The Ministry of Health and Social Protection, through Resolution No. 1066 of July 1, 2020, adopted transitional measures, as follows:

1. Establishments that market, distribute, dispense, deliver, report, store, and transport medications, herbal products, medical devices, biomedical equipment, and in vitro diagnostic reagents necessary for the prevention, diagnosis, or treatment of Covid-19 must comply with the Annex Technician No. 1 of Resolution 1066.
2. The Ministry of Health authorized the operation of the pharmaceutical service in places of expansion for the provision of health services required for the prevention, diagnosis and treatment of Covid-19, provided that it complies with Technical Annex No. 2 of Resolution 1066 .
3. The IPS will be able to manufacture medicinal gases once INVIMA declares the shortages or over-demand of these. For this purpose, the IPS must present the format defined by INVIMA which includes a description and photographs of the system for obtaining medical gases, the leak test and cross gases test of the in-hospital distribution network, the self-assessment guide of compliance with the Annex. Technician No. 3, manifestation of its commitment to provide the initial technical production and quality control package for the release, scale sketch of the drug label project.
4. Mixing centers interested in preparing parenteral nutrition, adapting or adjusting doses of sterile and non-sterile drugs can submit the request to INVIMA and must guarantee compliance with Technical Annex 4.
5. Those who, during the emergency, expand their capabilities with new ionizing radiation generating equipment must obtain a medical practice license once the emergency is over.

The Resolution applies to the following subjects, who must guarantee quality during the processes:

1. The establishments authorized to manufacture, market, distribute, adapt, dispense, carry out non-informed delivery, store or transport medications, phytotherapeutic products, medical devices, biomedical equipment, cosmetic products, household hygiene products and personal hygiene absorbents.
2. Qualified health service providers.
3. Places of expansion, exceptionally authorized.
4. Pharmaceutical services and establishments
5. INVIMA.
6. Secretaries and health institutes or entities with such faculties.

The subjects listed above will be responsible for the veracity of the information and the consequences it may have on the population that uses the products or services. Therefore, the owner, manufacturer or person responsible must:

1. Provide the information that INVIMA requires to guarantee the traceability of the products.
2. Report any event, effect or adverse incident that the use or consumption of the products may generate.

The subjects may exhaust the stocks of the products subject to the Resolution, provided they are within the useful life of the product, simply by notifying INVIMA.

INVIMA and the Territorial Health Entities may inspect, monitor and control the requirements established in the resolution.

Resolution No.1066 of 2020