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PXL/HO/Cir-039/2026-27 Date: 16.07.2026
Hyderabad
Subject: Invitation for Comments on Proposed Co-operation with Serbia in the Health/Pharmaceutical Sector
Dera Sir,
Greetings from Pharmexcil!
We are pleased to inform our member companies that Pharmexcil has received a communication from the EP (Pharma) Division regarding opportunities for enhancing pharmaceutical cooperation with Serbia.
It is understood that Serbia has a statutory provision for an accelerated review process (150 days) for medicinal products that possess a European Commission Marketing Authorization. This provision is incorporated under “Official Gazette of the Republic of Serbia” No. 30/2010 dated 7th May 2010. Relevant provision – Article 34 - Marketing Authorization Issuance according to the Accelerated Procedure in the Law on Medicinal Products and Medical Devices.
In this regard, member exporters are requested to examine the above provision and assess the opportunities and benefits available for Indian pharmaceutical companies in the Serbian market. Members are also invited to provide their comments and suggestions on the possibility of establishing a Memorandum of Cooperation (MOC) or Letter of Intent (LOI) in the Health/Pharmaceutical sector between India and Serbia to strengthen regulatory cooperation and facilitate market access.
We request all member exporters to actively participate by sharing their valuable inputs on the proposed cooperation with Serbia in the Health/Pharmaceutical sector.
Kindly submit your comments through the link provided below at the earliest by 17 July 2026, EOD:
https://forms.gle/1b61bPkZ66AyErbv5
Your timely inputs will greatly assist the Government in formulating appropriate recommendations to strengthen regulatory cooperation and enhance pharmaceutical trade relations between India and Serbia.
Thanking you,
Regards,
Raja Bhanu
Director General
Encl _ Article 34_ Market Authorisation Issuance _Accelerated Procedure
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