Drug registration in Colombia

The procedure, timelines and documents required for registration of drug products in Colombia depend on the type and origin of the drug product. The regulations distinguish these five different cases:

Registration Official timeline for approval Validity of marketing authorization
New drug products, included in Colombian pharmacological norms, foreign manufacturing. 80 days 5 years
New drug products, included in Colombian pharmacological norms, national manufacturing. 200 days 5 years
Simplified product registration procedure, for simple homeopathic drug products, national or foreign manufacturing. 40 days 10 years
Non-simplified product registration procedure for homeopathic drug products, and complex homeopathic drug products, national manufacturing. 190 days 10 years
Non-simplified product registration procedure for homeopathic drug products, and complex homeopathic drug products, foreign manufacturing. 190 days 10 years

For all cases, the steps to follow are:

1- Download or request registration solicitude form from website.

2- Pay the applicable fee through electronic bank transfer or at an affiliate of the Davivienda bank.

3- File the registration application at INVIMA’s Oficina de Atención al Usuario (Customer service office) including all the applicable documents.

4- Redeem the notice issued by the entity.

It is possible to follow up on the status of the case via telephone, internet at www.invima.gov.co or personally at the INMIVA office.

Application for renewal of the marketing authorization must be submitted at least 3 months before the expiry date of the registration

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2 Responses to Drug registration in Colombia

  1. Paola Rodriguez says:

    love it, really, can i suscribe to your updates or linkedin page?, can you tell me more about working as regulatory affairs analyst in Colombia?

  2. Manoj Kumar Agrawal says:

    Hi Maria,
    Thanks for above information.
    Could you please tell me, cases you have given up is mentioned anywhere in guideline by INVIMA.
    just help me to get reference for those cases.

    Thanks

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