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INVIMA's Measures until the Health Emergency Remains in Force 

by Maria Castellanos

Published: April, 2020

Submission: April, 2020

 



Through Resolution 2020012926 of April 3, 2020, INVIMA formalizes the measures adopted in connection with the person to person attention and proceedings that will be carried out before the entity during the health emergency, as well as the suspension of terms for some of INVIMA´s actions.


These are transitory measures, which will be in force during the health emergency, focused on the attending to the health emergency, so that the entity can urgently adopt measures, to prevent the spread of COVID 16, guaranteeing access to the products necessary for that purpose.


SUSPENSION OF PRESENTIAL ATTENTION TO THE PUBLIC (Art 4)


INVIMA formalizes its decision to suspend face-to-face attention to the public. All requests should be filed via web through the links specially included on the entity's website: proceedings related to products under INVIMA´s surveillance of its competition, as well as the chat to provide guidance, and for the reception of complaints and claims. The website will also be used as the main means of information for citizens (www.invima.gov.co).


Physical documentation will only be received exceptionally at Carrera 10 # 64 - 28, Citizen Attention Office, Bogotá.


REGULATORY PROCEEDINGS FOR FOOD PRODUCTS THAT ARE NOT SUSPENDED (Art 6)


In accordance with the Resolution, terms are not suspended for the general issuance of marketing authorizations, permits and notifications, renewals, amendments, issuance of Free Sales Certificates, proceedings before the Specialized Board of food products, corrections (including alcoholic beverages), authorizations of advertising, materials and packaging as well as promotional incentives and labels in contact with food.


On the other hand, terms related to application, renewal, modification of Marketing Authorizations and authorization of labels or exhaustion of alcoholic beverages are suspended, as well as certification procedures for GMPs, including certification or renewal audits (includes food and alcoholic beverages) and Certification for the implementation and operation of HACCP for food, animal benefit plants, stripping and depressing motor ships or fishing vessels.


REGULATORY PROCEEDINGS FOR PHARMACEUTICALS AND BIOLOGICALS THAT ARE NOT SUSPENDED (Art 7)


According to the Resolution, terms related with pharmaceutical and biological products those are not suspended, and only the procedures related to the health emergency will be processed as a priority. Thus, requests for authorization, manufacture, import of medicines and vital not available products, issuance of FSCs, requests for homologation and validation of GMPs, related to COVID-19, are not covered by the suspension.


Terms are suspended in all other legal terms related to pharmaceutical products.


REGULATORY PROCEEDINGS RELATED WITH MEDICAL DEVICES AND TECHNOLOGIES, THAT ARE NOT SUSPENDED (Art 8)


Terms are not suspended and procedures will be processed as a priority with respect to medical devices and biomedical equipment listed in Act 3 of 2020 and those declared as Vital Not Available, in vitro diagnostic reagents, required to attend the emergency and related to COVID-19.


Thus, they continue to manage, in the aforementioned procedures, the response to official actions, appeals, response to suspensions of health registration or marketing authorizations, corrections and notifications of administrative acts.


Terms are suspended in all other legal terms related to medical devices and other technologies.


REGULATORY PROCEEDINGS ON COSMETICS AND CLEANING PRODUCTS THAT ARE NOT SUSPENDED (ART 9)


Terms are not suspended, and procedures within the framework of the sanitary emergency regarding gels, antibacterial solutions, disinfectant products for domestic hygiene, soaps and detergents for washing clothes, surface cleaners, dishwashers and dishwashers will be carried out.


Thus, assignments, renewal, changes and modifications in NSO codes, automatic Free Sales and non-compulsory Certificates for cosmetics and household cleaning products, and certificates of capacity and production capacity for companies that continue to be managed They intend to manufacture products framed within the health emergency.


Terms are suspended in all other legal terms related to medical devices and other technologies.


PRIORITIZATION OF REGULATORY PROCEEDINGS (ART 3)


INVIMA, as a general rule and during the emergency, will give priority for processing, the new marketing authorization procedures, NSO, permits, renewals, changes and modifications related to the products necessary to attend the sanitary emergency that are filed through the virtual channels


Likewise, priority will be given to renewal requests "that can be made during the validity of the health emergency", subject to the provisions issued during the emergency provided for the renewal procedures that cannot be carried out during the emergency, since marketing authorizations that expire during the Health emergency will be understood to be extended for a month (1) counted from the date the emergency ends.


On the other hand, it is also on the list of proceedings prioritized by the entity, some actions related to the procedures for products necessary for the emergency, such as notifications of administrative acts in which the suspension of terms does not apply, filing responses to official actions, requirements, corrections, official reviews that do not need fee payment, on procedures under priority and in which the suspension does not apply.


The response to petition rights is also prioritized, which will be addressed in the terms established in article 5 of Decree 491 of 2020.


GENERAL CONDITIONS OF THE SUSPENSION OF TERMS (ART 1)


In general, INVIMA applies the suspension of legal terms to procedures that are not expressly excluded from the suspension.


The Resolution clarifies that it also applies to processes carried out by the entity in the disciplinary, coercive, punitive, contractual, and other fields in the exercise of the inspection, surveillance and control functions.


The terms will resume on the first business day following the termination of the Health Emergency, a date currently set for May 30, 2020, in accordance with the provisions of Resolution 385 of March 12, 2020, of the Ministry of Health and Social protection. During the suspension there are no terms of expiration, prescription or firmness.


Notifications during the suspension period will be advanced electronically.


Lastly, INVIMA will continue to exercise its inspection, surveillance and control functions.


 


SEE RESOLUTION2020012926 OF2020


 



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