Introduction
Since the enactment of Law 2316 of 2023, the Ministry of Health and Social Protection and INVIMA have conducted various roundtables to develop a comprehensive list of permitted modelling substances. This document outlines the key aspects of the list and the sales control registry for these substances.
Definition of Biopolymers
According to Law 2316 of 2023, biopolymers are substances comprising various macromolecules produced either by biological agents or through chemical synthesis. These biopolymers can originate from different sources, including petroleum derivatives, vegetable sources, and predominantly synthetic materials. Silicone is the primary base for many of these substances, but other materials such as methacrylate or collagen may also be included.
List of Permitted Modelling Substances
The Ministry of Health and INVIMA have established the "List of Permitted Modelling Substances," which encompasses injectable fillers used in body treatments for aesthetic purposes. This list is updated periodically and includes:
- Active ingredients of the substances
- Approved health registrations that authorize their commercialization
It is crucial for stakeholders to refer to this list regularly to ensure compliance with the regulations.
Sales Control Registry
The National Government has regulated the sales control registry of permitted modelling substances, as outlined in Article 6 of Law 2316 of 2023, through Decree 545 of May 2, 2024. The decree specifies:
- Entities and individuals required to report sales of permitted modelling substances
- Deadlines for reporting
- Information content required in the sales control reports
These regulations ensure that the distribution and use of permitted modelling substances are monitored and controlled effectively to maintain public safety.
Conclusion
The implementation of Law 2316 of 2023 and its associated regulations underscores the commitment to regulating the use of modelling substances in aesthetic treatments. Compliance with the list of permitted substances and the sales control registry is essential for ensuring the safety and efficacy of these products.
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