WORLD TRADE  
ORGANIZATION  IP/Q/MKD/1 
IP/Q2/MKD/1 
IP/Q3/MKD/1 IP/Q4/MKD/1 
3 June 2005 
 
 
(05-2286) 
Council for Trade-Related Aspects of Intellectual Property Rights Original:   English 
 
  
REVIEW OF LEGISLATION 
 
THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA
1 
  
 The present document reproduces the introductory statement made by the delegation of the Former Yugoslav Republic of Macedonia (FYROM), the questions put to it and the responses given 
in connection with the review of legislation unde rtaken at the Council's meeting of 8 March 2004.
2 
  
_______________ 
 
 I. INTRODUCTORY STATEMENT 
The FYROM welcomes the opportunity to presen t its legislation governing protection of 
intellectual property rights to be reviewed by the WTO Members.   Since its independence, the FYROM has given serious consideration to the protection of 
intellectual property.  Rights arising from scientif ic, art and other intellectual works are guaranteed 
under Article 74 of the Constitution.   Pursuant to paragraph 238 of the Final Repor t of the Working Party on the Accession of the 
FYROM, it has committed to fully apply all provis ions of the TRIPS Agreement as of the date of 
accession. 
  Hence, the past period encompassed corresponding modifications and adjustments of the existing legislation, as well as undertaking certain activities for the purpose of providing more efficient protection of intellectual property rights.  
A. C
OPYRIGHT AND RELATED RIGHTS  
1. Legal Framework 
Copyright and related rights are fundamentally regulated by the Law on Copyright and 
Related Rights (Official Gazette 47/96 and 3/98).  The Law on Copyrights and Related Rights was, in 
principle, in compliance with the international legal regimes: WIPO a nd UNESCO conventions, EU 
Directives and the minimum requirements of the TRIPS Agreement.  Full TRIPS compliance was 
achieved with the 2002 amendmen ts (Official Gazette 98/02). 
                                                      
1 As regards laws and regulations notified by the FYROM under Article 63.2 of the Agreement, 
reference is made to documents IP/N/1/MKD/1; IP /N/1/MKD/C/1; IP/N/1/MKD/I/1; and IP/N/1/MKD/L/1. 
2 The minutes of this meeting have been circulated as document IP/C/M/43. IP/Q/MKD/1, IP/Q2/MKD/1,  
IP/Q3/MKD/1, IP/Q4/MKD/1 Page 2 
 
 
Changes to the Law on Copyrights and Related Rights in compliance with Article 14 
paragraph 5 of TRIPS mainly concerned retroactive pr otection of rights of performers to recordings of 
their performances and rights of phonogram producers to  their phonograms.  Retroactive protection of 
the said owners of related rights now extends to 50 years from the adoption of the Law on Copyrights 
and Related Rights, calculated from the first legal r ecording, that is the first legal publication or 
communication to the public, in a procedure and under  terms provided for in Article 18 of the Bern 
Convention.  Retroactive protecti on of radio broadcasting organizati ons and other owners of related 
rights now extends to 20 years calculated from the fi rst legal radio broadcast, i.e. legal publication. 
 
Law on Copyrights and Related Rights is fully in compliance with the MFN principle as 
required by TRIPS Agreement and other international treaties.  
 The latest amendments to the Law on Copyri ghts and Related Rights (Article 171) provide 
precisely that foreign copyright and related right s owners, protected in the manner and under the 
conditions required by internationa l agreements, shall enjoy equal protection as domestic copyright 
and related rights owners, if so required under international agreem ents ratified by the FYROM. 
Where foreign owners of copyright and related ri ghts are not protected in the manner and under the 
conditions required under interna tional agreements, they shall en joy equal protection as domestic 
copyright and related rights owne rs in the manner and under the c onditions defined in the pertinent 
articles.  2. International Agreements Acceded by the FYROM 
The FYROM is a party to the following conventions: 
 
• Bern Convention for the Protection of Literary and Artistic Works. 
• Universal Copyright Convention. 
• Rome Convention for the Protection of the Performers, Producers of Phonograms and 
Broadcasting Organisations.  
• Convention for the Protection of the Producers of Phonograms Against Unauthorized 
Duplication of their Phonograms (Geneva Convention). 
• Convention Relating to Distribution of Program-Carrying Signals Transmitted by 
Satellite on a succession basis (Satellite Convention). 
• The WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty 
(ratified by the Assembly of the FYROM in July 2003.) 
 
3. Initiatives and Plans 
In accordance with the FYROM's government de termination to fulfil the TRIPS Agreement's 
requirements and, in particular, to provide a more ef ficient protection of copyrights and related rights, 
the following activities, under the Information for Enforcement and Protection of Copyrights and Related Rights Initiative adopted by th e government, have been undertaken: 
 
(a) A Coordinative Body for copyrights and related rights has been established.  The 
Ministry of Culture is the coordinator of th e activities of the Coordinative body, which is 
composed of representatives from: the Ministry of Justice, the Ministry of Finance, the 
Macedonian Customs Administration, the State Market Inspectorate, the Ministry of Interior, the Ministry of Education and Science and th e Sector for European Integration with the 
Government of the FYROM; 
  IP/Q/MKD/1, IP/Q2/MKD/1,  
 IP/Q3/MKD/1, IP/Q4/MKD/1  Page 3 
 
