On September 30, 2026, the National Directorate of Health Surveillance of Paraguay (DINAVISA) issued Resolution No. 409/2026, establishing an automatic renewal procedure for the Certificates of Good Manufacturing and Control Practices (BPFyC) and the Certificates of Good Storage and Distribution Practices (BPAyD) of personal hygiene products, cosmetics and perfumes, and household cleaning and disinfection products, which will take effect on October 15, 2026. The resolution also repeals Articles 5, 8 and 9 of Resolution No. 246/2021, and certificate renewal will thereafter be governed exclusively by the new rules.
From "Renewal upon Inspection" to "Automatic Renewal"
Paraguay manages establishments engaged in the production, import and export, fractionation, storage and distribution of the above products under the BPF certificate system. Under the former Resolution No. 246/2021, companies were required to submit an annual self-inspection report in January or February each year, with late submission subject to penalties under Law No. 1119/97; certificate renewal had to be applied for within 90 to 180 days before expiry, failing which the certificate would automatically expire, and automatic renewal was conditional on a full or partial on-site inspection within the three-year validity period of the certificate.
DINAVISA considered that the rigid deadlines and mandatory inspections imposed burdens on both parties and hindered the concentration of inspection resources on high-risk establishments, and has therefore shifted to a post-market oversight model based on sworn declarations and company self-inspections, supplemented by random inspections.
Automatic Renewal Procedure
Under the new procedure, certificate holders must apply online and pay the corresponding fee through the DINAVISApy system within the 90 calendar days preceding the certificate's expiry date and up to that date.
Three documents must be submitted:
- A self-inspection report completed in accordance with Annex I and issued in the form of a sworn declaration;
- A corrective action plan where non-conformities or partial compliances are identified in the self-inspection (including measures, responsible persons and deadlines);
- Sworn declarations issued by the establishment holder/legal representative and the technical director in accordance with Annex II.
Companies must keep at the establishment all supporting documents for the self-inspection report and the corrective and preventive actions (CAPA), readily available for inspection. The Annex I self-inspection checklist covers 15 areas, including quality assurance and documentation, facilities and equipment, receipt and storage, production, master formula, quality control and microbiology, stability, production water, batch records, and complaints and recalls.
Post-market Oversight and Liability
After certificate renewal, DINAVISA's General Inspectorate will conduct inspections (including random ones) under its annual planning, taking into account the health risk assessment results, the evaluation conclusions of the self-inspection reports and the corrective measures.
Those who fail to apply for renewal in time will lose their BPF certificate and must apply for a new certificate under Resolution No. 246/2021; those operating with an expired certificate will be subject to administrative, corrective and precautionary measures or even penalties; where the self-inspection report contains falsified, adulterated or omitted data, the certificate may be revoked or suspended and the establishment's activities halted after administrative proceedings, and the persons responsible may also bear civil, criminal and administrative liability.
Main Impacts on Cosmetics Companies
(1) Keep a close eye on the renewal window: applications are only accepted within the 90 calendar days before the certificate's expiry and up to the expiry date itself; those who apply late will lose their BPF certificate and must go through the complete certification process again.
(2) Ensure self-inspections are truthful and verifiable: each item's conclusion must be supported by records, and non-conformities must be accompanied by CAPAs; falsification may lead to certificate revocation and criminal prosecution.
(3) Prepare for random inspections: under the "certify first, verify later" regulatory logic, companies are advised to integrate self-inspection and CAPA into their daily quality systems, keeping records and on-site compliance in a state that can withstand inspection at any time.
CIRS Reminder
Cosmetics companies with local factories in Paraguay or cooperation with local importers and distributors are advised to check the expiry dates of their own and their partners' BPFyC/BPAyD certificates, start the online application 90 days in advance, and improve their self-inspection and CAPA systems accordingly.
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