PXL/HO/Cir-148/2021-22 Date: 11.03.2022
Subject: MAI Scheme for Product Registration Charges paid abroad-Eligibility criteria for submission of claims - Reference dates for calculating eligibility criteria for Retention.
In continuation to the Pharmexcil circular PXL/HO/Cir-004/2021-22 dated: 22.04.2021 it is to bring to your kind notice that the reference dates for calculating eligibility criteria for submitting the MAI claims for Retention of products for certain countries are modified considering the constraints faced by the applicants.
The Product registration certificates, Re-registration and Renewal certificates issued by the Overseas Drug Regulatory authorities are clearly reflecting the date of issue of certificate. However in the case of annual retentions required by some countries (eg: Kenya, Tanzania, Switzerland, Uganda and Zambia), it is observed that applicants are required to make the payment for annual retention fee but the Regulatory agencies are not issuing the Retention certificate. It has become a challenge for applicants to provide the evidence of granting the retention certificate and the reference date required to initiate MAI claims.
Hence, in those cases, wherever Regulatory agency is not issuing a product retention certificate the PAYMENT RECEIPTS issued by the overseas regulatory authority for retention of the products will be considered as a reference document for calculating the stipulated timeline for submitting the MAI claim applications.
In cases where the product retention certificates and receipts are not issued by the regulatory agency,INVOICES will be considered as the reference document for calculating the eligibility criteria for submitting the claims.
We are giving below some examples for Retention of Product approvals:
Malawi : Retention certificates
Uganda, Tanzania, Zambia & Kenya : Payment Receipt for Retention
Switzerland : Invoices for Retention
Member companies are advised to submit the claims considering the above reference documents for calculating the defined timelines (i.e 45 days). For any further clarifications, members may write to Dr. Gayatri, Assistant Director (email id: email@example.com).