 
(b) Drafting of new amendments and revisi ons to the Law on Copyrights and Related 
Rights in conformity with EU Directives is underway.  The new amendments and revisions to 
the Law on Copyrights and Related Rights will pr ovide a higher level of protection than the 
one required by the TRIPS Agreement.  These amendments shall include: provisions for 
sui generis  database protection, IT agenda provisions  covering the right of making available 
to the public, technological measures and right management information. 
(c) The Government of the FYROM shall adopt  the following strategic and development 
documents: (i) Programme for developing and impl ementing:  the system for protection of  
copyrights and related rights;  education and awareness campaigns;  and proposed short and 
long-term measures and activities; and, (ii) Acti on Plan for effective protection of copyrights 
and related rights in the FYROM; 
(d) Enactment of a separate Law on Customs Measures for Imports, Exports and 
Re-exports and Suspension Procedures for Counte rfeit and Pirated Goods in conformity with 
pertinent EU regulation has also been anticip ated.  Thus, customs protection will also be 
provided ex officio. 
B. I
NDUSTRIAL PROPERTY PROTECTION  
1. Legal framework 
Although the previous Macedonian industrial pr operty legislation was already in compliance 
with the TRIPS Agreement, in order to achieve  a higher level of compliance with the minimum 
standards prescribed by that Agreement, two ne w pieces of legislation were enacted:  The Law on 
Protection of the Topography of Integrated Circ uits (Official Gazette 5/98) and the new Law on 
Industrial Property (Official Gazette 47/02 and 42/0 3).  Macedonia also became a party to a number 
of international conventions and agreements. 
 
The Law on Industrial Property governs acquisiti on, exercising and protection of industrial 
property rights:  patents, industrial designs, trad emarks, appellations of origin and geographical 
indications.  The Law on Industrial Property was a dopted in July 2002 and came into force on 
1 January 2004.  This Law has specific provisions  on security and provisional measures, judicial 
protection, additional protection of well-known marks and compulsory licence.  It also extended the 
term of protection of industrial designs to a maximum of 25 years and created exceptions to patent protection. 
 
The Law on Industrial Property fully conforms with the MFN principle by providing equal 
rights for legal and natural persons from Member  countries of the Paris Union and the WTO.  
Additionally, pursuant to the Law, foreign legal and natural persons enjoy equal rights as domestic 
legal and natural persons in respect to protection of industrial property rights.  Transparency is 
provided through access to the registries and to the pub lications of the IPPO Journal and to the laws 
and regulations published in th e FYROM's Official Gazette. 
 It is our assessment that with these laws a nd the commitments undertaken under the Working 
Party Report of the accession of FYROM to the WTO, the TRIPS minimum requirements have been met. 
 
2. International agreements acceded by the Former Yugoslav Republic of Macedonia 
 The FYROM is a member of WIPO and has ratif ied all fundamental inte rnational conventions 
and agreements/treaties governing industrial property rights, agreements for international registration 
and application for protection of industrial property rights and intern ational classification agreements: IP/Q/MKD/1, IP/Q2/MKD/1,  
IP/Q3/MKD/1, IP/Q4/MKD/1 Page 4 
 
 
• Convention Establishing the World In tellectual Property Organization. 
• Paris Convention for the Protection of Industrial Property.  
• Madrid Agreement Concerning the Inte rnational Registration of Marks. 
• Nice Agreement Concerning the Internationa l Classification of Goods and Services for 
the Purposes of Registration of Marks. 
• Locarno Agreement Establishing an Interna tional Classification for Industrial Designs 
• Patent Cooperation Treaty. 
• Treaty for Cooperation with the European Patent Organization. 
• Protocol Relating to the Madrid Agreement for International Registration of Marks. 
• Budapest Treaty on the International Recogn ition of the Deposit of Micro-organisms for 
the Purposes of Patent Procedure.  
• Strasbourg Agreement Concerning the International Classification of Patents. 
• Hague Agreement Concerning Internati onal Deposit of Industrial Design.   
 
 The FYROM has signed a Cooperation Treaty (E nlargement Treaty) with the European 
Patent Organization that allows for extending the valid ity of European patents in the territory of the 
FYROM.  
3. Initiatives and plans 
Industrial Property Protection Office (IPPO), whic h is in charge of protection of industrial 
property rights, will begin accepting patent, trademark and industrial d esign software applications in 
the first half of 2004.  This will increase efficiency and quality of protection and accelerate the recognition procedure for industrial property rights. 
The FYROM is part of the regional CARDS Programme for intellectual property and the 
TEMPUS programme targeting all institutions in charge of protecting intellectual property rights.  It is 
our assessment that seminars, training for involved  institutions and activities for netting concerned 
institutions anticipated under the said programme s will contribute to an improved protection of 
intellectual property rights.  Under these programme s' activities, IPPO will promote the benefits 
coming from protecting industrial property rights.  It will also develop and raise awareness for 
protection of industrial property rights by way of printed materials, publica tions, announcements and 
coverage in the printed and other media. 
C. E
NFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS  
Enforcement of intellectual property rights is provided for by a comprehensive system of 
civil, administrative and criminal mechanisms in the following legislation: 
• Law on Industrial Property; 
• Law on Copyright and Related Rights; 
• Law against Limiting Competition; 
• Law on General Administrative Procedure; 
• Law on Administrative Disputes; 
• Law on Trial Proceedings; 
• Law on Criminal Procedure; 
• Law on Enforcement Procedure; 
• Criminal Code; 
• Law on Misdemeanour Procedure; 
• Law on Obligations; 
• Customs Law;  and  IP/Q/MKD/1, IP/Q2/MKD/1,  
 IP/Q3/MKD/1, IP/Q4/MKD/1  Page 5 
 
 
• Law on Trade 
 
 In order to provide more efficient protection of  intellectual property rights, the Ministry of 
Culture, the Ministry of Interior and the State Mark et Inspectorate have, in the course of the years, 
coordinated their inspection activities.  As a result,  pursuant to final court decisions, 30,000 copies of 
pirated editions of audio and visual goods were dest royed in the presence of the media, in December 
2003.  A number of such actions are anticipated for 2004.   
II. RESPONSES TO QUESTIONS POSED BY SWITZERLAND 
A. G
ENERAL  
1. Are the provisions of the TRIPS Agreement, in  so far as not implemented in national 
law, directly applicable in your legal system? 
Pursuant to Article 118 of the Constitution of  the FYROM, the international agreements 
ratified by the FYROM are considered as a part of the internal legal system and may not be changed 
by law. 
 
