What we do

Every year we handle an enormous number of commissions and propositions from industry, branch organisations, departments and authorities, the government and parliament, prescribers of medicines, health and medical care professionals, patients and patient interest groups.

This work results in a number of products, such as, recommendations, reports, approvals, laboratory analysis results and compilations of adverse drug reactions.

Approval of medicines

A major part of the Swedish Medical Products Agency’s work is devoted to the approval of medicines. Results are presented as assessment reports that are reviewed in several stages before receiving their final form. These preliminary reports are initially reviewed by groups comprising staff with special competence within drug quality, safety and efficacy. Following this, a project team presents an overall assessment and makes a draft recommendation that is passed on to the Medical Products Agency’s scientific quality assurance group. The issues surrounding an approval request are often complex and difficult to judge.

Systematic work

Behind all our processes lies an extensive working effort carried out in a systematic manner with the help of routines developed in agreement with international ISO standards. Our operations are continuously revised and improved to take into account new insights and changes in the world around us.

Expert consultation

To further ensure the quality of the agency’s recommendations, we consult an external expert body – the Board of Drugs – when necessary. This body is made up of leading scientists who represent different medical specialities and who have a profound knowledge of drug treatment.

Ambition and quality 

Our way of working is characterised by a high level of ambition plus very high quality demands. Skills development is an important part of our operations. All our staff are thus offered continuous training that is adapted to both current and coming needs.

 
 
 
 

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