Croatia Extends 5% VAT Rate to Medicines Imported Under Exceptional Authorisation

Summary 

• Croatia’s Tax Administration has confirmed that a medicine placed on the Croatian market under an exceptional import authorisation issued by HALMED may qualify for the reduced 5% VAT rate. The opinion broadens practical access to the reduced rate beyond medicines following the ordinary marketing-authorisation route. 

• The conclusion is relevant to importers, wholesalers, pharmacies and healthcare providers handling medicines sourced under exceptional procedures. Businesses should verify that the HALMED authorisation is valid, relates to the specific medicine and transaction, and is retained with customs, purchase and invoicing documentation supporting the reduced rate. 

• The opinion does not create a general reduced rate for all exceptionally imported healthcare products. Eligibility remains linked to the statutory category for medicines approved by the competent authority or included on the Croatian Health Insurance Fund list, with the exceptional HALMED authorisation serving as the relevant regulatory basis. 

Article 

The Croatian Tax Administration has clarified the VAT rate applicable to a medicine imported under an exceptional authorisation issued by the Agency for Medicinal Products and Medical Devices of Croatia, known as HALMED. Opinion No. 410-19/26-02/172, issued on 25 June 2026, concludes that the reduced 5% VAT rate may apply where a medicine is placed on the Croatian market through this exceptional regulatory route. 

Croatian VAT legislation applies the 5% reduced rate to qualifying medicines that are approved by the competent medicines authority or included on the Croatian Health Insurance Fund’s medicines list. The practical question was whether a medicine without a conventional marketing authorisation, but admitted under HALMED’s exceptional import procedure, could fall within the same reduced-rate category. 

The Tax Administration accepted that an exceptional HALMED authorisation can provide the necessary regulatory basis for applying the 5% rate. The conclusion reflects the substance of the product’s authorised medical use and market access rather than limiting the reduced rate to the standard approval route. This is commercially relevant where medicines are imported to address special patient needs, supply shortages or other circumstances in which ordinary authorisation is unavailable or impractical. 

Importers and distributors should nevertheless treat the opinion as fact-specific. The reduced rate should be supported by documentation linking the imported product to the HALMED authorisation, including the medicine’s name, form, quantity and authorised purpose. Customs declarations, supplier invoices, product records and subsequent sales invoices should use consistent product descriptions and VAT coding. 

ERP and tax determination systems may also require a controlled exception process. Defaulting all exceptionally imported products to 5% could create exposure because the opinion concerns medicines meeting the governing statutory conditions, not medical devices or other healthcare products generally. Conversely, automatically applying Croatia’s standard VAT rate may produce overcharges and downstream correction work where the exceptional authorisation supports the reduced rate. 

Businesses should therefore align regulatory, customs and indirect-tax records before importation and retain the authorisation in the audit file. Where the product, authorisation or supply chain differs materially from the facts addressed, a separate ruling or local advice may be appropriate. 

Source Links 

• Croatian Tax Administration, Opinion on VAT rate for an exceptionally imported medicine (25 June 2026) 

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