Annual report on deferrals

The European Medicines Agency grants deferrals for some medicines. These allow an applicant to delay development of the medicine in children until there is, for instance, enough information to demonstrate its effectiveness and safety in adults.

For information on how to apply for a paediatric investigation plan (PIP) deferral, see PIPs: questions and answers.

Annual reports

Marketing-authorisation holders that have received a deferral on a PIP are obliged to submit annual reports to the Agency. These reports should provide an update on progress with paediatric studies in accordance with the decision of the Agency agreeing the PIP and granting a deferral.

New medicines

If an agreed PIP for a new medicine contains a deferral, the applicant needs to send the first annual report to the Agency in the month before the first anniversary of the date of marketing authorisation.

There is no need to submit annual reports before the marketing authorisation is granted.

Medicines already authorised

For medicines that are already authorised:

• if the PIP decision is agreed less than six months before the anniversary date of the first marketing authorisation granted in the European Economic Area, the marketing-authorisation holder should send the annual report in the month before the next anniversary of the date of the marketing authorisation;
• if the anniversary date occurs more than six months after the date of the PIP decision, the report should be sent in the month before the anniversary date.

Use the date of the decision on the initially agreed PIP to calculate the due date of the first annual report. Do not use the date of any subsequent modifications of the agreed PIP.

Subsequent reports

Subsequent annual reports need to be submitted every year, within the sixty days preceding the anniversary of the marketing-authorisation date.

Do not submit outside this sixty-day window, as this may lead to the report being identified as "not submitted within the specified timeline" in the annual report to the European Commission.

This should continue until the final opinion on the compliance with the agreed PIP is adopted.

Submitting annual reports

Submit annual reports electronically using the Annual report on deferral granted in the paediatric investigation plan - (PED6) certified. (right-click on the template link and save the document in your local drive)

Marketing-authorisation holders should submit a separate report for each agreed PIP, even if more than one PIP covers the same medicine.

Submit the compiled PDF via the Syncplicity Web Client. Please follow the User guide to XML delivery file creation for paediatric submissions and use the six-digit number of the PIP procedure. Do not send annual reports to personal e-mail addresses at the Agency and please note that submissions by CD/DVD cannot be processed.