Nicaragua: Issues Regulations for Product Recalls

On November 9th , 2023, in use of her faculties, the Director of the National Health Regulation Authority (hereinafter “ANRS” by its abbreviation in Spanish), approved the Regulation for the withdrawal from the market, final disposal of products regulated by the ANRS and management of substandard and falsification products; which would have a transitory period of three (3) months counted from its execution, that is to say that, as from February 9th, 2024, all persons included in the regulation must comply, adjust their processes, request approval and inform the ANRS, of the acts to be carried out in relation to what is set forth therein and which details are described below.

This resolution answer to the objectives of the Sustainable Health Agenda for the Americas 2018-2030 (ASSA 2030 by its abbreviation in Spanish) and the need to create mechanisms to ensure the adequate withdrawal from the market of products regulated by the ANRS, classify unforeseen risks and apply corrective and preventive measures, as well as the application of sanctions.

The approved regulation is applicable to all public and private institutions, natural or legal persons engaged, either permanently or occasionally, in the manufacture, registration or sanitary authorization, import and distribution of medicines, including infant formula and breast milk substitutes, vaccines, biologicals, biotechnological products, natural medicinal and homeopathic products, food and beverages, nutritional supplements, medical devices and other health-related technologies, precursor chemicals, cosmetic and hygienic products, tobacco and its derivatives, biotechnological products, natural medicinal and homeopathic products, food and beverages, nutritional supplements, medical devices and other technologies related to health, precursor chemical substances, cosmetic and hygienic products, tobacco and its derivatives, and in general, any product regulated by the National Health Regulation Authority.

In the regulation we can find the normative aspects such as the definitions; prohibitions; the product recall process; the submission of recall reports; health risk assessment; recall classification; final disposal of products and the handling of substandard or counterfeit products.

According to the approved document, the marketing, offering or distribution of products subject to recall is prohibited, as well as the manufacture, import, distribution, marketing, offering or possession of substandard or counterfeit products; and not to proceed with the final disposal of regulated products without the supervision and control of the ANRS.

The ANRS, at any time, may order the withdrawal of regulated products for technical reasons related to deficiencies in their safety, efficacy, quality and safety. Also, manufacturers, registration or marketing authorization holders or importers may voluntarily initiate the voluntary withdrawal of regulated products, either due to complaints or due to evidence of damage to the health or safety of people, and in both cases, weekly reports must be submitted to the ANRS until the completion of the withdrawal from the market.

Also, an investigation report must be submitted in which the causes of the defect and the corrective and preventive actions to be taken, or the justification for the impossibility of submitting such report, are reported to the ANRS.

Among the functions of the ANRS is the evaluation of the health risk of the products to be withdrawn from the market, in accordance with the withdrawal classification, whether Class I, II and III, according to the nature of the health risk or adverse effects, determining the term of five, twenty and thirty calendar days respectively, according to each classification and, subject to determine a maximum term depending on the urgency and health risk.

It will be the responsibility of the ANRS or manufacturer, registration or sanitary authorization holder or importer, as appropriate, to adopt the final disposal of the products, after authorization from the ANRS and involvement of the environmental institutions or those involved in the process.

It is important to consider that in case of withdrawal of products and their final disposal, this cost will be assumed by the manufacturer, holder of the registration or sanitary authorization or importer.

According to the instrument, it is forbidden to manufacture, import, distribute, commercialize, offer, or possess substandard or counterfeit products, and the ANRS must inform the population of these findings, prior inspection and order the seizure and final disposal of the products.

Disciplinary sanctions will be applied in accordance with Law number 423, General Health Law and Law number 1068, Law Creating the National Health Regulation Authority; sanctions ranging from administrative measures (preventive and safety), fines from C$ 500.00 córdobas to C$ 50,000.00 córdobas, suspension or cancellation of authorizations, registrations, permits or licenses, without prejudice to indemnification for damages and criminal liability.

If you would like to know more about this matter, please do not hesitate to contact us through any of our official communication channels

Authors:
1. Róger Pérez - Partner in Arias Nicaragua
2. Tania Padilla - Associate in Arias Nicaragua

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