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data analysis uses epidemiological methods 1ДЄn EU competent authority may impose a non-interventional PASS, either as a condition of marketing authorisation (category 1) at the moment of granting the marketing authorisation or in the post-authorisation phase, or as a specific obligation in a conditional marketing authorisation or a marketing authorisation under exceptional circumstances (category 2).

patients do not undergo additional diagnostic or monitoring procedures.

the prescription of the medicine is clearly separated from the decision to include the patient in the study.

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deciding how to treat the patient is based on current practice and not a trial protocol.

the medicine is prescribed in the usual way in accordance with the terms of the marketing authorisation.

Guideline on good pharmacovigilance practices: Module VIII вЂ“ Post-authorisation safety studiesДЄ post-authorisation safety study (PASS) is defined in Article 1(15) of Directive 2001/83/EC as вЂњ 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 measuresвЂќ.

The Agency recommends that companies submit protocols and study reports in the same manner for voluntary PASSs, although this is not mandatory.ДЇurther guidance on PASSs is available in:

Timetable: Post-authorisation safety study (PASS) protocols and final results.

The timetable for the submission and assessment of imposed non-interventional PASS protocols is available below: MAHs have to follow the guidance since January 2013.ДЇor clinical trials, MAHs should follow the instructions in volume 10 of the rules governing medicinal products in the European Union (EU). The guidance is based on Commission Implementing Regulation No 520/2012 of 19 June 2012.

Template PRAC assessment report of an non-interventional imposed PASS final study report.

Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies.PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template.

Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies.Submitting a post-authorisation applicationДЇor imposed PASSs, the PRAC assesses the study protocol and the outcomes of these studies as given in the final study report.Д®MA has published guidance on the format and content of study protocols and final study reports for non-interventional studies, together with the PRAC assessment report templates.Post-authorisation efficacy studies (PAES).Outcomes of imposed non-interventional PASS.

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Direct healthcare professional communications.Changing the labelling and package leaflet (Article 61(3) notifications).Changing the (invented) name of a medicinal product.