ANMAT Revokes 25 Drug Certificates
Argentina's National Administration of Drugs, Foods and Medical Technology (ANMAT) canceled 25 certificates for medicines listed in the Registry of Medicinal Specialties (REM) because they had expired and their holders had not begun the re-registration process. The decision was formalized through Disposition 5866/2026, published in the Official Gazette and signed by ANMAT head Luis Eduardo Fontana. The agency ordered that the affected companies be notified so they can file a reconsideration appeal within 20 or 30 days.[S1][S2][S3][S4]
The affected laboratories, some with more than one product withdrawn, include CSL Behring S.A. (certificates 31273 and 32949), Lafedar S.A. (31858, 47816, 51545, 17638 and 21191), Microsules Argentina S.A. (32993), Aspen Argentina S.A. (38674), Lavimar S.A. (40066), Laboratorio Internacional Argentino S.A. (51557, 51911, 52159, 52172 and 3007), Savant Pharm S.A. (52195), Laboratorios Monserrat y Eclair S.A. (55174), Takeda S.A. (55225), Megalabs Argentina S.A.U. (55510), Eurofar S.R.L. (57583), Monte Verde S.A. (57594), Tecnonuclear S.A. (58460), Terumo BCT Latin America S.A. (58822 and 58925) and Laboratorio Elea Phoenix S.A. (59189).[S1][S2]
Why the Certificates Were Canceled
The sanctions followed a review of REM certificates by the Directorate of Technical Information Management, which found that several had not been re-registered. The inspection determined that the authorizations were expired and that their holders had not started the renewal procedure. ANMAT recalled that authorization to manufacture and market a medicinal specialty is valid for five years from the issuance of the enabling certificate, as established in Article 7 of the Drug Law No. 16,463.[S1][S2][S4]
Holders or representatives of products registered with ANMAT must request re-registration within 30 days before the certificate expires. Article 8 of Law No. 16,463 provides that manufacturing and sales authorizations can be canceled for modifications or breaches of the conditions under which they were granted, as well as for the expiration of the validity period. Based on that, the agency decided to annul the certificates listed in the annex of the disposition for failing to meet the current requirements for re-registration in the Registry of Medicinal Specialties.[S1][S2][S4]
Recent ANMAT Action on Unregistered Dermatological Product
Two days earlier, ANMAT banned the sale, distribution and use nationwide of products from the CAFLAB and CAFLAB Applied Science brands intended for human medicine after finding they lacked health authorization. The measure covers, among other items, a 30% trichloroacetic acid solution promoted for dermatological treatments. Disposition 5970/2026, published on September 21 in the Official Gazette, included any medicine or medical product identified with those brands, as well as those claiming to be manufactured by CAFLAB Applied Science and indicated for human use.[S1]
The action began after a complaint from a person who had bought the product through Mercado Libre. Based on that report, ANMAT's market control area reviewed labels, sales listings, the company's website and available records. The product was offered as a topical solution for removing warts and condylomata acuminata related to human papillomavirus. It was also promoted for keratosis, scars and peeling procedures on skin with acne or greater thickness. For the agency, the therapeutic indications, composition and presentation form allowed it to be classified as a medicine. However, there was no health registration to verify its formulation, safety, efficacy or manufacturing conditions.[S1]
The verifications included a query to the Helena system, which lists similar products from other manufacturers registered as medical devices. Information was also requested from the Pharmacy Directorate of the Ministry of Health of the province of Buenos Aires, which reported that no establishment was authorized under the name Laboratorio CAFLAB Applied Science. The provincial authority also indicated that at the address declared on the labels, located in Luis Guillón, Esteban Echeverría district, there was no authorization or procedure to operate as a pharmaceutical establishment. The investigation also led to a criminal complaint for an alleged offense against public health.[S1]
