TLV logotyp

Du är här:

Pricing and reimbursement of medicines

The Swedish government subsidises medicines for various reasons, but particularly to ensure universal access to high-quality, effective treatments. Not all medicines are subsidised. One of our tasks is to assess which medicines should be subsidised and included in the pharmaceutical benefits scheme .

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 drug 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 1992:859) 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.

Publicerad 11 september 2017
Uppdaterad 12 mars 2018

Öppettider

Måndag- fredag
09:00 - 16:00.

Växel: 09:00 -16:00.
Registratur:  09:00 -15:00.

 

Kontakt

Telefon växel: 08 - 568 420 50

Fax:
08 568 420 99


E-post: registrator@tlv.se

Besöksadress
Fleminggatan 18
112 26 Stockholm


Postadress
TLV
Box 225 20
104 22 Stockholm

Fakturaadress:
TLV
FE 909
838 74 Frösön


Organisationsnummer:
202 100 - 5364

 

Följ TLV