Croatia Pharmaceutical Licensing

This guide covers retail, wholesale, manufacturing and related import activities for industrial medicinal products for human use. Croatia has a nationwide regulatory framework; this verification did not identify a federal-style division under which operating licences could be summarised separately by province or state.

No single operating licence should be treated as universal market access. Pharmacy services, specialised pharmaceutical retail, wholesale, manufacturing/third-country imports, medicinal product marketing authorisations and individual pharmacists’ independent practice licences are governed by different laws or procedures.

— Pharmacies and pharmacy depots: retail sales are conducted under the special legislation on pharmaceutical services.

— Specialised pharmaceutical retail outlets: may sell non-prescription medicines only within the scope of the HALMED licence and the marketing authorisation.

— Wholesale and manufacturing/import: separate applications must be made to HALMED for the respective licences.

HALMED is the main implementing authority for manufacturing/import, wholesale and specialised pharmaceutical retail licences, and maintains public databases of manufacturing, wholesale/retail and related records. The ministry responsible for health handles medicines policy and market supervision, while the Croatian Chamber of Pharmacists performs public functions including pharmacist registration, independent practice licences and professional supervision.

The current medicines legislation listed by HALMED includes the Medicines Act and its amendments from 2014, 2018 and 2025, as well as implementing regulations on manufacturing GMP and wholesale GDP. Project documents should use the HALMED forms and legislative versions available on the filing date.

— HALMED: operating licences, product authorisations, certain inspections and databases.

— Ministry responsible for health: market supervision, security of supply and statutory policy functions.

— Croatian Chamber of Pharmacists: individual pharmacist registration, practice licences and professional supervision.

Retail sales of medicines follow two distinct pathways: pharmacies/pharmacy depots and specialised pharmaceutical retail outlets licensed by HALMED. Pharmacy retail includes ordering, storage, dispensing prescription and non-prescription medicines; specialised outlets may sell only non-prescription medicines that the marketing authorisation decision permits to be sold at those premises, and may be subject to dose and pack-size restrictions.

Specialised outlets may purchase only from wholesalers holding a pharmaceutical wholesale licence, or from manufacturers established in Croatia/the EU that hold a valid manufacturing licence and whose relevant medicines have Croatian marketing authorisations; the original packaging must be retained.

— Specialised outlets must display their name/registered office, outlet name and address, and opening hours.

— The medicines display area must be physically separated from areas containing other goods that could affect the quality of medicines.

— Medicines on shelves must be stored in a manner that prevents self-service sales.

Applicants for medicinal product wholesale activities established in Croatia must apply to HALMED for a wholesale authorisation. Authorisations are granted or refused according to the scope of activities, marketing authorisation status of the products, special product categories and storage requirements. The categories specifically listed in the Regulation include narcotic/psychotropic medicines, medicines derived from blood or plasma, immunological medicines, radiopharmaceuticals, medical gases, cold-chain products and investigational medicinal products.

For wholesale authorisation applications, compliance with GDP is verified by a pharmaceutical inspector. The inspector gives an opinion within 80 days of receiving a complete application, after which HALMED makes a decision; the 80 days is the deadline for the inspection opinion, not an unconditional commitment to a total approval timeframe.

— Submit the HALMED wholesale application form, the scope of activities/products, entity registration details and information about the responsible person.

— Submit evidence of rights to the premises, floor plans, use permit, equipment, quality system/SOPs and relevant service contracts.

— If there is no in-house warehouse, submit a service agreement for receipt, storage and dispatch with an entity holding a HALMED wholesale authorisation.

Natural or legal persons manufacturing medicinal products or investigational medicinal products in Croatia must apply to HALMED for a manufacturing authorisation. This authorisation confirms that the manufacturing facilities meet requirements concerning premises, equipment, personnel and the principles and guidelines of GMP. Manufacturing may include packaging, quality control, batch release, import, storage and delivery to wholesalers.

