PXL/HO/Cir-005/2021-22                                                                     Date: 24.04.2021

Hyderabad

Dear Sir/Madam,

Subject: MAI Scheme for Product Registration Charges abroad–Eligibility criteria for submission of claims- Reference dates for calculating eligibility period

Members are kindly aware that according to the MAI guidelines 2018, a company has to submit their claims on-line, complete in all aspects, within 90 (ninety) days from the date of issue of Product Registration Certificate (in case of registration) and re-registration certificates (re-registration). Though the timeline has extended to 180 days for the claims of FY-2019-20 and FY-2020-21, the applications pertaining to FY 2021-22 onwards should follow 90 days criteria for initiating the online MAI claim applications.

In spite of continuous guidance to the member companies by our MAI team on the timelines for initiation of application, we are observing that errors are being committed by applicants and some are filing the applications beyond 90 days from date of issue of Product Registration certificate, which could not be proceeded & recommended by the Pharmexcil.

To educate the members on the REFERENCE DATE TO BE CONSIDERED
(i.e date of issue of product registration/re-registration certificate) for 90 days criteria while initiating the claim applications we have developed a database of the product registration certificates of most of the countries (Listed below), wherein the Issue date is Highlighted in Red circle Marking.

Reference Dates for MAI Claims For Registration/ Renewal

• Burkina Faso (New Registration , Re-Registration)
• CAMBODIA (New Registration , Renewal )
• Chile (New Registration )
• Congo (New Registration , Renewal )
• Cote d Ivory (New Registration , Renewal)
• France (New Registration, Revision & Renewal)
• Ghana (New Registration , Re-Registration)
• Guatemala (New Registration , Re-Registration)
• Honduras (New Registration , Re-Registration)
• Kazakhstan for Drug products (New Registration ,Re-Registration)
• Kazakhstan for Veterinary products (New Registration , Re-Registration )
• Kenya (New Registration, Renewal)
• Moldova (New Registration , Re-Registration )
• Myanmar (New Registration , Re-Registration )
• Malawi (New Registration , Renewal)
• Niger (New Registration certificate , Re-Registration )
• Nicaragua (New Registration certificate , Re-Registration )
• Philippines (New Registration , Renewal)
• Russia (New Registration)
• Sri Lanka (New Registration , Re-registration)
• Switzerland (New Registration, Renewal)
• Tajikistan (New Registration certificate , Re-Registration)
• Tanzania (New Registration , Renewal)
• Turkmenistan (New Registration ,Re-registration)
• Ukraine (New Registration , Re-Registration )
• Uganda (New Registration , Renewal)
• Uzbekistan for Drug product (New Registration ,Re-Registration)
• Uzbekistan for Veterinary products (New Registration , Re-Registration)
• USA  (DMF and ANDA product)
• Zambia (New Registration ,Renewal)

The above details are shared for reference purposes only. Please note that applications which are initiated appropriately within 90 days from the date of issue of product registration/re-registration certificates will be considered and any deviation from the above will be returned immediately.

With regards

Udaya Bhaskar

Director General