EMA publishes access guidance

The European Medicines Agency has released a guidance document explaining how to request access to unpublished documents held by the agency.

In the guidance made available on 24 November, the agency states the steps to follow to request a document and lists the cases that might lead to a rejection of the request. This includes protection of personal data as well as the commercial interests of the companies involved in the document requested.

According to the EMA, a request could be rejected if disclosure would undermine the protection of “the commercial interests of a natural or legal person, including intellectual property, unless there is an overriding public interest in disclosure”.