IP/N/1/HRV/O/7  
 
4 July 2013  
(13-3551)  Page: 1/50  
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 
 
C
ROATIA  
This document reproduces the text1 of the Medicinal Products Act 2007, 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 la Loi modifiant la Loi sur les médicaments, notifiée 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 
 
CROACIA  
En el presente documento se reproduce el texto1 de la Ley de Productos Medicinales, de 2007, 
notificada por la República de Croacia el 8 de mayo de 2013 en virtud de lo dispuesto en el párrafo 2 del artículo 63 del Acuerdo (véase el documento IP/N/1/HRV/5). 
 
                                               
1 In English only./En anglais seulement./En inglés solamente. IP/N/1/HRV/O/7 
 
- 2 - 
 
  PP 3-50- Offset (Pdf file attached) 
PP 3 à 50 - Offset (fichier Pdf joint) PP 3-50 - Offset (fichero Pdf adjunto) 
 
 
  
THE CROATIAN PARLIAMENT   
2181 
Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby issue the   
DECISION  
PROMULGATING THE  
MEDICINAL PRODUCTS ACT  
 
I hereby promulgate the Medici nal Products Act passed by the Croatian Parliament at its 
session on 21 June 2007.  
 Class: 011-01/07-01/59 
Reg. No.: 71-05-03/1-07-2 Zagreb, 27 June 2007 
The President 
of the Republic of Croatia  
Stjepan Mesi ć, m.p. 
 
MEDICINAL PRODUCTS ACT 
 
I GENERAL PROVISIONS 
 
Article 1 
With a view to ensure efficacy, quality and safe ty of medicinal products as products of special 
importance for the protection of human health, th is Act lays down the pr ocedures for testing, 
placing on the market, manufacture,  labelling, classification, distribution, pharmacovigilance, 
advertising and information, supervision, a nd quality control of medicinal products. 
This Act also establishes conditions and met hods for placing on the market and control of 
homeopathic medicinal products.   
 
Article 2 
For the purposes of this Act, the following definitions apply: 
1. Medicinal product means any substance or combination of substances intended for treating 
or preventing disease in human beings; or any substance or co mbination of substances which 
may be administered to human beings either with a view to  restoring, correcting or modifying 
physiological functions by exerting a pharmacol ogical, immunological or metabolic action, or 
to making a medical diagnosis, 2. Substance  referred to in item 1 of this Arti cle may be of the following origins: 
– human, e.g. human blood and human blood products; 
– animal, e.g. micro-organisms, animals, parts of  organs, animal secretions, toxins, extracts, 
blood product; – vegetable, e.g. micro-organisms, plants, part s of plants, vegetable secretions, vegetable 
extracts; 
IP/N/1/HRV/O/7 
        - 3 - 
– chemical, e.g. elements, naturally occurring chemical substances and chemical products 
obtained by a chemical reaction, 
3. Active substance  means any substance conferring a drug product action, 
4. Excipient means any substance that instead of conferring a drug product action: 
– assists in giving a pharmaceutical form to a drug product;  – protects, supports and improve s stability, bioavailability a nd tolerance of a medicinal 
product; 
– assists in drug product identification, 
5. Raw material  means any substance of specified quality intended for a drug product 
manufacture, 6. Drug product  means
 any medicinal product that is industrially manufactured in order to be 
placed on the market, 7. Galenical preparation  means any medicinal product of veri fied quality, manufactured in a 
galenical laboratory of a pharmacy according to the procedure provided in the current 
pharmacopoeia or the relevant literature a nd GMP (Good Manufacturing Practice) standards 
for galenical laboratories, 8. Officinal formula means any  medicinal product prepared in a pharmacy in accordance with 
a prescription for an  individual patient, 
9. Name of the medicinal product means the name given to a medicinal product, which may 
be either an invented name or  a common or scientific name.  The common or scientific name 
must be followed by a trademark or the na me of the manufacturer or the marketing 
authorisation holder. The invented  name shall be different from and shall not be liable to 
confusion with the common name, 10. Common name  means the  international non-propr ietary name (INN) recommended by the 
World Health Organisation or, if one does not exist, the usual common name, 
11. Immunological medicinal product  means any medicinal product that is or consists of 
vaccines, toxins, serums or allergen products. 
Vaccines, toxins and serums shall cover in particular:  
– agents used to produce active immunity, such as vaccines against cholera, BCG, polio, 
small pox; 
– agents used to diagnose the state of immu nity, including in part icular tuberculin and 
tuberculin PPD, toxins for Schi ck and Dick tests, brucellin;  
– agents used to produce pass ive immunity, such as diphther ia antitoxin, globulin against 
small pox, antilymphocytic globulin.   
Allergen product means any medicinal product that  is intended to identif y or induce a specific 
acquired alteration in the immunological response to an allergising agent,  
12. Medicinal products derived fr om human blood or human plasma  means medicinal 
products based on blood constituents including, in  particular, albumin, coagulating factors and 
immunoglobulins of human origin, 
13. Radiopharmaceutical means any medicinal product that contains one or more 
radionuclides (radioactive isotopes ), intended for medical use,  
14. Radionuclide generator means any system incorporating a fixed parent radionuclide from 
which a particular radionuclide is produced for fresh preparation of a radiopharmaceutical, 
15. Radionuclide in a sealed radiation source  means any radioactive substance in a tightly 
sealed container used for external radiation treatment, 16. Radionuclide kit  means any preparation to be r econstituted or combined with 
radiounuclides in the final radiopharmaceuti cal, usually immediately prior to its 
administration, 
IP/N/1/HRV/O/7 
        - 4 - 
17. Radionuclide precursor means any radionucliude produced  for the radiolabelling of 
another substance prior to administration, 
18. Homeopathic medicinal product  means any medicinal product prepared from substances 
or combination of substances called homeopathic  stocks in accordance with a homeopathic 
manufacturing procedure described by the Eu ropean Pharmacopoeia or, in the absence 
thereof, by the pharmacopoeias currently used offi cially in the Member States; a homeopathic 
medicinal product may contain a number of principles, 19. Herbal medicinal product means any medicinal product, exclus ively containing as active 
ingredients one or more herbal substances or on e or more herbal prepar ations, or one or more 
such herbal substances in combination with  one or more such herbal preparations, 
20. Traditional herbal medicinal product means a herbal medicinal product whose efficacy 
and safety can be recognised on the basis of its long-term use in the Republic of Croatia or the 
European Union, and that fulfils the conditions laid down in this Act, 
21. Herbal substances means whole or fragmented or cut plan ts, plant parts, algae, lichen, 
fungi, in a dried or fresh form; certain exudates that have not been subjected to a specific 
treatment; herbal substances are precisely defi ned by the plant part used and the botanical 
name according to the binomial system (genus, species, variety and author), 
22. Herbal preparations means preparations obtained by s ubjecting herbal substances to 
treatments such as fractionation, extraction, fermentation, distillation, purification, concentration. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates, 23. Quality of the medicinal product  means the acceptable physical, chemical, biological, 
pharmaceutical and technological, as well as a ny other property of a medicinal product, 
24. Safety of the medicinal product means the acceptable relation between efficacy and 
harmfulness of a medicinal product, 25. Efficacy of the medicinal product  means the ability of a medi cinal product verified in 
clinical trials conducted in compliance with this Act, 
26. Risks related to the use of the medicinal product means: 
– any risk relating to the quali ty, safety or efficacy of the medicinal product as regards 
patients' health or public health; – any risk of undesirable effects on the environment, 27. Risk-benefit balance means an evaluation of the positive therapeutic effects of the 
medicinal product in relation to the risks as  defined in item 26 of this Article, 
28. Testing of the medicinal product means the procedure for establishing quality, safety and 
efficacy of a medicinal product, 29. Clinical trial means any investigation in  human subjects which is carried out in line with 
the protocol and which is intended to di scover or verify the pharmacokinetic and 
pharmacodynamic properties of one or more inve stigational medicinal product(s); and/or to 
discover any adverse reactions to  one or more investigational medicinal product(s) or their 
interactions; for the purpose of defini ng its (their) safety and/or efficacy, 
30. Protocol  means a document that describes the objective(s), design, methodology, 
statistical considerations and orga nisation of a trial. Th e term protocol refe
 rs to the protocol, 
successive versions of the protocol and protocol amendments, 31. Sponsor means any legal or natural person which ta kes responsibility for the initiation, 
management and/or financi ng of a clinical trial, 
32. Clinical trial applicant means a sponsor seated in the Republic of Croatia or any legal person seated in the Republic of Croatia and registered for the perf ormance of mediation 
activities relating to clinical trials who, on behalf of the sponsor  and by virtue of a power of 
attorney, files the application for a clinical trial,  
IP/N/1/HRV/O/7 
        - 5 - 
33. Investigational medicinal product means a pharmaceutical form of an active substance or 
placebo being tested or used as a reference in a clinical trial, including products already with a 
marketing authorisation but used or assembled (formulated or packaged) in a way different 
from the authorised form, or when used for an unauthorised indication, or when used to gain 
further information about the authorised form, 
34. Testing of safety of the medicinal product after its placing on the market means any 
pharmaco-epidemiologic or clinical trial conducted in line with the marketing authorisation and intended to determine or measure any possi ble safety risk of the authorised medicinal 
product, 35. Non-interventional trial  means a study where the medicinal product(s) is (are) prescribed 
in the usual manner in accordance with the terms of the marketing authorisation. The 
assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescripti on of the medicine is clearly 
separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be 
used for the analysis  of collected data, 
36. Non-interventional trial applicant  means a holder of the ma rketing authorisation,  
37. Pharmaceutical testing of  the medicinal product means any physicochemical, biological 
and/or microbiological testing to determin e the quality of the medicinal product,  
38. Sample of the medicinal product  means any quantity of the drug product requisite for 
pharmaceutical testing, 39. Reference standard  means any material or substance whose property or properties is used 
in pharmaceutical testing, 40. Pre-clinical test  means any toxicological and pharm acological testing to determine 
pharmacodynamic, pharmacokinetic and toxicologi cal properties of the medicinal product in 
animals and other appropriate models,  41. The Central Ethics Committee means an independent bod y consisting of medical 
professionals and other non-medical members whose responsibility is to ensure the protection 
of rights, safety and well-being of clinical trial subjects and to provide assurance of that 
protection by, among other things, giving opinions on trial protocols, suitability of investigators, legal persons on whose premises trials are conducted, equipment, methods and 
documents to be used for informing the trial subjects and obtaining their informed consents. 
The minister in charge of hea lth shall appoint the Central Ethi cs Committee (hereinafter: “the 
Minister”), 42. Bioavailability  means the rate and the degree of ava ilability of the active substance from a 
drug product (dosage form) determined according to the concentration-time curve in general circulation or excretions, 43. Bioequivalent medicinal products means pharmaceutical equivalents or pharmaceutical 
alternatives whose bioavailability after administ ration of the same molar dose is similar to the 
extent that it may be expected  to produce basically the same  effect, including efficacy and 
safety, 44. Bioequivalence means that two medicinal products, which are pharmaceutical equivalents 
or pharmaceutical alternatives, have similar bioa vailability when administered at the same 
molar dose to the extent that basically the same  effect, including efficacy and safety, can be 
expected, 45. Pharmaceutical equivalents means drug
 products containing the same active substance(s) 
in the same quantity and of the same dosag e form, administered by the same route and 
complying with the same or comparable standards, 
IP/N/1/HRV/O/7 
        - 6 - 
46. Pharmaceutical alternatives means drug products containing the same active substance 
but in the form of a different salt, ester and th e like, or in a different pharmaceutical form or 
of a different strength, 
47. Good laboratory practice means  a quality system related to organisational processes and 
conditions which must be observed for de signing, conducting, controlling, reporting and 
documentation of pre-clinical test s related to safe administration with respect to human health 
and the environment, 48. Good clinical practice means a set of internationally recognised ethical and scientific 
requirements which must be observed for designing, conducting, reco rding and reporting 
clinical trials, 49. Informed consent  means a signed and dated consent of  a trial subject given in writing, 
which proves the subject’s willingne ss to participate in a clinical  trial, after having received 
appropriately documented information on the natu re and significance, as well as involved 
consequences and risks.
 If a subject is incapable of giving such a consent or is a minor, his 
legal representative or a guardian may sign an informed consent, 50. Immediate packaging  means the container or other fo rm of packaging immediately in 
contact with the medicinal product, 51. Outer packaging  means a packaging into which th e immediate packaging is placed, 
52. Summary of the Product Characteristics means expert information on a drug product 
approved in an authorisation pr ocedure and intended for physicians, dental medicine doctors 
and pharmacists. Also used as a source of information for drawing up p ackage leaflets for end 
users, labelling of medicinal products , and for verification of advertising, 
53. Labelling  means any set of data provided on the immediate or outer packaging, 
54. Package leaflet means a leaflet containing information for the user, which accompanies 
the medicinal product, 55. Original medicinal product means the first world-wide version of  a medicinal product 
authorised for placing on the market on the grounds of complete efficacy, safety and quality documentation which complies with requirements in force, 56. Reference medicinal product means a medicinal product aut horised in the Republic of 
Croatia or in the European Union on the ba sis of the complete documentation on efficacy, 
safety and quality in line with valid requirements, 57. Generic medicinal product means a medicinal product which has the same qualitative and 
quantitative composition in active substances  and the same pharmaceutical form as the 
reference medicinal product, and whose bioequ ivalence with the reference medicinal product 
has been demonstrated by appropriate bioavail ability studies. The different salts, esters, 
ethers, isomers, mixtures of isomers, complexes or derivatives of an ac tive substance shall be 
considered to be the same active substance, unless they differ significan tly in properties with 
regard to safety and/or efficacy; the various  immediate-release oral  pharmaceutical forms 
shall be considered to be one and the same pharmaceutical form, 58. Medicinal product with a well-established medicinal use means a medicinal product 
containing active substance or substances that has or have had a well-established medicinal 
use with recognised efficacy and an acceptable leve l of safety for at least ten years following 
the first systematic and documented use in th e Republic of Croatia or the European Union, 
59. Biological medicinal product means a medicinal product in wh ich the active substance is a 
biological substance; biological substance means a substance that is produced by or extracted 
from a biological source and that needs for its characterisation and the determination of its 
quality a combination of physicochemical-biolo gical testing, together  with the production 
process and its control, 60. Biosimilar medicinal product means a medicinal product which has similar quality, safety 
and efficacy as the original biological medicinal product,
 
