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Frequently Asked Questions – FAQs

Who is required to submit a PSUR, and who is not?

Every marketing authorisation holder must submit PSURs in regular intervals to the competent authorities. This applies to medicinal products that were authorised in a national, centralised or “mutual recognition” process.

Holders of registrations are exempted from submitted PSURs for their registered products (§63 AMG).

What deadlines must be observed when submitting a PSUR?

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

  • Every 6 month 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.

What dose the pooled PSUR-Template contain?

The digital PSUR-template of the BPI Service contains all relevant literature cases and studies, line listings, summary tabulations, and a publication list for the reporting period. It also contains text modules to allow the firm to complete the PSUR in-house.

How do different routes of application affect the pooled PSURs?

When pooled PSURs are written in the Pooling Project for one substance, different application routes are grouped into “systemic” and “topical” application routes, when it seems pharmacologically reasonable to do so. In cases where this differentiation seems plausible, two templates are generated and the firms can choose which template that wish to purchase.