Donations of drug products
Requirements for the inflow of donated products into Argentina
Any organization receiving a donated drug product must inform I.NA.ME. (Instituto Nacional de Medicamentos – National Institute of Drugs) in writing about the donation arrival date, the Customs Office or bonded warehouse where it will be retained and the waybill numbers of the donation parcel. A list of the pharmaceutical products involved containing their active pharmaceutical ingredient, potency and expiry date may be also enclosed. The said documents may be submitted to I.NA.ME. prior to shipping the products from the origin country in order for it to perform an assessment of the donation documents and therefore prevent later inconveniences. Upon arrival of the donation at the Customs Office, I.NA.ME. inspectors will be informed about its arrival and perform and inspection on the product within a three-day period after the arrival notice date. Inspectors may reject the release of donated pharmaceutical products based upon the following criteria:
If the received products are expired or prohibited in our country.
If the shelf-life of the received products is less than three months from the date of receipt.
If the products are open or have been partially used.
If the cold chain has not been maintained in the cases of products requiring it.
If the active ingredient and/or potency of the donated product has not been registered at the Argentine Register of Proprietary Drugs.
At the end of the donation inspection, a record will be signed by the officials who took part in the procedure and the person designated by the recipient. Such record will include the name, batch number, active pharmaceutical ingredient, quantity and manufacturer of the donated product.
The officials involved in the procedure will submit the record to the I.NA.ME. Foreign Trade department. Then, the said department will issue a note authorizing the transportation of the product to the warehouse chosen by the recipient but without granting the recipient the permission to use it. Obviously, this does not apply to drug products under the criteria for authorization rejection set out above.
Samples of the products will be taken, unless the quantity is small (less than 100 units) or the product active pharmaceutical ingredient belongs to the wide therapeutic window type (that is to say, the dose needed is considerably lower than the toxic dose).
Relevant quality controls will be performed on the samples and only the compliant products will be released. Finally, the release will be granted by the I.NA.ME. Director and the Technical Coordination department or either the Foreign Trade department will grant a release certificate to the recipient.
Note: the requirements mentioned herein are those made by A.N.M.A.T.
There are also Customs Office requirements that must be met.
