In both countries the obligation to pay the fee arises upon the submission of the application. The main difference between the countries is that in Croatia the payment is before the submission and via application Web ponude in Slovenia, Jazmp issues the invoice after the submission of the application.
SLOVENIA
The obligation to pay the fee arises upon the submission of the application or upon the receipt of the Jazmp’s request for payment or its notification of the method of payment of the fee.
The Jazmp sends the notification of the method of payment of the fee by e-mail to the applicant at the e-mail address provided by the applicant at the time of submission of the application. The notification of the method of payment of the fee contains at least the details of the applicant, the application received, the subject matter of the fee charged (products), the amount of the fee, the reference number and other information necessary for payment. The notification of the method of payment of the fee makes the procedure manager from the information system designed for the management and recording of procedures. The applicant pays the procedure fee within 15 days after the receipt of the notification of the method of payment of the fee on the sub-account of the Jazmp.
The applicant will pay the fee to the JAZMP sub-account No: 01100-6000020296 and when paying the fee, shall refer to the reference number indicated on the invitation or notice on the method of payment of the fee.
The annual fee should be paid within 15 days after the receipt of the invitation for payment of the annual fees. The Jazmp send invitations for payment of the annual fees to the MAHs no later than 31 March of the current calendar year for all authorisations in force on 1 January of the current calendar year.
The tariff is set in points. The amount to be paid is the product of the value of the point and the number of points.
The value of one point is 5,50 euros (VAT not included).
Example:
- for the notification of the variation type IA at:
– National procedure: 50 points,
The fee in this case will be: 50 points x 5,5 euros (value of one point) = 275 euros
In the event of non-payment of the fee, the JAZMP may charge to the applicant statutory default interest.
CROATIA
Halmed informed the public about the dual pricing, in euros and kuna (VAT not included), on 6.9.2022. For the conversion of kuna into euros, it uses the fixed exchange rate of HRK 7.53450 to 1 euro, set by the Council of the European Union on 12 July 2022. From the 1st of January 2023 Croatia adopted the euro so that the euro is now the only currency of payment.
For the purpose of payment for the services under 1. Marketing a medicinal product, 2. Renewal of the marketing authorization for a medicinal product, 3. Variations to a marketing authorization for a medicinal product, withdrawal, revocation of an authorization and issuing reports on the medicinal product dossier, 4. Manufacturing and inspection, 5. Medicinal product marketing, 8. Medical devices, 10. Clinical trials and certain services under 11. Pharmacovigilance, the applicants are required to use the software application Web ponude. The software application allows the applicants to create proforma invoices for the procedures they want to initiate, pursuant to which the payments are carried out.
The Proforma Invoice that is created in software application Web ponude is not binding. In case of mistakes it is not possible to change data entry, it is necessary to create new Proforma Invoice.
The Proforma Invoice is valid until the price list of the Agency for Medicinal products and Medical Devices is changed.
All bank charges are to be borne by the debtor. On the payment always quote the Reference number otherwise the payment will not be recognized. The final Invoice will follow after the service will be done.
Source: Jazmp website, TARIFF of the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (Off. Gazette of RS, No. 209/21 and 165/22), Halmed website and application Web ponude
