National Drug Authority · Uganda
DEA-UG-2025-48246675
Tier 1 · Regulator-publishedUnclassifiedScheduling changeStatus · active
- Issuing authority
- National Drug Authority (NDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 04 Dec 2025The circulars page states no date. The month shown is when the document was uploaded to the Authority's website, which is not the date the Authority acted; that date is inside the PDF.
- Recorded by us
- 2026-09-09 18:49:17 UTC
- Product
- Paracetamol-containing oral solid dosage forms
- INN / active substance
- Paracetamol
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Scheduling change
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Safety signal
- Product type
- Medicine
- ATC code
- Not stated by the issuing authority
- Affected markets
- Uganda — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- The National Drug Authority (NDA) wishes to inform all Marketing Authorization Holders (MAHs) and Local Technical Representatives (LTRs) of the implementation of risk minimization measures for Paracetamol-containing oral formulations, following increasing health concerns regarding Paracetamol associated hepatotoxicity. All MAHs with currently registered products or products already undergoing registration that contain Paracetamol are hereby required to reformulate the affected products to comply with the revised maximum allowable strengths per dosage unit as stated below: 1. Single ingredient paracetamol should contain either 500 mg, 650 mg or 1000 mg per dosage unit. 2. Paracetamol-containing oral Fixed Dose Combinations (FDCs) with Opioids: not more than 325 mg per dosage unit. 3. Paracetamol-containing oral FDCs intended for management of cough, cold and flu symptoms: not more than 325 mg per dosage unit. 4. Paracetamol-containing oral FDCs for pain management: not more than 500 mg per dosage unit. For products that are already registered, Marketing Authorization Holders are required to undertake reformulation of the affected products to the acceptable Paracetamol strength limits within twenty-four (24) months from the date of this circular. During this transition period, the affected products may be maintained on the Drug Register, provided that all conditions for maintenance on the register continue to be met. At the end of the 24-month period, all products that remain non-compliant shall be subject to regulatory action.Original language: en
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 8
Where this record came from, and what is held to show it.
- Primary source
- https://www.nda.or.ug/wp-content/uploads/2025/12/2154G-DR-NDA-12-2025-CIRCULAR-NO.-008-DPAR-2025.pdf
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- 790df7ba8fffc30d36a427365b8c688a31fd8ab906aed41f0e817637d2718bf7SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-09 18:57:59 UTC
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| DEA-UG-2024-54413197 | 20 Feb 2024 | UG | Ketoconazole oral tablets | none published | Deregistration | Unclassified | Tier 1 · Regulator-published |
| DEA-BW-2023-20632138 | 13 Mar 2023 | BW | Bedaquiline-containing regimenscardiac adverse events | none published | Safety communication | Unclassified | Tier 1 · Regulator-published |
| DEA-BW-2023-10424004 | 13 Mar 2023 | BW | Suspected Adverse Drug Reactions of Angiotensin 11 converting enzyme inhibitors reported to BoMRA | none published | Safety communication | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2025). DEA-UG-2025-48246675: Paracetamol-containing oral solid dosage forms — Scheduling change, National Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/ug/2025/dea-ug-2025-48246675Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.