Comments on the List of Substitutable Medicinal Products

What products are on the list?

The list includes product groups where the MPA has made a decision regarding substitution, plus parallel distributed products.

How has the list been drawn up?

The Swedish Medical Products Agency approves all medicinal products, including generics and parallel imported products, with regard to their quality, safety and efficacy. The basic principles for substitution are that the products have the same active substance in the same amount and are otherwise medically equivalent.

The Summaries of Product Characteristics (SPCs) and Product Information Leaflets (PILs) can differ between the original and generic products. This is because medicinal products are approved across the EU, and within the EU there are different opinions as to the form of this information. A generic product often has more limited indications (the lowest common denominator) and more contraindications and warnings (the sum of all such indications and warnings from all EU member states) than the original product. This is not a medical problem. The products contain the same active substance in the same amount and are medically equivalent and when drawing up the list, these differences in information have not been considered except in special circumstances. Informational differences that can prevent substitution can occur only when differences in indications cause significant differences in the precautions text. Naturally, good communication between the doctor and patient regarding substitution is important.

 
 

Related information

The list of substitutable medicinal products is available in Swedish. Follow the link below and see "Gällande lista" in the right margin.

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information