USER’S GUIDE FOR THE ENTRY OF A NEW HEALTH DRUG REGISTRY

Introduction

This document is a technical-administrative tool whose objective is to assist the user with the
inscription of products according to the Pharmaceutical, Homeopathic, Natural, Nutritional
Supplemental, Biotechnological and Biological classifications and according to the National
origin, Foreign and Foreign Recognition.

Legal Base
Drug Law
Article 29

All medication commercialized in a country should have prior authorization from the National
Directorate of Medicines.

All products should have an authorized and valid registration for their commercialization. They
should be renewed every five years and any modification of the original registration is
considered a Post-Registration Procedure.

Definitions

-New sanitary registration or National and/or Foreign origin: it is the technical legal process that
ensures that the medication to be commercialized complies with the requirements of quality,
efficacy, and safety, which is finalized with the obtaining of a sanitary certification for the
commercialization sent out by the competent authority, according to the Drug Law and its
regulation which applies for products of national and foreign origin.
-Recognition of foreign health registry: It is the technical legal process that ensures that the
medication to be commercialized complies with the requirements of quality, efficacy, and safety,
which is finalized with the obtaining of a sanitary certification for the commercialization sent out
by the competent authority, according to the Legislative Decree No. 34, in which it will be
possible to recognize in an official way the registries granted by sanitary authorities of countries
whose Drug Regulatory Agencies have been certified to level 4 by the Pan-American Health
Organization (PAHO), as well as Sanitary Registries granted by sanitary authorities of the United
States of North America, Canada, Australia, Japan and the European Medicines Agency (EMA).
-Medicinal product: a simple or compound substance, of natural origin, synthetic or
semisynthetic that has therapeutic, prophylactic, or diagnostic properties and is presented in an
appropriate dosage and form for administration.
-Pharmaceutical product: substance of natural origin, synthetic, semisynthetic or a mixture
thereof, with a defined pharmaceutical form, used to prevent, diagnose, or treat diseases or
modify a physiological function in humans.
-Homeopathic medicinal product: a pharmaceutical substance that uses micro-doses of extracts
from vegetables, minerals, animals or a mixture of these, with therapeutic purposes that should
be commercialized under medical prescription prior to registration.
-Natural product: It is one whose composition contains active principles, parts obtained directly
or by means of specific procedures from vegetables, minerals or animals, whose use is enabled
and justified by the practice of traditional medicine or by scientific studies.
-Nutritional supplement: substance or a mixture of substances meant to be ingested orally to
supplement the nutrients normally presented in food, these can be vitamins, minerals, amino
acids, carbohydrates, proteins, fats or a mixture of these substances with extracts of vegetable,
animals, or enzyme origin, except hormones and their combination with vitamins. The term is
synonymous with nutritional complement, nutritional supplements, dietary supplement and
vitamin supplement.
-Biotechnical Medicine: it is the pharmaceutical product whose active principle is fabricated
from a living organism whose genetic structure has been modified through technology, through
techniques such as recombinant DNA, methods based on antibodies, etc. These medications can
recombinant proteins, monoclonal antibodies, vectors for transporting genetic material, vaccines,
etc.
Medicinal/biological product: They are substances composed of proteins, nucleic acids, sugars or
a complex combination of the previous or living entities such as cells or tissues or are derived
therefrom, obtained from living organisms or of their tissues. They include viruses, therapeutic
serum, toxins, anti-toxins, vaccines, blood, components of derivatives of blood, allergen
products, colony-stimulating factors, cytokines, antibodies, heparins, among others. They are
products utilized for the purpose of prevention, treatment, or in vivo diagnosis or certain
diseases.