Dear all,
We hereby inform you of the publication of MINISTERIAL AGREEMENT 13-2026, published on February 5, 2026 and effective as of February 7, 2026: Amendment to Ministerial Agreement 174-2025 of the Ministry of Public Health and Social Assistance dated June 25, 2025, which establishes Lists I, II, and III of Precursors and Chemical Substances (ATTACHED):
Below is a SUMMARY for your reference:
- Regulatory context
The Agreement is issued within the framework of:
- Political Constitution of the Republic (Arts. 93–96 and 194)
- Law of the Executive Branch (Decree 114-97)
- Health Code (Decree 90-97)
- Regulation for the Sanitary Control of Medicines
- Government Agreement 102-2025 (Regulation for the Authorization and Control of Precursors and Chemical Substances), which empowers the Ministry of Health to issue Lists I, II, and III of precursors and chemical substances
- Background
- Ministerial Agreement 174-2025 was issued on June 23, 2025
- It entered into force on June 28, 2025
- It was amended on July 30, 2025 (Ministerial Agreement 201-2025)
- It established a regularization period for newly controlled substances
- Following technical analysis by the Directorate of Regulation, Surveillance, and Health Control (DRVCS), the need to extend the deadline was determined, applying the principle of proportionality of WHO Good Regulatory Practices
- Purpose of the amendment
Article 4 of Agreement 174-2025 is amended, and the new article redefines the Official Lists as follows:
- List I: Chemical precursors under strict control
- List II: Other precursors subject to control
- List III: Controlled chemical substances
- Precursor Lists
List I
In addition to the precursors included in the list, salts, esters, and optical isomers of the listed substances are also included. Mixtures and dilutions containing substances listed shall be subject to the corresponding control.
Fragrance mixtures containing piperonal and/or benzaldehyde at a percentage equal to or less than 5% are exempt from control.
List II
In addition to the precursors included in the list, salts of the substances are also included, except for salts of hydrochloric and sulfuric acids.
Mixtures containing a listed substance at a percentage equal to or greater than 30% shall be subject to controls under the Regulation for the Authorization and Control of Precursors and Chemical Substances. When mixtures contain two or more listed substances, control applies when the combined percentage equals or exceeds 30%. Dilutions with water at concentrations equal to or greater than 30% of listed precursors are subject to control, except for hydrochloric acid at concentrations equal to or greater than 11%.
List III
In addition to the precursors included, mixtures of such substances are exempt from control, except those containing methyl alcohol exceeding 5%. In the case of Ketamine and Xylazine, their salts and derivatives, Levamisole, Phenacetin, and Medetomidine shall be controlled in mixtures and finished products.
After 12 months from the entry into force of the agreement, dilutions with water at concentrations equal to or greater than 30% of listed substances shall be subject to control.
Each precursor and chemical substance in the Official Lists includes:
- Tariff code
- Chemical name
- Synonyms
- CAS number
- Regularization
Entities holding stock in warehouses or inventories of precursors or chemical substances subject to control must, within a 12-month period, obtain or update the License for Handling Precursors and Chemical Substances and regularize such possession prior to legal commercialization before the Department for Regulation and Control of Pharmaceutical and Related Products (DRCPFA) of the Directorate of Regulation, Surveillance, and Health Control (DRVCS) of the Ministry of Public Health and Social Assistance (MSPAS), within the established timeframe.
We hope this information is useful.
Kind regards,