IP/N/1/HRV/O/7 
        - 7 - 
61. Counterfeit medicinal product means a medicinal product whose identity and/or the 
source is deliberately and fraudulently misl abelled, and it can contain proper or wrong 
ingredients, with or without  active substances, or cont ain a wrong quantity of active 
substances in a fake or counterfeit packaging.  Counterfeiting can apply to both brand name 
and generic products,  
62. Marketing authorisation means an authorisation issued by the Agency that completes the procedure for establishing that a medicinal pr oduct meets the quality, efficacy and safety 
requirements, 63. Marketing authorisation holder means a legal person seated in the Republic of Croatia 
holding an authorisation for the marketing of  a drug product in the Republic of Croatia, 
64. Manufacturing authorisation means a document issued by the Agency confirming that the manufacturer meets the conditions imposed on premises, equipment and staff of a drug product manufacturing plant(s) and applies principles and guidelines of Good Manufacturing Practice in accordance with this  Act and the ensuing regulations or the valid regulations of the 
European Union for manufacturers outside the Republic of Croatia, 
65. Manufacturer of the medicinal product  means a legal person re sponsible for production 
and development as well as quality, safety and efficacy of a medicinal product, regardless of whether it was manufactured by him or  some other person on his behalf, 
66. Manufacturer with respect  to manufacturing site  means a legal person holding the 
manufacturing authorisation for a plant or plants for drug product manufacturing, 
67. Manufacture of medicinal products comprises the whole process or individual parts of the process, such as pharmaceutical and technologic al preparation of a drug product, production 
of a substance by synthesis or further processing of procured substa nces and materials, 
technological processing and packaging as well as quality control, storage and delivery, 
68. Good Manufacturing Practice means the part of the quality assurance system which 
ensures that medicinal products are consisten tly produced and controlled in accordance with 
the relevant quality standards and in line with their purpose, 69. Qualified person for medicinal product manufacture means a master of pharmacy 
specialised in pharmaceutical technology or with at least five years of experience in the manufacture of medicinal products, unless ot herwise specified by special regulations, 
70. Qualified person for release of a medicinal product batch means a master of pharmacy specialised in testing and control of medicina l products or with at least five years of 
experience in medicinal products quality cont rol, unless otherwise specified by special 
regulations, 71. Pharmacovigilance means activities comprising dete ction, assessment, understanding and 
prevention of adverse reactions and acting in the event of thei r occurrence as well as new 
knowledge about any unsafe administ ration of medicinal products, 
72. Responsible person of the marketing authorisation holder responsible for pharmacovigilance  means a medical doctor specialised in  clinical pharmacology or a medical 
doctor or a dental medicine doctor or a mast er of pharmacy with at least two years of 
experience in pharmacovigilance or two years of  experience in the rele vant field with the 
appropriately documented trai ning in pharmacovigilance, 
73. Adverse reaction means any harmful and unintended reaction which occurs at authorised 
doses used for the prophylaxis or treatment of disease in humans or to restore, correct or 
modify a physiological function or make a dia gnosis; in clinical tr ials, all untoward and 
unintended responses to an investigati onal medicinal product related to any dose 
administered,
 
74. Unexpected adverse reaction means  an adverse reaction, the nature, severity or outcome 
of which is not consistent with  a summary of product characteri stics for an authorised product 
or investigator's brochure for investig ational products in clinical trails, 
IP/N/1/HRV/O/7 
        - 8 - 
75. Adverse event means any noxious and undesired si gn, symptom or di sease (including 
changes in laboratory findings) th at coincides with the use of a medicinal product, and which 
does not necessarily imply the causal relationship with the administration of a medicinal 
product, 
76. Serious adverse reaction/event means any adverse event or adverse reaction that is fatal, 
life-threatening, requires  hospitalisation or prolongation of existing hospitalisa tion, results in 
persistent or serious disabili ty or incapacity, congenital a nomaly/birth defect, and other 
medically significant conditions, 77. Wholesale shall cover procurement, acceptance, stor age, sale, delivery, other than delivery 
to end users, and import and export of a medicinal product, 
78. Wholesaler  means a legal person holding the aut horisation for the performance of 
wholesale activities issued by the Agency, 79. Importer/exporter of medicinal products means a legal person authorised by the Agency 
for import/export of medicinal products, 80. Retail sale  shall cover ordering, keeping and di spensing of Rx and over-the-counter 
medicinal products, as well as the preparati on and dispensing of officinal formulas and 
galenical preparations, 81. Dispensing of a medicinal product means the sale of a medicinal product to end users in retail outlets, with the consulta tion of a master of pharmacy, 
82. Good practice in wholesale of medicinal products means the standard for storage and 
transportation of medicinal pr oducts which ensures organisa tion, performance and control 
over storage in line with prescribed conditions, as well as transport to the wholesale user, 
83. Qualified person in wholesale of medicinal products means a master of pharmacy with 
five years of experience in the wholesale of medicinal products,  84. Specialised stores for retail  sale of medicinal products means a store selling over-the-
counter medicinal products in line with this Act and the ensuing regulations, 
85. Croatian pharmacopoeia  means a regulation that lays do wn requirements for preparation 
of medicinal products and homeopathic medici nal products, as well as  their quality and 
quality control procedures, and is appropriate ly referenced to and harmonised with the 
European Pharmacopoeia, 86. Agency for Medicinal Produc ts and Medical Devices means a legal person established 
pursuant to the Act on Medicinal Products a nd Medical Devices (Offi cial Gazette 121/03), 
hereinafter „the Agency“, whose scope of activ ities in the field of medicinal products and 
homeopathic medicinal products is governed by this Act.   
Article 3 
Testing, production, di stribution and quality control of medicinal and homeopathic medicinal 
products may be performed by legal and natural persons who meet the sp ecial conditions for 
performing these activities. 
The Minister shall issue an ordinance estab lishing the special conditions referred to in 
paragraph 1 of this Article.  
 
II MEDICINAL PRODUCTS 
1. TESTING OF MEDICINAL PRODUCTS 
 
Article 4 
For the purpo
se of placing on the market, the quality, efficacy and safety of each drug product 
shall be established. 
 
Article 5 
IP/N/1/HRV/O/7 
        - 9 - 
Testing of a medicinal product shall include phar maceutical and pre-clinic al tests and clinical 
trials. 
Tests and trials referred to in paragraph 1 of this Article shall be conducted in line with 
ordinances issued by the Minister. 
 
Article 6 
Medicinal products shall be tested on the premises of legal persons who fulfil the conditions 
laid down by the ordinance referred to  in Article 3 of this Act.    
Clinical trial can be conducted only by a legal person authorised by the Minister.  
Medicinal products shall be tested on the prem ises of the legal persons referred to in 
paragraph 1 of this Article at the expense and at the request of  the legal person requiring such 
testing as well as at the request of the Minister or the Agency. 
 
Article 7 
Pre-approval of the Minister  shall be required for conduc ting clinical trials of:  
1. a drug product without a marketing authorisa tion in the Republic of Croatia, but holding a 
marketing authorisati on in another country; 
2. a drug product without a marketing authorisa tion in the Republic of Croatia or any other 
country;  
3. a drug product that is au thorised for marketing in the Rep ublic of Croatia, but needs to be 
tested for new indications, new methods of administration, newly proposed active substance 
combinations and different dosage regimens comp ared with those previo usly approved, or for 
the purpose of gaining new clin ical experience required;  
4. a drug product whose bioavailability will be  tested either in comparison with the 
bioavailability of any product already authorised  for marketing in the Republic of Croatia or 
in comparison with that of a product that has not been authorised for marketing in the 
Republic of Croatia;  
5. a drug product intended for gene therapy, tr eatment with somatic cells, including xenogenic 
cells and treatment with medicinal products co ntaining genetically modified organisms.   
The Minister shall grant or refuse the pre-approval referred to in paragraph 1 of this Article by 
the decision that cannot be ap pealed, but against which admi nistrative proceedings can be 
instituted. 
The Minister shall grant or refuse the pre-approv al for clinical trials of the medicinal product 
referred to in paragraph 1, items 1, 3 and 4 of th is Article within 30 days from the receipt of 
the application and documentation to be esta blished in an ordinance issued by him.  
The Minister shall grant or refuse his pre-approv al for clinical trials of the medicinal product 
referred to in paragraph 1, item  2 of this Article within 60 days from the receipt of an 
application and documentation to  be prescribed by him.  
The Minister shall grant or refuse his pre-approv al for clinical trials of the medicinal product 
referred to in paragraph 1, item  5 of this Article within 90 days from the receipt of an 
application and documentation to be prescribed by him.    
By way of derogation from paragraph 5 of th is Article, there shall be no limitation to the 
period for granting pre-appr oval for xenogenic drugs.   
The pre-approval referred to in paragraph 1 of  this Article shall be granted only after 
establishing:  1. that previous tests were performed acco rding to current knowledge about medicinal 
products testing,  
IP/N/1/HRV/O/7 
        - 10 - 
2. that the prescribed documentation was subm itted and that the trial protocol was approved 
by the Central Ethics Committee. 
Should the Minister fail to grant or refuse th e pre-approval within the term referred to in 
paragraphs 3, 4 and 5 of this Article, the pre-approval shall be considered granted.   
A clinical trial of a drug produc t shall not start before the pr e-approval has been granted, 
except in the cases referred to in paragraph 8 of  this Article, or wit hout a favourable opinion 
of the Central Ethics Committee. 
The Minister shall issue an ordinance establishi ng the procedure for delivery of the opinion by 
the Central Ethics Committee.  
Article 8 
Each clinical trial shall be subject to obtai ning informed consent from the trial subject.  
Children may be subjects of a clinical trial on ly if tests on adults cannot produce appropriate 
results.  
In exceptional cases, informed consent shall be granted by a legal representative or a guardian 
of a person who is unconscious, has severe mental difficulties, is incapable of working or is a 
minor. 
Clinical trials shall not be c onducted if potential risks of a drug product use outweigh medical 
justification, as assessed by the Minister. Prisoners or persons who might be coerced into gi ving consent to participate in a clinical trial 
shall not be trial subjects. 
 
Article 9 
The principles of medical ethics as well as compulsory protection of subjects’ privacy and 
data shall be observed during clin ical trials of medicinal products, in line  with an ordinance 
on clinical trials of medicina l products and an ordinance on good clinical practice issued by 
the Minister. 
Clinical trials of medicinal products shall ta ke place only on the premises of legal persons 
referred to in Article 6, paragraph 1 of this Act, who have entered into agreements with 
clinical trial applicants.  
The agreement from paragraph 2 of this Article shall specify total costs of the clinical trial 
and the costs to be incurred by a clinical trial sponsor or applicant, in cluding costs of medical 
and other services incurred by a legal person fr om Article 6, paragraph 1 of this Act and 
compensations to investigators and subjects. 
The clinical trial applicant or  sponsor shall pay compensations  for investigators and subjects 
from paragraph 3 of this Article  to a legal person with whom he concluded the agreement on a 
clinical trial of the medicinal product. 
 
Article 10 
Pre-clinical tests shall be conducted in accordance with the ordinance on good laboratory 
practice issued by the Minister. 
 
2. PLACING DRUG PRODUCTS ON THE MARKET  
 
Article 11 
The granting of a marketing authorisation marks the comp letion of the procedure for 
establishing the quality, efficacy and safety of a drug product. 
The marketing authorisation sh all also be required for radionuclide generators, radionuclide 
IP/N/1/HRV/O/7 
        - 11 - 
kits, radiopharmaceuticals, radionuclide pr ecursors, and industrially prepared 
radiopharmaceuticals.  
The marketing authorisation referred  to in paragraphs 1 and 2 of this Article shall be issued by 
the Agency for a period of five years. If the drug product has not been on the market in  the Republic of Croatia for three consecutive 
years following the issuance of the marketin g authorisation, the Agency shall revoke the 
marketing authorisation for such a product. 
By way of derogation from paragraph 4 of this  Article and subject to  the approval by the 
Minister, the Agency shall not revoke the mark eting authorisation for the drug product when 
this is necessary to protect public health or wh en the validity of  the marketing authorisation in 
the Republic of Croatia is the prerequisite for the issuance and/or renewal of the marketing 
authorisation in other countries. 
The marketing authorisation holder shall notify the Agency in writing about the date of 
placing of the drug product on the market within  15 days following its placing on the market. 
By virtue of an ordinance, the Minister ma y lay down special conditions for placing on the 
Croatian market a drug product that has obtained a marketing authorisatio n in the EU Member 
States.  
 
Article 12 
By way of derogation from Article 11 of this Act, a marketing authorisation shall not be 
required for:  
– raw materials used in ma nufacture of drug products, 
– officinal formula,  
– galenical preparation,  
– medicinal products intended for in vitro  developmental research,  
– intermediate products intended for further processing by an author ised manufacturer,  
– whole blood, plasma or blood cel ls of human origin, except for plasma which is prepared by 
a method involving an industrial process, – radionuclides in a seal ed radiation source,  
– radiopharmaceuticals prepared exclusively from approved radionuclide generators, 
radionuclide kit or radionuclide precursor accordi ng to the manufacturer’s instructions at the 
time of its use by a natural or legal person authorised for such activity.  
Galenical preparations and offi cinal formulas shall be manufactured and placed on the market 
in line with special regulations. 
 
Article 13 
The Agency may temporarily entrust individu al tasks from the procedure for granting 
marketing authorisation to professional institutions , i.e. institutions engaged in scientific or 
scientific and educationa l activities, and to certa in experts in the field of medicinal products.  
Persons referred to in paragraph 1 of this Article shall keep confidential all data that come to 
their knowledge while carrying out the entrusted tasks.  
 
