to the population in a small-packed 
form with mandatory instructions printed in Ukrain ian concerning the safe use of such pesticides and 
agro-chemicals. 
 Employees of business agents whose activities relate to wholesale and retail trade in 
pesticides and agro-chemicals must have special e ducation and training, undergo retraining once per 
three years and medical examination, as well as have  a permit to work with the said pesticides and 
agro-chemicals, certificate and medical book. 
 A term of a licence for carrying out the above bu siness activity shall be three years.  A licence 
fee shall be charged in the amount of UAH 340.  WT/ACC/UKR/151 
 Page 11 
 
 
   Pursuant to Article 9 of the law of Ukrain e "On Medicines," the Cabinet of Ministers of 
Ukraine shall determine the procedure for state re gistration of medicines.  The Resolution of the 
Cabinet of Ministers of Ukraine "On the Appr oval of the Procedure for State Registration 
(Re-registration) of Medicines and Fees for State Registration (Re-registration) of a Medicine," 
No. 1422, dated September 2000, as changed and amended by the Resolution of the Cabinet of 
Ministers of Ukraine, No. 678, dated 21 June 2001, established the following fees for state registration 
(re-registration) of a medicine. 
 The applicant shall pay a fee for state registra tion (re-registration) of a medicine to the State 
budget of Ukraine. 
 A fee for state registration (re-registration) of a medicine shall be paid in Hryvnias or in a 
foreign currency.  Conversion into Hryvnias shall be e ffectuated pursuant to the official exchange rate 
of the National Bank of Ukraine as of the date of state registration (re-registration) of a medicine. 
 A fee for state registration (re-registration) of a medicine shall be charged in Hryvnias in the 
following amounts: 
 (a)  for state registration: 
- of a medicine (except for radioactive medicines, diagnostic means and simple 
or complex (halenic) preparations of plant medical raw materials) – in the amount equal to €1,000 for each medical form, €100 for each next dose and €100 for each next package of a medicine; and 
- of a radioactive medicine, diagnostic m eans and simple or complex (halenic) 
preparations of plant medical raw materials – in the amount equal to €500 for 
each medical form, €50 for each next dose and €50 for each next package of a 
medicine. 
 (b)  for re-registration: 
- of a medicine (except for radioactive medicines, diagnostic means and simple 
or complex (halenic) preparations of plant medical raw materials) – in the 
amount equal to €500 for each medical form, €50 for each next dose and €50 
for each next package of a medicine; and 
- of a radioactive medicine, diagnostic m eans and simple or complex (halenic) 
preparations of plant medical raw mate rials – in the amount equal to €250 for 
each medical form, €25 for each next dose and €25 for each next package of a medicine. 
 (c)  for state registration (re-registration): 
- of a medicine supplied in bulk, as well as of medicine packed up in Ukraine 
from in bulk supply – in the amount equal to €25 for each medical form and €25 for each next package of a medicine; and 
- of substances (active and auxiliary ma tters) – in the amount equal to €25 for 
each item. 
__________