Outcomes of imposed non-interventional post-authorisation safety studies
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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Hydroxyethyl starch : List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0031 (PDF/251.1 KB)
First published: 24/06/2022
EMA/605749/2022 -
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Hydroxyethyl starch : CMDh Scientific conclusions and Conditions for lifting the suspension of the marketing authorisations - EMEA/H/N/PSR/J/0031 (PDF/247.79 KB)
First published: 24/06/2022 -
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Hydroxyethyl starch : CMDh Divergent position - EMEA/H/N/PSR/J/0031 (PDF/62.69 KB)
First published: 24/06/2022 -
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Hydroxyethyl starch : PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0031 (PDF/412.3 KB)
Adopted
First published: 24/06/2022
EMA/596511/2022 -
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Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (PDF/120.29 KB)
First published: 18/01/2021
EMA/33992/2021 -
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Teicoplanin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0025 (PDF/190.6 KB)
First published: 18/01/2021 -
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Thiocolcicoside: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0023 (PDF/313.6 KB)
First published: 28/04/2020
EMA/230507/2020 -
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Thiocolcicoside: CMDh Scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0023 (PDF/90.27 KB)
First published: 28/04/2020 -
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Domperidone: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0015 (PDF/289.49 KB)
First published: 20/03/2019
EMA/185142/2019 -
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Domperidone: CMDh Scientific conclusions and grounds for variation, conditions and timetable for the implementation - EMEA/H/N/PSR/J/0015 (PDF/35.04 KB)
First published: 20/03/2019 -
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Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016 (PDF/91.83 KB)
First published: 12/12/2018
EMA/854912/2018 -
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Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016 (PDF/131.88 KB)
First published: 12/12/2018 -
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Numeta: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0017 (PDF/69.04 KB)
First published: 10/12/2018
EMA/850681/2018 -
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Numeta: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0017 (PDF/37.52 KB)
First published: 10/12/2018 -
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Thiocolchicoside: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0008 (PDF/787.76 KB)
First published: 10/04/2018
Last updated: 26/06/2018
EMA/224020/2018 -
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Thiocolchicoside: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/J/0008 (PDF/35.35 KB)
First published: 10/04/2018
Last updated: 26/06/2018 -
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Poly (o-2-hydroxyethyl) starch: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0009 (PDF/148.61 KB)
First published: 30/10/2017
Last updated: 30/10/2017
EMA/723696/2017 -
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Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 (PDF/20.53 KB)
First published: 23/02/2017
Last updated: 23/02/2017
EMA/68246/2017 -
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Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0003 (PDF/129.78 KB)
First published: 23/02/2017
Last updated: 23/02/2017
EMA/101714/2017 -
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Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0005 (PDF/26.44 KB)
First published: 23/02/2017
Last updated: 23/02/2017 -
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Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0005 (PDF/129.08 KB)
First published: 23/02/2017
Last updated: 23/02/2017
EMA/101726/2017 -
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Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 (PDF/25.74 KB)
First published: 23/02/2017
Last updated: 23/02/2017 -
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Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0006 (PDF/156.64 KB)
First published: 23/02/2017
Last updated: 23/02/2017
EMA/101741/2017 -
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Cyproterone/ethinylestradiol: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003; EMEA/H/N/PSR/J/0005; EMEA/H/N/PSR/J/0006 (PDF/123.83 KB)
First published: 23/02/2017
Last updated: 23/02/2017
EMA/68246/2017 -
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Trimetazidine: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 (PDF/1.26 MB)
First published: 04/10/2016
Last updated: 04/10/2016
EMA/283107/2016 -
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Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/0001 (PDF/238.84 KB)
First published: 04/10/2016
Last updated: 04/10/2016
EMA/283098/2016 -
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Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (PDF/749.78 KB)
First published: 04/10/2016
Last updated: 04/10/2016
EMA/637689/2016