IP/N/1/HRV/O/8  
 
4 July 2013  
(13-3554)  Page: 1/9  
Council for Trade-Related Aspects  
of Intellectual Property Rights  Original: English/anglais/inglés  
 
  
MAIN DEDICATED INTELLECTUAL PROPERTY LAWS AND 
REGULATIONS NOTIFIED UNDER ARTICLE 63.2 
OF THE AGREEMENT 
 
CROATIA  
This document reproduces the text1 of the Act on Amendments to the Medicinal Products Act, as 
notified by the Republic of Croatia on 8 May 2013 under Article 63.2 of the Agreement 
(see document IP/N/1/HRV/5).  
Conseil des aspects des droits de propriété 
intellectuelle qui touchent au commerce   
PRINCIPALES LOIS ET RÉGLEMENTATIONS CONSACRÉES À 
LA PROPRIÉTÉ INTELLECTUELLE NOTIFIÉES AU TITRE 
DE L'ARTICLE 63:2 DE L'ACCORD 
 
C
ROATIE  
Le présent document contient le texte1 de Loi sur la représentation dans le domaine des droits de 
propriété industrielle et de la Loi modifiant la Loi sur la représentation dans le domaine des droits 
de propriété industrielle, notifiées par la République de Croatie le 8 mai 2013 au titre de l'article 63:2 de l'Accord (voir le document IP/N/1/HRV/5). 
 
Consejo de los Aspectos de los Derechos de Propiedad 
Intelectual relacionados con el Comercio  
 
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA 
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD 
DEL PÁRRAFO 2 DEL ARTÍCULO 63 DEL ACUERDO 
 
C
ROACIA  
En el presente documento se reproduce el texto1 de la Ley por la que se modifica la Ley de 
Productos Medicinales, notificada por la República de Croacia el 8 de mayo de 2013 en virtud de lo dispuesto en el párrafo 2 del artículo 63 de l Acuerdo (véase el documento IP/N/1/HRV/5). 
 
                                               
1 In English only./En anglais seulement./En inglés solamente. IP/N/1/HRV/O/8 
 
- 2 - 
 
  PP 3-9- Offset (Pdf file attached) 
PP 3 à 9 - Offset (fichier Pdf joint) PP 3-9 - Offset (fichero Pdf adjunto) 
 
 
 PROVISIONAL TRANSLATIONCROATIAN PARLIAMENT 
1035 
 
Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby issue the  
 
DECISION 
PROMULGATING THE ACT ON AMENDMENTS TO  
THE MEDICINAL PRODUCTS ACT 
 
I hereby promulgate the Act on Amendments to th e Medicinal Products Act, passed by the Croatian 
Parliament at its session on 3 April 2009. 
 No: 011-01/09-01/71 
Reg: 71-05-03/1-09-2 
 Zagreb, 6 April 2009  
The President of the Republic of Croatia 
Stjepan Mesi ć, m.p. 
 
 
  
THE ACT ON AMENDMENTS TO THE MEDICINAL PRODUCTS ACT  
 
 
Article 1 
In the Medicinal Products Act (O fficial Gazette 71/07), after Ar ticle 2, item 60, item 60 a. is 
added which reads:  “60.a Advanced therapy medicinal product means the medicinal product based on 
manufacturing processes focused on genes and/ or therapeutically modified cells and/or 
therapeutically modified tissues.”
 
 In item 64, the word “Agency” is repl aced by the words “competent authority”. 
 
 
Article 2 
In Article 7, paragraph 8 is amended to read:  “If the Minister does not give or refuse his pr e-approval within the deadline referred to in 
paragraphs 3, 4 and 5 of this Article, the approval shall be deemed granted.” 
  
Article 3 
In Article 15, item a) is amended to read:   “a) the medicinal product is e ssentially similar to the refere nce medicinal product, provided 
that the reference product was granted marketin g authorisation in the Republic of Croatia or 
any EU Member State more than six years ag
o, or the reference medicinal product was 
granted marketing authorisation in the European  Union using the centralised procedure more 
IP/N/1/HRV/O/8 
        - 3 -PROVISIONAL TRANSLATION 2than ten years ago, for any strength, pharm aceutical form, method of  administration or 
packaging, or” 
  
Article 4 
After Article 15, a new Article 15.a is added which reads: 
 
“Article 15.a 
The marketing authorisation appl icant referred to in Article 14 of this Act shall not be 
required to enclose results of pre-clinical tests or  the results of clinical trials if any of the 
following can be demonstrated:  a) the medicinal product is of th e same kind as the reference me dicinal product, provided that 
the reference product was granted marketing aut horisation in the Republic of Croatia or any 
EU Member State more than eight years ago for any strength, pharmaceutical form, method of 
administration or packaging.  b) the medical use of active substance or activ e substances of the drug product has been well-
established in the European Union or the Republic of Croatia for at least ten years, with 
recognised efficacy and safety, as determin ed on the basis of a detailed scientific 
bibliography, or that 
c) the manufacturer of a reference product and the holder of the marketing authorisation for 
that reference product authorised  in the Republic of Croatia or the European Union have 
agreed to use from their files the pharmaceutic al, pre-clinical and clinical data on the 
reference product for the purpose of assessment of  documentation enclosed  to application for 
obtaining the marketing authorisation for anothe r medicinal product with the same qualitative 
and quantitative composition in active substanc es and of the same pharmaceutical form.“ 
 
