The respirators were donated by the Lionel Messi Foundation to the municipality of Rosario. (Photo: AP / Fernando Vergara)
Hours after it was revealed that there more than 30 respirators donated by Lionel Messi ten months ago that are stranded at the Rosario airport, the government issued a release to clarify the situation. “The ANMAT did not authorize the entry of products called Mechanized Automated Resuscitation Balloon (referred to as“ respirators ”), which were donated by Lionel Messi through its foundation to the municipality of Rosario, for not presenting to this National Administration the necessary documentation for the authorization of entry of the donation, “says the statement.
The text adds that “they are prototypes that do not have the certificate of free sale issued by the health authority of origin. The entry request initiated by the recipient of the donation entered in August of the year 2020, and during the same month it was indicated that there were missing documentation, and from that moment Has not been received no documentation ”.
Finally, the official statement provides the link available on the ANMAT website in reference to the requirements and steps that donated medical products must complete:
Ten months ago, 32 of the 50 respirators donated by Lionel Messi to Rosario through the Foundation that bears his name, for assistance against coronavirus. But the key supplies for patients with more severe disease are found stranded since your arrival at Rosario International Airport. They are waiting for the aforementioned authorization of the ANMAT, confirmed sources of the organism to TN.com.ar. Subtract the presentation of product records by the health authority of origin (Europe), among other documents.
The president of the Rosario area terminal Eduardo Romagnoli explained in TN that “what is needed is a authorization of income ”that the ANMAT must have. He clarified that it is the “Only organism that can function as an enforcement authority ”to release inputs.
The president of the air terminal explained in TN that the supplies “are preserved in a suitable place” (Photo: Twitter @ Messismo10).
He explained that the guard costs are in charge of the airport, that the respirators “are preserved in a suitable place” and that “There is no risk” from deteriorating.
He said that both the Messi Foundation and the Rosario Health Secretariat are “in permanent contact”, that they monitor the situation and that there is concern because these equipment could not yet be used.
ANMAT requirements to donate medical equipment
You need to comply with a series of conditions for the ANMAT to enable donated medical products. Prior to shipment, the entity that receives them must send data to this body. Among them a list of the material to be entered with the generic name, brand, model, date of manufacture and if it is new or used. The payroll must be signed by the owner of the organism receiving the donation, as an affidavit.
In the event that the product is registered with the National Administration of Drugs, Food and Medical Technology, you will have to present a copy of the current registration on the date of entry of each of the donated medical products. Otherwise you will have to attach a copy of the marketing authorization (Certificate of Free Sale) valid on the date of entry, issued by the health authority where the medical product is offered.
Once the endorsement of the National Institute of Medical Products has been obtained, the import authorization request for donated products can be made. The entity that receives it must accept the responsibility for these products. It will also have to “explicitly commit to assume the cost of re-export, in case they are declared unfit for use in human beings by the ANMAT”, as established by the regulations of the agency.