In order to avoid the shortage of antiseptic and disinfectant products for external use, the Colombian Ministry of Health issued Resolution 520 of March 28, 2020 in order to establish new requirements for the manufacture of the above-mentioned products within the Colombian territory.
The regulation states that the companies authorized to manufacture and commercialize said products are those that have the following authorizations:
- GMP Certifications for Pharmaceuticals
- GMP Certifications for Phythotherapeutics
- GMP Certifications for Alcoholic Beverages
- Certificate of producción capacity for the manufacture of cosmetics
The above-mentioned certifications must be in force and must cover the liquid or semi-solid areas.
The requirements for submission are:
- Submit the request to INVIMA in the established form
- Qualitative and quantitative formula of the producto
- Description of the manufacturing process
- Draft of the labels for commercial presentation containing: Active ingredient, concentration, pharmaceutical form and route of administration
On April 1, 2020, in order to complement the information published in Resolution 520 of 2020, INVIMA published a practical guide for manufacturers interested in the manufacture and distribution of antiseptics and/or antibacterials, establishes the following list of products authorized and declared as Vitals not Available:
- Ethyl Alcohol Gel 63% 65%
- Ethyl Alcohol 70% Solution
- Ethyl Alcohol Topical solution 96 ° 72.9 mL / 100 mL
- Ethyl Alcohol + Chlorhexidine Gluconate Topical solution70% + 2%
- Ethyl Alcohol + Chlorhexidine Gluconate Topical solution70% + 1% (P / V)
- Ethyl Alcohol + Chlorhexidine Gluconate Topical solution 76.5mL + 0.45mL / 100mL
- Ethyl Alcohol + Isopropyl Alcohol Gel 63g + C. S. P 100mL
- Ethyl Alcohol + Glycerin Topical solution 96% + 4%
- Ethyl Alcohol + Menthol Lotion 70% + 0.5%
- Ethyl Alcohol + Menthol Lotion 70% + 0.39%
- 99% Isopropyl Alcohol Topical solution 63 g / 100 mL
- Isopropyl Alcohol + Iodine Lotion 72% + 7.5%
- Isopropyl Alcohol + Iodopovidone Lotion 72% + 7.5%
- Chlorhexidine Gluconate Topical solution 0.07% 0.08% 0.45% 2% 1%
- Chlorhexidine Gluconate + Isopropyl Alcohol Topical solution 2% + 70%, 4% + 70%