B. PATENTS  
2. Does your legislation grant patent protection for inventions relating to products and 
processes in all fields of technology?  Are there an y exceptions?  If so, please explain what these 
exceptions are and how they comply wi th Article 27 of the TRIPS Agreement. 
Pursuant to Article 2, indent 1 and 7 and Ar ticle 19, paragraph 1 of  the Law on Industrial 
Property, inventions in all fields of technique an d technology which are new, involve inventive step 
and are susceptible to industrial application shall be protected by patent.  This definition is also in 
conformity with Article 27,  paragraph 1 of TRIPS. 
 
Pursuant to Article 72, the patent granted for a process shall also refer to the products and 
substances obtained from that process. 
 Exceptions are anticipated in Article 20 of the Law on Industrial Property and they are 
entirely in compliance with the exceptions anticipated  in Article 27, paragraphs 2 and 3 of TRIPS.  
They refer to the new animal species and plant varieties, surgical and diagnostic methods and 
inventions, the publishing or applica tion of which is contrary to pub lic order and morality.  In the old 
Law on Industrial Property, the plant varieties and hybrids could have been protected with a patent, 
but with the adoption of the Law on Seeds and Se edling Material, the requirement from Article 27, 
paragraph 3(b) of TRIPS, which provides for excl usion of the same from patent inventions by 
provision of an efficient sui generis  system of protection, has been fulfilled. 
 3. Does your legislation, in accordance with Arti cle 27.1 in combination with Article 31 of 
the TRIPS Agreement, consider importation as  "working" a patent and therefore preclude 
compulsory licensing, if a product is being imported? 
Article 76 of the Law on Industrial Property s tipulates that if the patent owner does not 
exploit the protected invention or exploits it to the extent which is insufficien t to satisfy the needs of 
the Macedonian market, and refuses to conclude  a licence agreement or sets forth non-market 
conditions for conclusion of such agreement, the righ t of use of the invention may be given to another 
person with obligation to pay rem uneration to the patent owner.  Compulsory licence shall not be IP/Q/MKD/1, IP/Q2/MKD/1,  
IP/Q3/MKD/1, IP/Q4/MKD/1 Page 6 
 
 given if the patent owner proves the existence of legitimate reasons justifyi ng the non-exploitation or 
insufficient exploitation of the protected invention. 
 Satisfying the needs of the market means to satisfy the needs with domestic production or 
production from abroad. 
 
4. Does your legislation make the granting of a compulsory licence subject to all the 
conditions enumerated in Article 31 TRIPS of the TRIPS Agreement?  Please cite the relevant provisions of law. 
Articles 76 through 81 of th e Law on Industrial Property regulate the institution of 
compulsory licence, which is in compliance with Article 31 of TRIPS. 
 Pursuant to Article 76, paragraph 1 of the La w on Industrial Property, the compulsory licence 
is issued for the purpose of satisfying the needs of  the Macedonian market in cases where the patent 
owner does not exploit the protected invention, refuses to conclude  a licence agreement or sets forth 
non-market conditions for conclusion of such ag reement. This is entirely in compliance with 
Article 31, paragraphs (b), (c) and (d) of TRIPS.   Paragraph 2 of Article 76 shall determine the 
conditions due to which a compulsory licence is not  to be issued which is in compliance with 
Article 31, paragraph (a) of TRIPS. 
 
The court shall decide in a trial procedure upon request for issuance of compulsory licence 
(Article 77 of the Law on Industrial Property), which is in conformity with Article 31 of TRIPS.  The 
reimbursement is regulated with Article 79 of the Law on Industrial Property, pursuant to Article 31, 
paragraph 3(e) of TRIPS. 
 
The validity period of the compulsory licence is  exclusively related to the validity of the 
reason due to which it has been issued (Article 80 of the Law on Industrial Property, pursuant to 
Article 31 paragraph (i) of TRIPS). 
 
5. Does your legislation provide for the principle of the reversal of burden of proof in a 
process patent litigation?  Please cite the relevant provisions of law. 
In cases of civil court procedures (Article 201 through 211 of the Law on Industrial Property) 
initiated due to infringement of the patent right, th e court may, pursuant to Article 72 of the Law on 
Industrial Property, request evidence in case of ex istence of reasonable doubts that the product has 
been produced in a protected process which is in compliance with Article 34 of TRIPS.  The burden 
of proof shall fall on the alleged infringer (72, pa ragraph 4 of the Law on Industrial Property), which 
is in conformity with the provision fro m Article 34, paragraph 2 of TRIPS. 
 In the part of safety measures, there is a po ssibility for the right-owner to request from the 
persons related to the infringement of the right to present for inspection the data and documentation 
relating to the infringement (Article 214, paragra ph 1 of the Law on Industrial Property).  Such 
possibility is anticipated in Article 50, paragraph 5 of TRIPS. 
 
In a civil procedure, the judges ma y, for the needs of the procedure, order experts to testify, as 
well as request provision of other evidence material  (Articles 204-261 of the Law on Trial Procedure), 
in criminal procedure (Articles 198-252 of the Law on Criminal Procedure) and administrative 
procedure (Articles 159-201 of the Law on Administrative Procedure). 
 
In an administrative procedure, the procedur e upon proposal for declaring nullity of the 
decision, the person filing the proposal shall be obligated to submit the necessary evidence 
(Article 225, paragraphs  3 and 4 of the Law on Enforcement Procedure).  IP/Q/MKD/1, IP/Q2/MKD/1,  
 IP/Q3/MKD/1, IP/Q4/MKD/1  Page 7 
 
 
Submission of evidence to the opposite party requesting a reply is anticipated for all 
procedures. 
 
