Periodic safety update reporting

PSUSA (Periodic Safety Update Single Assessment)

Since 1 September 2014, all periodic safety update reports (PSUR) have been processed via a so-called PSUSA procedure (Periodic Safety Update Single Assessment).

The submission of periodic safety update reporting is generally carried out in accordance with the schedule described in the Guideline on good pharmacovigilance practices (GVP), Module VII – Periodic safety update report, which is applicable from 2 July 2012 and replaces Volume 9A.

Products approved as generic medicinal products [Chap 4, § 13 Swedish Medicinal Products Act (2015:315)], as homeopathic medicinal product (Chap 4, § 4 Swedish Medicinal Products Act) supported by well established medicinal use ([Chap. 2 § 3 Medicinal Products Order (2015:458)], such as traditional herbal products (Cap 4, § 5 Swedish Medicinal Products Act) do not need to submit periodic safety update reports unless it is specified as a condition for marketing authorisation or in the European Union Reference Date (EURD) list. This list is updated by EMA and is available on EMA's website.

The appointed rapporteur for the substance writes a scientific assessment report, a so-called Single Assessment Report.

Detailed provisions on the content and format of the periodic safety update reports are available in the Commission Implementing Regulation (EU) no. 520/2012.

The new format laid down in the Commission Implementing Regulation (EU) no. 520/2012, Annex II*, must be used from 10 January 2013. The new format necessitates an evaluation of both the benefits and the risks of the medicinal product.

Pursuant to Article 2(7) of Directive 2010/84/EU, the use of the PSUR repository will become mandatory 12 months after the functionalities of the repository have been established and have been announced by the European Medical Agency. On the 11 June 2015 the EMA Management Board confirms that the repository meets the pre-agreed full functional specifications as per Article 25a of Regulation (EC) No 726/2004.

The PSUR Repository will become mandatory on the 13 June 2016; from this moment on all PSUR submissions across Europe will be submitted to the EMA only via this channel. The Medical Product Agency is updating the provisions (LVFS 2012:14) accordingly.

During the switch-on phase the EMA will also manually upload all the PSURs that are received by NCAs only, during the so called "reconciliation process". This process applies to nationally authorised medicines only. The manual upload is the second pillar of the "switch-on" phase as it will allow the system to host full data sets for all procedures, thereby allowing the NCAs to fully test complete download capability. In order to support this phase of the project, and in addition gain further experience with the system, MAHs are strongly encouraged to submit all PSURs and supplementary information for nationally authorised medicines to the PSUR repository in addition to the submissions to the relevant NCAs. This will allow the EMA to rely less on the reconciliation process with the Member States, ensuring timely inclusion of PSURs in the system and better adherence to the procedural timetable; ultimately ensuring that no PSUR is left unassessed or assessed late.

Please be reminded that for centrally authorised medicines submission to the PSUR Repository is already mandatory. MAHs for nationally authorised medicines are also reminded that PSUR submissions both to the PSUR Repository and NCAs must be structured electronic submissions, i.e. eCTD or NeeS. PSURs submitted as pdf documents cannot be uploaded into the PSUR Repository, and will entail follow up with the relevant MAH.

More information is available on EMAs website:
Periodic Safety Update Reports

* Commission Implementing Regulation (EU) no. 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) no. 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council.


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