Are health approvals renewable? What happens with the previously authorized good between the lapsing date and the renewal date of a health approval?

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Health approvals are renewable in Colombia. The deadline for the renewal of a health approval depends upon the type of product, as indicated in the table below.

(Homeopatic) Medicines, Alimentation, Medical Devices, Dietary supplements, Phytotherapeutic productsThree (3) months before the expiry date of the health approval
Alcoholic beveragesSix (6) months before the expiry date of the health approval
Cosmetics, Cleaning products, Agents for in vitro diagnosticsUntil the expiry date of the health approval
Household pesticidesBetween twelve (12) and six (6) months before the expiry date of the health approval

In case the renovation was presented within the time limit, the health approval remains in force as long as there is no decision in the opposite sense by INVIMA. If the renewal request has not been filed within the said time frame, the request will be treated as an application for a new health approval.

If the health approval has expired without a timely request for renovation, the respective product can no longer be imported to Colombia or manufactured, depending on the case. If there is a stock of the previously authorized product in the market, INVIMA grants the interested parties a period of time which cannot be longer than six (6) months to recall those products. INVIMA will order the confiscation of any specimens of the product which are still available in the market after the end of said period.