EMA Policy 43: Revised Policy on Access to Documents

By Kristin McDougall, Work Stream Lead, Transparency & Disclosure

The European Medicines Agency (EMA) recently placed a new notification on its website revising who can request access to unpublished documents under the scope of Policy 43. EMA Policy 43 pertains to the legal right of access to documents that were sent to the EMA for now-approved medicinal products for human and veterinary use. The brief notification states:

“The Agency is no longer in a position to process access to documents requests issued from outside the EU.”

EMA cites the high volume of requests resulting in an excessive workload as the main reason for the change in who can make requests.

A 2017 annual report from the EMA showed that the majority of requestors had affiliations with the pharmaceutical industry and that the total number of requests has more than doubled in recent years. To avoid jeopardizing the EMA’s core business tasks and performance, this revised policy on access to documents means that only citizens of the European Union (EU) or persons residing in or having their registered office in an EU Member State, have the right to make requests to documents held by the EMA.

General Overview of EMA Policy 43

When a Marketing Authorization Holder (MAH) receives a notification from the EMA that a 3rd party has made a request for one of their documents, the MAH only has five days to review the document and respond with commercially confidential information (CCI) and protected personal data (PPD) proposed redactions in place. EMA performs an initial redaction of PPD, but in our experience they often miss information that should be redacted. Therefore, it’s important to perform a thorough review.

Documents can range in size, so having a vendor already in place is critical for meeting the tight deadlines. All findings for CCI and PPD must be placed in a Justification Table with a proposed rationale and provided back to the EMA within those five days. With Synchrogenix’s AI-enabled redaction process, meeting tight deadlines and ensuring personal data is protected is a guarantee.

Click here to learn more about Synchrogenix’s redaction and anonymization services or email us at contactus@synchrogenix.com.

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