. /.  WORLD TRADE  
ORGANIZATION  IP/C/W/421/Add.1 
6 September 2004 
 (04-3705) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
REVIEW OF LEGISLATION 
 
Response from the Former Y ugoslav Republic of Macedonia  
to a question from Switzerland1 
 
Addendum  
 
 
 The following communication, dated 3 August 2004, is being circulated at the request of the 
Delegation of the Former Y ugoslav Republic of Macedonia. 
 
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Follow-up to question 6  
 
 In your answer, you mention that the protection of confidential information from researches and other information submitted in  the procedure for approval of sale and 
marketing of pharmaceutical and agricultural chem ical products is ensured in your legislation 
by the provisions for unfair competition of the Law on Trade, the Law Against Unfair 
Competition, the Law Against Limiting Compet ition and the Law on Medicines, Medications 
and Medical Devices. 
  Please explain in more detail how this legislation ensures that undisclosed test or other 
data submitted by an applican t to the responsible State agency in the procedure for market 
authorization of a pharmaceutical or of an agr icultural chemical product is protected against 
disclosure and unfair commercial use by a competitor.  Does your legislation for example 
prohibit a second applicant from relying on, or from referring to, the original data of the first 
applicant, when applying subsequently for market authorization for his own product?  If this is 
the case, does your legislation provide for excepti ons to this? If yes, under what conditions 
would such exceptions apply?  
 Does your legislation provide for a specific te rm of protection for such undisclosed test 
data? 
 
 Protection of undisclosed test or other data submitted in the procedure for market authorization of a pharmaceutical product is prov ided for with the provisions of the Law on 
Medicines, Medications and Medical Devices (Offi cial Gazette of RM no. 21/98).  Article 28, 
paragraph 3 of this Law sets out that data contained in documentation supporting a market 
authorization for medicines, medications and medical devices are considered a business secret.  
Disclosure or unauthorized attaining of business secrets are criminal acts in compliance with Article 281 of the Criminal Code. 
                                                     
 
1 This question posed by Switzerland to the FYRO M was circulated in document IP/C/W/419/Add.1.  IP/C/W/421/Add.1 
Page 2  
 
 Notwithstanding paragraph 3 of Article 28 of the Law on Medicines, Medications and 
Medical Devices, data contained in a market authori zation may be used by a third party provided it is 
in the interest of the health of the population an d the animals or for the purpose of exchanging 
information among administrative bodies (paragraph 4 of Article 28).  Administrative servants are 
obliged to keep the secret in compliance with Article 20 of the Law on Administrative Servants. 
 
 The Law on Medicines, Medications and Medical  Devices defines the information that needs 
to be included in every market authorization for a certain medicine (Article 29), market authorization 
for a certain medication (Article 30) and market aut horization for certain medical devices (Article 31).  
In other words, each submitted market authorizatio n for medicines, medications and medical devices 
should contain the information from the above listed Articles. 
  With respect to agricultura l chemical products, data submitted by companies for obtaining 
market authorization are protected by the Regulation on the Procedure for Market Authorization for Substances for Protection of Plants (Official Gazette  of RM no. 65/2001).  Article 3 of the Regulation 
sets out that if the person submitting an application for testing substances considers that certain data 
constitute a business secret s/he should label them as such.   A period, in which data submitted in a market authorization are protected, is not provided for. 
  
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