Medicinal products for human use
Scope of application
Procedures for testing, placing on the market, manufacture, labelling, classification, distribution, pharmacovigilance, quality control, advertising, supply of the Croatian market with medicinal products and supervision of medicinal products, investigational medicinal products, active substances, and excipients.
The provisions of this Act apply to medicinal products for human use intended to be placed on the market and either prepared industrially or manufactured by a method involving an industrial process.
The provisions of this Act shall not apply to the following:
magistral preparations,
galenic products, with the exclusion of the quality control provisions,
medicinal products intended for research and development, with the exclusion of medicinal products in clinical trials,
intermediate products intended for further processing by an authorized manufacturer,
whole blood, plasma or blood cells of human origin, except for plasma which is prepared by a method involving an industrial process,
radionuclides in a sealed radiation source,
advanced-therapy medicinal products which are prepared exclusively according to specific requirements and used in hospitals under professional responsibility of a physician, based on medical prescription for an individual patient in the Republic of Croatia.
Main requirements that the business user needs to know about
The benefit-risk ratio of the medicinal product must be considered favourable, therapeutic efficacy of the medicinal product must be sufficiently substantiated, the qualitative and quantitative composition of the medicinal product must correspond to the declared composition, the labelling and the package leaflet must comply with the provisions of the Medicinal Products Act and with the data provided in the summary of the product characteristics, the data, documents and files attached to the application must fulfill the requirements laid down in the aforementioned Act.
In addition to the application for granting of a marketing authorization for a medicinal product in the Republic of Croatia, the applicant is obliged to enclose the dossier which contains the following data and documents:
a) name and address of the applicant and, where applicable, of the manufacturer,
b) name of the medicinal product,
c) qualitative and quantitative composition of all constituents of the medicinal product, including the reference to its international non-proprietary name, if such exists, or other common name,
d) evaluation of the potential environmental risks posed by the medicinal product,
e) description of the manufacturing process,
f) therapeutic indications, contra-indications and adverse reactions,
g) posology, pharmaceutical form, method and route of administration, and expected shelf life,
h) reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for waste management, together with an indication of all potential risks presented by the medicinal product for the environment,
i) description of the control methods employed by the manufacturer,
j) where applicable, a written confirmation that the manufacturer of the medicinal product has verified the compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice,
k) results of:
pharmaceutical (physiochemical, biological and/or microbiological) tests,
pre-clinical (toxicological and pharmacological) tests,
clinical trials,
l) a summary of the applicant’s pharmacovigilance system,
m) RMP describing the risk management system which the applicant will introduce for the medicinal product concerned, together with the summary thereof,
n) a statement confirming that clinical trials carried outside the European Union comply with the ethical requirements laid down in Directive 2001/20/EC,
o) a summary of the product characteristics, a mock-up of the outer and immediate packaging of the medicinal product, together with a package leaflet,
p) a document showing that the manufacturer is authorised in his own country to produce medicinal products (manufacturing authorisation),
r) copies of the following:
any authorisation, obtained in another EU Member State or in a third country to place the medicinal product on the market, a summary of the safety data including the safety data contained in the periodic safety update reports, and, where available, suspected adverse reactions reports, together with the list of those EU Member States in which an application for authorisation is being examined;
the summary of the product characteristics proposed by the applicant in the authorisation procedure currently underway in EU Member States or the one(s) last approved by competent authorities of other EU Member States; the package leaflet proposed in the authorisation procedure currently underway in the EU Member States, or the mock-ups of last approved one(s) by competent authorities of other EU Member States
details of any decision to refuse authorisation, whether in any EU Member State or a third country, and the reasons for such a decision,
s) a copy of any designation of the medicinal product as an orphan medicinal product, accompanied by a copy of the EMA's opinion,
detailed summaries provided by experts on parts of the medicinal product documentation,
evidence that the applicant has at his disposal a qualified person responsible for pharmacovigilance with permanent residence in the Republic of Croatia and his/her contact details.
For medicinal products authorised by the Agency, the marketing authorisation holder who is not established in the Republic of Croatia shall be required to designate a representative established in the Republic of Croatia.
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
Scope of application
The procedure, conditions and documentation required for granting, renewal, revocation, and transfer of authorizations for the marketing of medicinal products in the Republic of Croatia, contents of the summary of product characteristics, package leaflets, and labelling of medicinal products, registration, form and content of documentation, proof of traditional use and the rules of labelling traditional herbal medicinal products, and registration and content of documentation for the registration of homeopathic medicinal products. Applicable to all medicinal products for which a marketing authorization in the Republic of Croatia is sought.
