Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombian medicines and food regulator; issues the GMP compliance certificate against the manuals set by Resolución 1160 de 2016 of the Ministerio de Salud y Protección Social. Not a PIC/S participating authority.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
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.
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
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 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 is not a PIC/S participating authority — in Latin America only Argentina, Mexico, and Brazil have joined — so anchor the expectation to the WHO GMP the resolution adopts rather than to PIC/S inspection practice.
- 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.
What an inspection under this authority actually probes
WHERE IT SITS INTERNATIONALLY
INVIMA anchors its GMP expectations to the WHO Technical Report Series annexes that Resolución 1160 de 2016 adopts, and it sits on WHO’s transitional list of WHO-Listed Authorities. It is not a PIC/S participating authority — in Latin America only Argentina (ANMAT), Mexico (COFEPRIS), and Brazil (ANVISA) have joined PIC/S. For a manufacturer already operating a WHO- or PIC/S-grade quality system the technical requirements are recognisable, so the effort concentrates on local certification and Spanish-language documentation rather than a different standard.
INVIMA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN INVIMA’S REMIT
INVIMA: frequently asked questions
Reference answers on Instituto Nacional de Vigilancia de Medicamentos y Alimentos’s mandate, what it publishes, and how its requirements acquire force.
What does INVIMA require for market access in Colombia?
INVIMA issues the GMP compliance certificate required for products marketed in Colombia and inspects manufacturers against the adopted WHO-based manuals. Certification is mandatory for market access, so build the inspection lead time into launch planning.
What GMP standard does Colombia apply?
GMP manuals and inspection guides are adopted by Resolución 1160 de 2016, based on WHO Technical Report Series annexes (Report 37 Annex 4 and Report 45 Annex 6). Read those to understand the expectation, because the resolution adopts rather than restates them.
Is INVIMA a PIC/S member?
No. INVIMA is not a PIC/S participating authority — in Latin America only Argentina (ANMAT), Mexico (COFEPRIS), and Brazil (ANVISA) have joined PIC/S. INVIMA anchors its GMP expectations to the WHO Technical Report Series annexes adopted by Resolución 1160 de 2016, and it appears on WHO’s transitional list of WHO-Listed Authorities.