Environmental License for the Pharmaceutical Industry in Guatemala: What You Need to Know
Written by: Sara Scheel
The purpose of an Environmental License is to ensure that projects are carried out in compliance with environmental prevention, mitigation, and compensation requirements. In this article, we explain which companies must obtain it, how to do it, and the most common mistakes during the process.
1. Who needs to obtain an Environmental License in Guatemala?
Any individual or legal entity, public or private, planning to carry out a project, work, industry, or activity that may generate significant environmental impacts must obtain an Environmental License from the Ministry of Environment and Natural Resources (MARN).
Legal basis: Decree 68-86 of the Congress of the Republic and Governmental Agreement 137-2016.
This includes the construction of buildings, shopping centers, highways, as well as agricultural, hydroelectric, industrial, or natural resource extraction projects.
For the pharmaceutical industry, for example, it is a mandatory requirement for Distributors, Drugstores, and especially for Factories, Formulation Plants, Laboratories, among others.
2. How can I obtain my Environmental License in Guatemala?
The process is conducted through the Ministry of Environment, with the assistance of an environmental consultant. The basic steps are:
- Determining the project category according to its level of impact (Category A, B1, B2, or C).
- Preparing the environmental instrument.
- Technical review by MARN and, if applicable, requests for additional information or adjustments.
- Approval of the instrument and issuance of the Environmental License.
- Fulfillment of environmental commitments.
Scheel Consulting provides personalized assistance throughout each step.
3. What are the most common mistakes when applying for an Environmental License?
Some common mistakes include:
- Not registering the project from the beginning, which can result in fines.
- Starting construction without a valid Environmental License (which may lead to penalties).
- Inconsistencies or lack of technical information in the environmental studies.
- Not knowing the correct project category, which forces the applicant to re-submit the file to MARN and restart the process.
4. How long is an Environmental License valid?
The Environmental License is valid for 1 to 5 years.
It is important to renew it before it expires.
5. DABI or Environmental License – what’s the difference?
In the context of environmental licensing in Guatemala, the Low-Impact Environmental Diagnosis (DABI) is an environmental instrument used to evaluate and mitigate the potential environmental impacts of low-impact projects, works, industries, or activities that are already in operation. It is a correctiveinstrument, unlike the Initial Environmental Assessment (EAI), which ispredictive and applies before project execution.
In other words, the DABI is a prerequisite for obtaining an Environmental License.
For more information about this service, contact us at info@scheelconsulting.com or +502 4149 3915.
Service available in Guatemala.