The marketing authorisation holder may not pl ace the medicinal product from paragraph 1, 
item a) of this item on the market within ten years following the obtaining of the first 
marketing authorisation for this  reference medicinal product. 
 The ten-year period from paragraph 2 of this item may be prolonged for an additional year if, 
during the first eight years of the ten-year peri od, the holder of the mark eting authorisation for 
the reference medicinal product is granted authorisation for one or more new therapeutic 
indications for the same medicinal product that are considered to  be clinically  significantly 
beneficial compared to the existi ng use of the medicinal product.”  
  
Article 5 
In Article 20, paragraph 6 is amended to read: 
 “In the procedure for issuance of the marketing authorisation, the Agency shall approve the Summary of Product Characteristics, the Patient  Information Leaflet and the labelling, and 
submit them to the marketing authorisation holder.”  
 
 
Article 6 
In Article 22, paragraph 1, item c) after the Croatian word translated as: “proven”, another Croatian word is deleted, with no re levance to the English translation. 
 
IP/N/1/HRV/O/8 
        - 4 -PROVISIONAL TRANSLATION 3Article 7 
In Article 24, paragraph 8 is amended to read: 
 
“If the approved amendment requires amendments to data in the decision on the marketing authorisation, the Agency shall issue, along with the approved amendment, a decision on 
amendments to the marketing authorisation. The Agency’s decision may be appealed, though 
administrative proceedings may be instituted.”   After paragraph 8, a new paragraph 9 is added which reads:  “If the approved amendment requires amendments  to the Summary of Product Characteristics 
and/or Patient Information L eaflet and/or labelling, the Ag ency, along with the approved 
amendment, shall approve the new amended Summary of Product Char acteristics and/or 
Patient Information Leaf let and/or labelling.” 
 The previous paragraphs 9 and 10 become paragraphs 10 and 11.  
 
 
Article 8 
In Article 47, paragraph 1, item 1 is amended to read: 
 “1) the name of the medicinal product followed by its strength and pharmaceutical form, and, 
if appropriate, whether it is inte nded for nursing infants, childr en or adults. The international 
non-proprietary name (INN) or, where unavaila ble, its common name, shall be included 
where the medicinal product contains up to three active substances.” 
 
 
Article 9 
In Article 63, paragraph 1, the word “licence” is replaced by the word “approval”. 
 
Paragraph 2 is amended to read: 
“The provision of paragraph 1 of  this Article shall not apply to issuing the import approval 
for: 
– medicinal products manufactured from human blood or human plasma,  
– substances used for the manufacture of immunological medicinal products and 
 immunological medicinal products,  
– radiopharmaceuticals.“ 
 
After paragraph 2, paragraph 3 is added which reads: 
 
“The Minister shall issue an ordinance establ ishing detailed conditions for issuing the import 
approval for drug products from paragraph 2 of this Article.” 
 
 
Article 10 
In Article 71, paragraph 2 the words: “and to the Agency”, are replaced by the words: “other 
than those for which this is required neither by  the trial protocol no r by the investigator’s 
brochure.” 
 
 
IP/N/1/HRV/O/8 
        - 5 -PROVISIONAL TRANSLATION 4Article 11 
In Article 72, paragraph 2, item 1, the words:  “to the Agency and the Central Ethics 
Committee”, are replaced by the words: “at the request of the Agency and/or the Central 
Ethics Committee.” 
 Item 3 is amended to read: 
 
“3. immediately, and within no later than 15 days of learning of the information, ensure that 
all other suspected and serious unexpected adverse reactions are reported to the Agency and 
the Central Ethics Committee.”  Item 5 is amended to read: 
 
“5. submit on an annual basis the ag gregate report about the clinical drug fo r the period of one 
year, which contains the list of all suspected serious adverse reactions recorded during the 
reporting period, and the report on safety of tria l subjects, to the Agency and the Central 
Ethics Committee, and exceptionally also as requ ired by the Agency and/or the Central Ethics 
Committee.” 
 
Article 12 
In Article 110, after paragraph 2, pa ragraph 3 is added which reads:  
 
“The costs of the procedure for registratio n, amendments to registration, renewal of 
registration, and refusal and delis ting of the homeopathic medicinal product from the register 
of homeopathic medicinal products shall be defi ned by the Agency, subject to approval by the 
Minister, and borne by the applican t or the registration holder.” 
 
 
Article 13 
In Article 111, after paragraph 8, pa ragraph 9 is added which reads: 
 “The provisions of Article 24 of this Act shall appropriately apply to the approval of 
amendments to authorised homeopathic medicinal products.”   
Article 14 
In Article 114, paragraph 1, the number “113” is replaced by the number “108”.  In paragraph 1, subparagraph 2, the words: “who is the holder of the marketing authorisation 
for homeopathic medicinal products” are replace d by the words: “who is the holder of the 
registration of the homeopathic medicinal product in the regist er of homeopathic medicinal 
products”. 
 
