Product sample

An application for a Marketing Authorisation in Sweden should be accompanied by a sample of the finished product (one package per medicinal product/‌pharmaceutical form/‌type of packaging).

The sample should be presented as the product in its intended package, but does not need to have the final labelling. Any co‍-‍packed component, as for example a measuring device, should also be provided.

Samples of the active substance shall be replaced by placebo:

• If the active substance is classified as a controlled substance (according to The Medical Products Agency’s regulation LVFS 2011:10). Such drug samples with active substance are not accepted by the Swedish Medical Products Agency. If such a drug sample is submitted, it will be destroyed, and the Swedish Medical Products Agency will await receipt of a placebo sample before the assessment can proceed.
• If the active substance is cytostatic or otherwise particularly toxic.

Placebo samples instead of drug containing samples may be submitted in other cases as well. If justified, an empty sample of the package can be sufficient, for example if the filled package is very large.

The sample should be accompanied by the form “Product sample”. The form contains information on where to send the sample and which information regarding the sample that should be provided.

Please ensure that the samples are well packed and labeled appropriately.

The sender is responsible for customs and shipping costs. The Swedish Medical Products Agency should be stated as the recipient and not as the importer of the product samples.

The package must be sent with a service bringing the package directly to the address of the Swedish Medical Products Agency and not a service bringing the package to a pick‍-‍up location. The Swedish Medical Products Agency does not collect product samples that have been sent to a pick‍-‍up location. Label the package as “Product Samples”.

Please note that refrigerated transport is not required for product samples. The purpose of the sample is not to perform any laboratory analyses or to evaluate the labelling but rather to facilitate the assessment of the container/closure system, for example its fitness for use.

All questions concerning product samples should be sent via RIC: RIC@lakemedelsverket.se.