The national list of substitutable medicinal products

Which products are on the list?

The Swedish Medical Products Agency approves all medicinal products, including generics and parallel imported products, with regard to their quality, safety and efficacy. Only authorized medicinal products are considered for the list. Please note that no pre-authorization assessment of generic substitutability will be made.

How often is the list revised?

The list is normally revised eight times a year. The dates and deadlines for the different stages of the revision process are published in Swedish on the website of the Swedish Medical Products Agency:

How has the list been drawn up?

The basic principles for generic substitution are that the products contain the same active substance in the same amount, have the same pharmaceutical form and that they are bioequivalent or otherwise medically equivalent. If necessary, sub-groups (denoted A, B etcetera) are formed. Products in the same (sub-)group are considered substitutable. Generic substitution between different (sub-)groups is not allowed.