biotin
As the list published 4 Feb 2026 has it, binding since 25 Mar 2020. 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
- Not stated
- PSUR frequency
- 7 years
- Data lock point
- 1 Jan 2026
- Submission date
- 1 Apr 2026
- 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
DLP was updated on 25/09/2019 PRAC Representative and Lead Member state assigned on 04/07/2018
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 |
|---|---|---|
| Data lock point | 2026-01-01 | 2033-01-01 |
| Submission date | 2026-04-01 | 2033-04-01 |
| Notes | DLP was updated on 25/09/2019 PRAC Representative and Lead Member state assigned on 04/07/2018 | DLP was amended on 23/09/2026 |
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- Data lock point 1 Jan 2033Submission by 1 Apr 2033
- Data lock point 1 Jan 2040Submission by 31 Mar 2040
- Data lock point 1 Jan 2047Submission by 1 Apr 2047
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
- alfatocopherol / ascorbic acid / biotin / calcium pantothenate / colecalciferol / cyanocobalamin / magnesium / manganese / pyridoxine / riboflavin / thiamine / vitamin a / zinc
- ascorbic acid / acid folic / alfa-tocopherol / biotin / cholecalciferol / cyanocobalamin / nicotinamide / pantothenic acid / pyridoxine hydrochloride / retinol / riboflavin / thiamine
- ascorbic acid / biotin / calcium pantotenate
- thiamine / riboflavin/ pyridoxine / ascorbic acid / nicotinamide / glucose, thiamine / riboflavin / pyridoxine / ascorbic acid / nicotinamide, ascorbic acid / biotin / cyanocobalamin / folic acid / nicotinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine, riboflavin / thiamine / calcium folinate / cyanocobalamin / nicotinamide, calcium pantothenate / nicotinamide / pyridoxine / riboflavin / thiamine, dexpanthenol / nicotinamide / pyridoxine / riboflavin / thiamine, biotin / calcium pantothenate / cyanocobalamin / nicotinamide / pyridoxine / riboflavin / thiamine
In earlier versions of the list
EMA/630645/2012 Rev.164 · published 23 Sept 2026
biotin — every 7 years, data lock point 1 Jan 2033
EMA/630645/2012 Rev.156 · published 4 Feb 2026
biotin — every 7 years, data lock point 1 Jan 2026
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
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Report a discrepancy — if this page and the published file disagree, the file is right and we want to know.