Guidance on the Preparation of PSURs

A PSUR should include the following:
1. Details of the MA holder and product (to include names and MA number), and the period covered by the PSUR.
2. An update on any regulatory or MA holder actions taken for safety reasons, if applicable, since the last PSUR.
3. The latest version of the Summary of Product Characteristics (SPC) for the MA concerned.
4. The number of doses or the amount of the product sold in the UK within the period of the report. The sales volume should be expressed per presentation in an appropriate form, e.g. liquid in litres, powder in kilograms, etc. (see Volume 9 guideline above). For PSURs covering more than one year, sales volume should be broken down by calendar year or part year.
5. An estimation of the number of animals treated in the UK within the period of the report. It should be explained how the number of animals treated is derived from the volume sold. For products authorised for use in more than one species, the approximate percentage use per species should be included.
6. The incidence of suspected adverse reactions (SAR) during the period of the PSUR expressed as a percentage. The incidence (%) of adverse reactions (reports assigned a causality of A, B, O or O1) should be calculated by dividing the total number of animals reacting during the period by an estimate of the number of animals treated during the period of the report and multiplying by 100. Adverse reactions (A, B, O and O1) that occur after recommended and off-label use in the
target species should be included in the calculation.
7. For products authorised for use in more than one species, if more than 50% of the adverse reactions are reported in one of the target species, a separate incidence for that species.
8. The incidence of suspected lack of expected efficacy (SLEE) for the period of the PSUR (see 6 above), if there have been any such reports.
9. Individual case histories should be presented as line listings in an appendix to the PSUR,.
For PSURs submitted electronically, the line listings should be provided separately in a format suitable for sorting and analysis, e.g. Excel, to assist assessment of the PSUR.
For PSURs submitted as paper copies, it is helpful if the line listings are first sorted by country.
In addition, adverse reactions considered to have involved the off-label use of a product should be clearly indicated in the column headed ‘Was product used as recommended?’ An explanation as to why the use was off-label should be provided, either in the same column or in the column for the MA holder’s conclusions .
Competent Authority (CA) reference numbers, where they are known by the company. This includes CA references that were sent with acknowledgements of company reports, as well as where the original reports
were received by the CA and copied to the company.
10. A narrative review of individual or group case histories in the overall summary, if more information or explanation is appropriate. For example, discussion of a lack of expected efficacy problem.
11. Reports from other sources, if appropriate. For example, post-authorisation studies or published adverse reaction reports.
12.A literature review for the period covered by the PSUR based on the product.
13. An overall analysis of the data and a critical evaluation of the benefit-risk balance of the product, written by the Qualified Person for Pharmacovigilance (QPPV). This section should include the following:
i. Evidence of previously unidentified toxicity.
ii. Increased frequency of known toxicity or expected undesirable effects,e.g. incidence greater than 1 in 10,000 animals treated.
iii. Drug interactions.
iv. Adverse reactions associated with off-label use including overdose.
v. Urgent safety issues that occurred during the period.
13.Any important information received after the data lock point, e.g. a serious adverse reaction which could have an impact on the overall safety evaluation.