Main requirements that the business user needs to know about
It is mandatory to follow the European Pharmacopoeia, the guidelines of the European Medicines Agency, European Commission, Coordination group for MRP and DCP and the intergovernmental body Heads of Medicines Agencies while preparing the medicinal product dossier.
The medicinal product documentation is to be submitted in electronic form of CTD (Common Technical Document).
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
National legislation
Ordinance on Pharmacovigilance (Official Gazette, No. 83/2013)
Scope of application
The requirements for, and procedures and activities of healthcare professionals, applicants submitting an application for marketing authorisation for a medicinal product, marketing authorisation holders for medicinal products, holders of the authorisation for parallel imports, importers, the wholesale, clinical trial sponsors or the representative of clinical trial sponsors and the Agency for Medicinal Products and Medical Devices in the field of pharmacovigilance, in order to ensure the safe use of medicinal products.
The pharmacovigilance system is regulated for the detection, assessment, understanding and prevention of, and actions to be taken in the case of, adverse reactions caused by medicinal products.
Main requirements that the business user needs to know about
The pharmacovigilance system needs to be established and maintained in accordance with the Guideline on Good Pharmacovigilance Practices (GVP).
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
Scope of application
The requirements of good manufacturing practice to be observed by manufacturers and importers of medicinal products and investigational medicinal products established in the Republic of Croatia, and the requirements for issuing manufacturing authorizations and certificates of good manufacturing practice.
Main requirements that the business user needs to know about
Medicinal products and/or investigational medicinal products may be manufactured by natural or legal persons established in the Republic of Croatia only on the basis of, and in accordance with the manufacturing authorization.
The manufacturer and the importer of medicinal products shall ensure that all manufacturing operations for medicinal products and/or investigational medicinal products are carried out in compliance with the following: good manufacturing practice, the manufacturing authorization and approved documentation in the marketing authorization procedure, and in the case of investigational medicinal products in accordance with the data submitted to the competent Ministry responsible for health in the procedure of granting approval for conducting a clinical trial.
The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, ensure a sufficient number of competent and suitably qualified personnel, have appropriate manufacturing facilities and equipment, establish and maintain a record keeping system, conduct manufacturing procedures according to pre-set written instructions and procedures, establish and maintain a quality control system , conduct self-inspections.
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
National legislation
Ordinance on the Requirements and Method of Establishing the Requirements of Good Manufacturing Practice and Good Practice in the Wholesale of Active Substances and on the Procedure of the Entry in the Register of Manufacturers, Importers and Wholesalers of Active Substances, and on Issuing the Certificate for the Implementation of Good Manufacturing Practice (Official Gazette, No. 83/2013)
Scope of application
Conditions to be met by manufacturers, importers and wholesalers of active substances established in the Republic of Croatia for good manufacturing practice, good practice in the wholesale distribution of active substances, and the procedure of entry in the register and the issuing of the certificates for the implementation of good manufacturing practice and good practice in the wholesale distribution.
Main requirements that the business user needs to know about
The manufacturers of active substances shall meet the following conditions:
employ an adequate number of qualified persons given the scope and complexity of manufacture of active substances,
premises, installations and equipment shall be located, designed, constructed, adapted and maintained to suit the intended manufacture, supervision, safe keeping and transportation of active substances in compliance with good manufacturing practice for active substances,
ensure that all manufacturing processes for active substances are carried out in compliance with good manufacturing practice, including active substances that are intended solely for export.
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
National legislation
Ordinance on Good Practice in the Distribution of Medicinal Products, on Issuing Authorisations for Wholesale Distribution of Medicinal Products, Registration for Brokering of Medicinal Products and on Issuing Certificates on Good Practice in Wholesale Distribution of Medicinal Products (Official Gazette, No. 83/2013, 19/2020, 32/2021 and 146/2022)
Scope of application
Requirements of good practice to be met in order to perform wholesale distribution of medicinal products and investigational medicinal products, the conditions, documents and information with regard to issuing the authorization for the performance of wholesale distribution, brokering of medicinal products, and the procedure of the registration of natural and legal persons established outside the Republic of Croatia that fulfill the requirements for the performance of wholesale distribution or brokering of medicinal products in a Member State of the European Union, and that intend to carry out that activity on the territory of the Republic of Croatia, and the issuing of the certificate of good practice in the wholesale distribution of medicinal products.
Main requirements that the business user needs to know about
Participants in the wholesale distribution of medicinal products are obliged to establish a quality management system, must have an employee responsible for the wholesale distribution of medicines, employ a sufficient number of experts in the relevant profession, ensure staff training, provide suitable premises, installations and equipment, establish and maintain a record keeping system, have fully described operating procedures, conduct self-inspections and ensure that medicinal products are transported appropriately.