Article 14 
Legal persons seated in the Republic of Cr oatia shall submit applications for marketing 
authorisation to the Agency.  
The following data and documents shall accompany applications referred to in paragraph 1 of 
this Article: 
IP/N/1/HRV/O/7 
        - 12 - 
a) name and address of the applicant, and if necessary also of the manufacturer, 
b) name of the medicinal product,  
c) qualitative and quantitative pa rticulars of all medicinal product constituents , including an 
international non-proprietary name or in the absence thereof, some other common name,  
d) assessment of potential environmental imp acts of medicinal products, done on a case-by-
case basis, and designing special procedur es for containment of those risks,  
e) description of the manufacturing method,  
f) therapeutic indications, contrai ndications and adverse reactions,  
g) dosing, pharmaceutical form, method and route of administration, and expected shelf life,  
h) if necessary, reasons for any precautionary an d safety measures to be  taken for the storage 
of the medicinal product, its administration to pa tients and for the disposal of waste products, 
together with an indication of potential risks presented by  the medicinal product for the 
environment, 
i) description of the quality control methods employed by the manufacturer (qualitative and 
quantitative analyses of active substances, exci pients and drug product, any special tests),  
j) results of:  
– pharmaceutical tests (physicochemical, biolog ical and/or microbiological tests);   
– pre-clinical tests; – clinical trials,  k) a detailed descrip tion of the pharmacovigilance and, where appropriate, of the risk-
management system which the applicant intends to implement, 
l) a statement to the effect that  clinical trials carri ed out outside the Rep ublic of Croatia meet 
the ethical requirements of  good clinical practice, 
m) the summary of the product characteristics, proposal for la belling of outer and immediate 
packaging and the package leaflet,  
n) the manufacturing authorisation,  
o) copies of any authorisation obt ained in other states together with a list of states in which 
the authorisation procedure is underway; copies of the summary of the product characteristics 
approved in other states or proposed in the authorisation procedure currently underway in 
other states; copies of the package leaflet approved in other states or proposed in the 
authorisation procedure currently underway in other states; details of  and reasons for any 
decision to refuse a marketing authorisation in other states, 
p) evidence that the applicant uses serv ices of a qualified person responsible for 
pharmacovigilance and fulfils the condition to  report on any suspec ted adverse reaction 
detected either in the Republic of  Croatia or in any other country, 
q) a copy of any designation of the medicina l product as an orphan medicinal product, if 
applicable. 
In addition to the applicati on for marketing authorisation, at the Agency’s request the 
applicant shall submit the samples of the medicinal product, as well as prescribed reference 
standards requisite for pharmaceutical testing. 
The Minister shall issue an ordi nance defining in greater detail the contents of the data and 
documents referred to in paragraph 2 of this Article, as well as the procedure and method of 
granting a marketing authorisation.   
Documentation received by the Agency shall be considered confidential.  
The costs for the granting, renewal, amendments and transfer of the marketing authorisation 
shall by defined by the Agency, subject to th e approval by the Minister, and incurred by the 
applicant. 
IP/N/1/HRV/O/7 
        - 13 - 
 
Article 15 
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 he can 
demonstrate that:   
a) the drug product is essentially similar to the reference medicinal product, provided that the 
reference product was granted marketing authoris ation in the Republic of  Croatia or any EU 
Member State more than six years ago for any strength, pharmaceutical form, method of 
administration or packaging, or 
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 marketing authorisation for that 
reference product authorised in th e Republic of Croatia or the European Union have agreed to 
use from their files the pharmaceutical, pre-clinic al and clinical data on the reference product  
for the purpose of assessment of documentati on enclosed to application for obtaining the 
marketing authorisation for another medici nal product with the same qualitative and 
quantitative composition in active substances  and of the same pharmaceutical form. 
 
Article 16 
In the event referred to in Article 15 item a) of this Act, if a reference medicinal product has 
no marketing authorisation in the Republic of Croatia, the applicant shall specify the EU 
Member State in which the marketing authoris ation was issued for the reference medicinal 
product and the year of issue of the first ma rketing authorisation, in  an application for 
marketing authorisation of a generic product. 
 
Article 17 
The marketing authorisation applicant referred to in Article 14 of this Act shall provide the results of the appropriate pre-clinical tests or clinical trials: a) where the medicinal product does not fully fall within the definition of a generic medicinal product or where the bioequivalence cannot be demonstrated through bioavailability studies 
or in case of changes in the active substa nce(s), therapeutic i ndications, strength, 
pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, 
b) where a biological medicinal product is similar to a reference biological product 
(biosimilar) which does not comply with the de finition of a generic medicinal product, owing 
to raw materials or differences in the manufact uring processes of biosimilar and the reference 
biological medicinal product. In the case of medicinal products containing active substances used in the composition of 
medicinal products authorised in the Republic of Croatia or the European Union, but not 
hitherto used in combination for therapeutic purposes, the marketing au thorisation applicant 
referred to in Article 14 of this Act shall provide  the results of new pre- clinical tests or new 
clinical trials relating to that  combination, but shall not be required to provide scientific 
references for every active substance. The Minister shall issue an ordinanc e on methods for bioequivalence testing. 
  
Article 18 
IP/N/1/HRV/O/7 
        - 14 - 
A medicinal product shall be designated as an orphan medicinal product in the Republic of 
Croatia if it is authorised as an orphan medicinal products in th e European Union in line with 
the requirements set in the European Union and if: 
–it is intended for the diagnosis, prevention or treatment of a life-thre atening or chronically 
debilitating condition affecting not  more than five in 10 thousand persons in the Community 
or –it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously 
debilitating or serious and chr onic condition and it is unlikely to be placed on the market 
without incentives due to high develo pment costs, and 
–there exists no satisfactory method of diagnosis, prevention or treatment of the conditions in question or, if such method exists, the medicinal product will be of signifi cant benefit to those 
affected by those conditions.  
Article 19 
In order to obtain traditional- use registration, the applicant sh all submit the appropriate data 
and documents referred to in Article 14 of this Act. Instead of results of pre-clinical tests and clinical trials, the applicant from paragraph 1 of this Article shall submit: 
– bibliographical or expert evidence to the effect that the medicinal pr oduct in question, or a 
corresponding product has been in medicinal use throughout a period of  at least 30 years 
preceding the date of the application, including at least 15 years in the Republic of Croatia or 
the Community, – a bibliographic review of safe ty data together with an expe rt report, and where required by 
the Agency, upon additional request, data necessa ry for assessing the safety of the medicinal 
product. A corresponding product, as referred to in para graph 2, subparagraph 1 of this Article, is 
characterised by having the same active ingredients, irrespective  of the excipients used, the 
same or similar intended purpose, equivalent strength and posology and the same or similar route of administration as the medicinal product applied for. 
The procedure for granting of marketing authorisation for traditional herbal medicinal products can be conducted for medicinal products  satisfying the following requirements:  
(a) they have indications exclusively appropr iate to traditional herbal medicinal products 
which, by virtue of their composition and pur pose, are intended and designed for use 
without the supervision of  a medical practitioner, 
(b) they are exclusively intended for administ ration in accordance with a specified strength 
and posology, 
(c) they are an oral , external and/or inhalation preparation, 
(d) the period of traditional use complies with  paragraph 2, subparagraph 1 of this Article, 
(e) the data on the traditional use of the medi cinal product are sufficient; in particular the 
product proves not to be harmful in the speci fied conditions of use and the pharmacological 
effects or efficacy of the medicinal product ar e plausible on the basis of long-standing use 
and experience. 
Traditional herbal medicinal products can also contain vitamins and minerals for the safety 
of which there is well-documented evidence, provided that the action of the vitamins or 
minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). 
Within the procedure for granting of marketing authorisation for tradi tional herbal medicinal 
products, the Agency can establis h that the product satisfies th e requirements from Article 15 
IP/N/1/HRV/O/7 
        - 15 - 
item b) or Article 107 of this Act for the pl acing of the drug product or the homeopathic 
medicinal product on the market, in which case the provisions of this Arti cle shall not apply.  
The Minister shall issue an ordinance establishi ng the form and the contents of documentation 
to be submitted for the procurement of marketing authorisation for traditional herbal 
medicinal products, requisite evidence about th eir medicinal use over a 30-year period, and 
rules for labelling and advertising of traditional herbal medicinal products.  
 
Article 20 
The Agency shall grant or refuse a marketing authorisation within 210 days from the receipt 
of a valid application.  
An application referred to in paragraph 1 of th is Article shall be deemed valid if within a 
maximum of 30 days from its receipt the Agency verifies that all the data and documents 
referred to in Articles 14, 15, 16, 17, and 19 of this Act have been submitted, about which the 
Agency shall keep records and shall inform the applicant.  
Should the Agency require the applicant to supp lement the application,  the time limit referred 
to in paragraph 1 of this Article shall be suspended until such time as the required 
supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant for givi ng a verbal or written explanation.    
The authorisation referred to in paragraph 1 of  this Article shall be granted or refused by a 
decision which cannot be appealed, but agains t which administrative proceedings can be 
instituted.   
The list of marketing authorisations shall be published in the Official Gazette.  
Along with the decision on granting the market ing authorisation, the Agency shall send the 
approved summary of the product characteris tics, the approved pack age leaflet and the 
approved labelling, which are integral parts of the decision on granting the marketing 
authorisation, to the au thorisation holder.  
The marketing authorisation holder shall be resp onsible for the conformity of the summary of 
the product characteristics, the package leaflet and th e labelling with the summary, the leaflet 
and the labelling accepted at the ti me of issuing the marketing authorisation or at the time of 
any subsequently approved amendments.  The Agency shall draw up a report on the re levant documentation and the tests performed. 
The report on documentation and tests shall be updated with any new information of 
importance for assessment of the quality, safety  or efficacy of the drug product concerned. 
Based on collected data, the Agency may change  the decision on the marketing authorisation. 
 
Article 21 
In accordance with Article 14, paragraph 2, item i), of this Act and in order to examine a 
marketing application, the Agency may decide to  test the product, its raw materials and, if 
applicable, its intermediate products or other constituents, for the purpose of checking the 
compliance of quality control procedures used an d described by the manufacturer in the data 
supporting his application refe rred to in Article 6, para graph 3, of this Act. 
 
Article 22 
The Agency shall refuse marketing authorisat ion if, after checking the data and documents 
referred to in Articles 14, 15, 16, 17, and 19 of this Act, it establishes: 
a) that the drug product is harmful under normal conditions of use, or   
b) that its therapeutic efficacy is lacking or is  insufficiently substantiated by the applicant, or 
c) that its quantitative and/or qualitative composition is not as declared, or 
IP/N/1/HRV/O/7 
        - 16 - 
d) that labelling or package l eaflets are not in accordance w ith the provisions of Articles 41 
through 47 of this Act or with the data provided in the summary of the product characteristics.   
The Agency shall likewise refuse the marketing authorisation if relevant data and documents 
submitted alongside the application do not comply  with Articles 14, 15, 16, 17, and 19 of this 
Act.  
 
Article 23 
No later than 180 days before the expiry of th e marketing authorisation referred to in Article 
11, paragraph 3, of this Act, an application for the renewal of the marketing authorisation may 
be submitted to the Agency.  
The marketing authorisation can be renewed for a five-year period. 
The marketing authorisation can be issued for an indefinite period of tim e after the Agency re-
evaluates the risk-benefit balance and if the ma rketing authorisation holder has submitted the 
documentation supplemented with the updated data  on quality, safety and efficacy of the drug 
product, including all amendments as from the date of obtaining the marketing authorisation, 
for the purpose of renewal of the marketing authorisation. Following the renewal of the marketing authorisat ion pursuant to paragraph 3 of this Article, 
the marketing authorisation shall be valid for an  indefinite period of time, unless the Agency 
requires the procedure for authorisation renewal to  be reinstituted pursuant to paragraph 3 of 
this Article due to reasons relating to pharmacovigilance. 
The Agency shall grant or refuse the renewal of  the marketing authorisation within 180 days 
from the receipt of a valid application.  
If an application is not valid, the Agency shall invite the applicant in writing to rectify 
deficiencies explicitly stated  in the written notification, an d submit the requested data and 
documents within a maximum of 30 days.  
Should the Agency require the applicant to supp lement the application,  the time limit referred 
to in paragraph 5 of this Article shall be suspended until such time as the required 
supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant for gi ving a verbal or written explanation.   
The Minister shall issue an ordinance detaili ng the contents of the documentation referred to 
in paragraph 3 of this Article, submitted for the purpose of renewal of the marketing authorisation. 
 
Article 24 
After obtaining a marketing authorisation, its hold er shall be obliged to  keep abreast of the 
latest scientific and technical  developments from the fiel d of production procedures and 
quality control, and implement necessary chan ges which would ensure that the medicinal 
product is manufactured and its qu ality controlled in line with generally accepted scientific 
methods.   
Since implementation of changes referred to in  paragraph 1 of this Article may require 
amendment to the marketing authorisation or documentation accepted in the procedure of the 
marketing authorisation issuance, the holder of the marketing authorisation shall beforehand submit an application to the Agency for the approval of such changes.  
He shall forthwith inform the Agency of a ny other new information which might influence 
the amendments to the documentation accepted within the procedure for granting of the 
marketing authorisation, and in  particular any other new info rmation which might influence 
the evaluation of the risk-benefit balance and of the degree of prohibi tion or restriction 
measures imposed by other countries in which the medicinal product was placed on the 
market.  
IP/N/1/HRV/O/7 
        - 17 - 
The marketing authorisation holder shall enclos e data and documents to  the application for 
amendment, in accordance with th e type of relevant changes. 
The amended authorisation from paragraph 9 of this Article shall remain in force until the 
expiry of the original authorisation.  
If the application from paragraph 4 of this Ar ticle is not valid, the Agency shall invite the 
applicant in writing to amend or supplement the application within the term of 30 days. 
Should the Agency invite the applicant to s upplement the application, the time limit referred 
to in paragraph 9 of this Article shall be suspended until such time as the required supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant to provi de verbal or writte n explanation.    
If the approved amendment requires amendment to the decision on the marketing 
authorisation or its integral parts, the Agency shall issue a decision on such amendment. The Agency’s decision cannot be appealed, but ad ministrative proceedings can be instituted 
against it.  The Agency shall approve or refuse an amendment to the decision on the marketing authorisation or the approved amendment, depe nding on the type of change, within maximum 
90 days of receipt of a valid application. The Minister shall issue an ordinance specifyi ng the acceptance procedur es and contents of 
documentation to be submitted for the purpose of the marketing authorisation amendment.   
Article 25 
The marketing authorisation holder can apply for transfer of the marketing authorisation to another legal person seated in  the Republic of Croatia.  
The Minister shall issue an ordinance specifyi ng the procedure, time lim its and contents of 
documentation to be submitted for transfer of the marketing authorisation.   
Article 26 
Should a marketing authorisation holder decide  to discontinue production of a medicinal 
product or withdraw it from the market before th e expiry of its marke ting authorisation, he 
shall accordingly inform the Agency six months in  advance, except in the event of an urgent 
recall. In the event referred to in para graph 1 of this Article, the Ag ency shall revoke the marketing 
authorisation upon the holder's request. The decision from paragraph 2 of this Article cannot be appealed. However, the 
administrative proceedings can be instituted.  
 
Article 27 
The marketing authorisation holder shall take emergency precautions if he obtains any new 
safety information which calls for restriction in medicinal product administration as compared 
to the valid authorisation. The emergency precaution shall imply an amendmen t to the package leafle t related to one or 
more parts of the summary of the product characteristics as follows: 
– therapeutic indications, – posology and method of administration, – contra-indications, – special warnings and precautions for use,  – target group, and – recall period, based on any new data which a ffect safe use of the medicinal product.  
The marketing authorisation holder shall forthw ith inform the Agency in writing about any 
emergency precaution. The emergency precaution shall be deemed accepted if the Agency 
IP/N/1/HRV/O/7 
        - 18 - 
does not require any additional precautions wi thin 24 hours from the receipt of a written 
notification.   
Within 15 days from the date of implementation of emergency precautions, the marketing authorisation holder shall file an application for amendment to the marketing authorisation 
pursuant to Article 24 of this Act.  On account of new data affecting the safety  of the medicinal product, the marketing 
authorisation holder shall take all emergenc y precautions required by the Agency and shall 
file an application for the ma rketing authorisation amendment in line with the required 
emergency precautions and within the time limit set by the Agency.  
 
Article 28 
The emergency recall shall be  conducted by the Agency ex officio  or upon the request of a 
pharmaceutical inspector from the ministry competen t for health (hereinafter: „the Ministry).  
The measures for recall of the medicinal produc t or a batch of a medicinal product shall be 
carried out if established that: – the medicinal product is harmful under usual conditions of use, or – it lacks therapeutic effect, or – the risk-benefit balance is unfavourable wi th respect to the authorised use, or  
– the qualitative and quan titative composition of the medicinal product is not as declared, or 
– the medicinal product is not manufactured in  line with its manuf acturing authorisation. 
 
