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Unprecedented Resolution of the Agency Authorizes, for 120 Days, the Production of the Drug Used in the Treatment of Methanol Poisoning in Brazil
The National Health Surveillance Agency (Anvisa) published, in an extraordinary edition of the Official Gazette of the Union this Friday (3), the Board Resolution (RDC) No. 994/2025, which temporarily authorizes the emergency manufacturing of absolute injectable ethyl alcohol in the country.
The measure was classified as “extraordinary and of an emergency nature” and has an initial validity of 120 days, which may be extended as necessary for public health.
According to the text of the resolution, the aim is to facilitate the use of injectable ethyl alcohol in the treatment of methanol poisoning, a highly toxic substance found in adulterated products, solvents, and fuels. Accidental or intentional consumption of methanol can cause blindness, multiple organ failure, and death.
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Emergency Authorization and Exemption from Registration
According to the document, the medications produced under this regulation will be regularized through notification, and will not need a traditional sanitary registration, as is the norm in regular situations.
However, manufacturing companies must have a valid Good Manufacturing Practices certificate, comply with the quality criteria of the Brazilian Pharmacopoeia, and take full responsibility for the safety, efficacy, and traceability of the products.
Anvisa also determined that the medications manufactured under these conditions must have a maximum validity period of 120 days, maintain samples of three batches for stability studies, and send samples for monitoring analysis within five days, whenever requested by the Public Health Laboratory Management (GELAS) of the Agency.
Quality Control and Technical Monitoring
The text published in the Extra Bulletin of the Official Gazette (Edition 189-A) specifies that the General Management of Medications (GGMED) will publish a Product-Specific Guide, with information about the permitted excipients and the technical requirements necessary for the safe administration of absolute injectable ethyl alcohol.
Additionally, the resolution requires that companies maintain a record of internal quality control, including results of sterility and purity tests, and notify Anvisa of serious adverse events within 24 hours, according to the protocols of the Sanitary Surveillance Notification System (Notivisa).
Oversight and Penalties
Anvisa reinforced that it may suspend the manufacturing authorization at any time if sanitary non-conformities are detected. Noncompliance with the rules of RDC No. 994/2025 will constitute a sanitary infraction, subject to the penalties of Law No. 6,437/1977, which provides for fines up to suspension of production activities.
Why the Measure Is Important
Recent cases of methanol poisoning have been recorded in different Brazilian states, mainly due to the consumption of adulterated beverages. Injectable absolute ethyl alcohol is an effective antidote in these cases, as it competes with methanol for the enzyme alcohol dehydrogenase, preventing the conversion of the toxic substance into formic acid, which is responsible for neurological and visual damage.
Anvisa’s decision aims to ensure the national supply of this medication, especially in emergency hospitals and toxicology centers, which often face shortages of specific products for the treatment of acute poisonings.
RDC No. 994/2025 was signed by Chairman Leandro Pinheiro Safatle and came into effect on the date of its publication, as determined by Article 18 of the resolution.
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