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
Scope of application
The benchmarks for classification of medicinal products with regard to their method of dispensing, and the manner of prescription and dispensing of medicinal products subject to medical prescription.
Main requirements that the business user needs to know about
Medicinal products may be dispensed on a prescription in a pharmacy, without a prescription in a pharmacy or without a prescription in a pharmacy and specialized retail stores for the medicinal products, depending on the manner and place of dispensing specified in the marketing authorisation licence issued by the Agency for Medicinal Products and Medical Devices.
In the marketing authorisation licence, the Agency determines the manner of prescribing of medicinal products as: renewable prescription, non-renewable prescription, special prescription or restricted prescription.
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
National legislation
Ordinance on the Quality Control of Medicinal Products (Official Gazette, No. 60/2014)
Scope of application
The procedure for quality control of medicinal products and galenic preparations.
Main requirements that the business user needs to know about
The manufacturer of a medicinal product who holds a marketing authorisation for the medicinal product in the Republic of Croatia is obliged to perform regular quality control of each batch of the medicinal product.
Each batch of a medicinal product derived from human blood or human plasma and of vaccines shall be subject to a special quality control, with the exception of batches in respect of which the competent authority of a Member State of the European Union, the European Economic Area (EEA) or Switzerland conducted quality control and issued a certificate of quality control (»EU Official Control Authority Batch Release Certificate«, EU OCABR certificate).
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
National legislation
Ordinance on the Suspension of the Placement on and Withdrawal of Medicinal Products from the Market (Official Gazette, No. 122/2014)
Scope of application
The conditions and manner of suspension of the placement and withdrawal of medicinal products from the market, and the deadlines and manner of notification of the suspension of the placement and withdrawal of medicinal products from the market.
Main requirements that the business user needs to know about
The holder of the marketing authorization for the medicinal product, holder of the authorization for parallel import of the medicinal product, manufacturer of the medicinal product, importers and wholesalers included in manufacturing or in performing wholesale trade of medicinal products are obliged to inform the Agency in writing of each observed case which could result in the suspension of the placement or withdrawal of the medicinal product from the market, or limitations to the use of the medicinal product that are not listed in the approved summary of product characteristics and the approved package leaflet.
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
National legislation
Ordinance on the Manner of Advertising Medicinal Products (Official Gazette, No. 43/2015)
Scope of application
The manner of advertising medicinal products.
Main requirements that the business user needs to know about
All claims listed in the advertisements for the medicinal product must be aligned with the claims stated in the most recently approved package leaflet and summary of product characteristics of the medicinal product in the Republic of Croatia.
Advertising of the medicinal product must ensure the transfer of true and scientifically proven information on the medicinal product, with the abidance of ethical criteria, for the purpose of the proper and rational treatment of patients, without misleading health care professionals to recommend, prescribe or dispense medicinal products, and medicinal product users in cases when advertising is permitted towards the population.
Advertising to general public is permitted exclusively for medicinal products that are dispensed without a prescription, in accordance with the marketing authorisation licence ,for the medicinal product.
Given the complexity of the regulation and given that medicinal products are products of special importance for human health, it is not possible to extract the main technical requirements that need to be fulfilled. The complete regulation should be studied instead.
National legislation
Ordinance on the Marketing, Labelling and Advertising of Traditional Herbal Medicinal Products (Official Gazette, No. 89/2010)
Scope of application
Advertising of traditional herbal medicines (the Ordinance was repealed by the Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 83/13.), except in the part which refers to the advertising of traditional herbal medicines).
Main requirements that the business user needs to know about
When advertising a traditional herbal medicinal product, in addition to the requirements from the Act and Ordinance on the manner of advertising the following message must be contained within the advertisement or notice: “Traditional herbal medicinal product for use for the listed indications based on the experience of long-term use”.
National action - Medicinal Products Act (Official Gazette, No. 76/2013, 90/2014, 100/2018)
The applicant/marketing authorisation holder needs to have at his disposal a qualified person responsible for pharmacovigilance with permanent residence in the Republic of Croatia.
For medicinal products authorised by the Agency, the marketing authorisation holder who is not established in the Republic of Croatia shall be required to designate a representative established in the Republic of Croatia.
Competent authority
Agency for Medicinal Products and Medical Devices of Croatia
Email: uredzajavnost@halmed.hr
Phone: +385 1 46 07 555
Web: https://zdravlje.gov.hr/
Market Surveillance Authority
Ministry of Health
Email: farmaceutska.inspekcija@miz.hr
Agency for Medicinal Products and Medical Devices of Croatia
Email: inspekcija@halmed.hr
Link to the TRIS database
In the TRIS database you can look up the notification of the technical rule