Procedures of Sanitary Regulation for “Non-Indispensable” Products in times of COVID19

In these strange times, the role of health authorities in regard to product management is essential to properly handle and ward off the crisis. In Colombia, the authority in charge of granting authorization to enter the market for consumer goods and products for human consumption is INVIMA. From foodstuffs to biomedical equipment, these must go through this authority before they can be marketed in our country.

As a result of the health crisis, INVIMA has played a leading role in managing the situation, as the authority that can guarantee that supplies and essential goods reach our health personnel in clinics and hospitals and that all in our homes we have products that help us to better prevent risk.

INVIMA has correctly defined a list of products that will not need market approval for their manufacture / import, in order to make them more available in crisis management. Similarly, the authority had to reinvent itself in a matter of days and go from being an entity that handled the vast majority of its procedures physically, to be an entity with completely digital and online handling of procedures.

But this change and crisis management is focused exclusively on the products that are used directly to manage the health emergency.

What happens then with other products?

At the date of publication of this article, it is not possible to carry out any type of procedure before INVIMA for products that are not directly related to the management of the health crisis caused by the pandemic. The pandemic management products have been determined to be all foods, since it has been understood that protecting and maintaining the supply chain is essential at this time; certain cosmetics such as disinfectant gels or soaps that reduce the risk of contagion, medical devices such as thermometers, mechanical ventilation equipment, personal protection elements; and a specific list of drugs that are considered to be necessary to treat the virus.

INVIMA issued a resolution suspending the deadlines (will not accept new procedures) for new procedures for products other than those listed above. The applications for all kinds of different products that were already in process before the declaration of the pandemic continue, and in fact we can verify that requirements and decisions are served via email, that is, the work continues.

We fully agree with INVIMA that all the authority’s efforts should be focused on this crisis, however, we consider that it is not sustainable to completely suspend activities for such a significant number of products, even if import procedures for all previously approved products Is currently possible.

In the health sector and for the treatment of other types of conditions, there are many products that are essential and whose procedures should not be put on hold longer than necessary. A kit for open heart surgery, a prosthesis, an oncological medicine, are products that have long and complex procedures which are currently frozen. This does not only harm to companies involved; public health can be affected, and we should not wait for declarations of shortages to carry out this type of procedures.

Even for other products that we understand are not essential, as makeup cosmetics or alcoholic beverages, we insist that we know that at this time they are not a priority, but if we want the economic effect of this crisis to be as minor as possible, If there are companies that continue to trust Colombia and are willing to embark on new projects, if we want people who work in companies in these sectors to be better protected, if we want to try to return to the (new) normality as soon as possible, it is necessary that normality returns to the place where it all begins: The public entity that approves whether these products are marketed or not.

We trust that INVIMA will be able to adapt to these new times and that having the proper management of the pandemic as its north, it will be able to support the industries of products that are not essential for the direct management of the crisis as soon as possible, as that they are all important for indirect management of it.