Sweden - Provisions and Guidelines

An application for authorization shall be submitted to the Medical Products Agency for each prospective study on patients or trial subjects of a chemical or biological substance with the purpose of clarifying properties as a potential medicinal product. This also applies to the testing of a medicinal product with an approved indication, dosage and route of administration in order to shed further light on its efficacy and/or safety (phase IV trial) and what are referred to as PMS studies.

No application normally need be submitted to the Medical Products Agency for trials in which a substance or medicinal product is included without the purpose being to study its properties. Approval from an ethics committee is sufficient in these cases. This may be the case for example when utilising the known properties of a substance to bring about a physiological condition with the purpose of studying this condition or when the intention is to standardize concurrent pharmacological treatment in the study of a non-pharmacological treatment.

The Medical Products Agency should be consulted in the event of doubt as to whether authorization is required for a trial.

If there is a coordinator in a multi-centre trial who does not himself take part in the practical conduct of the trial, this can be indicated in connection with the application from a centre being sent in. If it is desirable for practical reasons, any correspondence from the Medical Products Agency can be sent direct to the coordinator. Contacts between the Medical Products Agency and the responsible investigator for the centre from which the application has been sent in then take place in the same way as with the responsible investigator at the other centres.

Less detailed information may be sufficient in applications for authorization for a trial on patients which only relates to the usability of a pack or the testing of a flavouring additive. No application for authorization is required for testing an approved flavouring additive on healthy trial subjects.

If a medicinal product and a medical device are intended to be evaluated in the same clinical trial, an application for clinical medicinal product testing shall be submitted to the Medical Products Agency and notification of clinical testing of the medical device to the National Board of Health and Welfare. The examination of the two trials can be coordinated if the two authorities receive the necessary information for this to be done.