EEA manufacturers/importers must hold manufacturing and import authorisations and GMP inspection results from the Member State in which they are established. Finished medicinal products from third countries may be imported into Croatia only by an importer holding a manufacturing authorisation, with arrangements for receipt, quarantine storage, quality control and batch release by an EU-qualified person.

— Use the HALMED “Manufacturing and Import” application form.

— Undertake to provide the person responsible for batch release with the conditions and resources to perform their duties independently, and to manufacture in accordance with GMP.

— For imports from third countries, specify the manufacturing site and hold a GMP certificate issued by an EU competent authority.

The person responsible for a pharmacy must be a master of pharmacy who meets the requirements of the Pharmacy Act. Before beginning work in a pharmacy, pharmacists must be registered with the Croatian Chamber of Pharmacists and obtain an independent practice licence; this individual licence is separate from an entity’s retail, wholesale or manufacturing authorisation.

A specialised medicinal product retail outlet must be managed by a master of pharmacy. If the manager works part-time, a full-time-employed pharmacy technician who has passed the professional examination is also required. Wholesale activities must have a responsible person and a sufficient number of suitably qualified professionals; a manufacturing authorisation requires suitable personnel and the independent performance of duties by the person responsible for batch release.

— The Croatian Chamber of Pharmacists handles pharmacist registration, independent practice licences, renewals and revocations.

— Renewal of a pharmacy professional licence is linked to continuing professional development; the Official Gazette sets out a competency assessment rule once every six years.

— Specialised retail outlets must keep records of training and continuing education for the responsible person and professional personnel.

A specialised medicinal product retail outlet must have functionally connected premises suitable for the safe storage, safekeeping and supply of medicinal products. The Regulation specifies a dispensing/display area, storage area, office area, staff sanitary facilities and changing area, and requires appropriate equipment to maintain, control and monitor the storage microclimate.

Premises and equipment for wholesale and manufacturing are not expressed in terms of generic area or capital thresholds; they must meet GDP or GMP requirements and the requirements of the proposed scope of activities and product storage. The definition of a manufacturing authorisation directly identifies premises, equipment, personnel and GMP as assessment criteria.

— Specialised retail outlets must support their application with a premises description and drawings prepared by an authorised designer.

— Wholesale applications usually include evidence of rights to the premises, a premises description/floor plans, a use permit and an equipment list.

— Manufacturing sites should be equipped for the specific processes, dosage forms and quality control activities, and are subject to GMP assessment.

Natural or legal persons apply to HALMED for a specialised medicinal product retail outlet licence. Documents include entity registration, evidence of rights to the premises, a premises description/floor plans, the qualifications and employment contracts of the responsible person and professional personnel, and proof of payment of procedural and administrative fees. A two-person HALMED committee verifies compliance on site and/or through the procedure and draws up a record; it may request additional documents.

Wholesale applicants submit the wholesale form and information on scope, entity, personnel, premises, equipment and the quality system to HALMED, and undergo GDP verification by a pharmaceutical inspector. Manufacturing/import applicants use the HALMED “Manufacturing and Import” form, submit statutory documents, declarations and proof of fee payment, and undergo the GMP inspection and reporting procedure.

— First determine the application route and the exact activities, product categories, premises and outsourced arrangements.

— Prepare entity, personnel, premises, equipment and quality system information, together with statutory proof of payment.

— Respond to requests for additional documents or explanations of deficiencies; once the authorisation is granted, commence activities only within its approved scope.

The retail, wholesale and manufacturing regulations verified all require proof of payment of procedural and administrative fees. However, this review did not obtain a current, uniform official amount applicable to all entities and scopes, so no fee figures are provided. Applicants should confirm the applicable fees with HALMED at the time of application and according to the specific scope.

