PXL/HO/Cir-047/2022-23                                                        Date: 06.10.2022

Hyderabad

Subject: Status Update & Feedback on Utilization of Pharma Annex under India UAE CEPA

Members are kindly aware that Bilateral Cooperation Agreement for Pharmaceuticals under the India-UAE CEPA ,  allows automatic registration of Indian pharmaceuticals and grant of market authorization within ninety (90) days without any inspections for Pharmaceutical Products approved by the relevant Regulatory Authorities of reference countries namely  Australia, Canada, European Union, Japan, the United States of America, or the United Kingdom.

In this regard, we would like to know the feedback from the member companies if they have been able to utilize the benefits of automatic registration and marketing authorization for their products as envisaged under the Agreement.  We would appreciate it if you could let us know the no.of applications filed by your company after 1st May 2022 (effective date of  India-UAE CEPA agreement) and the time period for getting the registration from UAE for those products already approved by the abovementioned regulatory authorities. 

Kindly share your feedback to Ms. Lakshmi Prasanna, Director-Regulatory Affairs, email ID: regulatory@pharmexcil.com latest by 7th Oct 2022. This would enable the council to appraise the Department of Commerce and to further take up the issues/concerns of members, if any, with the UAE side during the upcoming bilateral ministerial level meeting. 

With Regards,

Udaya Bhaskar

Director General