Periodic safety update reports (PSURs)

Marketing authorisation holders (MAHs) shall submit regularly to EMA and national authorities periodic safety update reports (PSURs) containing:

(a) summaries of data relevant to the benefits and risks of the medicinal product, including results of all studies with a consideration of their potential impact on the marketing authorisation;

(b) a scientific evaluation of the risk-benefit balance of the medicinal product; the evaluation shall be based on all available data, including data from clinical trials in unauth orised indications and populations;

(c) all data relating to the volume of sales of the medicinal product and any data in possession of the marketing authorisation holder relating to the volume of prescriptions, including an estimate of the population exposed to the medicinal product.

Submission of PSURs in PSUR Repository

As of 13 June 2016, MAHs with PSUR submission responsibilities in EU are required to submit all PSURs to the central PSUR repository using the eSubmission Gateway/ Web Client.

Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure.

For more information on how to use the PSUR repository, see Periodic Safety Update Report (PSUR) repository mandatory use: questions and answers on EMA website.

Additionaly, information on preparation of PSURs by the MAHs and submission to the Authorities are available on EMA website here.

EURD List

MAHs for active substances and combinations of active substances that are subject to assessment at EU level must submit the relevant PSURs according to the requirements set up in the list of EU reference dates (EURD) list.

The purpose of the EURD list is to facilitate the harmonisation of data lock points and the frequency of submission of PSURs for medicines containing the same active substances or combinations of active substances. This optimises the management and also the assessment of PSURs within the EU, allowing a single assessment of the risk-benefit balance for an active substance, based on all available safety data.

The EURD list is available on the EMA website and can be accessed here.

EMA updates the EURD list every month. The list does not include substances assessed at national level, although their PSURs must nonetheless be submitted via the PSUR repository. For these active substances, the frequency of submission is established at national level.

For more information, see: CMDh best practice guide

Assessment of PSURs

EU PSUR single assessment (PSUSA) procedure.

The aim of the PSUSA procedure is to carry out a single European assessment of the PSURs for medicinal products containing the same active substance (or combination of active substances), thus ensuring a harmonised position at the European Union level.

This single assessment of the PSURs is carried out by the Pharmacovigilance Risk Assessment Committee (PRAC). Following the assessment, the PRAC issues recommendations to the CHMP/CMDh.

The PSUSA procedure applies to medicinal products authorised in more than one EU Member State, containing an active substance (or combination of active substances) that is included in the EURD list and for which there are legal responsibilities for PSUR submission.

For more information on PSUSA procedure is available on EMA website here.

Publication of conclusions of PSUR assessments carried out within the PSUSA

Products reviewed within PSUSA	Only CAP	mixed CAP/NAP	NAP*
PSUSA – publication of conclusions of PSUR assessments	EMA website (EPAR of the product) Community register	Community register	section Periodic safety update report single assessments (PSUSAs) on EMA website

*for PSUSA conclusion for a specific active substance, filter data on the column Active substances in scope of procedure in the excel table Download periodic safety update report single assessments data table and then click on the link displayed in the column PSUSA URL

The Regulatory outcome column from the excel table named Download periodic safety update report single assessments data table indicates whether or not the PSUSA procedure was concluded with recommendations for product information update. If it is the case, the updates are available in all official EU languages, including Romanian language. Marketing authorization holders from Romania can use the available translations to update the information on medicinal products authorized in Romania.

The changes to the product information recommended within PSUSA are also applicable to medicinal products for which the submission of routine PSURs is not required (e.g. generic, well-established use, homeopathic or herbal medicinal products with well-established use).

In accordance with Art. 736, paragraph (3) of Law no. 95/2006 on healthcare reform, as republished, the MAH must update the product information whenever necessary:

”The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge, including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.”

National non-PSUSA procedure

The national non-PSUSA procedure applies to medicinal products authorised in Romania through a national procedure, that contain active substances or combinations of active substances for which the active substance/combination of active substances is not available in the EURD list (does not fall under the PSUSA procedure) and for which there are legal responsibilities for PSUR submission.

Informal PSUR Worksharing

This type of procedure applies to medicinal products authorised in Romania through a MRP/DCP procedure, that contain active substance or combination of active substance for which an European reference date and a common PSUR submission frequency have not been established (the active substance is not available in the EURD list).

More information on this type of procedure, as well as outcome of informal PSUR worksharing procedures, are available on the CMDh website.

Reference legislation (available on NAMMDR website):

Law no. 95/2006 on healthcare reform, as republished, TITLE XVIII- The Medicinal Product;

GVP Module VII – Periodic safety update report;

DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use;

DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

DIRECTIVE 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance;

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;

REGULATION (EU) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

REGULATION (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.