Article 29 
A marketing authorisation shall be revoked before  the expiry of its five-year term if found 
that:  
– the drug product was placed on the market contrary to the provisions of this Act,  
– the drug product is unacceptably harmful or lacking therapeutic efficacy under provided 
conditions of use, or that the risk-benefit balance is unfavourable under provided conditions 
of use, – the quantitative and qualitative composition of  the drug product is not as declared in the 
documentation supporting the application for gran ting either the marke ting authorisation or 
the authorisation for its amendment, 
– inaccurate data have been provided in the drug product documentation,  
– inaccurate data have been provided about the marketing authorisation holder, 
- the drug product has not been on the market of the Republic of Croatia for three consecutive 
years following the issuance of the marketing authorisation in acco rdance with Article 11, 
paragraph 4, of this Act. 
The decision on revoking of the marketing authorisation cannot be appealed, but 
administrative proceedings can be instituted. 
The list of decisions on revoking of marketing author isations shall be pub lished in the Official 
Gazette on an annual basis. 
The costs of the procedure for revoking a marketing authorisation shall be defined by the Agency subject to the approval by the Minister, and incurred by the marketing authorisation 
holder. 
 
3. MANUFACTURING AUTHORISATION 
 
Article 30 
Manufacture of a medicinal product  within the territory of the Republic of Croatia shall be 
allowed only to a legal person holdi ng a manufacturing authorisation. 
IP/N/1/HRV/O/7 
        - 19 - 
The manufacturing authorisation referred to in paragraph 1 of this Article shall be issued by 
the Agency. 
The manufacturing authorisation shall be required equally for the entire and for partial 
manufacture of the medicinal product. The manufacturing authorisation shall be issued for a plan t or plants manufacturing a 
pharmaceutical form or a medicinal produc t or a group of medicinal products.  
Pursuant to this Act, preparati on of an officinal formula or ga lenical preparati on shall not be 
considered as manufacture.  
 
Article 31 
A legal person seated in the Re public of Croatia shall submit an  application for obtaining the 
manufacturing authorisation to the Agency. Along with the application from paragraph 1 of  this Article and the evidence about the 
fulfilment of good manufacturing practice requirements from Article 34 of this Act, the 
applicant shall enclose the follo wing data and documents:  
- full name and head office of the legal person, - evidence of entry in the court register, 
- evidence of entry of the act ivity in the court register, 
- evidence of professional competencies and employment contract with a qualified person, 
- evidence of professional competencies and em ployment contract with a person responsible 
for production, 
- evidence of professional competencies and em ployment contract with a person responsible 
for distribution, 
- personal data of the person responsible fo r production, quality c ontrol and distribution, 
–description of the whole or a part of the relevant manufact uring procedure,  
– a list of relevant medicinal products and pharmaceutical forms,  – full name and address of the manufact uring and quality control plants.   
 
Article 32 
The Agency shall issue a decision on granti ng or refusing a manufacturing authorisation 
within 90 days from the day of receipt of a valid application.  
An application referred to in paragraph 1 of th is Article shall be deemed valid if within 30 
days from its receipt the Agency verifies that all the data and documents referred to in Article 
31 of this Act have been submitted. 
If the application is not vali d, the Agency shall invite the applicant in writing to rectify 
deficiencies explicitly stated in the writte n notification and submit the requested data and 
documents within 30 days. Should the Agency require the applicant to supp lement the application,  the time limit referred 
to in paragraph 1 of this Article shall be suspended until such time as the required 
supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant for gi ving a verbal or written explanation.   
The manufacturing authoris ation referred to in para graph 1 of this Article shall be granted or 
refused by issuing a decision that cannot be appealed, but against which administrative 
proceedings can be instituted. 
 
Article 33 
In the procedure for evaluating conditions for granting the manufacturing authorisation, 
IP/N/1/HRV/O/7 
        - 20 - 
besides the data and documents referred to in Article 31 of this Act, the Agency's Expert 
Commission shall establish whether the GMP guidelines have been observed during the 
manufacture of a medicinal product or a group of medicinal products, while a pharmaceutical 
inspector from the Ministry shal l deliver the relevant opinion.  
 
Article 34 
An applicant shall be deemed to observe the principles of Good Manufacturing Practice if:   
1. given the scope and complexity of manufact ure of either one or  a group of medicinal 
products, he has the adequate number of qualified persons w ith a university diploma in 
pharmacy, chemistry, biology, biochemistry, biotechnology, chemical technology, medicine, 
dental medicine, veterinary medicine  or other correspond ing professions,  
2. he has at his disposal the services of a qua lified person for the release of a medicinal 
product batch who should be permanently available,  
3. he has at his disposal the services of a qualifie d person for drug product manufacture and 
distribution,  
4. he has at his disposal suitable premises and equipment requisite for the manufacture, 
quality control, storage and de livery of medicinal products,   
5. he observes the principles and guid elines of Good Manufacturing Practice, 
6. he uses only active substances manufactured  in line with good manufacturing practice as 
raw materials, as well as excipients, when laid down by special regulations, 
7. he enables the qualified person to carry out his activities independently, and ensures all 
requisite resources. 
The Minister may prescribe that persons enga ged in the manufacture of specific medicinal 
products and specific pharmaceutical forms have other degrees of qualification or other fields 
of specialisation.  
The Minister shall issue an ordinance deta iling the GMP requirements to be fulfilled by 
manufacturers of medicinal produc ts as well as the procedure for defining such requirements. 
 
Article 35 
The manufacturing authorisation shall be issued for a period of five years. 
If established that an applicant has failed to co mply with any of the prescribed conditions, the 
Agency may issue a temporary authorisation a nd set a time limit for rectifying the established 
deficiencies. The costs of issuing, withholding, amending and revoking a manufacturing 
authorisation shall be determined by the Agen cy subject to the approval by the Minister and 
paid by the applicant or the manuf acturing authorisation holder.  
 
Article 36 
In the event of any amendment to the data  and documents on the basis of which the 
manufacturing authorisation was issued, a manuf acturing authorisation holder shall file an 
application with the Agency for ap proval of any such amendment.  
If the amendments refer to the data and documents from Articles 31 and 34 of this Act, the 
required procedure and decision shall be completed within a maximum of 30 days from the 
date of receipt of a valid application. In exceptional cases the time limit may be extended to 
90 days.   
If the application from paragraph 1 of this Ar ticle is not valid, the Agency shall require the 
applicant in writing to rectify deficiencies explicitly given in a written notification, and 
submit the requested data and documents within a maximum of 15 days. 
Should the Agency require the applicant to supp lement the application,  the time limit referred 
IP/N/1/HRV/O/7 
        - 21 - 
to in paragraph 2 of this Article shall be suspended until such time as the required 
supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant for gi ving a verbal or written explanation.   
 
Article 37 
A manufacturing authorisation holder seated in the Republic of Croatia may file an 
application for the issuance of the certificate of good manufactu ring practice with the Agency, 
which establishes whether good manufact uring requirements have been met. 
The certificate of the implementation of good ma nufacturing practice sh all be issued by the 
Agency. 
The minister shall issue an or dinance laying down the procedure for issuance of the certificate 
of good manufacturing practice.  
Article 38 
The Agency shall revoke a manufacturing authoris ation if established that a manufacturer has 
failed to comply with requirements laid dow n by this Act and the ensuing regulations. 
The decision to revoke the manufacturi ng authorisation cannot be appealed, but 
administrative proceedings can be instituted against such a decision.  
 
Article 39 
The Agency shall verify whether manufactur ers with manufacturing sites outside of the 
Republic of Croatia are capable of manufacturing and performing quality control of medicinal 
products in the manner laid down by this Act, the ensuing regul ations and the regulations of 
the European Union.  
The costs of verification referred to in paragra ph 1 of this Article shall be determined by the 
Agency subject to the approval by the Minister and paid by a foreign manufacturer or by a 
marketing authorisation holder. 
 
Article 40 
A valid manufacturing authorisation shall be also compulsory for foreign manufacturers.  
The manufacturing authorisation referred to in paragraph 1 of this Article shall be deemed 
valid if issued by a competent authority of another state in accordance with requirements 
complying with those laid down by this Act and the ensuing regulations or regulations of the 
European Union. 
 
4. LABELLING AND PACKAGE LEAFLET 
 
Article 41 
The following particulars sha ll appear on the outer and immediate packaging of a drug 
product or, where there is no outer packagi ng, only on the immediate packaging:   
–  the name of the medicinal product followed by its strength and pharmaceutical form, and, if 
appropriate, whether it is intended for babies, children or adults; where the product contains 
up to three active substances, the international non-proprietary name (INN) shall be included, 
or, if one does not exist, the common name,  
- the qualitative and the qua ntitative composition in activ e substances, using common 
names, for each presentation of the medicina l product, or depending on the pharmaceutical 
form per volume or weight, 
– the pharmaceutical form and content in weight, volume or units of dosage,  
- list of excipients of known action or effi cacy, and in the event of medicinal products 
IP/N/1/HRV/O/7 
        - 22 - 
administered as injections or topically or ophthalmologic medicinal products, all exicipients 
shall be indicated, 
– the method of administration and, if necessar y, the route of administ ration; space shall be 
provided for the prescribed dose to be indicated,  – a special warning that the medicinal product mu st be stored out of the reach and sight of 
children,  
- specific precautions, if necessary, 
–expiry date (month and year),  – special storage precautions, if applicable,  – special precautions for disposal of unused me dicinal products or waste materials derived 
from such medicinal products, if  appropriate, along with inst ructions for the appropriate 
system for their collection,  –name and address of the mark eting authorisation holder,  
–number of the marke ting authorisation,  
–batch number,  
– in case of over-the-counter medicinal products, the instructions for us e of such medicinal 
products.   Where the immediate packaging takes the form of a blister or a small p ackaging, not all the 
data referred to in paragraph 1 of this Article shall be required.  
Where the immediate packaging takes the form of  a blister and it is  placed in the outer 
packaging which complies with requirements from paragraph 1 of this Article, it shall contain 
at least the following information: 
- name of the drug product in line w ith paragraph 1 of this Article, 
- name or a designation of the manufacturer or the marketing au thorisation holder, 
- expiry date, - batch number. 
In the event of a small immediate packaging that  cannot contain all data from paragraph 1 of 
this Article, it shall contain at least the following: - name of the drug product in line with para graph 1 of this Article and, if necessary, 
administration route, 
- method of administration, 
- expiry date, - batch number, 
- content in weight, volume or units of dosage. 
The Minister shall issue an or dinance regulating in greater de tail labelling of medicinal 
products.  
Article 42 
The data given on the outer and immediate packag ing shall be easily legible, comprehensible, 
indelible and written in the Croa tian language and Latin script.  
The name of the medicinal product from Article 41, paragraph 1, subparagraph 1, of this Act 
shall be also be provided in the Braille on th e packaging. Upon the request of the patients' 
association, the marketing author isation holder shall provide and deliver the format of the 
package leaflet acceptable to the blind and vi sually impaired people to the association 
concerned. 
IP/N/1/HRV/O/7 
        - 23 - 
If so required during the proce ss of granting the marketing aut horisation and if approved by 
the Agency, the data on the immediate blister packaging and on the small container shall not 
have to be provided in the Croatian language.   
 
Article 43 
The Minister may require that certain other data  also appear on the packaging of a medicinal 
product, such as those referring to:   
– the price of the medicinal product,  – reimbursement by obligatory health insurance,  
– dispensing (on prescripti on, or over-the-counter),  
– identification and authenticity of the packaging.  
 
Article 44 
A package leaflet with information for the user  shall be inserted into each medicinal product 
packaging. 
By way of exception, the package leaflet shal l not be obligatory wh ere all the required 
information is directly conveyed on the outer packaging or on the immediate packaging of a 
medicinal product.   
 
Article 45 
The package leaflet shall be clear and comprehensible to the user and written in the Croatian 
language and Latin script.  
Alongside Croatian and Latin script, other langua ges and scripts may also be used provided 
that the conveyed data are identical.   
Article 46 
The summary of the product characteristics shall contain, in the order indicated below, the 
following information: 
1. name of the medicinal product followed by the strength and the pharmaceutical form, 
2. qualitative and quantitative composition in terms of the active substances and 
constituents of the excipient, knowledge of which is essentia l for proper administration of 
the medicinal product; the usual common name or chemical description shall be used, 
3. pharmaceutical form, 4. clinical particulars: 
4.1. therapeutic indications; 
4.2. posology and method of administration for adults and, where necessary for children; 
4.3. contra-indications; 
4.4. special warnings and precautions for use and, in the case of immunological medicinal 
products, any special precautions to be ta ken by persons handling such products and 
administering them to patients, together w ith any precautions to be taken by the patient; 
4.5. interaction with other medicinal produc ts and other forms of interactions; 
4.6. use during pregnancy and lactation; 
4.7. effects on ability to drive and to use machines; 4.8. undesirable effects; 
4.9. overdose (symptoms, emerge ncy procedures, antidotes), 
IP/N/1/HRV/O/7 
        - 24 - 
5. pharmacological properties: 
5.1. pharmacodynamic properties; 
5.2. pharmacokinetic properties; 
5.3. preclinical safety data, 
6. pharmaceutical particulars: 
6.1. list of excipients; 
6.2. major incompatibilities; 
6.3. shelf life, when necessary after reconstitu tion of the medicinal product or when the 
immediate packaging is opened for the first time; 
6.4. special precautions for storage; 
6.5. nature and conten ts of container; 
6.6. special precautions for disposal of a used medicinal product or waste materials derived 
from such medicinal product, 7. name and address of the marketing authorisation holder, 
8. marketing authorisation number(s), 
9. date of the first authorisation or renewal of the authorisation, 
10. date of revision of the text, 11. for radiopharmaceuticals, full details of internal radiation dosimetry, 12. for radiopharmaceuticals, additional detailed instructions for extemporaneous preparation 
and quality control of such preparation and, where appropriate, maximum storage time during 
which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will 
conform to its specifications. The Minister shall issue an ordinance specify ing the contents and manner of inserting the 
summary of the product characteristics.  
Article 47 
The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall in clude, in the following order: 
- for the identification of  the medicinal product: 
(1) the name of the medicinal product followe d by its strength and pharmaceutical form, 
and, if appropriate, whether it is intended fo r babies, children or adults. The common name 
shall be included where the product contains only one active substance and if its name is an 
invented name; 
(2) the pharmaco-therapeutic group (ATC classifi cation) or type of activity in terms easily 
comprehensible for the patient; 
- the therapeutic indications; 
- a list of information which is necessary  before the medicinal product is taken: 
(1) contra-indications; (2) appropriate precautions for use; 
(3) forms of interacti on with other medicinal products a nd other forms of interaction (e.g. 
alcohol, tobacco, foodstuffs) which may aff ect the action of the medicinal product; 
(4) special warnings; - the necessary and usual instructions  for proper use, and in particular: 
IP/N/1/HRV/O/7 
        - 25 - 
(1) the dosage, 
(2) the method and, if necessar y, route of administration; 
(3) the frequency of administration, specifying if necessary the appropriate time at which 
the medicinal product may or must be administered; and, as appropr iate, depending on the 
nature of the product: (4) the duration of treatment,  where it should be limited; 
(5) the action to be taken in case of an  overdose (such as symptoms, emergency 
procedures); (5) what to do when one or more  doses have not been taken; 
(6) indication, if necessa ry, of the risk of withdrawal effects; 
(8) a specific recommendation to consult the doctor or the pharmacist , as appropriate, for 
any clarification on th e use of the product; 
- description of adverse reactions which may occur under normal use of the medicinal 
product and, if necessary, action to be taken in such a case; patients should be expressly 
asked to notify their doctors or pharmacist  about any adverse reaction which is not 
mentioned in the package leaflet; - a reference to the expiry date indicated on the label, with: 
(1) a warning against using th e product after expiry date; 
(2) where appropriate, special storage precautions; 
(3) if necessary, a warning concerning cer tain visible signs of deterioration; 
(4) the full qualitative composition (in ac tive substances and excipients) and the 
quantitative composition in active substances , using common names, for each presentation 
of the medicinal product; (5) for each presentation of the product, the pharmaceutical form and content in weight, 
volume or units of dosage; 
(6) the name and address of the marketing authorisation holder, 
(7) the name and address of the manufacturer; 
(8) the date on which the package leaflet was last revised. 
The package leaflet shall take into account the particular conditions of certain categories of 
users (children, pregnant or breastfeeding wo men, the elderly, persons with specific 
pathological conditions) and indi cate, if appropriate, possible e ffects on the ability to drive 
vehicles or to operate machinery. It shall also list those ex cipients knowledge of which is 
important for safe and effective use of the medicinal product. 
The list of excipients that may affect safety  and efficacy of medici nal products shall be 
issued by the Minister. 
The package leaflet shall reflect the results of  consultations with ta rget patient groups to 
ensure that it is legible, clear and easy to use. 
 
