2 of july of 2020
Invima resumes suspended legal terms

Through Resolution 2020020185 of June 23, 2020, National Institute of Food and Drug Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos - Invima) took some measures regarding the legal terms suspended through Resolution 2020012926 of April 3, 2020.

In particular, the measures adopted by INVIMA include:

1. To resume the legal terms of:
a. The Internal Disciplinary Control processes, 
b. The inspection, surveillance and control actions carried out within the framework of the risk management model adopted by the General Directorate for this purpose, 
c. The application, monitoring and decision on the sanitary measures related to the products of Invima's competence.

2. To resume the legal terms in the sanctioning processes, administrative actions, and other procedures in charge of the Invima's Sanitary Responsibility Directorate.

3. To resume the legal terms in all actions and procedures in charge of the Food and Beverage Directorate.

4. To resume the legal terms in the following actions in charge of the Directorate of Medicines and Biological Products:

a. Procedures related to Cannabis-based products, Phytotherapeutics, Homeopathy and Dietary Supplements.
b. Research protocols and associated procedures.
c. Over-the-counter (OTC) advertising authorizations for medicines, phytotherapeutic and homeopathic over-the-counter products, and all dietary supplements.
d. Automatic renewals and modifications of chemically synthesized medicines.
e. VAT exclusion procedures.
f. Scheduling and carrying out of virtual or mixed Good Practice (GP) certification visits for applications filed before 3 April 2020.

5. To resume the legal terms in the following actions in charge of the Directorate of Medical Devices and Other Technologies:

a. Modifications to health records and marketing permits.
b. Product exhaustion and advertising authorizations.
c.  Applications for marketing permits for controlled technology biomedical equipment.
d. Storage capacity and conditioning certification visits.
e. Certification and visit in Health Conditions for Tissue and Bone Marrow Banks.
f. Certification and visit in Good Practices (BP) for: Tissue and Bone Marrow Banks.
g. Good Practice (GP) requirements verification visit for Tissue Banks.
h. Verification visit of tissue temporary storage centers.
i. Verification visits of health requirements of reproductive biomedicine units, sperm banks and all other anatomical component banks.
j. Procedures of the Specialized Room for Medical Devices and In Vitro Diagnostic Reagents.

6. To resume the legal terms of all actions and procedures in charge of the Directorate of Cosmetics, Toiletries, Pesticides and Domestic Hygiene Products.

7. To resume the legal terms in all actions and procedures in charge of the Directorate of Health Operations.

Notifications of administrative acts issued by Invima will be made by electronic means, as long as the Health Emergency persists


 

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