BPI - Pooling Project Pharmacovigilance

General Deadlines And Reporting Period Harmonisation

The deadlines for the submission of PSURs are defined in §63b of the German Arzneimittelgesetz (AMG) as follows:

Every 6 months in the first two years following authorisation and/or marketing
Every year in the next two years
Every 3 years thereafter.

The PSUR must be received by the competent authority within 60 days after data lock.
(4. Bekanntmachung der Bundesoberbehörde vom 29. April 2005, Abs. 8.3 ).

§141 of the AMG defines certain exceptions which allow the first PSUR submitted after September 5, 2005, to be a 5-year PSUR if the marketing authorisation holder was in a 5-year PSUR cycle at that time.

Harmonisation of PSUR data lock points

The European harmonisation of PSUR-deadlines is being planned for the near future. To reduce the work load of European compentent authorities and to make the comparison of different PSURs more feasible, the Heads of Medicines Agencies (HoA) initiated a project to harmonise the birth dates and reporting periods of medicinal products with the same active ingredients.

In the beginning of 2006, the HoA began collecting suggestions for European harmonised birth dates (EU HBD) from marketing authorisation holders of original products. These EU HBD are then to be published as a reference for the European-wide harmonisation of PSURs. The first list of EU HBDs EU harmonised birth dates was published on October 3rd, 2006, though not all active substances are covered.

Based on these EU HBD, the harmonisation of data lock points will be performed within the Pooling Project Pharmacovigilance. For substances not covered by the list, the project will offer pooled PSUR-templates based on the individual data lock points of each firm until the publication of an EU HBD for the substance.

If you are interested in receiving a cost estimate for a customised or pooled PSUR for a particular active substance, please contact us to find out the next possible harmonised data lock point.

You can also download the „pooled PSUR“ form or the „customised PSUR“ form to receive this information, including a free cost estimate. Please send the complete forms to us via email: psur@bpi-service.de or via Fax: +49 (0) 30 2 79 09 – 337. We will contact you with the estimate.