Post Authorisation Safety Studies (PASS)

A post-authorisation safety study (PASS) is defined in Article 1(15) of Directive 2001/83/EC as any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.

PASS may be interventional or non-interventional studies.

Interventional PASS are clinical trials and are subject to the requirements of Directive 2001/20/EC. Further information on national requirements for clinical trials and contact details for queries in relation to clinical trials can be found on the clinical trials section of the HPRA website.

The guideline on good pharmacovigilance practices (GVP) module VIII provides comprehensive guidance on non-interventional PASS conducted by a Marketing Authorisation Holder (MAH) either voluntarily or pursuant to an obligation imposed by a competent authority (see link under ‘further information’ below). 

National requirements for submission of non-interventional PASS protocols and reports to the HPRA

In accordance with legislative requirements and  GVP- Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 2), non-interventional PASS protocols, updated study protocols following substantial amendments, progress reports and final study reports should be submitted directly to the HPRA for non-interventional PASS imposed as an obligation by a competent authority where the study is being conducted on a site or sites within Ireland. In this case the final agreed study protocol and updated study protocols following substantial amendments (following PRAC endorsement), progress reports and final study reports may be submitted directly to the HPRA to the Vigilance Assessment Section of the Human Products Monitoring Department of the HPRA at medvigilance@hpra.ie with an explanatory cover letter confirming the following details:

  • The name of the marketing authorisation holder
  • The brand name(s), marketing authorisation number(s) of the products and the substance (i.e. INN) addressed by the PASS
  • That the study is a non-interventional PASS imposed as a condition in a marketing authorisation
  • That the study is to be conducted or is being conducted in Ireland
  • That the submission concerns either an endorsed study protocol or substantial amendment, a progress report or a final study report
  • That the study has been registered in the EU PAS Register, the date of registration and the registration number (include link to study details on EU PAS register wherever possible)

 

For studies initiated, managed or financed voluntarily by MAHs (i.e. not imposed as a condition of their marketing authorisation), study protocols, updated study protocols following substantial amendments and study reports do not require direct submission to the HPRA and  will  be notified to the HPRA via the EU PAS register.

Further information

For detailed guidance on PASS structures and process and the operation of the EU network, please refer to GVP- Module VIII – Post-authorisation safety studies (Rev. 2) on the EMA website.

For requirements on the format and content of protocols, abstracts and final study reports for PASS please refer to Commission Implementing Regulation (EU) No 520/2012.

For further information on Member States’ requirements for submission of information on non-interventional PASS, please refer to (Rev. 2) on the EMA website.

For further information on non-interventional PASS please see post-authorisation safety studies: questions and answers  on the EMA website.

For further information on reporting of pharmacovigilance data relating to non-interventional PASS to the HPRA please refer to GVP- Module VIII – Post-authorisation safety studies ,  Module VI – Management and reporting of adverse reactions to medicinal products on the EMA website and the National Reporting of Adverse Drug Reactions section of the HPRA website.