efavirenz
As the list published 4 Feb 2026 has it, binding since 22 Apr 2026. Each entry binds six months after its own publication date (Article 107c(7) of Directive 2001/83/EC).
What the list says
- EU reference date
- 28 May 1999
- PSUR frequency
- 5 years
- Data lock point
- 16 Apr 2027
- Submission date
- 15 Jul 2027
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Nationally authorised (NAP)
Are PSURs required for products referred to in Articles 10(1), 10a and 16a of Directive 2001/83/EC?
Yes — the list requires PSURs for these products.
The list asks this as one question for Articles 10(1), 10a and 16a together, and does not answer it for Article 14 at all. A PSUR may in any case be required at the request of a competent authority or as a condition of the marketing authorisation.
Notes in the list
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 Entry re-activated on 22/10/2025 PSUR frequency and DLP were updated on 21/12/2022 PSUR frequency and DLP were updated on 18/12/2019 DLP was updated on 19/12/2018 DLP was updated on 19/12/2017 Reference to NAP added on 23/05/2017 Correction of PRAC Rapporteur name on 28/02/2017 Next DLP was updated on 18/11/2016 PSUR Frequency and Next DLP was amended on 21/12/2015. "Are PSURs required for products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 23 Mar 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.
| Field | Applies today | From the date above |
|---|---|---|
| Notes | Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 Entry re-activated on 22/10/2025 PSUR frequency and DLP were updated on 21/12/2022 PSUR frequency and DLP were updated on 18/12/2019 DLP was updated on 19/12/2018 DLP was updated on 19/12/2017 Reference to NAP added on 23/05/2017 Correction of PRAC Rapporteur name on 28/02/2017 Next DLP was updated on 18/11/2016 PSUR Frequency and Next DLP was amended on 21/12/2015. "Are PSURs required for products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 | Reference to CAP added on 23/09/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 Entry re-activated on 22/10/2025 PSUR frequency and DLP were updated on 21/12/2022 PSUR frequency and DLP were updated on 18/12/2019 DLP was updated on 19/12/2018 DLP was updated on 19/12/2017 Reference to NAP added on 23/05/2017 Correction of PRAC Rapporteur name on 28/02/2017 Next DLP was updated on 18/11/2016 PSUR Frequency and Next DLP was amended on 21/12/2015. "Are PSURs required for products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 |
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- Data lock point 16 Apr 2027Submission by 15 Jul 2027
- Data lock point 16 Apr 2032Submission by 15 Jul 2032
- Data lock point 16 Apr 2037Submission by 15 Jul 2037
Counted from the data lock point the list gives, on the cycle it states: the submission date is 90 days after the data lock point — 70 days for a cycle of twelve months or less, 90 days for a longer one, as GVP Module VII sets out.
Combinations containing this substance
In earlier versions of the list
EMA/630645/2012 Rev.164 · published 23 Sept 2026
efavirenz — every 5 years, data lock point 16 Apr 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
efavirenz — every 5 years, data lock point 16 Apr 2027
Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.156, published 4 Feb 2026. Open the published file
Kreastel is a planning and oversight aid for pharmacovigilance obligations. It tracks dates like these for a marketing authorisation holder's own products.
Report a discrepancy — if this page and the published file disagree, the file is right and we want to know.