By: Gelmis Lopez
This Administrative Resolution will apply to all public and private institutions and all natural or legal persons that are permanently or occasionally dedicated to manufacturing, holding registration or health authorizations, importing and distributing medicines, including formula and breast milk substitutes. , vaccines, biologicals, biotechnological; natural medicinal and homeopathic products; food and drinks; nutritional supplements; medical devices and other health-related technologies; precursor chemicals; cosmetic and hygiene products; tobacco and its derivatives; and, in general, any product regulated by the National Health Regulation Authority (ANRS).
Art. 2: No person may market, offer and distribute products subject to recall.
Art. 3: No person may proceed to the final disposal of regulated products without the supervision and control of the ANRS.
Art. 4: No person may manufacture, import, distribute, market, offer or have in their possession substandard or counterfeit products.
Art. 5: The ANRS may order the withdrawal of a regulated product from the market at any time, for technical reasons related to deficiencies in its safety, efficacy, quality and safety.
The cost of the market withdrawal must be assumed by the manufacturer, the holder of the health registration or authorization or the importer, as applicable, for which they must provide the information indicated in this resolution. It is mentioned that the manufacturer, the holder of the registration or marketing authorization or the importer may voluntarily initiate the withdrawal of any product regulated by the ANRS after receiving complaints from users or upon verifying after an investigation that the product can cause harm to the health or safety of the patient.
Art. 6: The manufacturer, the holder of the registration or marketing authorization or the importer must report weekly to the ANRS on the progress and completion of the withdrawal of a product from the market. This activity must be supervised by delegates of the ANRS, the reports must include product reconciliation of quantities delivered and recovered; as well as the causes of the defect, corrective and preventive actions or the causes that make the presentation of the report impossible.
Art. 7: ANRS will carry out an assessment of the health risk posed by a product that is being recalled or is being considered for withdrawal from the market. The ANRS will assign the product recall a classification in the form of Class I, Class II or Class III to indicate the relative degree of risk that the product represents to health.
Art. 8: The withdrawal of the product will be made based on the classification and this is dependent on the nature of the health risk or adverse events. Class I is for life-threatening products that result in a serious health risk or death; class II those that cause temporary problems in the health of patients; and class III to those that are defective or unlikely to cause any health problems or that do not comply with packaging requirements. The maximum period to withdraw classes I, II and III will be five, twenty and thirty calendar days, respectively.
Art. 9: The decision to begin with the final disposal of regulated products may be adopted by the ANRS, the manufacturer, the holder of the registration or health authorization or the importer. The application must be submitted to the ANRS who will analyze its origin and decide on its authorization, as well as the final destination of the product, designating an inspector for inspection and control. In turn, the ANRS will inform the applicant so that they can contact the institution responsible for environmental management about the method of destruction; the cost of the final disposal of the product is assumed by the applicant.
Art. 10: The discovery of substandard or counterfeit products must be immediately reported to the ANRS, indicating the presentation of the product, batch number and product reference. The ANRS will inform the population of the discovery of substandard or counterfeit products, as well as the dangers of use and consumption. The ANRS will also proceed with the seizure and final disposal of counterfeit or substandard products.
Art. 11: According to Laws 423 and 1068 of the NIC, disciplinary actions will be taken.
This Administrative Resolution will have a transitional period of three (3) months from its signature. Given in the city of Managua, on the 09th day of November of the year two thousand twenty-three.