 
Article 15 
In Article 115, after paragraph 1, a new paragraph 2 is added which reads: 
 
“The advertising of homeopathic medicinal pr oducts referred to in Article 108 of this Act 
shall be prohibited.” 
 
IP/N/1/HRV/O/8 
        - 6 -PROVISIONAL TRANSLATION 5In former paragraph 2, which becomes paragr aph 3, the number “1” is replaced by the number 
“2”. 
 
Article 16 
Article 120 is amended to read: 
 
“The Agency shall engage in the following activities:  
– granting marketing authoris ations for medicinal products  and homeopathic medicinal 
products;   
– keeping the register of ho meopathic medicinal products; 
– providing expert assessment of the qualit y, efficacy and safety of medicinal products 
and homeopathic medicinal products;  – conducting pharmaceutical testing of medi cinal products and homeopathic medicinal 
products; 
– performing quality control of  medicinal products and ho meopathic medicinal products 
and issuing quality control certificates a nd marketing authorisations for imported 
medicinal products; 
– analysing and evaluating adve rse reactions and safety of subjects in clinical trials; 
– drawing up the Croatian pharmacopoeia; 
– issuing manufacturing aut horisations to manufacturer s of medicinal products and 
homeopathic medicinal products; 
– issuing Good Manufacturing Pr actice (GMP) ce rtificates; 
– issuing wholesale distributio n authorisations for medici nal products and homeopathic 
medicinal products; 
– issuing retail sale authorisations to stores  specialised in the retail sale of medicinal 
products; 
– issuing import and export li cences for medicinal products; 
– giving approvals for import and export of medicinal products; 
– monitoring adverse reactions and non-compliance of medicinal products; 
– carrying out urgent recall procedures for medicinal products; 
– monitoring the consumption of medicinal products and promoti ng their rational use; 
– proposing measures to the Minister for th e supervision of cons umption of medicinal 
products; – engaging in waste management activities (for its own needs); – providing information and edu cation about medicinal products; 
– offering expert advice from its scope of activities; 
– proposing the alignment of me dicinal product regulations with those of the European 
Union and with regulations and guidelines of international institutions; 
– establishing internatio nal co-operation in the field of medicinal products; 
– keeping the register of medical device manufacturers and the register of medical 
devices; 
– analysing and evaluating adverse events and safety of subjects in clinical trials of 
medical devices; 
– issuing wholesale distribution au thorisation for medical devices; 
- issuing retail sale authorisations to stores sp ecialised in the retail sale of medical devices; 
- issuing import and export licences for medical devices; 
IP/N/1/HRV/O/8 
        - 7 -PROVISIONAL TRANSLATION 6- giving approvals for the import and export of medical devices; 
- performing vigilance of medical devices; 
- carrying out urgent recall procedures for medical devices; 
- performing classificatio n of medical devices; 
- issuing the certificate of registration of medical devices in the register of medical 
devices; 
- providing information and edu cation about medical devices; 
- establishing international co-operation in the field of medical devices; 
- proposing the alignment of regu lations in the field of medical  devices with those of the 
European Union and the regulations and guidelines of international institutions; – carrying out other tasks from the area of medicinal products and homeopathic medicinal 
products in accordance with this Act and regu lations passed pursuant thereto, and from the 
area of medical devices in accordance with the Medical Devices Act and the regulations passed pursuant thereto.”  
  
Article 17 
In Article 135, item 18, the words: “paragraph 1”, are followed by the words: “and 2”. 
  
Article 18 
The Agency is obliged to align its work and opera tions with the provisions of this Act within 
three months from the date of its entry into force.   
Article 19 
Applications for issuance of the marketing authorisation for medicinal products submitted 
prior to the entry into force of Article 3 of this Act shall be completed pursuant to the provisions of Article 15 of the Medicina l Products Act (Official Gazette 71/07). 
 Applications for issuance of the marketing authorisation for medicinal products submitted 
until the entry into force of Article 4 of this Act shall be completed pursuant to the provisions 
of Article 15 of the Medicinal Products Act (Official Gazette 71/07). 
  
Article 20 
The provisions of Article 15 of the Medicina l Products Act (Official Gazette 71/07) shall 
cease to have effect upon the expiry of three ye ars of the date of acce ssion of the Republic of 
Croatia to the European Union.   
Article 21 
This Act shall enter into force on the eighth day after the day of its publication in the Official 
Gazette, with the exception of Article 3 of this Act which shall enter into force on the date of 
accession of the Republic of Croatia to the European Union, and Article 4 which shall enter into force following the lapse of three years from the date of accession of the Republic of Croatia to the European Union.     Class: 530-01/09-01/01 
IP/N/1/HRV/O/8 
        - 8 -PROVISIONAL TRANSLATION 7Zagreb, 3 April 2009 
 
THE CROATIAN PARLIAMENT 
The President of the Croatian Parliament 
Luka Bebi ć, m.p. 
    
IP/N/1/HRV/O/8 
        - 9 -