Reimbursement

Reimbursement applications

We provide advisory on:

applying for official prices to be established and registration of products into reimbursement lists, including support in preparation of applications along with justifications and annexes, as well as participation in negotiations with the Negotiating Team of Economic Commission;
preparation of applications for a retrial in the event of a negative decision of enrolment of products on the reimbursement product list, as well complaints to the Regional Administrative Court;
support in pricing and reimbursement proceedings, including preparation of applications for pricing and reimbursement motions being examined once again, drawing up strategies for handling negative decisions of the Minister of Health.

Reimbursement of medicines and medical devices

The reimbursement of drugs, medical devices, and foods for special medical purposes is one of the most important issues for pharmaceutical companies and manufacturers of medical devices and special categories of foods. Effective management of this process requires not only knowledge of applicable regulations but also a strategic approach to negotiations with decision-making bodies. In a changing legal environment, the support of experts who can help navigate complex administrative and legal procedures is crucial.

Food & Pharma Legal offers comprehensive reimbursement advice, helping companies optimize their strategies and maximize their chances of obtaining a positive reimbursement decision. Due to experience and in-depth knowledge of legal regulations, the firm’s specialists can support clients at every stage of the process..

Preparation and submission of reimbursement applications

For a drug or medical device to be eligible for reimbursement, a detailed analysis of costs, clinical effectiveness, and potential benefits for patients is necessary. The key element of this process is the proper preparation of the reimbursement application, which must meet a number of formal and substantive requirements.

Food & Pharma Legal experts:

analyze regulations and guidelines regarding reimbursement,
assist in preparing the complete documentation required for submitting an application,
support communicating with public administration bodies,
develop arguments justifying the reimbursement of a drug or medical device.

Due to many years of experience working with pharmaceutical and medical companies, our law firm adapts its approach to the specifics of a given product, which translates into a greater chance of obtaining a positive reimbursement decision.

Appeal procedure in the event of a negative pricing and reimbursement decision

Not every reimbursement decision is positive. In case of a denial, it is crucial to quickly prepare a correct application for reconsideration. Food & Pharma Legal lawyers:

analyze the reasons for reimbursement denials,
develop arguments that increase the chances of a decision being changed,
support clients in contacts with decision-making bodies,
prepare the necessary documentation for the appeals procedure.

Negotiations with decision-making institutions

The reimbursement process also requires effective communication

Ministry of Health,
National Health Fund,
Agency for Health Technology Assessment and Tariff System.

The Food & Pharma Legal law firm offers support in negotiations, helping clients obtain favorable reimbursement conditions.

Benefits of working with a lawyer specializing in reimbursement of drugs and medical devices

Using specialist advice on the reimbursement of medicines and medical devices can bring many benefits:

Saving time and resources – submitting a complete and properly prepared application reduces the risk of rejection and the need to resubmit documents.
Minimizing the risk of errors – as part of our legal advice on medical devices, our law firm ensures that all required documentation complies with current regulations.
Opportunity for a better negotiation outcome – Food & Pharma Legal experts support clients in negotiations with decision-making institutions, which can significantly impact reimbursement terms.

Obtaining reimbursement for a drug or medical device is a process that requires thorough analysis, careful documentation preparation, and skillful negotiation. Collaborating with a law firm allows pharmaceutical and medical companies to effectively manage this process, increasing the chances of a successful decision and optimizing their market strategy.