technetium (99mTc) bicisate

As the list published 23 Sept 2026 has it, binding since 16 Apr 2024. 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: 8 Oct 1993
PSUR frequency: 15 years
Data lock point: 7 Oct 2034
Submission date: 5 Jan 2035
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?

No — the list does not require 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

PRAC Rapporteur name was amended on 18/10/2023

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The next three reports

Data lock point 7 Oct 2034Submission by 5 Jan 2035
Data lock point 7 Oct 2049Submission by 5 Jan 2050
Data lock point 7 Oct 2064Submission by 5 Jan 2065

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.

In earlier versions of the list

EMA/630645/2012 Rev.164 · published 23 Sept 2026
technetium (99mTc) bicisate — every 15 years, data lock point 7 Oct 2034
EMA/630645/2012 Rev.156 · published 4 Feb 2026
technetium (99mTc) bicisate — every 15 years, data lock point 7 Oct 2034

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.164, published 23 Sept 2026. Open the published file

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