The notified draft technical regulations establish good manufacturing practice (GMP) manuals for phytotherapeutic products, including sterile products, as well as their corresponding inspection guides. They define the technical and sanitary requirements for manufacturers and other stakeholders involved in the production, quality control, storage, packaging, and labelling stages, with the objective of ensuring the quality, safety, and consistency of these products.They also establish the conditions for obtaining the GMP Compliance Certificate from the National Food and Drug Surveillance Institute (INVIMA), health surveillance provisions, and a transition period for the implementation of the new requirements. The measure applies to phytotherapeutic products manufactured in Colombia or imported products that are marketed in Colombia, in accordance with international guidelines.G/TBT/N/COL/275- 2 -