C. P
ROTECTION OF UNDISCLOSED INFORMATION  
6. Please explain in detail if your legislation en sures that undisclosed test or other data 
submitted by an applicant to the responsible State agency in the procedure for market authorisation of a pharmaceutical or of an agr icultural chemical product is protected against 
disclosure and against unfair commercial use by a competitor, for example by prohibiting a second applicant from relying on, or from referring to the original data of the first applicant, 
when applying subsequently for market  authorisation for his own product. 
Does your legislation provide for exceptions to  this?  If yes, under what conditions would 
such exceptions apply?  
Does your legislation provide for a specific term  of protection for such undisclosed test 
data? 
 
 Protection of confidential information is ma inly dealt with by the provisions for unfair 
competition of the Law on Trade Companies (A rticles 176 through 178b) and the Law on Trade 
(Articles 31 through 37).  
 Protection of confidential information from re searches and other information submitted in the 
procedure for approval of sale and marketing of pharmaceutical and agricultural chemical products 
(Article 39.3 of the TRIPS Agreement) is obtained with the provisions for unfair competition (Articles 
31, 34 and 37) of the Law on Trade (Official Gazette 23/95, 30/96, 43/95 and 43/99), Law Against Unfair Competition (Official Gazette 80/99) a nd Article 23 and 24 of the Law Against Limiting 
Competition (Official Gazette 80/99).  In addition to  that, the protection of confidential information 
and records for pharmaceutical products is provide d for in the law on Medicines, Medications and 
Medical Devices (Official Gazette 21/98). 
 The revealing and unauthorized acquiring of business secrets are considered as criminal acts 
pursuant to Article 281 of the Criminal Code.  Civil servants are requested to keep secret pursuant to 
Article 20 of the Law on Civil Servants.  Confidenti al information revealed during public trials and 
court procedures are protected pursuant to the La w on Administrative procedure (Article 150), Law 
on Trial Procedure (Article 292), Law on Crim inal Procedure (Article 280) and Law on 
Misdemeanours. 
 
Follow-up question:
 
 
 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 authorisation for his own product?  If this is IP/Q/MKD/1, IP/Q2/MKD/1,  
IP/Q3/MKD/1, IP/Q4/MKD/1 Page 8 
 
 
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 
authorisation 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 
authorisation for medicines, medications and medical devices are considered a business secret.  Disclosure or authorized attaining of business secret s are criminal acts in compliance with Article 281 
of the Criminal Code.  
 Notwithstanding paragraph 3 of Article 28 of the Law on Medicines, Medications and 
Medical Devices, data contained in a market authori sation 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. 
 
 Law on Medicines, Medications and Medical Devices defines the information that needs to be 
included in every market authorisation for a certain medicine (Article 29), market authorisation for a certain medication (Article 30) and market authori sation for certain medical devices (Article 31).  In 
other words, each submitted market authorisation 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 authorisation are protected by the Regula tion on the Procedure for Market Authorisation 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 authorisation are protected, is not provided for. 
 
Further follow-up to question 6:
 
 Article 39.3 of the TRIPS Agreement establishes two specific obligations:  to protect 
undisclosed test or other data submitted by an applicant to the responsible State agency in the 
procedure for market authorisation of a pharmaceu tical or of an agricultural chemical product 
from unfair commercial use and against disclosure.   We would like to thank the FYROM for its answer to the question regarding the obligation to protect such data against disclosure  by mentioning the provisions relating to 
business secrets in the Law on Medicines, Medica tions and Medical Devices and the Regulation 
on the Procedure for Market Authorisatio n for Substances for Protection of Plants. 
  Concerning the question regarding the obligation to protect such data against unfair 
commercial use  you mention in the last sentence of your answer, that a period, in which data 
submitted in a market authorisation are protect ed, is not provided for in your legislation.  
Please explain in detail how your legislation fulfil s this obligation and ensures that such data is 
protected against unfair commercial use by a comp etitor?  Does your legislation, for example, 
prohibit a second applicant from relying on, or fr om referring to the original data of the first 
applicant, when applying subsequently for market authorisation for his own product?  IP/Q/MKD/1, IP/Q2/MKD/1,  
 IP/Q3/MKD/1, IP/Q4/MKD/1  Page 9 
 
 
 If this is not the case, how is this pa rticular obligation of the TRIPS Agreement 
implemented in your legal framework? 
 
 In addition to the previously given answ er to the question from the Swiss delegation 
regarding the protection of investigation data, as we ll as other data filed in a market authorization 
procedure for pharmaceutical products, we would lik e to clarify the implementation of the following 
provisions:   The time-frame for keeping data that are consid ered business secrets is not limited, i.e. such 
data may not be available for other applicants in the market authorization procedure for medicines, 
medications or medical devices.   In case a producer or its representative files an application for obtaining market authorization for generic medicine, which has already been regi stered in the FYROM, it may not refer to the 
documentation already filed by a previous app licant, but must file its own documentation. 
  The licensing has been regulated in general by  the Law on Plant Protection (Official Gazette 
No. 25/98), since it does not contain any specific pr ovisions nor specified time-frames.  Validity of 
the licence is defined with a decision and indicated w ith the special sign for protection.  It has been 
regulated by Articles 40 and 41 of the Law on Plant Protection and Article 3 of the Regulation of the 
Manner of Issuing Permissions for Marketing th e Plant Protection Products (Official Gazette 
No. 65/01).  If the producer defines the confidential data pursuant to Article 3 of the Regulation of the 
Manner of Issuing Permissions for Marketing the Pl ant Protection Products, the competent bodies, in 
accordance with Article 20 of the La w on Civil Servants, are obliged to  respect the confidentiality of 
data and not disclose them to other interested parties. 
 
 According to the current legislation, the right to  the protection of data is regulated by a single 
law, but by the several aforementioned laws.   As part of the process for integration with  the EU, the domestic legislation will be 
harmonized, particularly in the field of phytop harmaceuticals, by the adoption of the Law on Plant 
Protection Products.  This Law defi nes that the holder of a decision or the entity that obtained an 
approval from the holder has the right to register a product.  It also determines the time-frame for 
protection of data, which is 10 years from the first inclusion of the active substance in the List of 
Active Substances from Annex 1 of the Directive of  the Council 91/414/EEC, with a possibility for 
extension for an additional five years. 
 
