Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombian regulator and PIC/S member; GMP manuals are set by Resolución 1160 de 2016.
WHAT INVIMA COVERS
The Instituto Nacional de Vigilancia de Medicamentos y Alimentos regulates medicines, food, and medical devices in Colombia. GMP manuals and inspection guides are adopted by Resolución 1160 de 2016 of the Ministerio de Salud y Protección Social, based on WHO Technical Report Series annexes.
WHERE IT SITS INTERNATIONALLY
INVIMA became a PIC/S participating authority in 2021 and has been designated a WHO-Listed Authority, anchoring its expectations to WHO GMP and PIC/S inspection standards. That dual status makes Colombia one of the more predictable Latin American markets for a manufacturer already operating a PIC/S-grade quality system — the technical requirements are recognisable, and the effort concentrates on local certification and language.
HOW ITS REQUIREMENTS BITE
INVIMA issues the GMP compliance certificate required for products marketed in Colombia and inspects manufacturers — domestic and foreign — against the adopted WHO-based manuals. Certification is mandatory for market access, making inspection scheduling a live commercial constraint.
WHAT INVIMA PUBLISHES
- 01Resolución 1160 de 2016 — the adopted GMP manuals and inspection guides
- 02GMP compliance certificates for manufacturing sites
- 03Sanitary registration requirements for medicines and devices
- 04Health alerts and recall communications
- 05Technical guidance and circulars
WHAT PRACTITIONERS GET WRONG
- ›The manuals track WHO TRS annexes (Report 37 Annex 4 and Report 45 Annex 6) — read those to understand the expectation, because the resolution adopts rather than restates them.
- ›INVIMA GMP certification is mandatory for marketing in Colombia; build the inspection lead time into launch planning rather than treating it as a formality at the end.
- ›Colombia joined PIC/S in 2021, so expect continuing convergence with international inspection practice and a rising evidentiary bar year on year.
- ›Spanish-language documentation is expected, and foreign certificates typically require legalisation or apostille to be accepted in a dossier.
- ›INVIMA regulates food and devices as well as medicines, so a multi-product site may face more than one certification track.
INVIMA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN INVIMA’S REMIT
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