Requirements · Drugs · Colombia
Marketing authorization requirements for chemically synthesized drugs in Colombia
The legal and technical documents INVIMA asks for to import and sell a chemically synthesized drug in Colombia. Tick what you already have, see what is missing, and copy or print the list.
The essentials
Key findings
- 017 documentsfor the legal file, from the power of attorney in favor of SPI to the business license of each party.See it
- 0214 documentsfor the technical file, from the Pharmacological Standards listing to bioequivalence studies.See it
- 0317 countriesand bodies whose GMP certificate is accepted, besides one issued by INVIMA.See it
- 04IUM(Unique Drug Identifier): its application is one of the legal requirements.See it
- 05In parallelgoes the pharmacological evaluation if the active ingredient is not in the Pharmacological Standards list.See it
- 06Zone IVbis the climate zone stability studies must cover.See it
- 07In Englishis how technical documents may be submitted in Colombia.See it
- 08In your namethe sanitary registration can stay, even if your company is foreign.See it
Chapter 1 of 4
Legal requirements
These documents show that the product is authorized in its country of origin, that it is made under Good Manufacturing Practices (GMP), and who acts for you in Colombia. They must be apostilled or legalized and, when needed, officially translated into Spanish.
Legal documents
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Accepted reference GMP authorities
- USA
- Canada
- Germany
- Switzerland
- France
- United Kingdom
- Denmark
- Netherlands
- Sweden
- Japan
- Norway
- Australia
- South Korea
- FDA
- WHO
- PAHO
- EMA
Besides the 13 countries, certificates issued by the FDA (US Food and Drug Administration), the WHO (World Health Organization), PAHO (Pan American Health Organization) and the EMA (European Medicines Agency) are accepted.
Chapter 2 of 4
Technical requirements
The technical dossier describes the product, how it is made and how its quality is controlled. In Colombia these documents may be submitted in English.
Technical documents
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These are general requirements. As the process advances, we will provide the detailed requirements for your product type and regulatory classification.
Chapter 3 of 4
Considerations
- Legal documents: must be legalized in the country of origin and come with an official translation in the destination country.
- Technical documents: in Colombia, they may be submitted in English.
- Marketing authorization holder: in Colombia, foreign companies may hold sanitary registrations directly.
Chapter 4 of 4
How the process works with SPI
- 01 · DiagnoseFree initial assessmentWe review your product and tell you which filing applies, how long it takes and what it costs.
- 02 · RegisterDossier and filing before INVIMAWe build the dossier from your documents and file it before INVIMA.
- 03 · ProtectTrademark registration before the SICWe register your trademark before the Superintendence of Industry and Commerce.
- 04 · Operate & growLocal representation and distributorsWe represent you in Colombia and help you find distributors.
Let's talk
Registering a drug in Colombia?
Tell us which product you want to register and we will tell you which documents apply, how long it takes and what it costs. The first conversation is free.