 Should another applicant report an identical product, according to this Law, it must submit information or data for identification of the produc t and acquire an approval from the holder of the 
first decision for the purpose of preventing double-t esting.  In case of failing to reach an agreement 
upon such issues, the competent bodi es of the FYROM shall mediate. 
 
D. P
ROVISIONAL MEASURES  
7. Do your judicial authorities have the authority to adopt, on the request of a right holder, 
a provisional measure inaudita altera parte  before an action leading to a decision on the merits 
of the case has been lodged?  Please cite the relevant provisions of law. 
Articles 263 through 276 of the Law on Enforcemen t Procedure and provisions of the Law on 
Trial Procedure authorize judges to issue provisional prohibitions and assistance for the purpose of 
preventing infringement and keeping of evidence.  The Law on Copyrights and Related Rights (Articles 159, 162 and 168), Criminal Code (Ar ticle 157) and Law on Industrial Property (Article 
213) also provide for provisional measures pronounced  by a court decision.  The provisional measures IP/Q/MKD/1, IP/Q2/MKD/1,  
IP/Q3/MKD/1, IP/Q4/MKD/1 Page 10 
 
 are permitted inaudita altera parte  in cases of copyrights pursuant to Article 162, paragraph 2 of the 
Law on Copyrights and Related Righ ts. Provisional measures in cases of intellectual property are 
permitted in compliance with Articles 263 throug h 275 of the Law on Enforcement Procedure and 
Articles 257 and 260 of the Law on Trial Procedure.  In accordance with these provisions, the 
provisional measures may be adopted inaudita altera parte. 
 
8. Does your legislation provide for any restrict ions for obtaining provisional measures? 
If so, what are these restrictions?  Please cite the relevant provisions of law. 
 
There are no restrictions regarding the tim e of pronouncing a provisional measure.   
  Pursuant to Article 264 of the Law on Enforcement Procedure:  "An interim measure may be allowed before a nd during a court or administrative procedure, 
and after the conclusion of such procedures,  but before the actual implementation of the 
enforcement."  Pursuant to Article 265 of the Law on Enforcement Procedure:  "An interim measure shall not be allowed if  there are grounds [conditions] for allowing a 
preceding measure capable of achieving the same goal." 
 
Pursuant to Article 266 of the Law on Enforcement Procedure:  "An interim measure for securing a monetary claim may be permitted if the creditor has made 
the existence of the claim evident and if there is  a risk that the debtor would obstruct or make 
significantly more difficult the collection of th e claim, in the absence of such a measure by 
transferring all of his/her property or assets, con ceal them or dispose of them in another way. 
 The creditor need not prove the risk if s/he makes evident that the debtor would suffer only 
insignificant damages. 
 
A risk shall be deemed to exist if the claim is due abroad.  An interim measure for preventing payment agai nst an acceptance order may be allowed if 
the proposal for such a measure was made in a complaint." 
 
Pursuant to Article 268 of the Law on Enforcement Procedure: 
 "An interim measure for securing a non-monetary claim may be permitted if the creditor 
makes evident the existence of th e claim and the risk that without such a measure the debtor 
would obstruct or make significantly more difficult the collection of the claim. 
  
 An interim measure may also be allowed if the creditor makes evident that the measure is 
necessary to prevent the use of force or th e damage caused could be indemnified. 
  The provisions pertaining to paragraphs 2 and 3 of Article 266 of this Law also apply to 
interim measures for securing a non-monetary claim."  
  IP/Q/MKD/1, IP/Q2/MKD/1,  
 IP/Q3/MKD/1, IP/Q4/MKD/1  Page 11 
 
 
9. Please describe the provisional measures provided for in your legislation, including 
those useful to combat counterfeiting and piracy.  Please describe the procedures that must be 
followed and cite the relevant provisions of law. 
The following activities of Article 162 of the La w on Copyrights and Related Rights:  seizure, 
removal from circulation and preservation of copies,  devices, equipment and documents;  prohibition 
of activities of eventual infringement or their c ontinuation and other sim ilar measures – provisional 
measures.  If there is a well founded suspicion that th is protection may not be realized later, the court 
may pronounce and execute such measures without prio r notification and hearing of the adverse party.  
The procedure for securing of evidence shall be summary. 
 
In Article 163 of the Law on Copyrights and Re lated Rights the provision of evidence is also 
considered as a provisional measure - in cases wher e it is known that the evidence will be destroyed 
or impossible to obtain at a later period of time, the court may also obtain them without prior notification and hearing of the adverse party.  The procedure for securing of evidence shall be 
summary. 
 Pursuant to Article 213 of the Law on Industrial Property:  "The right-owner who can initiate an action fo r infringement of his rights under this Law may 
also submit to the court request for ruling pr ovisional measures under the conditions and in 
the manner provided for by the Law on executive procedure." 
 Pursuant to Article 214 of the Law on Industrial Property:  "(1) The right-owner may request the person s who were in any way connected with the 
infringement of the right acquired under this La w (producer, publisher, importer, distributor, 
consignor, owner, seller, owner of samples, ite ms or means with which his right was infringed 
and other persons) to submit the data and doc uments regarding the infringement without 
delay.  (2) If the persons referred to in paragraph (1) of this Article fail to submit the data or 
document at their disposal, they shall be res ponsible for remuneration of damages caused by 
that failure.   (3) If the right-owner referred to in paragr aph (1) of this Article abuses the data or 
documents acquired from the persons under para graph (1) of this Article, causing them 
damages, he shall be obliged to remunerate  the damages under the general provisions for 
remuneration of damages." 
 
