Before we can make a decision about each case, certain requirements must be fulfilled.
First, the pharmaceutical company must submit an application for pricing and reimbursement. Then, we determine whether the medicine should be eligible for reimbursement status and included in the pharmaceutical benefits scheme.
It is our board of experts, the Pharmaceutical Benefits Board, that makes the final reimbursement decision.
The company applying for reimbursement is responsible for demonstrating that the medicinal product meets applicable legal requirements.
Sometimes a medicine stops being reimbursed. This happens when the medicine has been deregistered, the pharmaceutical company has asked to leave the benefits or that the reimbursement status has been reviewed by TLV.
Towards a more predictable praxis
Each decision we make further interprets the legislation and regulations we are subject to and establishes an even more predictable praxis. You can find more information on this topic in our Annual Report.
Legislation and regulations on the sale of medicinal products
As a general rule, a medicinal product must be approved by the Swedish Medical Products Agency or the European Commission in order to be sold in Sweden.
The Medicinal Products Act (SFS 2015:315) describes the basic provisions governing control and oversight of medicinal products in Sweden. Special regulations and requirements also apply within the EU with respect to which medicinal products may be sold on the European market.