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Specific rules for medicinal products

Applying for authorisation for clinical trials on medicinal products

Clinical trials where medicinal products are studied can be covered by the definition of clinical trials, and special permission is required. This can apply to both studies that are performed on new medicinal products under development, but also studies on medicinal products that are already approved for sale. The purpose can be both commercial and academic.

For guidance on whether your planned clinical trial is subject to authorisation, a guide has been published on the Swedish Medical Products Agency's website.

Find out whether your clinical trial is subject to authorisation, the Swedish Medical Products Agency External link.

Apply according to old or new regulations

On 31 January 2022, a new EU regulation on clinical trials on medicinal products apply. During a transitional period, it will be possible to apply for and carry out studies both in accordance with the old EU Directive 2001/20 / EC with associated national legislation and in accordance with the new EU Regulation EU 536/2014 (also called Clinical Trials Regulation, CTR).

More information about transitional rules, the Swedish Medical Products Agency External link.

For clinical trials on medicinal products conducted in accordance with national legislation and EU Directive 2001/20 / EC

It will be possible to apply according to the old regulations until 31 January 2023. In that case, an application must be sent to the Swedish Ethics Review Authority via their own system Ethix and a separate application must be sent to the Swedish Medical Products Agency. You'll get two separate decisions from these two authorities.

For details on the application for authorisation for clinical trials on medicinal products in accordance with the old regulations, the Swedish Medical Products Agency External link.

For details on the application for authorisation for clinical trials on medicinal products in accordance with the old regulations, the Swedish Ethics Review Authority (in Swedish) External link.

For clinical trials on medicinal products conducted in accordance with EU Regulation EU 536/2014

If an application is to be made in accordance with the new regulations, the application must be submitted via the EU portal CTIS (Clinical Trials Information System). Both the Swedish Medical Products Agency and the Swedish Ethical Review Authority will then have access to this application. Coordination takes place and the applicant will only receive one decision that applies to both authorities.

For details on the application for a permit for clinical trials on medicinal products according to the new EU regulation, the Swedish Medical Products Agency External link.

Includes your clinical trial on medicinal products biobank samples

If your clinical trial on medicinal products includes biobank samples, an approved biobank application is required. According to the new application routine, the biobank application must be sent to kliniskaprovningar@biobanksverige.se in parallel with the application being sent to CTIS.

Biobank application according to the new EU regulation, Biobank Sweden (in Swedish) External link.

If you during the transition period, 31 January 2022 - 31 January 2023, choose to apply according to the old EU directive, another routine applies.

Application routine during the transition period according to the old EU directive, Biobank Sweden (in Swedish) External link.