10. Please describe the measures provided by your legislation to combat counterfeiting and 
piracy at the border.  Please explain whether the competent authorities are empowered to act 
ex officio and, if so, please indicate the enforceme nt actions that may be taken.  Please cite the 
relevant provisions of law. 
Pursuant to Article 215 of the Law on Industrial Property: 
 " (1) If the right-owner lodges an applicati on that the import of given goods in the 
Republic of Macedonia infringes his rights acquired under this Law, at his request, the 
customs officials may rule the following border measures: 
  1. An authorized customs employee, accompanied by the right-owner or his 
representative, to inspect the goods which are being imported and exclude IP/Q/MKD/1, IP/Q2/MKD/1,  
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them from trade or store them in a safe place, unless the importer has authentic evidence on the production of the goods he is importing. 
  (2) At request of the customs officials or th e importer, the right-owner shall be obliged to 
submit bail for possible damages caused by the measures under paragraph (1) of this Article. 
  (3) The customs officials shall immediately notify the importer and receiver of goods of 
the ruled measures. 
 
 (4) The customs officials shall suspend th e ruled measures under paragraph (1) of this 
Article if the right-owner does not institute an action for infringement of right to the competent court within 8 days from the date of filing the request." 
 
Pursuant to Article 165 of the La w on Copyright and Related Rights: 
 
"If the right holder reports that his exclusive ri ght according to this Law has been infringed by 
the importation of certain goods in the state, the customs authorities may, on his demand 
determine the following customs measures:  - The right holder or his agent to inspect the goods;  and 
 
 - The goods to be seized, removed from circulation, or stored in a secure place.  
Together with the demand of this Article, para graph 1, the right holder shall be obliged to 
deliver to the customs authorities a detailed description of the goods, necessary evidence of 
his exclusive rights and their presumable infringeme nt.  On the customs authorities' order, the 
right holder shall be obliged to provide a secur ity against damage that may be caused by such 
measures. 
The customs authorities shall be obliged promptly  to notify the importer and the recipient of 
the goods of the measures adopted. The customs authorities shall rescind the measures adopted insofar the holder of right does not file a suit or initiate some other proceedings for 
executing the measures adopted within ten days." 
Regarding the availability of the Customs Aut horities to act ex officio, the Ministry of 
Finance and the Customs Administration sh all adopt the Law on Customs Measures for 
Protection of Intellectual Property during the 2004.  This Law is in the Plan of Acts and Activities, which will be prepared and proposed, or undertaken by the organizational units of 
the Ministry of Finance in the year 2004.  Th is Law shall enable the Customs Administration 
to act ex officio in the process of protection of the intellectual property.  
E. E
NFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS  
11. Please describe how your legislation meets the requirements of Article 41 of the TRIPS 
Agreement. Please cite the relevant provisions of law. 
Article 41.1 of TRIPS  
 
Pursuant to the LCRR and other legal regulati ons, authors and other holders of the copyright 
and related rights, the Inspectorate of the Ministry  of Culture, as well as other authorized state bodies 
(administrative and court) shall be authori zed for initiating and/or undertaking measures for 
prevention of the misuse of the copyright and related rights. 
  IP/Q/MKD/1, IP/Q2/MKD/1,  
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A person whose rights under this Law have been  infringed may demand protection of his/her 
rights and claim indemnity, unless otherwise determined by this Law.  The right holder may also demand protection under this Article, paragraph 1, when  there is a serious threat of infringement of 
the rights according to this Law (Article 156). 
 
When there are several right holders according to this Law, each of them may demand 
protection of the right in its entirety.  When there are several infringers of a right as per this Law, each 
of them shall be liable for the infringement, in its entirety (Article 157).  
A person shall be considered to be infringing th e exclusive rights according to this Law, when 
s/he manufactures, imports, possesses for commercial purposes, distributes, rents or in any other way uses any devices which sole or main purpose is, unauthorized removal or damage of technical 
equipment or a computer program that is used as le gal protection against unauthorized use;  and that 
makes possible or assists, without authorization, the public to receive encoded broadcasters program-
carrying signals (Article 158). 
 
Authors and other holders of copyright and related rights, independently or through a 
representative that may be a collective organization as well, may initiate court procedures (trial procedure - as unique initiators of the procedure, misdemeanour or criminal procedures for which the 
Inspectorate at the Ministry of Culture may al so appear as initiator).  The foregoing entities may 
submit criminal charges for initiation of a criminal procedure for the performed criminal acts before 
the public prosecutor and if ther e is evidence for the performed criminal act, which according to 
Article 157 of the Criminal Code (Official Gazet te of the FYROM No. 37/96) shall be prosecuted 
officially, the public prosecutor shall press charges.   At the same time, protection measures to be 
undertaken may be demanded.  Under the Law on Copy rights and Related Rights, the infringement of 
the copyright and related rights is also anticipated and is subject to sanctions. 
 The Inspectorate at the Ministry of Culture  shall perform regular and extraordinary 
supervisions and control and investigate each case se parately.  If it finds that certain copyright and 
related rights have been infringed, it shall unde rtake the prescribed measures and press misdemeanour 
charges.  At the same time with the misdemeanour  charges, protection measures shall be undertaken. 
 
When an authorized person (her eafter: inspector) in the course of his supervisory activity, has 
well-founded suspects that an infring ement has been committed, he sh all temporarily seize the objects 
that have been or are intended to be used for committing an infringement, or have been created by 
such an infringement. The inspector shall submit the temporarily seized objects, together with a writ 
for institution of misdemeanour proceedings, to the competent authority in misdemeanour 
proceedings (Article 170,  paragraph 2 and 3). 
 Civil legal protection according to Law on Copy rights and Related Rights is stipulated in 
Articles 159 through 163. 
  
