Until recently, companies in Argentina were required only to list the relevant clinical study protocol number when importing or exporting biologic specimens. Now, as of July 1, 2017, importers and exporters must obtain specific approval from Argentina’s ministry of health, ANMAT, for shipments of biologic specimens.
According to ANMAT notification No. 0004[i], companies involved in clinical research must apply for authorization to import/export biologic specimens by submitting the new application “Request for export/import of biological samples linked to clinical pharmacology studies.” The application gathers information about the import/export shipment which includes:
- Name and address of clinical sponsor/investigator authorized to conduct the study
- Study protocol information (for studies taking place both in and outside of Argentina)
- Type of specimen(s)
- Information about the specimen(s)’ destination
- Information about the specimen(s)’ origin
Additionally, shipments of biologic specimens linked to studies approved in Argentina before 2013, require a certification letter from Argentina’s Drug Evaluation and Registration Directorate (DERM).
The certification letter must validate the need to continue importing/exporting biologic specimens for protocols approved five years ago or more. This new rule aims to ensure that study protocols used to authorize import/export of biologic samples are still current and under proper supervision.
Companies in Argentina can apply for the DERM certification by using the new application “Request for proof of the validity of the authorization for the import/export of biological samples linked to clinical studies.”
Considering that ANMAT published notification 004 on June 15th and the new import/export rules went into effect on July 1st, companies in Argentina have had little time to react and comply with the new requirements.
Marken Argentina has already begun working with local labs and CROs to explain the new rules, help obtain the new import/export approvals and has successfully handled import/export shipments covered under the new requirements.
For further information about Argentina’s new import/export rules, please contact email@example.com.
Reynaldo Roman LCB, CCS
Senior Manager Regulatory Compliance