Legal & Regulatory > Romania > Post Market-Approval Processes and Regulations

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. What are the pricing models, processes and principles for originator drugs?

The main enactment setting out the pricing models and approval procedures for medicines is Ministry of Health’s Order no. 368/2017 approving the Norms regarding the calculation method and the approval procedure of the maximum prices of medicinal products for human use, providing that:

• the Ministry of Health is the competent authority to approve the price of medicinal products released based on medical prescription (Rx medicines) and over-the-counter medicinal products (OTC medicines) prescribed to patients in the social health insurance system; in the case of other OTC medicines, the price can be freely determined and modified by their marketing authorization holders;
• in order to obtain the price approval, the medicine’s marketing authorization holder should submit an application dossier to the Ministry of Health, including, among other documents, a standard application form and a comparison with the maximum manufacturer price of the same product, authorized in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany;
• as a rule, the maximum manufacturer price proposed by the marketing authorization holder for the CANAMED catalogue in Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in the 12 comparison countries;
• by way of exception, the price of certain medicines (e.g., immunologic medicines and of medicines derived from blood or human plasma) should be lower than or (at most) equal to the average of the lowest 3 (three) prices of the same product in the 12 comparison countries. If the medicine has a price approved in only one of the 12 comparison countries, the price proposed for Romania should be lower than or (at most) equal to the price in the respective country. If there is no price approved in any of the 12 comparison countries, the price for Romania could be approved at the level proposed by the marketing authorization holder or its representative;
• the prices of medicinal products (including the manufacturer price, as well as the maximum wholesale and retail prices) should be approved within 90 days, and should be published by the Ministry of Health in an order approving the price catalogue.

2. What are the pricing models, processes and principles for generics and biosimilars drugs?

According to the Ministry of Health’s Order no. 368/2017 approving the Norms regarding the calculation method and the approval procedure of the maximum prices of medicinal products for human use:

• in order to obtain the price approval for generic and/or biosimilar medicines, the medicine’s marketing authorization holder should submit an application dossier to the Ministry of Health, including, among other documents, a standard application form and a comparison with the maximum manufacturer price of the same product, authorized in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany;
• the price of generic medicinal products should be lower than or (at most) equal to the generic reference price (65% of the price of the reference innovative medicinal product), while the price of biosimilars should be lower than or (at most) equal to the biosimilar reference price ( 80% of the price of the reference biological medicine);
• in case the reference innovative/biological medicine does not have an approved price, the generic/biosimilar reference price should be established by the 12-country comparison rule and the 65% / 80% referencing rule would not apply;
• the prices of medicinal products (including the manufacturer price, as well as the maximum wholesale and retail prices) should be approved within 90 days, and should be published by the Ministry of Health in an order approving the price catalogue.

3. What are the reimbursement approval processes and principles for originator drugs?

In order to determine if a medicinal product could be included in the list of the international non-proprietary names (“INN Reimbursement List”), the NAMMD performs a health technology assessment (“HTA”), by taking into account, amongst others, the cost of the therapy (including the price approved by the Ministry of Health) and the HTA reports issued by other competent authorities, such as the HTA agencies from France, Great Britain and Germany.

The HTA report should conclude if the INN meets the criteria and the score for being included unconditionally or conditionally in the INN Reimbursement List, following which NAMMD issues a decision accordingly.

The inclusion in the INN Reimbursement List is approved by the Romanian Government, after the HTA evaluation, by government decision. The medicinal products are included in the relevant sub-list (A, B, C1, C2, C3 or D) of the INN Reimbursement List depending on the level of their reimbursement set by the competent authorities (e.g., 20%, 50%, 90% or 100% of the reimbursement price).

Following the inclusion of the product’s INN in the INN Reimbursement List, NHIH and, in certain cases, NHIH jointly with the Ministry of Health performs the inclusion of the medicinal product in the Trade Names Reimbursement List(s). Such list mentions the reimbursement prices of the medicines granted in the health insurance system and in the national health programs;

Once a medicinal product is included in the Trade Names Reimbursement List, it could be acquired by the insured patients at a reduced price or free of charge, depending on the medicine’s price and the value which is reimbursed according to the applicable regulations (i.e., its reimbursement price).

4. What are the reimbursement approval processes and principles for generics and biosimilar drugs?

The reimbursement approval process for generics and biosimilars is similar to the process for innovative medicines.

Thus, in order to determine if a medicinal product could be included in the list of the international non-proprietary names (“INN Reimbursement List”), the NAMMD performs a health technology assessment (“HTA”), by taking into account, amongst others, the cost of the therapy (including the price approved by the Ministry of Health) and the HTA reports issued by other competent authorities, such as the HTA agencies from France, Great Britain and Germany.

Compared to innovative medicines, the HTA evaluation for generic/biosimilar medicinal products could be performed by NAMMD over a shorter period of time.

Following the inclusion of the product’s INN in the INN Reimbursement List based on a Government Decision, NHIH and, in certain cases, NHIH jointly with the Ministry of Health performs the inclusion of the medicinal product in the Trade Names Reimbursement List(s). The medicines included in the respective list(s) could be acquired by the insured patients from pharmacies at a reduced price or free of charge, depending on the medicine’s price and the value which is reimbursed according to the applicable regulations.

5. Are there any other special processes to be considered for certain types of drugs?

N/A