The Law on Industrial Property anticipates provision of efficient protection in case of 
infringement of an industrial property rights through: 
 - A procedure upon proposal for declaring nu llity of a decision (Article 224 and 225 of 
the Law on Industrial Property); 
 
- Provisional measures (Article 213);  - Submission of data and other documenta tion (Article 214 of the Law on Industrial 
Property); 
 IP/Q/MKD/1, IP/Q2/MKD/1,  
IP/Q3/MKD/1, IP/Q4/MKD/1 Page 14 
 
 
- Court protection (201-212);  - Customs measures (215);  
- Misdemeanors (228 of the Law on Industrial Property). 
 The Criminal Code provides for criminal acts such as unauthorized use of other's business 
name (Article 385) and unauthorized use of other' s invention (Article 286).  Objects produced with 
the above-mentioned criminal acts shall be seized,  while the prosecution shall be initiated upon a 
proposal. 
 Procedures for the legal, civil legal protecti on, misdemeanor and criminal protection are 
regulated in the relevant articles of the followi ng regulations: Law on Administrative Procedure, Law 
on Trial Procedure, Law on Obligations (Compe nsation of Damages), Law on Misdemeanors, 
Criminal Code, Law on Criminal Procedure, Law on Enforcement Procedure, etc. 
 
Article 41.2 of TRIPS
 
 
The following provisions refer to enforcem ent of fair, simple and cheap procedures: 
 
The Law on Criminal Procedure anticipates th e following basic principles:  the accused 
person for a criminal act shall be considered as innocent until the guilt is proven on the basis of facts 
which the court determines in a favourable ma nner for the accused - presumption of innocence 
(Article 2), the accused person needs to be notifie d about the reason for which the procedure has been 
initiated against him/her in the la nguage which s/he understands (Artic le 3), the accused person shall 
have a right to a just and public trial in a reas onable time period (Article 4), it is prohibited and 
punishable to elicit confession (Article 10), the proc edure shall be carried wi thout delay (Article 13), 
the obligation of the court and other state bodies for a truthful and complete determination of facts 
(Article 14), evaluation of evidence shall not be re lated or limited with special formal evidence rules 
(Article 15). 
 
Provisions regarding the criminal procedure shall also be applied in the misdemeanour 
procedure.  
The Law on Trial Procedure anticipates the following basic principles:  determination of 
limits of the request (Article 2), the parties may freely dispose with the requests (Article 3), the court 
shall decide upon the complaint request orally, immediately and in public (Article 4), an opportunity 
for each party to express its opinion upon requests of th e other party (Article 5), an obligation of the 
court for complete and honest de termination of the disputable facts and evaluation of evidence 
(Article 7), the court shall be obligated to carry out the procedure without delay and with the least 
expenses (Article 10), educating an ignorant party about th e possibilities for initia ting trial procedures 
(Article 11). 
 
The Law on Administrative Procedure, anticipates the following basic principles:  solving the 
problem according to law (Article 4), provision for protecting the citizens and public interest 
(Article 5), efficient realization of the rights (Ar ticle 6), determination of the real conditions by 
analysing all the facts (Article 7), guaranteed opportu nity for the parties to express their opinion about 
the facts and circumstances (Article 8), the proced ure to be carried out with the least expenses 
(Article 13), providing assistance to ignorant parties for the purpose of protecting his/her rights, that 
belong to him/her according to the Law (Article 14).   IP/Q/MKD/1, IP/Q2/MKD/1,  
 IP/Q3/MKD/1, IP/Q4/MKD/1  Page 15 
 
 Article 41.3 of TRIPS
 
 
Decisions of competent bodies in written form, containing explanation and based on evidence 
presented by the parties in a dispute are stipulated  in the provisions of the following regulations: 
 
Pursuant to the Law on Criminal Procedure the verdict shall be pronounced and published 
(Article 337), the court shall base the verdict only on  facts and evidence presented at the main hearing 
(Article 339), the published verdict sh all be prepared in written form with in 8 days from the date of its 
publishing, or if more complex within 15 days (Ar ticle 347), the verdict needs to contain introduction, 
disposition/statement and e xplanation (Article 348). 
 Pursuant to the Law on Trial Procedure, th e verdict shall be pronounced and published 
(Article 321), the announced verdict shall be prepar ed in written within 8 days, while for more 
complex procedures, as an exception, within 15 days  from the date of its publishing (Article 323), the 
verdict needs to contain an introduction, statem ent (disposition) and expl anation (Article 324).  
 Pursuant to the Law on Administrative Procedur e, the authorized body shall make a decision 
(Article 202) and it shall be in a written form and shall contain: an introduction, statement 
(disposition) and explanation (Article  206).  The procedure shall be administered while the decision 
shall be made and submitted to the party within  60 days, unless otherwise provided by the law. 
 
Article 41.4 of TRIPS
 
 
Complaints upon final administrative decisions and decision of first instance court authorities.  
An appeal against first instance decision may be filed to the Second Instance Committee of 
the Government (Article 14 Law on Enforcement Procedure) and (Article 144, 145 of the Law on 
Copyrights and Related Rights). 
 A complaint may be filed for the purpose of initiation an administrative procedure against a 
decision adopted in a second instance administrativ e procedure (Law on Administrative Procedure). 
 
An administrative procedure may be initiated within 30 days upon the receipt of the second 
instance decision (23 and 24 of the Law on Administra tive Procedure).  The complaint is filed to the 
Supreme Court of the FYROM (Article 3, paragr aph 1of the Law on Administrative Procedure). 
 
In compliance with Article 350 of the Law on Criminal Procedure, it is anticipated a right on 
complaint within 15 days from the submission of  the verdict upon which the second instance court 
shall decide (the Appellate Court). 
 Also, some extra legal remedies have been antic ipated upon an effective verdict, such as: 
repetition of the criminal procedure (Articles 388- 398) and decision of the first instance court; 
extraordinary alleviation of the punishment (Art icles 399-402) upon which the Supreme Court shall 
decide;  demand for protection under the Law (Ar ticles 403-410) upon which the Supreme Court shall 
decide and request for extraordinary check of th e effective verdict (Article 411-415) upon which the 
Supreme Court shall decide.  
Pursuant to Article 75 of the Law on Misdem eanours an appeal may be filed to a second 
instance court (Appellate Court) against a verdict a nd decision of the first instance.  Extraordinary 
legal remedies are the following: Demand for Repetition of the Misdemeanour Procedure and 
Demand for Protection of the Rule of Law. 
 IP/Q/MKD/1, IP/Q2/MKD/1,  
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Pursuant to Article 334 of the Law on Trial Pr ocedure a right to an appeal is anticipated 
within 15 days from the day of submission of th e verdict upon which the second instance court shall 
decide (Appellate Court). 
 
