No Licenses for Pharmaceutical Companies Without Settlement of Tax Dues

Pharmaceutical companies will soon be required to submit a tax clearance certificate with all files lodged with the National Agency for Pharmaceutical Products, as a condition for administrative acceptance. The measure aims to ensure the settlement of outstanding tax obligations owed to the Public Treasury.

The measure applies to applications for the registration of pharmaceutical products, the approval of medical devices, and the renewal, amendment, or transfer of registration and approval decisions. It also covers advertising visas, their renewal, and all licenses or regulatory procedures subject to fees. A three-month grace period has been granted to allow companies to regularize their tax situation before the certificate becomes fully mandatory for the acceptance of any file.

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