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Regulatory Services in Colombia: All You Need to Know

October 29, 2018

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Colombian Lawyer Holding Data Files for Regulatory Services
Did you know that if you are a foreign manufacturing company or entrepreneur you still can introduce your products in Colombia? Yes, thanks to the Colombian legislation in regulatory services, it is possible to commercialize your products for human consumption or medical devices in the country, however, you must accomplish a registration process following certain steps and requirements to be approved by Invima, the entity in charge of drugs and food surveillance. But, you don't have to go throughout the process by yourself, hiring an attorney in Colombia will provide you with the experience and knowledge required to have the best outcome, whether you are in the country or not.

First, let's learn about Invima. This public entity is known as The National Institute for Drug and Food Surveillance (INVIMA), is an institutional entity in charge of making sure that all the products you consume are manufactured in appropriate establishments, with good manufacturing practices, trained personnel, and quality raw materials. This institutional entity was created with the purpose of implementing policies related to health surveillance and quality control of all products that may have an impact on individual or collective health of Colombians.

In other words, the Invima is responsible for ensuring the effectiveness and quality of products such as medicines, food, beverages, medical devices, cosmetics, pesticides or toiletries in Colombia. As one of their slogan states, they are "the authority that looks after the health of all Colombians." Among other procedures, this institution is responsible for issuing the Invima sanitary registry, a public document which grants the authorization to a natural or legal person to manufacture, import, pack, process and market in Colombia any of the aforementioned products, whether they are produced inside or outside the country.

For its part, the Invima sanitary registration is mandatory for all products with a name and brand that is sold directly to the final consumer in Colombia. This document guarantees that a product circulates legally in the country and that it complies with the technical requirements established by law.

Once a person, whether natural or legal, has their health record, they are assigned a registration number so that they can sell their merchandise throughout the Colombian territory; this code must appear visible on the label of the products to be marketed. The Invima offers the consumer a consultation portal on its website so that any Internet user can verify the status of the health record of any product; therefore, being properly registered is essential to maintain the reputation and quality of your merchandise. To process this document, you need a file that can be composed of basic information forms, application forms for registration, technical data sheets, commercial register of the owner, fee payments. The requirements vary depending on the type of product to be registered.

Besides, there are several steps in the process that can confuse anyone who is not familiar with the process: what products can be covered under the same sanitary registration, how to properly complete the application forms, what is the appropriate payment rate according to the procedure to request, how long it takes a record to expire, when a health record must be renewed, among other important aspects at the time of beginning a registration request. For the comfort of foreign applicants who are not in the country they can hire the service of law firms with specialists in regulatory matters who can help them with all the requirements mentioned above.

Benefits of Hiring an Attorney in Colombia to Submit an Invima Registration

The attorney will prepare all the documentation required to submit the request such as application forms and payment fees, so you don't need to worry about mistakes while filling them out.
  • Colombian Attorney Shaking Hands with a Foreigner for Regulatory ServicesA specialized attorney is up to date on the new information related to Invima, so they don't get caught off guard, offering a quality and updated service to their customers.

  • There will be a constant communication between the applicant and the attorney during the whole process in order to solve any problem that may arise.

  • You can receive assistance in selecting the Colombian distributors for your product according to your marketing requirements.

  • The attorney will provide you with the information about the products and devices not eligible for this process.

  • Hiring an attorney in Colombia that arranges everything for you when you are not living in the country it's a great help and gives you the tranquility of receiving a successful request without wasting your time and money.
Every year, more and more foreign manufacturers and entrepreneurs are interested in commercializing both products for human consumption or medical devices in Colombia, due to the growing economy of the country. For this reason, Invima is always trying to adapt their requirements in order to facilitate the process for those foreign companies so they can have a legal representative to complete the registration.

At AGT Attorneys, we work with all the industrial sectors to advise them on these regulatory and health issues before the different public entities of the country. We rely on experienced attorneys that will assist you before, during and after the submission of the Invima request. Our trajectory in regulatory services ensures the success of the process without delays or inconvenience.

The procedure to obtain the Invima health registration is considerably facilitated thanks to the appropriate legal assistance. We will be happy to help you with your registration so that you can legally market your products in the country. Contact us at +57 1 702-3671 or you can also fill out our contact form below. We'll be glad to assist you!

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