ESTABLISHING A PHARMACEUTICAL COMPANY IN COLOMBIA
In order to stablish and operate a pharmaceutical manufacturer or distributor in
Colombia, the first most step is to complete the legal paperwork to create a business
with three different, but complementary, corporate roles: Import, distribution and
marketing of pharmaceutical products. Consulting the commercial lawyer during this
initial phase is mandatory to navigate the complex legalities of constitution and registry
process, import regulations, business structure, warehouse requirements, taxing and
corporate roles (as mentioned) to ensures the company complies with all necessary
obligations from the very start. This minimizes the risk of legal roadblocks down the line.
It is also a requirement that this company have the physical presence of a business
domicile, not just for mailing, record files and archive; but to connect the organization
with the government (visits, inspection and presentation of documents to obtain
approval for commercial activities) and clients. The cost and timeframe for product
registration in Colombia depend on the number of products you wish to register
simultaneously. This upfront cost is separate from the legal fees associated with
establishing your company in Colombia.
The big market for companies seeking to establish a foothold in Colombia is Bogotá,
the national capital. Not only does it boast the largest population by a significant margin,
but it also serves as hub for all government agencies and major corporations,
concentrating all the resources critical for developing business. Bogota offers an
combination of scale, market and access for establishing a national presence while
keeping an eye on broader Colombian growth as there are several other major cities
exceeding two million inhabitants (Medellín, Cali, Barranquilla and Bucaramanga),
each influencing their respective regions as provincial hubs. These centers represent
natural opportunities for expansion as company gains traction.
The government agency in charge of granting permissions for the commercialization
of medicines and supplements in Colombia is INVIMA (an FDA alike agency). To
obtain the proper permits, it is important to determine what kind of products are
intended to be placed on the market: pharmaceuticals or nutraceuticals products.
Each one has different and precise requirements to obtain the INVIMA license.
Furthermore, for some drugs (opioids, antidepressants, anesthetics, etc.) additional
and stringent requirements are placed.
INVIMA conducts a strict supervision and thorough evaluation of all pharmaceutical
products distributed on the local market. In recent years, it granted express temporal
emergency import licenses only for some COVID vaccines, five to be precise. Short
after, it suspended and revoked the license of three. So, it is unlikely to expect any
exceptional treatment from them, not even for emergency scenarios.
Following company formation and obtaining the necessary INVIMA registrations for
each product, you'll define your sales channels. The intended use or benefit of your
products determines the optimal approach – selling directly to hospitals, distributors
or large drugstore chains. It requires building a local sales team with experienced
business managers and executives in target cities.
As for the EPS, nowadays the Colombian healthcare landscape is undergoing a
transformation, with the role of EPS potentially shifting towards other entities.
However, for businesses like yours, the impact on your specific products depends
mostly on their nature. For instance, generic pharmaceuticals offering lower-cost
alternatives to innovative drugs remain highly relevant to the institutional market.
The legal process to create a company varies and the overall timeline for market
entry typically falls within a year:
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Product Registration (INVIMA): ± 10 months (4-5 months processing,
additional time for special requirements)
Market Analysis: ± 6 months (determining target audience and sales
channels)
Importation & Pricing: ± 4 months (importing products and setting marketcompetitive prices)
Sales Channel Entry: ± 3-4 months (securing initial sales within chosen
channels)
Return on Investment (ROI): Achieving a positive ROI typically takes 2-3 years of
consistent sales in the Colombian market.
The Colombian pharmaceutical market is known for extended payment terms, typically
ranging from 90 to 120 days. Additionally, each client may have their own specific sales
requirements that need to be negotiated for a mutually beneficial agreement.
Questions for Potential Pharmaceutical Client:
1. Company Structure:

Can you elaborate on your company's primary function? Are you primarily a
manufacturer of pharmaceutical products, a marketer of products from other
manufacturers, or do you represent other pharmaceutical companies as a
distributor?
2. Existing Presence in Colombia:

Could you provide more information about your existing relationship with IPCA
and Fresenius Kabi? These companies currently have established operations in
Colombia.
3. Product Portfolio:

We are interested in learning more about the specific products you are
considering for registration in Colombia. Could you provide a detailed product
brochure outlining the type of products, their intended medical indications, and
any existing international registrations (e.g., FDA, EMA, Orange Book)?
4. Market Analysis:

Based on your experience in other countries, what do you perceive as the primary
market for these products in Colombia?