What do you have to do when you want to submit application for a generic active substance to list of medicinal products distributed at a discount?
- You have to fill out an application and send it to info [at] haigekassa.ee
- By solving the application EHIF considers the following:
- the generic medicine is at least 30% cheaper than the originator with the same active ingredient entered into the list of medicines;
- in case of a biologically similar medicine, the fact that the said medicine is at least 15% cheaper than the originator product entered into the list of medicines;
- in case of medicine with the secondary marketing authorisation, the fact that the medicine is at least 10% cheaper than the originator product entered into the list of medicines;
- after the establishment of a reference price in a group of medicines with the same active ingredient and method of administration, the fact that the price of the medicine upon solving of the first three applications is at least 10% cheaper and upon solving of the following applications, not higher than the price of the cheapest medicine entered into the list of medicines.
- Before making a decision, the health insurance fund may prepare a thorough opinion and request an opinion from the State Agency of Medicines and the committee.
- In the solving of an application, EHIF may ask additional information from the applicant.
The health insurance fund may request the opinion of the committee, if:
- solving of the application may have an excessive budget impact;
- the decision is of principle importance for the Estonian medicines policy.
In most cases the management of the health insurance fund solves the application within 90 days from submission of the application.
If you need more information about submission and processing of applications, it is described in the regulation of the Minister of Social Affairs: Procedure for drafting and amendment of a list of medicinal products of the Estonian Health Insurance Fund and the content of criteria establishing the list and evaluators of compliance with the criteria