Article 48
 
The Minister shall issue an ordinance specify ing the contents and manner of inserting the 
package leaflet. 
 
Article 49 
IP/N/1/HRV/O/7 
        - 26 - 
Medicinal properties of a medi cinal product shall be given neither on the outer nor on the 
immediate packaging if such a medicinal product does not have a marketing authorisation as a 
medicinal product or a homeopathic medicinal produc t, or if it is not en tered in the Agency's 
register as a homeopath ic medicinal product. 
The prohibition from paragraph 1 of this Article shall not apply to galenical preparations and 
officinal formulas.  
 
5. CLASSIFICATION OF MEDICINAL PRODUCTS 
 
Article 50 
Dispensation of medicinal products shall be regulated in the decision on marketing 
authorisation of drug products. 
With respect to dispensation, medicina l products fall into two categories: 
1. Medicinal products subject  to medical prescription, 
2. Medicinal products not subj ect to medical prescription. 
The Minister shall issue an ordinance establishi ng more detailed criteri a for classification of 
medicinal products.  
 
Article 51 
Medicinal products shall be dispensed only on medical prescr iption if they:  
- are likely to present either di rect or indirect hazard, even when used correctly, if taken 
without medical supervision, or  - are frequently and to a great extent used incorrec tly, and as a result likely  to present direct or 
indirect hazard to human health, or - contain substances or preparations whose ac tivity and/or adverse r eactions require further 
investigation, or - are usually prescribed by a docto r for parenteral administration.  
Medicinal products not governed by the criteria from  paragraph 1 of this Article may be 
dispensed without medical prescription. The Minister shall issue an ordinance regulating in greater detail  the dispensation of medicinal 
products on medical prescription.  
Article 52 
For the purpose of marketing authorisation re newal or when new facts are brought to its 
attention, the Agency shall ex amine current classification of medicinal products by applying 
the criteria listed in  Article 51, paragraph 1, of this Act.  
 
6. DISTRIBUTION OF ME DICINAL PRODUCTS 
 
Article 53  
Distribution of drug products in th e territory of the Republic of Croatia shall be subject to the 
possession of the marketing authorisation.  
Data listed in Articles
 41 and 42 of this Act shall be indicated on the outer and immediate 
packaging of drug products referred to in paragr aph 1 of this Article, with the exception of 
key medicinal products for hospital use whose annual import is limited.  
On Agency's proposal, the Minister  shall issue an annual list of  medicinal products referred to 
in paragraph 2 of this Article by 31 January of every year. By way of derogation from the provision of paragraph 1 of this Article, a batch of manufactured or imported drug product with a va lid shelf life may stay in circulation up to 18 
months after expiry of its marketing authorisation.  
IP/N/1/HRV/O/7 
        - 27 - 
 
Article 54 
In order to prevent any changes in quality or  misuse of medicinal products, all legal and 
natural persons and government bodies coming in possession of medi cinal products shall 
ensure their transportation, holdi ng and storage in conformity w ith prescribed conditions.  
The Minister shall issue an or dinance on good practice in wholes ale distribution of medicinal 
products.  
 
Article 55 
Wholesale distribution of medicinal products shall be carried out by:  
– legal persons holding the Agency's authorisat ion for wholesale dist ribution of medicinal 
products (wholesale distributor s of medicinal products), 
– manufacturers of medicinal products seated in  the Republic of Croatia, for products they 
manufacture and products whose marketing authorisations they hold, 
– The Croatian National Institute of Public H ealth for wholesale distribution of sera and 
vaccines, and  
– The Croatian Institute for Transfusion Medi cine for wholesale distribution of blood and 
blood components.  
Article 56 
Wholesale distributors shall be  allowed to procure medicinal products directly from 
manufacturers, or from importers or  from other wholesale distributors. 
 
Article 57 
Pursuant to Article 53 of this Act, wholesale distributors and manufact urers shall be allowed 
to supply medicinal products to:  
– pharmacies and pharmacy depots,  
– healthcare institutions and companie s engaging in pharmacy business,  
– other wholesale distributors,  
– private surgeries in quantities require d for treatment of acute conditions.  
The Minister shall issue the list and the requir ed quantities of medici nal products allowed to 
the surgeries referred to in paragra ph 1, subparagraph 4, of this Article.  
The Croatian National Institute of Public Heal th shall supply infusion solutions, vaccines and 
sera to healthcare institutions and private surgeries.  
The Croatian Institute for Transfusion Medicine shall supply blood and blood components to 
healthcare institutions.  
Pursuant to this Act and the ensuing regulati ons, in exceptional cases, wholesale distributors 
may supply other legal and natura l persons with medicinal products for which the Agency has 
granted approval on the basis of  marketing authorisations.  
The importer shall supply medicina l products to wholesalers only. 
 
Article 58 
Wholesale distribution of medi cinal products shall be carr ied out only by legal persons 
holding the Agency's wholesal e distribution authorisation. 
Applicants for the authorisation referred to in  paragraph 1 shall meet at least the following 
conditions: 
1. have at their disposal  suitable premises, installations and equipment, in order to ensure 
proper storage and wholesale distribution of medicinal products,  
IP/N/1/HRV/O/7 
        - 28 - 
2. have adequate staff, and in particular  qualified persons resp onsible for wholesale 
distribution of medicina l products as well as for documentation review, 
3. observe the principles of good practice in wholesale distribution of medicinal products, 
4. maintain the documentation in a manner which would enable urgent recall of medicinal products from the market as ordered by the Agen cy or in co-operation with the manufacturer 
or marketing authorisation holder. The Minister shall issue an or dinance specifying conditions, pr ocedures, documents and data 
for obtaining the wholesale distribution authorisation for medicinal products. 
 
Article 59 
The Agency shall process an application for the distribution authoris ation referred to in 
Article 58, paragraph 1 within 90 days of  receipt of a valid application.   
Should the applicant fail to submit a valid app lication, i.e. required da ta and documents, the 
Agency shall invite the applicant in writing to rectify deficiencies explicitly stated in the 
notification and furnish the requested data before the expiry of 30 da ys of the invitation 
receipt.  Should the Agency invite the applicant to s upplement the application, the time limit referred 
to in paragraph 1 of this Article shall be suspended until such time as the required 
supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant to gi ve a verbal or written explanation.   
The authorisation for wholesale distribution of  medicinal products shall be granted by a 
decision which cannot be appealed, but agains t which administrative proceedings can be 
instituted.  
The Agency, subject to the approval by the Mini ster, shall determine the costs of issuance, 
denial, amendment or revoking of wholesale di stribution authorisation. The costs shall be 
settled by applicants or holders of wholesale distribution authorisations. 
 
Article 60 
The Agency shall revoke a wholesale distributi on authorisation where th e data or documents 
provided with the application are inaccurate or where the authorisation holder no longer fulfils 
the conditions based on which the authorisation wa s granted.   
The wholesale distribution authorisation sh all be revoked by a decision which cannot be 
appealed, but against which administrative proceedings can be instituted.  The wholesale distribution authorisation and the decision on its revoking shall be published in the Official Gazette. 
 
Article 61 
Holders of wholesale distribution authorisations sha ll notify the Agency in writing about all 
changes in conditions, documentation and data based on which the authorisation for wholesale 
distribution was granted. 
The Agency shall issue the decision on amendmen t to the wholesale dist ribution authorisation 
within 90 days of receipt of a valid application.  Where an application is not valid, i.e. requi red data and documents are not submitted, the 
Agency shall invite the applicant to rectify de ficiencies, i.e. to submit the required documents 
and data within 30 days of receipt of the written invitation.  Should the Agency invite the applicant to s upplement the application, the time limit referred 
to in paragraph 2 of this Article shall be suspended until such time as the required supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant to give  a verbal or writte n explanation.    
IP/N/1/HRV/O/7 
        - 29 - 
Amendment to the authorisation for the wholesal e distribution of  medicinal products shall be 
granted by a decision which cannot be appealed, but against which administrative proceedings 
can be instituted.  
 
Article 62 
Wholesale distributors and importers of drug pr oducts shall carry out the import and export of 
medicinal products.  Only the legal persons holding the Agency’s wholesale distribution au thorisation or import 
and export licence for medicinal products shall be  allowed to engage in  import and export of 
medicinal products.    The Minister shall issue an or dinance laying down the conditions  to be met by legal persons 
applying for the licence for import a nd export of medicinal products.  
The Agency, subject to the approval by the Mini ster, shall determine the costs of issuance, 
denial, amendment or revoking of the import and export licences. The costs shall be settled by 
applicants or licence holders.     
Article 63 
The legal persons referred to in Article 62 shall not be required to appl y for the import licence 
of:   – drug products with mark eting authorisations,  
– substances referred to in Article 2, para graph 1, items 2, 4 and 5, of this Act, 
– partially technologically processed substa nces and various pharmaceutical forms of 
medicinal products whose techno logical processing (with the exception of packaging) has 
been completed, and which are used for furthe r technological processing or packaging by the 
Croatian manufacturers of medicinal products.  Provision of paragraph 1 shall not apply to granting the import licence for: 
– blood, blood components and blood products,  
– substances used for the manufacture of immunological medicinal products,  
– radiopharmaceuticals.  
 
Article 64  
The Agency may exceptionally allow impor t of drug products which do not have 
authorisation for marketing in the Republic of Croatia, provid ed that there is an urgent 
medically justified need, as for example: 
– for purposes of research, – for clinical trials, – for pharmaceutical testing, – for pre-clinical tests, – in case of natural disast ers or other emergencies, 
– for emergency treatments of individual patien ts with a drug product pr escribed by a medical 
doctor or dental medicine doctor in charge. The Minister shall issue an or dinance establishing more deta iled conditions for granting the 
import licence referred to in paragraph 1. Provisions of a special Act on Combating Narc otics Abuse shall apply to import, export, 
transportation and transit of narcotics, substances for their manufacture and drug products containing narcotics.  
Article 65 
Retail sale of medicinal produc ts shall be carried out by le gal and natural persons with 
authorisation to engage in pha rmacist activities granted under a separate Act, as well as 
IP/N/1/HRV/O/7 
        - 30 - 
specialised retail stores holding the Agency’s authorisation for retail sale of medicinal 
products.    The Minister shall issue an ordinance specify ing detailed conditions for retail sale of 
medicinal products.   In accordance with Article 50, paragraph 2, of  this Act, products issued on medical 
prescription may be dispensed only by pharmacies, while over-the counter di spensation is also 
allowed in specialised retail st ores for medicinal products in conformity with the Agency’s 
decision on the marketing authorisation for drug products. The Agency may impose restriction on streng ths and package sizes of medicinal products 
dispensed through specia lised retail stores.  
The Minister shall issue an or dinance specifying conditions fo r granting authorisations to 
specialised retail stores.   
 
Article 66 
The Agency shall grant the authorisation referre d to in Article 65, paragraph 1 within 90 days 
of receipt of the valid application.  In case the application referred to  in paragraph 1 is not valid, i. e. required data and documents 
are not submitted, the Agency shall invite the a pplicant in writing to rectify deficiencies  
explicitly stated in the invita tion and furnish required data a nd documents within 30 days of 
receipt of the invitation.   Should the Agency invite the applicant to s upplement the application, the time limit referred 
to in paragraph 1 of this Article shall be suspended until such time as the required supplementary information has been provided. Likewise, the time limit shall be suspended for 
the time allowed to the applicant to give  a written or verbal explanation.    
The authorisation for the retail sale of medicinal products shall be granted by a decision which 
cannot be appealed, but against which administrative proceedings can be instituted.  
The Agency, subject to the approval by the Mini ster, shall determine the costs of issuance, 
denial, amendment or revoking of  retail sale authorisations. The costs shall be settled by 
applicants or holders of retail sale authorisations.  
Article 67 
The Agency shall revoke the authorisation grante d to a specialised reta il store if the data 
supporting the application are found to be inaccurate a nd if the authorisation holder no longer 
fulfils the conditions based on which the authorisation was issued.   The authorisation for the reta il sale of medicinal products shall be revoked by a decision 
which cannot be appealed, but against which administrative proceedings can be instituted. 
 
 
Article 68  
All legal persons engaging in wholesale distribu tion of medicinal produc ts, as well as legal 
and natural persons engaging in retail sale of medicinal products, shall submit a report on 
distribution of medicinal products to the Agency, at least on a yearly basis.   
The Minister shall issue an ordi nance specifying the type of da ta and the method of preparing 
the report referred to in pa ragraph 1 of this Article.  
 
Article 69  
The Minister shall issue an ordinance on cond itions and method for wholesale distribution of 
blood, blood components and blood products, as  well as immunological medicinal products 
and radiopharmaceuticals.   The Minister shall also issue an ordinance on wholesale distribution and retail sale of 
narcotics, substances for their prepara tion, and drug products containing narcotics.
 