Extraordinary remedies are:  Revision (A rticles 368-386) upon which the Supreme Court 
shall decide;  demand for protection of the rule of law (Articles 387-394) upon which the Supreme 
Court shall decide and repetition of the procedur e (Articles 395-402) upon which the first instance 
court shall decide). 
 
According to the Law on Copyrights and Rela ted Rights, upon a decision for issuance or 
revocation of a licence for collective realization of the copyright and related rights, an appeal is 
allowed to be submitted to the Government of the FYROM within 15 days from the submission of the 
decision.  Upon the second instance act an  administrative trial may be initiated.  
 
12. Please indicate the authorities responsible for the application of the measures provided 
by your legislation to combat counterfeiting a nd piracy.  Please explain whether the competent 
authorities are empowered to act ex officio and,  if so, please indicate the enforcement actions 
that may be taken.  Please cite the relevant provisions of law. 
The Ministry of Culture monitors the implem entation of the Law on Copyrights and Related 
Rights - Managing Board of Associations for Coll ective Exercise of the Copyrights and Related 
Rights and Inspection Surveillance.  The inspection is  carried out ex officio and upon request by right 
holders.  The inspection may initiate misdemeanor pr ocedure.  The inspection also has authorization 
to seize objects and equipment - provisional measure - with a compulsory initiation of the misdemeanor procedure. 
 
The Ministry of Economy – State Market Inspection carries out inspection on practicing the 
trade rules ex officio - origin of goods, provision for consumers protection and alike. 
 The Ministry of Internal Affairs carries out inspection ex officio in cases where the 
unauthorized use of works and objects protected by the Law on Copyrights and Related Rights 
reaches the level of organized crime. 
 The Public Prosecutor shall ex offi cio initiate criminal procedure. 
 The Customs Administration undertakes border measures of search for right holders. 
 
Courts decide upon civil, misdemeanor and crim inal procedures.  The civil procedure may be 
initiated only by right holders; misdemeanor proce dures – inspections, right holders, as well as the 
public prosecutor; criminal procedure may be  initiated only by the Public Prosecutor. 
 Associations for collective exercise of rights a nd right holders may individually initiate civil 
and misdemeanor procedures, while for initiation of a criminal procedure, they file a request to the 
Public Prosecutor.  
The Customs Administration, in compliance with Article 215 of the Law on Industrial 
Property (Official Gazette 47/02) has a right to act in the following manner.  When a property right 
holder has doubts that a certain company will import or is already importing piratical and 
counterfeited goods, s/he shall address the Customs Administration. 
 An authorized person from the Customs Administ ration, escorting the right holder or his/her 
representative may check the goods subject of impor ts and prohibit the release of the same on the 
market and store it in a safe place, in case he im porter does not possess a relevant evidence for the  IP/Q/MKD/1, IP/Q2/MKD/1,  
 IP/Q3/MKD/1, IP/Q4/MKD/1  Page 17 
 
 production of the imported goods.  In such a case, the Customs Administration has the right to keep the goods and prohibit the import of su ch piratical or counterfeited goods. 
 
13. Please describe any new initiatives that a re planned to improve the enforcement of 
intellectual property rights in your country, part icularly initiatives to combat counterfeiting 
and piracy. Is there a particular action plan in place? 
In accordance with the expressed  readiness of the Government for providing implementation 
of the requirements pursuant to the TRIPS Agreement,  and in particular for applying more efficient 
protection of copyrights and related rights on the basis of the Information for Exercise and Protection 
of Copyrights and Related Rights, the fo llowing activities have been undertaken: 
 (1)  A Coordinative Body for copyrights and related rights has been established, where 
the coordinator is the Minister of Culture.  Repr esentatives of the following ministries and institutions 
participate in its work: Ministry of Justice, Ministry of Finance, Customs Administration of the 
FYROM, Ministry of Economy, State Market Inspecti on, Ministry of Internal Affairs, Ministry of 
Education and Science and the Sector for European  Integration in the Government of the FYROM. 
 (2)  The Government of the FYROM shall adopt the following: Program for improving 
and implementing the regime for realization and pr otection of copyrights and related rights and for 
education and awareness by analyzing the status a nd proposal for short-term  and ling-term measures 
and activities and Action plan for efficient realizati on of the protection of copyrights and related rights 
in the FYROM – strategic and developing documents.  
(3)  Currently, the Law on Copyrights and Rela ted Rights is in the process of amending 
for the purpose of putting it into compliance with th e EU Directives.  These amendments shall provide 
for a higher level of protection than the one determ ined in TRIPS.  The most significant amendments 
are the following: provisions for database protection sui generis , IT agenda provisions covering the 
right to making available to the public, technologi cal measures, and right management information. 
 
(4)  The following legislation shall be a dopted - Law on Governing Customs Measures 
for Import, Export and Re-Export and Suspension Pr ocedures for Counterfeit and Pirated Goods - in 
conformity with the provisions of the pertinent le gislation of the European Union.  This Law shall 
provide for customs protection to be realized ex officio, as well.  
The FYROM is part of the regional CARDS pr ogramme for intellectual property and the 
TEMPUS programme targeting all institutions in charge of pr otection and implementation of 
intellectual property rights.  Our estimation is th at these projects, where numerous seminars, training 
and plans for netting of the concerned institution ar e planned, will contribute to our efforts for 
improving the protection of intellectual property rights.    
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