Outcomes of imposed non-interventional post-authorisation safety studies

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The European Medicines Agency (EMA) publishes the outcomes of final study results of imposed non-interventional post-authorisation safety studies (PASS) for medicines authorised in the European Union (EU).

The rules on submitting results for imposed non-interventional PASS fall under Art 107q of Directive 2001/83/EC.

A PASS is a study carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures. A PASS is non-interventional if:

  • the medicine is prescribed in the usual way in accordance with the terms of the marketing authorisation;
  • deciding how to treat the patient is based on current practice and not a trial protocol;
  • the prescription of the medicine is separate from the decision to include the patient in the study;
  • patients do not undergo additional diagnostic or monitoring procedures;
  • data analysis uses epidemiological methods.

An EU competent authority may impose a non-interventional PASS, either as a condition of marketing authorisation (category 1) or as a specific obligation in a conditional marketing authorisation or a marketing authorisation under exceptional circumstances (category 2). For more information, see GVP Module VIII - PASSs.

EMA’s scientific committees (PRAC and CHMP) and the CMDh carry out the assessment of PASS study protocols and final study results. For more information, see PASS: questions and answers.

The outcomes of imposed non-interventional PASS final study results assessments for active substances found only in centrally authorised medicines are published as part of each medicine's European public assessment report (EPAR). 

The outcome for nationally authorised medicinal products included in 'mixed' procedures where centrally authorised products were also involved can be found on the Community register maintained by the European Commission.

Protocols and abstracts of results of imposed non-interventional PASS are publicly available in the EU PAS Register on the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) website.

Outcomes for active substances contained in nationally authorised products

The table below lists the outcomes of imposed non-interventional PASS final study results for active substances contained in nationally authorised medicines, by alphabetical order.

When the assessment of PASS final study results for a nationally authorised product leads to a variation of marketing authorisations, marketing authorisation holders for products containing the active substance concerned by the PASS final report should submit a variation to align their marketing authorisation with the adopted outcome.

Marketing authorisation holders for products containing the same active substance but not concerned by the PASS final report should consider whether the proposed changes to product information apply to their products.

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Document(s) Language Publication date
Poly (o-2-hydroxyethyl) starch: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0009 (English only) 2017-10-30
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 BG = bălgarski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 ES = español 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 CS = čeština 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 DA = dansk 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 DE = Deutsch 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 ET = eesti keel 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 EL = elliniká 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 EN = English 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 FR = français 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 IT = italiano 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 LV = latviešu valoda 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 LT = lietuvių kalba 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 HU = magyar 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 MT = Malti 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 NL = Nederlands 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 PL = polski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 PT = português 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 RO = română 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 SK = slovenčina 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 SL = slovenščina 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 FI = suomi 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 SV = svenska 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 HR = Hrvatski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 IS = Islenska 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 NO = Norsk 2017-02-23
Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0003 (English only) 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 BG = bălgarski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 ES = español 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 CS = čeština 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 DA = dansk 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 DE = Deutsch 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 ET = eesti keel 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 EL = elliniká 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 EN = English 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 FR = français 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 IT = italiano 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 LV = latviešu valoda 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 LT = lietuvių kalba 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 HU = magyar 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 MT = Malti 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 NL = Nederlands 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 PL = polski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 PT = português 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 RO = română 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 SK = slovenčina 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 SL = slovenščina 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 FI = suomi 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 SV = svenska 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 HR = Hrvatski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 IS = Islenska 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable-EMEA/H/N/PSR/J/0005 NO = Norsk 2017-02-23
Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0005 (English only) 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 BG = bălgarski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 ES = español 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 CS = čeština 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 DA = dansk 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 DE = Deutsch 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 ET = eesti keel 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 EL = elliniká 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 EN = English 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 FR = français 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 IT = italiano 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 LV = latviešu valoda 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 LT = lietuvių kalba 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 HU = magyar 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 PL = polski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 RO = română 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 SK = slovenčina 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 SL = slovenščina 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 FI = suomi 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 SV = svenska 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 HR = Hrvatski 2017-02-23
Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 IS = Islenska 2017-02-23
Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0006 (English only) 2017-02-23
Cyproterone/ethinylestradiol: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003/0005/0006 (English only) 2017-02-23
Trimetazidine: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 (English only) 2016-10-04
Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/0001 (English only) 2016-10-04
Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (English only) 2016-10-04