. /.   WORLD TRADE  
ORGANIZATION  IP/C/W/530/Add.1 
3 June 2009 
 
 (09-2656) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
REVIEW OF LEGISLATION 
 
Responses to questions posed by Switzerland  
 
UKRAINE 
 
Addendum  
  
 By means of a communication from the Delega tion of Ukraine, dated 2 June 2009, the 
Secretariat has received the following response to the follow-up question posed by Switzerland, as 
circulated in document IP/C/W/528/Add.1.  
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A. 
UNDISCLOSED INFORMATION  
1. Ad response to question 7 
In your response, you mention that "if a medicine has been registered in Ukraine, it 
shall be prohibited to use registration informat ion during five years from the date of such 
registration (…) to submit an application for st ate registration of another medicine, except for 
cases where the right to refer to or use such in formation has been obtained in accordance with 
the established procedure" . 
Could you please explain the content of th e above-mentioned "established procedure", 
the competent authority and the conditions examin ed by it?  Please cite the relevant provisions 
of law. 
According to Article 9 of the Law of Ukraine "On medicines" "if a medicine has been 
registered in Ukraine, it shall be prohibited to u se registration information during five years from the 
date of such registration (…) to submit an appli cation for state registration of another medicine, 
except for cases where the right to refer to or u se such information has been obtained in accordance 
with the established procedure". 
In accordance with paragraph 19 of Article 9 of the Law the procedure of state registration (re-
registration) of medicine (as well as procedure and requirements for protection of exclusiveness of 
registration data of medicine’s do ssier) is determined by the Cabinet of Ministers of Ukraine.  
Regarding the provisions of Article 3.2 of Pro cedure on State registration (re-registration) of 
medicines and amount of charges for State registra tion (re-registration), approve d by the Decree # 376 
of the Cabinet of Ministers of Ukraine as of 26 May 2006 (Ukrainian version of this Decree is 
available at:  http://zakon1.rada.gov.ua/cgi-bin/laws /main.cgi?nreg=376-2005-%EF), it is forbidden to IP/C/W/530/Add.1 
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  use registration information on safety and efficiency of registered medicine, which is contained in 
application and annexes to it, for presentation of a pplication on State registration of other medicine 
during five years from the date of State registrati on, except the cases when the right of reference or 
usage of such information is acquired from the person or organization w ho or which gave the 
information in accordance with the procedure establishe d by legislation or information is prepared by 
applicant or for applicant. 
There is no special procedure for acquirement of right to use or refer on registration 
information of medicine in Ukrainian legislati on because of the absence of necessity, as indicated 
information is the object of intellectual property right s, so the right of usage is acquired to business 
entities by the owner of such information or by hi s/her authorized representa tives in accordance with 
Civil Code of Ukraine, Code on Economic Activity,  Laws of Ukraine "On protection of rights to 
industrial designs", "On protection of rights to mark s for goods and services", "On protection of rights 
to indication of origin of goods", "On protection of rights to inventions and utility models", "On 
copyright and related rights".  
Pursuant to above-mentioned normative acts,  the ownership right to the registration 
information can be acquired on the basis of the agreem ent, and the right to use it (refer to it) – on the 
basis of license contract or other agreements. 
As to authorized body and requirements which ar e examined by it during the registration of 
medicine, in accordance with Procedure on State regi stration, registration of medicine for usage on 
the territory of Ukraine is provided by the Ministry  of Health of Ukraine on the basis of conclusions 
of "State Pharmaceutical Centre" under the Ministry  of Health of Ukraine.  According to the 
Procedure of expertise of registration material s, which are submitted for State registration (re-
registration), Centre examines the registration materials and in case of registration dossier disconformities with national legislation the Centre has a right to require additional information or 
materials from the applicant for the State registra tion of medicine.  If the applicant doesn’t give 
corrected materials or the letter with argumentati on of terms during the appoi nted period of time and 
if given additional or missing data or informa tion doesn’t provide the compliance of registration 
dossier with statutory requirements, the me dicine is removed from the examination. 
 
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