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Ecuador has three main documents that together establish the rules for chemical industry in the country:
- Technical Regulation 078 on transport, storage, and management of hazardous materials
- Acuerdo Ministerial 099 on instructions for the registration of hazardous chemical substances and environmental obligations
- Decreto 752/2019 that states the creation of a chemical inventory and a chemical registry
Additionally, Ecuador is part of the Andean Community, which indicates that the communal regulation for chemical pesticides for agriculture is in place (Resolución 2.075/2019).
News
Ecuador Updates Regulations on Good Practices for Pharmaceutical and Medical Devices
The Republic of Ecuador has announced significant amendments to its Sanitary Technical Regulation on Good Practices for Storage, Distribution, and/or Transportation for pharmaceutical companies and manufacturers of medical devices for human...
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Ecuador Updates Registration Guidelines for Hygienic and Disinfectant Products
Jan-13-2025
The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) in Ecuador has released Version 2.0 of the External Instruction Document, which contains updated requirements for the registration, re-registration, and modification...
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