By: Gelmis Lopez
This Ministerial Resolution came into force in August 2023, which was shared in a timely manner. Said Resolution concerns payments for services provided by the National Health Regulation Authority (ANRS) of NIC.
On p. 9 of the Resolution is the concept of payment Authorization of contract for the manufacturing of Medicines for Human Use to third parties (maquila), payment in foreign currency is the equivalent of $50. This process must be carried out in the cases that apply in the different procedures that are presented in the Pharmacy Division, it is clarified that this process of requesting contract acknowledgments has been recently implemented by the MINSA.
Requirements and process:
- Referral letter, made by the responsible professional
- Payment at the MINSA cash register
- Original manufacturing contract with its proper legalized translation
- Authenticated copy, this is up to us
- In cases where contracts are signed by other subsidiaries of the same company, a document must be presented to support that you are authorized to sign said quality agreement.
- According to the Resolution, the result of the review is received within 10 business days.
- When the result is positive, an acknowledgment of the contract is received from the SAJ of the ANRS, then this acknowledgment is presented in a simple copy in the various procedures that require presenting the document.
- If the result is negative, corrected documentation must be presented and the respective payments made.
- Take into account that manufacturing contracts must comply with what is indicated in Resolution No. 446-2021
Important notes:
- In cases where acknowledgment is being requested in a process in progress, the contract must be submitted promptly to the MINSA since they do not authorize an extension of time to correct the rejection minutes.
- For future procedures to be entered, it is recommended to first submit the contracts so that the procedure is not affected by not having the respective acknowledgment of quality agreement.