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Guide on COVID-19 Vaccination: Regulatory Issue

COVID-19, the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe causing severe economic and social disruption worldwide. While the world continues to see the detrimental effects of COVID-19, it also begins to welcome the unfolding global endeavour of vaccine development and deployment. The global pharmaceutical industry has announced its commitment towards developing vaccines for COVID-19, and several vaccines have since been authorised by various national regulatory authorities for public use, with vaccinations taking place in several countries across Southeast Asia.

This quick guide explores the various regulatory issues arising in different parts of Southeast Asia, briefly covering vaccine registration and administration, as well as each country's regulatory framework, as of 20 April 2021.

OJK Introduces Rules on Going Private and Obligation to Identify Controlling Shareholders

Indonesia's Financial Services Authority, or OJK, recently enacted Regulation No. 3/POJK.04/2021 on Implementation of Capital Market Activities. In line with its title, this regulation governs various capital market activities and the actors in it. The two main elements of this regulation are introducing the procedures to go private and identifying a public company's controlling shareholders and its obligations.

In the regulation, OJK identifies three situations where a public company can go private: voluntarily, based on an order from OJK, or based on an order from IDX. Meanwhile, on controlling shareholders, the regulation affirms OJK's policy of requiring public companies to disclose their controlling shareholders, whether direct or indirect.

OMNIBUS LAW 2020: Shift to Risk-Based Licensing Set to Transform Indonesia's Investment Climate

Following the enactment of the Omnibus Law, the government has introduced the necessary implementing regulations to the law. Of the proposed changes under the Omnibus Law, one, in particular, will affect all businesses, namely the shift from a commitment-based licensing regime to a risk-based licensing regime. The new regime is reflected under Government Regulation No. 5 of 2021 on the Implementation of Risk-Based Business Licenses (“Regulation”). The Regulation is aimed at administering a more streamlined and efficient business licensing process, and in some instances, even removing the licensing requirement for certain businesses.