Important Dates

If the notification is flawless and all comments have been addressed, the medical device is included in the Device List on the 4th month after the notification (by the end of the month).

Example:

Note: If the release of the ZP List falls on a weekend or holiday, the ZP List is released on the previous business day.

If your ZP is not on the draft ZP List (the “ZP Checklist”) or the requested change has not been incorporated into the new draft ZP List, you have until the twenty-second day of the calendar month (in which the draft ZP List was issued) to comment on the draft ZP List. The Institute will evaluate the comments and make corrections.

When can I make a year-over-year increase in the originator’s price, decrease in price, change in supplement, etc.?

By the end of the month prior to the issuance of the checklist. For example, you report a year-to-year increase in the price of an originator by the end of July 2024, it will appear on the Checklist on August 15, 2024, i.e., the Checklist issued on August 24, 2024, which is effective September 1, 2024.

Where can I find the Change Request Template in excel?

All requests can only be submitted through the ISZP. The submission of change requests using the excel template has been discontinued as of 18 February 2024.

What VAT should I choose for my medical device? The Medical Devices Reimbursement Unit follows the reported VAT rate collected by the reporter when submitting their reports to the State Institute for Drug Control (the “Institute”) to the Categorization and Reimbursement Regulation System. The notifiers are governed by the tariff code. The Institute is not the competent authority to determine and control the amount of VAT. If you are unclear about the classification of your funds, please contact the General Directorate of Customs.