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Salient features of Pharma Annexure under "India-UAE CEPA & India-Australia ECTA​
 

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PXL/HO/Cir-009/2022-23                                                                            Date: 04.05.2022

Hyderabad

 

Dear Sir/Madam,

 

Subject: Salient features of Pharma Annexure under "India-UAE CEPA" & "India-Australia ECTA"

 

Pharmexcil is pleased to inform members that India and the United Arab Emirates (UAE) have signed the Comprehensive Economic Partnership Agreement (CEPA) on 18 February 2022 and entered into force from 1st May 2022.  The India-UAE CEPA is expected to boost the bilateral merchandise trade from US$ 60 billion to US$ 100 billion in 5 years,  For the first time in a Trade Agreement, a separate Annexure on "Bilateral Cooperation on Pharmaceutical Products" has been incorporated to facilitate access of Indian pharmaceuticals products having regulatory approvals from reference countries namely  Australia, Canada, European Union, Japan, the United States of America, or the United Kingdom.  

 

Salient features of Pharma Annexure under INDIA-UAE CEPA are as follows:

·   Recognition of GMP certificates issued by Stringent Regulatory Authorities: UAE will be accepting Pharmaceutical products of Indian origin without the need for prior inspection,  provided that these products are approved by the Regulatory Authorities of reference countries 

·   Fast Track Approval for Product Registration:UAE does not need to carry out a full assessment or inspect its manufacturing sites for the products already approved by reference countries and  fast-track the procedures for Pharmaceutical Products having approvals from at least one of the reference countries 

·        a) Marketing authorisation shall be provided within ninety (90) days without any inspections by for Pharmaceutical Products of the approved by the relevant Regulatory Authorities of reference countries.

·        b) For all other Pharmaceutical Products where inspections are required, UAE shall, to the extent possible, and only as practicably possible, grant marketing authorisation within two hundred and seventy (270) days of application. 

 

Further, India and Australia have also signed the Economic Cooperation and Trade Agreement (Ind-Aus ECTA) on 2 April 2022. It is anticipated that the IndAus ECTA will enhance the bilateral trade from US$ 27.5 bn to about $ 45 to $ 50 Billion in next 5 years.   

 

·    Australia has agreed for an Annex on Pharmaceutical products under this agreement, which will enable fast track approval for patented, generic and biosimilar medicines using the Comparable Overseas Regulator Pathway. It will also enable fast track quality assessment of manufacturing facilities using, as appropriate, the inspection reports of the comparable overseas regulators. This is expected to be a significant trade facilitation measure for India's pharma sector which will enable Indian Pharma companies to access the Australian market and aid in boosting India’s pharma exports.

 

Please find the India-Australia ECTA.

 

To create awareness among members, Pharmexcil is sharing the Copy of the Annex on Pharmaceutical products under both agreements along with  the FAQs on both the agreements. 

 

 

With Regards,

 

Udaya Bhaskar

Director General

 

 

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