Verifiable partial deadlines include: the wholesale inspector gives an opinion within 80 days of receiving a complete application; following a manufacturing GMP inspection, the inspector prepares a report within 30 days; and HALMED enters complete notification materials from wholesale/distribution entities established in other EU Member States into the register within 90 days. Requests for corrections, on-site inspections and case complexity can affect the actual completion time.

— In the specialised retail outlet procedure, the correction period is up to 30 days; the statutory authorisation period does not run during that correction period.

— A conditional manufacturing authorisation may include a deadline for corrective action; it becomes invalid if the deficiencies are not remedied within that period.

— A GMP certificate is valid for a limited period; the Regulation states that the period of compliance is generally three years from the inspection date, but it may be shortened or extended according to risk management.

Manufacturers/importers must operate a pharmaceutical quality system, written procedures, quality control and self-inspection. HALMED normally conducts routine GMP inspections of manufacturing/import entities in Croatia every two to three years, and may also conduct special inspections in response to quality complaints, recalls, abnormalities or risk signals.

Wholesale participants must continuously maintain a GDP quality system, responsible personnel and training, suitable premises/equipment, documented procedures, self-inspection and compliant transportation. Specialised retail outlets must retain records of procurement, storage conditions, cleaning and maintenance, equipment maintenance/calibration, personnel training and consumption for at least five years.

— Pharmacy personnel must comply with professional ethics and good pharmacy practice; maintenance of pharmacists’ individual independent practice licences is separately governed by Chamber rules.

— Relevant entities must report to HALMED under the applicable regulations any matter that could lead to a suspension of supply, recall or quality risk.

— Statutory electronic reporting obligations for shortages, and for planned/ordered/supplied or dispensed quantities and inventory, apply separately under the 2025 amendments.

Holders of wholesale authorisations must notify HALMED in writing of all changes relating to the conditions, documents and information underlying the original authorisation, and attach information on the changes. If a change affects GDP, HALMED may request an opinion from a pharmaceutical inspector. Manufacturers must apply to amend their manufacturing authorisation for changes to documents or information forming the basis of that authorisation; the inspection mechanism applies if GMP is affected.

For retail authorisations, the current 2025 Medicines Act makes failure to report changes to the conditions, documents and information underlying a retail authorisation an offence. Changes to the establishment, relocation, ownership or operating form of a pharmacy must still be handled under the special law governing pharmacy services and the requirements of the competent authority for the particular case; the amendment procedure for specialised retail outlets or wholesale activities cannot be applied by analogy.

— Before relocating, renovating premises, changing outsourced warehousing, the responsible person, product categories, cold-chain capability, quality system or scope of activities, confirm in writing whether approval or an inspection is required.

— Map shareholding, change of control, mergers, asset transfers or name changes against every authorisation and the information on its applicant entity before closing.

— Retain notices, amendment applications, decisions and updated authorisations/written notifications submitted to or received from HALMED.

An entity’s business authorisation is not the same as a product authorisation permitting a medicinal product to be supplied on the Croatian market. HALMED expressly states that only medicinal products granted a marketing authorisation by HALMED or the European Commission may be supplied on the market; the HALMED database covers products authorised by HALMED and those with European Commission centralised authorisations.

Imports of finished medicines from third countries are subject to manufacturing/import authorisation, GMP, quarantine storage, quality control and batch-release requirements. Wholesale/distribution entities established in the EU are subject to a special mechanism for notifying HALMED and being entered in the register, provided they meet national requirements. The manufacture, import and wholesale of active substances are also subject to a separate HALMED registration system.

— The marketing authorisation application covers product-level information such as quality, non-clinical and clinical data, labelling/package leaflet, manufacturing authorisation, pharmacovigilance and risk management.

— The marketing authorisation applicant/holder must have a qualified pharmacovigilance contact person resident in Croatia; a HALMED-authorised holder not established in Croatia must appoint a representative established in Croatia.

— Entry/import of medicines, parallel import and cross-border movement of controlled medicines must not be assumed to be authorised solely by virtue of a general wholesale authorisation.