  
IP/N/1/HRV/O/7 
        - 31 - 
Article 70  
  
Medicinal products that are no longer usable sha ll be disposed of at the expense of their 
owners.   
Regulations in force applicable to the dispos al of hazardous waste sh all also apply to the 
disposal of medicinal products referred to in paragraph 1 of this Article.   
 
7. PHARMACOVIGILANCE 
 
Article 71  
Healthcare professionals coming in contact  with users of me dicinal products and 
manufacturers of medicinal pr oducts or marketing authorisa tion holders shall notify the 
Agency in writing about adverse reactions, in particular about serious  and unexpected adverse 
reactions, while in case of vaccines they shall also notify the Croatian National Institute of 
Public Health. Healthcare prof essionals shall report serious and unexpected adverse reactions 
within the shortest possible time.  
Healthcare professionals who participate in clin ical trials as investigators shall forthwith 
report all serious adverse reactions to the clinical trial sponsor s and to the Agency.  
  
Article 72  
Marketing authorisation holders shall be required to: 1. appoint a pharmacovigilance expert who sh all be at their dis posal at all times, 
2. maintain detailed records of all suspected ad verse reactions occurring either in the Republic 
of Croatia or any other country,  3. report promptly to the Agency, and no late r than 15 days following the receipt of the 
information, all suspected adverse reactions which occurred in th e territory of the Republic of 
Croatia and which are brought to their attention by a h ealth-care professional,  
4. report promptly to the Agency, and no late r than 15 days following the receipt of the 
information, all other suspected serious advers e reactions occurring in the territory of the 
Republic of Croatia and any suspected transmissi on via a medicinal produc t of any infectious 
agent that falls under the reporting obligation, 5. ensure that all suspected serious unexp ected adverse reactions  and any suspected 
transmission via a medicinal product of any infec tious agent occurring in  the territory of any 
other country are reported promptly to the Agency, and no later than 15 days following the receipt of the information,   6. submit reports of all adverse reactions to the Agency in th e form of a Periodic Safety 
Update Report, immediately upon request or peri odically. The Periodic Safety Update Reports 
shall include an evaluation of the risk-benefit balance of the me dicinal product.  
Clinical trial sponsors shall: 1. keep detailed records of all adverse events reported by investigators,  and send the data to 
the Agency and the Central Ethics Committee, 2. ensure that all data on susp ected serious unexpected advers e reactions, which are either 
fatal or life threatening, are immediately repor ted to the Agency and the Central Ethics 
Committee, and no later than seven days followi ng the receipt of the information (follow-up 
report to be submitted within the next eight days),   3. report unexpected adverse reactions to th e Agency and the Central Ethics Committee 
immediately, and no later than 15 days fo llowing the receipt of the information,  
4. notify investigators about all suspected serious unexpected adverse reactions,   
5. submit the aggregate annual report for the prev ious year with the li st of all suspected 
serious adverse reactions record ed during the reporting period, as well as the report on safety 
IP/N/1/HRV/O/7 
        - 32 - 
of trial subjects, to the Agency and the Cent ral Ethics Committee by 31 March of the current 
year. 
 
Article 73  
The Minister shall issue an or dinance on pharamacovigilance. 
 
Article 74  
Healthcare professionals coming in  contact with medicinal products or their users, as well as 
legal and natural persons engaging  in manufacture or distributi on of medicinal products, shall 
notify the Agency in writing about any incomplian ce of medicinal products  quality that they 
learn about.   
In case of suspected counterfeit medicinal products, the persons referred to in paragraph 1 of 
this Article shall within 24 hours notify the Agency and the marketing authorisation holder 
about such suspicion.  An ordinance on the method of monitoring the quality incompliance of  medicinal products 
shall be issued by the Minister.   
 
8. QUALITY CONTROL OF MEDICINAL PRODUCTS 
 
Article 75 
Within the meaning of this Act, quality cont rol shall imply the proc edure for establishing 
conformity of medicinal product  quality with predetermined  quality requirements in 
accordance with this Act and the ensuing regulations.  
Quality control can be performed:  
– on a regular basis, 
– in exceptional cases, – in distribution, and – in special cases. The Minister shall issue an ordinance on the qua lity control method referred to in paragraph 2 
of this Article.    
 
Article 76  
Regular quality control shall apply to:  
– every batch of a manufactured  or imported drug product,  
– every batch of a substance whether in origin al manufacturer’s pack aging or placed on the 
market by a wholesale distribu tor in his packaging.    
A drug product manufacturer seated in the Re public of Croatia and holding a marketing 
authorisation for every manufactured batch of the drug product shall be obliged to subject 
every batch of the drug product to  regular quality  control.  
Wholesale distributors of imported drug products, or importers of drug products, shall subject 
every single batch of an imported drug produc t for regular quality control to the Agency. 
By way of derogation from paragraph 3 of this Article, where the quality control of a batch 
has been performed in the European Union, w holesale distributors distributing imported drug 
products and importers of drug products shall su bmit to the Agency the manufacturer's quality 
control certificate for every batc h of imported drug product, in evidence of performed quality 
control in the European Union.   
In addition to the certificate re ferred to in paragraph 4 of this  Article, wholesale distributors 
and importers shall submit samples of drug products to the Agency who will check the data indicated on outer and immediate p ackaging and package leaflets.  
IP/N/1/HRV/O/7 
        - 33 - 
Based on received certificates and samples referr ed to in paragraph 5 of this Article, the 
Agency shall grant authorisation for ma rketing of imported drug product batches. 
The Agency shall either grant or refuse an au thorisation within 8 days of receipt of the 
certificate referred to in para graph 4 of this Article.  
In case of any doubt, the Agency shall be entitled  to carry out quality control of the imported 
drug product batch referred to in paragraph 4 of this Article,  and for this purpose wholesale 
distributors or importers shall supply the Agency with sufficient quantity of samples for 
analysis and reference standards.  The costs of regular quality control referred to in paragraph 1 of this Article and of granting 
an authorisation referred to in paragraph 6 shall be settled by the manufa cturer seated in the 
Republic of Croatia, or a holder of marketing authorisation if the drug product comes from 
import, or the wholesale dist ributor, or the importer.  
Where the initial doubt proves to be ungrounded after quality control of the imported drug-
product batch referred to in para graph 8, the costs referred to in  paragraph 9 shall be covered 
by the Agency.    
 
Article 77  
Exceptional quality cont rol shall apply to: 
– first batch of every drug product following the issuance of marketing authorisation, 
– every batch of drug product from blood or pl asma and of immunological medicinal product, 
– other medicinal products specified by the Minister on the Agency's proposal. The Agency shall perform the exceptional quality control.  The Agency shall complete the quality control wi thin 30 days of receipt of the samples.   
Costs of quality control referred to in paragraph 1 shall be settled by manufacturers seated in the Republic of Croatia, or in case of imported drug products, they shall be settled by holders of the marketing authorisation, or wholesale dist ributors or importers if  medicinal products do 
not have marketing authorisations. 
 
Article 78  
Quality control from distribution shall apply to drug products and galenical preparations taken from distribution by the Ministry's pharmaceutical  inspectorate in accordance with inspection 
plan, and it shall be performed for every pharm aceutical form and strength of a drug product 
at least once in five years.   The Agency shall perform quality control of samples of medicinal products taken from distribution. 
The Agency shall complete the quality control fro m distribution within 30 days of receipt of 
samples of medicinal products or galenical preparations.  
Costs of the first quality control in five years and samples of medicinal products or galenical 
preparations referred to in paragraph 1 shall be settled by: 
– holders of marketing authorisations for medicinal products, and in absence of marketing 
authorisation, the importing wholes ale distributors or importers, 
– healthcare institution or pharmacy that has ma nufactured the relevant galenical preparation. 
Costs of the second and all subs equent quality controls over the five year period shall be 
settled by: – the Ministry if the relevant medicinal pr oduct or galenical prep aration proves to be 
compliant; – a marketing authorisation holder, and in absence of the marketing authorisation the 
importing wholesale distributor or  importer, if the relevant medicinal product is incompliant 
or if its package leaflet and labelling are not in conformity with those approved;  
– legal or natural person whose incorrect activities in  production or distribution have resulted 
in incompliant medicinal product quality, 
IP/N/1/HRV/O/7 
        - 34 - 
–healthcare institution or pharmacy which manufact ured the relevant gale nical preparation, if 
it proves to be incompliant.  
 
Article 79  
Special quality control shall be conducted on request of the Ministry or the Agency in case of 
any unusual or suspicious signs relevant to the quality of a medicinal product. The Agency 
shall carry out the special quality control.  The Agency shall complete the special quality co ntrol within 30 days of receipt of the sample 
and of the minutes providing data on suspected product quality. Costs of the quality control referred to  in paragraph 1 shall be settled by:  
– proposer of special quality control i.e. the Mini stry or the Agency if the medicinal product is 
compliant;  – marketing authorisation holder,  and in absence of the marke ting authorisation the importing 
wholesale distributor or importer if the relevant medicinal product is of poor quality or if the 
package leaflet and labelling are not in conformity with those approved, 
– legal or natural person whose incorrect activities in  production or distribution have resulted 
in incompliant medicinal product quality.   
Article 80
 
Quality control shall be carried out in lin e with procedures laid down in the accepted 
medicinal product documentation accompanyi ng the application for the marketing 
authorisation or in the absence thereof, the procedures adopted by the Agency. The scope of quality control of individual medicinal products shall be determined by the Agency.  The quality of a medicinal product or raw materials for its manufacture, including raw 
materials for outer and immediate packaging, sh all comply with the Croatian Pharmacopoeia, 
while the medicinal product sh all be manufactured and subjec ted to quality control in 
accordance with procedures and requirements of the valid European Pharmacopoeia. Where medicinal product is not included in either Croatian or European Pharmacopoeia, its quality shall comply with a pharmacopoeia recognised in the European Union or with other internationally recognised standards.  Following the Agency’s proposal, the Minister  shall adopt the Croatian Pharmacopoeia. 
 
 
Article 81  
Manufacturers, wholesale distributors and all importers of medicinal products shall keep 
registers on performed regular, exceptiona l and special quality controls.    
The Agency shall keep the register of performed quality control.  Registers referred to in paragraphs 1 and 2 shall be kept for a year  after expiry of  shelf life of 
the relevant medicinal product. The Minister shall issue an ordinance on the cont ents and maintenance of the register referred 
to in paragraphs 1 and 2 of this Article. 
 
 
9. INFORMATION AND ADVERTISING  
 
Advertising of Medicinal Products  
 
Article 82  
Within the meaning of this Ac t, advertising of medicinal products shall imply any form of 
communication designated to promote prescrip tion, dispensing, sale and consumption of 
medicinal products, be it in written, pictorial, audio, oral, electronic, digital or any other form.  
  
IP/N/1/HRV/O/7 
        - 35 - 
Article 83  
Advertising of medicinal products  referred to in Article 50, para graph 2, items 1 and 2, of this 
Act shall be allowed in technical literature, at  professional and scientific meetings, and to 
healthcare professionals.  
Advertising of medicinal products referred to in Article 50, paragraph 2, item 2, of this Act to 
the general public shall be allowed.   
Advertising of medicinal products referred to in Article 50, paragraph 2, item 1, of this Act to 
the general public sh all be prohibited.  
The prohibition referred to in paragraph 3 shall not apply to public-health activities promoting immunisation, seroprophylaxis and chemoprophyla xis according to the programme passed by 
the Minister in compliance with the Act on Protec tion of Population from In fectious Diseases.   
Advertising of drug products wit hout marketing authorisation shall be prohibited, with the 
exception of advertising at profe ssional and scientific meetings and in technical literature, but 
only if the procedure for obtaining the marketing authorisation has been initiated and if the 
common name of the relevant medicinal produc t is used without any reference to the 
manufacturer. These restrictions shall not apply to international gatherings held in the Republic of Croatia.  
  
Article 84  
Advertising of medicinal products shall be objective, it sh all promote rational 
pharmacotherapy, and it shall not be misleading.  
The Minister shall issue an ordinance es tablishing the methods of advertising.  
 
Article 85  
Product advertisements shall not refer to therap eutic properties of medicinal or homeopathic 
medicinal products which have no marketing authorisation or, in case of homeopathic 
medicinal products, which are not entered in the Agency’s register. The prohibition referred to in paragraph 1 sh all not apply to galenical preparations.  
 
 
Information about Medicinal Products  
 
Article 86  
The provision of information about medicinal products referred to in Ar ticle 50, paragraph 2, 
items 1 and 2, of this Act shall be allowed.  
Within the meaning of this Act, information shall imply:  – informative release of facts and technical information concerning, for example, package 
changes, adverse reaction warnings  and precau tions, trade catalogues an d price lists, provided 
that they do not contai n any statements about medicinal products, 
– informative release of clinical trial results, and   – any unbiased, objective information about dise ases, prevention and available methods of 
treatment, released to the general public. The Minister shall issue an ordinance speci fying methods of provi ding information about 
medicinal products.
 
 
10. SUPPLY OF CROATIAN MEDI CINAL PRODUCTS MARKET    
 
Article 87  
The Agency shall monitor the consumption of me dicinal products in the Republic of Croatia. 
The Agency shall submit reports on the consum ption of medicinal products referred to in 
paragraph 1 of this Article a nd shall propose measures for supervising the consumption of 
medicinal products to the Minister.  
IP/N/1/HRV/O/7 
        - 36 - 
 
Article 88  
The Minister shall issue an ordinance on pric e calculation criteria for medicinal products.  
  
Article 89  
The Croatian Institute for Compulsory Health In surance shall adopt a re imbursement list of 
medicinal products in complian ce with a separate Act.  
Criteria for inclusion of medicinal products on th e reimbursement list referred to in paragraph 
1 of this Article shall be specified in  an ordinance issu ed by the Minister. 
 
11. SUPERVISION  
 
Article 90  
The Ministry's pharmaceutical inspectorate  shall supervise te sting, manufacture and 
preparation, distribution, quality control, pharm acovigilance, advertising and provision of 
information on medicinal products. 
The Minister shall issue an ordinance specifyi ng the methods of supervision referred to in 
paragraph 1 of this Article.   
  
Article 91  
In the framework of inspectional supervision referred to in Article 90 of this Act, a pharmaceutical inspector shall have the following rights and obligations:   
1. order engagement in activities in complian ce with conditions laid down in this Act and 
other regulations,   2. order rectifying of detected irregularities and defects with in a specified limit of time, 
3. prohibit activities which are contrary to this Act and other regulations,  
4. temporarily prohibit work of legal or natu ral persons who fail to observe requirements 
related to employees, equipment and premises,   5. prohibit work of legal or na tural persons engaged in tes ting, manufacture and preparation, 
distribution and quality control of  medicinal products without an  authorisation of the Agency, 
6. prohibit placing of a medicinal product on th e market and submit to the Agency an  
application for its recall in the following cases: – where proven that a medicinal product could be harmful under normal conditions of use, or  
– that it lacks therapeutic efficacy, or – where its qualitative and/or quantitative co mposition is not identical to the composition 
declared in the application fo r marketing authorisation, or 
– where quality control of a drug product and/or the contained raw materials was not carried 
out, or  – where shelf life of a drug product has expired, or – where any other requirement or condition for granting the marketing authorisation has not 
been met,  7. submit an application to the Agency for th e recall of medicinal products batches which do 
not meet the conditions laid down in  this Act and other regulations,  
8. declare that a product established as incomp liant represents hazardous waste and order its 
disposal,  9. prohibit work and propose to the Agency to revoke the oper ating licence in cases where 
non-compliance with conditions defined in this Ac t or other regulations could be hazardous to 
human life and health,   10. prohibit the sale of medicinal products a nd homeopathic medicinal products which do not 
have marketing authorisation, or of homeopathic medicinal products which are not entered in 
IP/N/1/HRV/O/7 
        - 37 - 
the Agency's register of homeopathic medi cinal products, in cases where therapeutic 
properties are indicated on outer  or immediate packaging,    
11. propose to the Agency revoking of the marketi ng authorisation if its holder does not have 
an established pharmacovigilance system and a qualified person responsible for 
pharmacovigilance, or fails to meet other obligat ions laid down in Article 72 of this Act, 
12. order other measures falling under his competence pursuant to this Act and other regulations. 
 
 
Article 92  
Where established during insp ection that a sampled medicinal product is incompliant, the 
costs of quality control, recall or disposal shall be covered either by legal persons responsible 
for its placing on the market or import, or legal or natural persons responsible for the product deterioration on account of their incorrect product storage or handling. 
 
Article 93  
Besides rights and obligations referred to in Ar ticle 91 of this Act, pharmaceutical inspectors 
shall also have the followi ng rights and obligations:   
– temporarily suspend marketing authorisation decisions for all medicinal products and dosage forms covered by a manufacturing authorisation, if any of requirements specified in Articles 34, 39 and 40 of th is Act was not fulfilled, 
– temporarily suspend marketing authorisation decisions on account of br each of provisions 
from Article 76, paragraphs 2, 3 a nd 4 and Article 77 of this Act.
 
 
Article 94  
Pharmaceutical inspectors are persons with unive rsity degree in medical or other related 
fields, and five-year experien ce on corresponding jobs, who have  passed the state examination 
and who fulfil other requirements to be laid dow n in an ordinance issued by the Minister.   
 
Article 95  
Pharmaceutical inspectors shall have official identity cards in eviden ce of their official 
capacity, identity and authority.  The Minister shall issue an ordinance establishing  the form and contents of official identity 
cards as well as the manner of issuance and ma intenance of the register of issued official 
identity cards.  
 
Article 96  
Where during supervision a pharmaceutical inspector discovers that misdemeanour or criminal act was committed by breach of regul ations, he shall immediately, within maximum 
15 days after supervision, submit a claim or  report to the competent authority.   
The competent authority to which the claim or report referred to in paragraph 1 was submitted shall inform the Ministry about the outcome of the relevant proceedings.  
 
Article 97  
Legal and natural persons shall enable pharmaceutic al inspectors to carry out supervision, and 
shall provide a required quantity of samples for quality control as well as necessary data and 
information.  
 
Article 98  
During inspectional supervision, pharmaceutical inspectors shall examine business premises, 
buildings, equipment, facilities and documentation.  
IP/N/1/HRV/O/7 
        - 38 - 
Article 99 
In carrying out supervision, pharmaceutical inspectors shall observe confidentiality 
regulations with respect to business, state, military, official and professional secrets.  
Legal and natural persons concerned shall info rm pharmaceutical inspectors about definition 
of secret under their by-laws. 
 
Article 100 
Pharmaceutical inspectors shall pass verbal decisions in the following cases:   
1. where threat to human health or life requires immediate implementation of a certain measure,   2. where some evidence could be hidden, repl aced or destroyed unless a measure is 
immediately taken;  Pharmaceutical inspectors may order immediate execution of a verbal decision. The decision 
shall be entered into the supervision report.  Pharmaceutical inspectors shall draw up a writ ten communication of verbal decision within 
eight days of passing the verbal decision. 
 
Article 101 
Decisions of pharmaceutical inspectors cannot be appealed, but administrative proceedings can be instituted instead. 
 
Article 102 
Pharmaceutical inspectors shall draw up reports on  completed supervision, established status 
and taken or ordered measures, as well as on performed activities.  Pharmaceutical inspectors shall send a copy of the report to a natura l person or a qualified 
employee of the legal person whose premises were inspected. 
 
Article 103 
Activities of pharmaceutical inspectors shall be governed by the provisions of the Act on 
General Administrative Procedure, unless otherwise regulated by this Act.  
Article 104 
Pharmaceutical inspectors shall keep register s of performed inspectional supervisions.  
The method of register keeping sha ll be prescribed by the Minister.  
 
Article 105 
Pharmaceutical inspectors shall be responsible for:  1. any failure to take or order measures under their competence,  
2. exceeding their authorities, 3. any failure to submit a claim or report to comp etent authorities on established irregularities 
or defects. 
 
III HOMEOPATHIC MEDICINAL PRODUCTS 
  
THE PLACING OF HOMEOPATHIC ME DICINAL PRODUCTS ON THE MARKET 
 
Article 106 
Only homeopathic medicinal products with mark eting authorisations granted by the Agency 
or entered in the Agency’s register in accord ance with this Act and the ensuing regulations 
shall be placed on the market. 
IP/N/1/HRV/O/7 
        - 39 - 
 
Article 107 
Applications for obtaining mark eting authorisations for homeopathic medicinal products shall 
be submitted to the Agency. Applications shall be accompanied with data and documents 
required in line with conditions for placing me dicinal products on the market, referred to in 
Articles 14 and 15 of this Act.   
  
Article 108 
The marketing authorisation sha ll not be required for homeopat hic medicinal products entered 
in the Agency's register if they meet the following conditions: –they are intended for oral or  external administration,   
–there is no reference to their therapeutic i ndications on the packagi ng or in the product 
documentation, –they are sufficiently diluted to guarantee safe use; in particular, su ch products shall not 
contain more than one part per 10000 mother tincture, or more than 1/100th of the smallest 
therapeutic dose of the activ e substance which would requ ire medical prescription.   
 
Article 109  
For register entry, the Agency shall specify dispensing classification of the products.  An 
ordinance on the register c ontents and maintenance shall be issued by the Minister.  
No evidence of therapeutic effect shall be  required for homeopat hic medicinal products 
referred to in Article 108 of this Act. 
 
Article 110 
An application for entry in the Agency’s regist er may comprise product  batches derived from 
the same homeopathic stock or stocks.  
In order to demonstrate the pharmaceutical quality and batch-to-batch homogeneity of the 
products concerned, the application sha ll be supported with the following: 
– scientific name or other pharmacopoeial na me of homeopathic stock or stocks, and 
description of diverse administration methods, pharmaceutical forms and dilutions,  
–documentation showing how homeopathic stock or stocks are obtained and tested and 
providing evidence on its/their homeopathic nature on the basis of the relevant bibliography,   
– manufacture and quality control file for ev ery pharmaceutical form and description of the 
dilution and potentisation method,  
– manufacturing authorisation for individual products,  
– evidence of register entries or marketing au thorisations obtained for the same product in 
other states, 
– a specimen of outer and immediate packaging of the product for which the authorisation is 
applied for,  
– product stability data. 
 
Article 111 
The Agency shall grant or refuse the marketing authorisation within 210 days of receipt of the 
valid application.   
An application referred to in paragraph 1 of th is Article shall be deemed valid if within 30 
days of its receipt the Agency establishes that all the data and documents referred to in Article 
107 have been submitted, about which the Agency sh all keep records and no tify the applicant.  
The marketing authorisation shall be  issued for a period of 5 years. 
For reasons referred to in Article 22, the mark eting authorisation for homeopathic medicinal 
IP/N/1/HRV/O/7 
        - 40 - 
product shall not be granted. 
Not less than 180 days before expiry of a ma rketing authorisation for homeopathic medicinal 
products, an application for its renewal may be submitted to the Agency.  Provisions of Article 11, paragr aphs 4, 5, 6 and 7 shall also apply to homeopathic medicinal 
products. 
The Minister shall issue an or dinance specifying the contents of data and documents required 
for renewal of the marketing authorisation.  
Provisions of Article 29 shall a ppropriately apply to withdrawal  of marketing authorisations 
for homeopathic medicinal products be fore expiry of their validity.  
 
Article 112  
Provisions of Article 20, paragraphs 3, 4 and 5 shall also appropriately  apply to homeopathic 
medicinal products.   
2. LABELLING AND PACKAGE LEAFLET 
 
Article 113 
Provisions of Articles 41 to 47 shall also appropriately appl y to homeopathic medicinal 
products requiring the ma rketing authorisation.  
Homeopathic nature shall be clearly and legibly indicated on the product’s outer and 
immediate packaging.   
 
Article 114 
In addition to a clear label reading “hom eopathic medicinal product”, the following 
information shall appear on outer  and immediate packaging and, if necessary, package leaflets 
of homeopathic medicinal products  referred to in Article 113:  
– scientific name of homeopathic stock or  stocks and indicatio n of dilution using 
pharamacopoeial symbols,  – name and address of the legal person seated in  the Republic of Croatia who is the holder of 
the marketing authorisation for homeopathic  medicinal products and, if necessary, the 
manufacturer’s name and address,  
– method of administration and, if required, route of administration, 
– shelf life, – pharmaceutical form, – product composition, – special storage instructions, where applicable, 
– special warnings, where applicable, 
– batch number, – entry number in the Agency’s register, 
– label reading  »homeopathic medicinal product without proven  therapeutic indications«,  
- a warning instructing patients to consult a phys ician if symptoms fail to disappear during use 
of the product. 
 
 
3. ADVERTISING AND INFORMATION 
 
Article 115 
IP/N/1/HRV/O/7 
        - 41 - 
Prohibitive provisions from Article 83, paragraph 5 and Article 85, paragraph 1 shall 
appropriately apply to advertising of homeopathic medicinal products. 
The Minister shall issue an ordinance on the me thod for advertising of homeopathic medicinal 
products. 
 
Article 116 
Provisions of Article 86 shall appropriately apply to providing information about homeopathic 
medicinal products.   
 
Article 117 
The Minister shall issue an ordinance on providing informati on about homeopathic medicinal 
products. 
 
4. OTHER PROVISIONS 
 
Article 118 
Manufacture, wholesale distributi on, retail sale and quality control of homeopathic medicinal 
products shall be more closely defined in  an ordinance issued  by the Minister.  
 
Article 119 
Provisions of this Act concerning supervision of  medicinal products sha ll also appropriately 
apply to homeopathic medicinal products.  
Pharamacovigilance provisions of this Act sh all also appropriately apply to homeopathic 
medicinal products with marketing authorisations. 
 
IV. AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES  
 
Article 120 
The Agency shall engage in the following activities:  – granting of marketing authorisations for medicinal produc ts and homeopathic medicinal 
products,   
– maintaining the register of homeopathic medicinal products,  
– providing expert assessment of quality, e fficacy and safety of medicinal products and 
homeopathic medicinal products,   
– conducting pharmaceutical testing of medici nal products and homeopathic medicinal 
products,  –  keeping records of clinical trials conducted in the Republic of Croatia, filing final reports, 
analysing information about adverse reac tions of tested medicinal products,  
– performing quality control of medicinal products and homeopathic medicinal products and 
issuing quality control certificates, 
– drawing up the Croatian pharmacopoeia,   
– issuing manufacturing auth orisations to manufacturer s of medicinal products and 
homeopathic medicinal products, 
– issuing Good Manufacturing Pr actice (GMP) ce rtificates,  
– issuing wholesale di stribution authorisation for medi cinal products and homeopathic 
medicinal products,  
– issuing retail sale authorisation to stores speci alised in retail sale of medicinal products,  
– issuing import and export li cences for medicinal products,  
IP/N/1/HRV/O/7 
        - 42 - 
– giving approvals for import and e xport of medicinal products,   
– monitoring adverse reactions and incompliances of medicinal products, 
– carrying out urgent recall procedures for drug products  
– monitoring the consumption of medicinal products and promoti ng their rational use, 
– proposing measures to supervise consumpti on of medicinal products  to the Minister, 
– engaging in waste management activities (for its own needs),  – engaging in training and providing information on medicinal products, 
– offering expert advice from its scope of activities,  
– proposing harmonisation of medicinal products regulations with those of the European 
Union as well as with regulations and gui delines of internatio nal institutions,  
– establishing international cooperation in the filed of medicinal products,  
– maintaining the register  of medical devices,  
– providing expert assessment of  quality or conformity and safety of medical devices, 
– conducting laboratory te sting medical devices, 
– supervising clinical trials of  medical devices, keeping records of clinical trails of medical 
devices carried out in the Republic of Croatia, filing final reports, analysing information on 
adverse reactions of tested medical devices,  
- issuing manufacturing aut horisations to manufactur ers of medical devices, 
– issuing wholesale distribution au thorisation for medical devices, 
- issuing retail sale authorisations to stores specialised in retail sale of medical devices, - issuing import and export licences for medical devices, 
- giving approval for import and export of medical devices, 
– monitoring adverse reactions and incompliances of medical devices, 
- providing information on medical devices, 
- establishing international cooperati on in the field of medical devices, 
– carrying out other tasks from the area of me dicinal products and homeopathic medicinal 
products in accordance with this Act and the ensuing regulations. 
 
Article 121  
The Agency shall have a Statute which shall regu late its organisational structure, authorities 
and decision making process of its individual bodies as well as  conditions and procedure for 
appointing the manager and other issues of importance for the Agency’s activities and 
operations in accordance with this Act.  
The Agency’s Administrative Council shall adopt  the Statute subject to approval by the 
Government of the Republic of Croatia.  
 
Article 122  
Besides the Statute, the Agency shall have its by-laws in line with this Act and other 
regulations. Rights and obligations of the Agency’s employ ees and other employment-related issues shall 
be regulated by the Labour Relations By-law. The Administrative Council shall ad opt the Labour Relations By-l aw and other by-laws of the 
Agency, unless this Act and the Statute require their adoption by the Agency’s manager.   
  
Article 123  
IP/N/1/HRV/O/7 
        - 43 - 
The bodies of the Agency shall comprise: th e Administrative Council, the Manager, the 
Expert Council and other bodies defined by the Statute. 
 
Article 124  
The Agency shall be managed by the Administrative Council.  The Administrative Council shall have 5 members. The president and members of the Administ rative Council shall be appointed by the 
Government of the Republic of Croatia on proposal of the Minister.   Members of the Administrative Council shall be appointed fo r a period of four years. 
 
Article 125  
The Government of the Republic of Croatia  may relieve a member of the Agency’s 
Administrative Council before the expiry  of his term of office in the following cases: 
– if the member himself demands to be relieved from duty,  
– if in his work he seriously or repeatedly br eaches the law and other regulations relevant to 
the Agency’s operations and activities,  
– if in his work he causes damage to the Agency,  
– in other cases defined by the law and the Statute. 
 
Article 126  
The Administrative Council shall:  
– adopt the Agency’s Labour Relati ons By-law and other by-laws, 
– adopt the Agency’s business and financial plan,  – adopt the Agency’s annual accounts and business reports,  – appoint and relieve from duty the Agency’s manager,  
– make decisions on the Agency’s in ternal organisational structure, 
–make decisions on other issues defined in the Agency’s Statute. 
 
Article 127  
The Agency’s manager shall manage the Agency’s operations.  
The Agency’s manager shall be appointed for the term of four years. Af ter the expiry of his 
term of office, the manager may be re-appointe d without restrictions on the number of his 
terms of office.  
 
Article 128  
The Agency’s manager shall:  – run and manage the Agency’s operations,  
– act as  the Agency’s agent and representative,  
– propose the adoption of acts under his comp etence to the Administrative Council,  
– decide on other matters defined by the Statute.  
  
Article 129  
The Administrative Council shall relieve the mana ger from duty before the expiry of his term 
of office if he:  
IP/N/1/HRV/O/7 
        - 44 - 
– requests to be relieved,  
– fails to observe the Agency’s regulations and by-laws,  
– unjustifiably refuses to implement decisions of the Agency’s Administrative Council made 
within the scope of the Council’s competence,  
– causes substantial damage to the Agency through unconscientious and inaccurate work,  
– frequently neglects or uncons cientiously performs his duties thus causing difficulties in the 
Agency’s operations.   
Article 130  
The Agency’s assets sh all consist of operating funds which shall be provided by its founder, 
or acquired by rendering services, or from other sources.    
The funds for the Agency’s activities shall be provided from:  
– the Agency’s operating revenues (from rende ring services and from annual fees)   
– other sources in accordance with this Act or other regulations. 
The Agency shall specify the am ount of annual fees subject to the approval by  the Minister. 
Annual fees shall be paid by holders of mark eting authorisations for drug products and 
holders of entry in the register of homeopathic medicinal products.   
 
Article 131  
Legal aspects of the Agency’s operations shall be supervised by the Ministry.   
 
Article 132  
The Agency shall submit annual reports to th e Minister and to the Government of the 
Republic of Croatia.   
Article 133  
General labour regulations and the collective ag reement shall govern the legal status of the 
Agency’s employees, employment conditions, salaries and other is sues that are not regulated 
by this Act.  The Act on Public Servants’ Salaries  shall not apply to the Agency. 
 
V PENAL PROVISIONS 
 
Article 134 
Legal persons shall be liable to a fine  between HRK 100 000.00 and HRK 150 000.00 for the 
following misdemeanours: 
1. for placing medicinal products on the market  without performed trials or for conducting 
trials of  medicinal products contrary to pr ovisions of this Act and the ensuing regulations 
(Article 4; Article 5, paragraph 2; Articl e 6, paragraph 3; Articles 7, 8, 9 and 10), 
2. for paying fees to investigators and trial su bjects contrary to th e provision of Article 9, 
paragraph 4 of this Act, 3. for placing medicinal products on the market  in the Republic of Croatia without the 
required marketing authorisation (Art icle 11 and Article 53, paragraph 1), 
4. for providing incorrect data in the documentation accompanying the marketing 
authorisation application (Article  14, paragraph 2 and Article 15), 
5. if qualitative and quantitativ e composition of medicinal produc ts does not comply with the 
composition provided in the documentation acco mpanying  the application for marketing 
IP/N/1/HRV/O/7 
        - 45 - 
authorisation or application for its amendment, or if pr oven that the drug product is 
unacceptably harmful, or insufficiently effectiv e under prescribed conditi ons of use (Article 
29, paragraph 1), 
6. for manufacturing a medicinal product in  the Republic of Croatia without the 
manufacturing authorisation (Article 30, paragraph 1), 
7. for providing incorrect data in the applica tion for manufacturing authorisation and for 
failing to inform the Agency about change s of data on the grounds of which the 
manufacturing authorisation was issu ed (Article 31 and 36, paragraph 1), 
8. for engaging in wholesale and retail sale of medicinal products without authorisation 
(Article 55 and Article  65, paragraph 1), 
9. for engaging in import and export without im port or export licence (Article 62, paragraph 
2), 10. for carrying out quality contro l of medicinal products contrary to provisions of this Act 
and the ensuing regulations (Articles 75 to 81), 11. for advertising and providing information about  medicinal products contrary to provisions 
of this Act and the ensuing re gulations (Articles 82 to 86), 
12. for calculating a medicinal produ ct price contrary to criteria from Article 88 of this Act, 
13. for failing to act in due course in accordance with legally valid ruli ng of a pharmaceutical 
inspector which prescribes certain measur es or prohibits work (Article 91), 
14. for failing to enable a pharmaceutical inspec tor to carry out supervision in accordance 
with provisions of this Act and the ensuing regulations (Article 97), 
15. for placing homeopathic medicinal products  on the market without the Agency's 
authorisation or entry in the Agency's register (Articles 106 and 108), 
16. for providing incorrect data in the documen tation accompanying the application for entry 
in the register of homeopathic medicinal products (Article 110). For misdemeanour referred to in paragraph 1, natural persons and qualified employees of 
legal persons shall be liable to a fine between HRK 10 000.00 and HRK 15 000.00. 
 
Article 135 
Legal persons shall be liable to a fine  between HRK 70 000.00 and HRK 100 000.00 for the 
following misdemeanours: 1. for carrying out tests and quali ty control of products covere d by this Act without meeting 
the conditions laid down in this Act a nd the ensuing regulations (Article 3), 
2. for conducting unauthorised clinical trials  of medicinal products (Article 7), 
3. for conducting or allowing clinical trials contra ry to provisions of Ar ticle 9, paragraph 2, of 
this Act,   4. for distribution of drug products  subject to marketing authorisa tions that are not valid in the 
Republic of Croatia (Article 11, paragra ph 3 and 4, and Article 53, paragraph 1), 
5. for placing on the Croatian market drug products  that are unlabelled or without package 
leaflet in compliance with provisions of this Ac t and the ensuing regulations (Article 41 and 
44), 6. for dispensing drug products in a manner and at  the place contrary to the issued marketing 
authorisation (Article 50), 7. for failing to ensure transportation and storag e of medicinal products in accordance with 
storage conditions indicate d on products (Article 54), 
8. for providing incorrect data in documenta tion accompanying the application for wholesale 
distribution authorisation and marketing authorisation for medicinal products (Article 58), 
9. for importation of medicinal products withou t prescribed import licence (Article 64), 
10. for failing to submit data on medicinal products distribution to the Agency (Article 68, paragraph 1), 
IP/N/1/HRV/O/7 
        - 46 - 
11. for failing to meet the obligation from Article 72 herein,  
12. for failing to subject every batch of manu factured or imported drug product to regular 
quality control, contrary to Article 76 of this Act,  
13. for failing to supply the Agency with sufficient quantity of samples (Article 76, paragraph 8), 14. for failing to subject a drug product to exceptional quality control (Article 77), 
15. for placing a medicinal product on the Croatian market if its quality, including the quality 
of all raw materials for its production and ma terials for immediate packaging, do not comply 
with the Croatian pharmacopoeia or other pha rmacopoeia as referred to in Article 80, 
paragraph 3 herein,  16. for failing to maintain register of regular, exceptional and specia l quality control in 
accordance with provisions of this Act and the ensuing regulations (Article 81), 
17. for failing to put data required by this Act on outer and immediate packaging (Article 113 
and Article 114), 18. for advertising homeopathic medicinal produ cts referred to in Ar ticle 115, paragraph 1 
herein. For misdemeanour referred to in paragraph 1, natural persons and qualified employees of 
legal persons shall be liable to a fine between HRK 7 000.00 and HRK 10 000.00. 
 
Article 136 
Any legal person who provides incorrect data du ring the procedure of import licence issuance 
for a medicinal product without ma rketing authorisation in the Republic of Croatia shall be 
liable to a fine between HRK 50 000.00 and HRK 70 000.00 (Article 64, paragraph 1). For misdemeanour from paragraph 1, a responsib le person of the legal person shall be also 
liable to a fine between HRK 5 000.00 and HRK 7 000.00. A medical doctor or a dental medicine doctor who prescribes  a medicinal product that does 
not have marketing authorisation in the Republic  of Croatia, contrary to Article 64, paragraph 
1 and the ordinance referred to in Article 64, paragr aph 2, of this Act, shall be liable to a fine 
between HRK 5 000.00 and HRK 7 000.00.  
Article 137 
Legal or physical persons shall be liable  to fine between HRK 30 000.00 and HRK 50 000.00 
in the following cases: 1. for disposing of unusable medicinal products c ontrary to provisions of this Act and valid 
regulations (Article 70), 2. for failing to notify the Agency in writing about adverse reactions, or the Croatian National Institute of Public Health in case of vaccines, in conformity with provisions of this Act and 
the ensuing regulati ons (Article 71), 
3. for failing to notify the Agency in writing about incompliance of a medicinal product or 
suspected counterfeit, contrary to Articl e 74 herein and the ensuing ordinance, 
4. for placing on the market a homeopathic medicinal product which is not labelled in accordance with provisions of th is Act (Article 113 and 114). 
A qualified employee of the legal person shall be liable to a fine between HRK 3 000.00 and 
HRK 5 000.00 for misdemeanour referred to in paragraph 1 herein.  
 
VI TRANSITIONAL AND FINAL PROVISIONS 
 
Article 138 
The Minister shall issue the ordinances placed under his competence by this Act within a year 
from the date of entry into force of this Act. 
IP/N/1/HRV/O/7 
        - 47 - 
 
Article 139 
Until the entry into force of ordinances referred  to in Article 138 of this Act, the following 
ordinances shall remain in force: 
1. Ordinance on monitoring adverse drug reactions  to medicinal products and medical devices 
(Official Gazette 29/05), 
2. Ordinance on advertising and providing info rmation on medicinal products, homeopathic 
medicinal products and medical de vices (Official Gazette 62/05), 
3. Ordinance on good laboratory prac tice (Official Gazette 51/06.), 
4. Ordinance on clinical trials  and good clinical practice (O fficial Gazette 175/03 and 55/04), 
5. Ordinance on classification, pr escribing and dispensation of medicinal products (Official 
Gazette 123/05 and 112/06), 6. Ordinance on quality control of medici nal products (Official Gazette 56/05), 
7. Ordinance on pharmacovigilan ce (Official Gazette 36/05), 
8. Ordinance on testing bioavail ability and bioequivalence of medicinal products (Official 
Gazette 71/99), 9. Ordinance on the licensing requirements specialised stores for retail sale of medicinal products and medical devices (Offici al Gazette 29/05, 81/06 and 5/07), 
10. Ordinance on good manufacturing practice related to medicinal products (Official Gazette 
40/05), 11. Ordinance on the procedure and method of granting marketing authorisations for drug 
products (Official Gazette 143/98.), 12. Ordinance on the type of da ta and reporting on the distribution of finished medicinal 
products (Official Gazette 29/05), 13. Ordinance on special conditions  for placing on the market of the Republic of Croatia drug 
products with a marketing authorisation in EU  Member States (Official Gazette 86/04.), 
14. Ordinance on good practice in wholesale distribution of me dicinal products (Official 
Gazette 29/05), 15. Ordinance on the conditions and the proc edure of obtaining the for the wholesale 
distribution of medicinal products and the impor t and export of medici nal products (Official 
Gazette 29/05), 16. Ordinance on the criteria for wholesale pric ing of medicinal products  and the methods for 
reporting wholesale prices (Official Gazette 91/06), 
17. Ordinance on identity cards of pharmaceutic al inspectors (Official Gazette 19/05), 
18. Ordinance on the conditions of manufacture,  placing on the market, quality control and 
the register of homeopathic medicina l products (Official Gazette 62/05). 
 
Article 140 
Procedures for granting, amending and renewal of drug product marketing authorisations, for 
issuing manufacturing authorisations, authorisat ion for wholesale distri bution and retail sale 
of medicinal products, licences for import and e xport of medicinal products, which have been 
initiated before the entry into force of this Act, shall be completed in conformity with provisions of the Act on Medicinal Products a nd Medical Devices (Offi cial Gazette 121/03 
and 177/04).  
Article 141 
Legal persons holding manufacturi ng authorisation on the date of entry into force of this Act 
shall harmonise their work and operations with provision of Article 34 of this Act within one 
year from its entry into force.  
 
IP/N/1/HRV/O/7 
        - 48 - 
Article 142 
Marketing authorisations issued on the grounds of  regulations valid unti l the entry into force 
of this Act shall remain in force till expiry of their original term. 
 
Article 143 
Legal persons holding marketing authorisations for drug products on the date of entry into 
force of this Act shall harmonise their work and operations with Article 72  of this Act within 
a year from its entry into force.    
Article 144 
Legal persons who hold marketing authorisations  for drug products shall harmonise labelling 
and package leaflet as well as the summary of the product characteristic s with provisions of 
this Act and the ensuing ordinanc es within six months of the en try into force of ordinances 
referred to in Article 41 para graph 5, Article 46 paragraph 2 and Article 48 herein.   
 
Article 145 
The Agency shall harmonise its work and operations  with provisions of this Act within three 
months of its entry into force.  
 
Article 146 
The following ordinances shall remain effective till the date of the entry into force of a 
separate act on medical devices: 1. Ordinance on classification, placing on the ma rket, essential requirements, conformity 
assessment procedures and the register of medical devices (Official Gazette 54/05), and 
2. Ordinance on good practice and conditions for i ssuing authorisations for distribution of 
medical devices (Official Gazette 54/05). 
 
Article 147 
Provisions of the Act on Medicinal Products a nd Medical Devices (Official Gazette 121/03 
and 177/04) shall cease to have eff ect on the date of entry into force of this Act, with the 
exception of provisions of Artic le 43 paragraph 1, Article 51 paragraphs 4, 5, 6, 7 and 8, 
Article 52, Articles 76 to 86, in the part which c oncerns medical devices as well as Articles 99 
to 123. The Act on Medicinal Products and Medical  Devices shall cease to have effect one 
year from entry into force of this Act.   
 
Article 148 
This Act shall enter into force on 1 October 2007,  with the exception of provisions of Article 
23, paragraphs 3 and 4, Article 42, paragraph 2 a nd Article 47, paragraph 4, which shall enter 
into force on the date of accession of the Republic of Croatia to the European Union.  Class: 530-08/07-01/01 Zagreb, 21 July 2007  
  
THE CROATIAN PARLIAMENT 
The President of the Croatian Parliament 
Vladimir Šeks, m.p. 
   
IP/N/1/HRV/O/7 
        - 49 - 
 
   
IP/N/1/HRV/O/7 
        - 50 -