MANILA – Local vaccine manufacturers now have access to the green lane, which facilitates the expedited permitting process for the establishment and operation of “bulk import, fill and finish Covid-19 manufacturing facilities” in the Philippines.
The Anti-Red Tape Authority (ARTA) on Wednesday led the signing of the Joint Memorandum Circular (JMC) together with the Department of Health (DOH), Food and Drug Administration (FDA), Department of Trade and Industry-Board of Investments (DTI-BOI), Department of Science and Technology (DOST), and National Task Force Against Covid-19 (NTF Covid-19).
The JMC titled “Establishment of a Green Lane for Securing Permits, Licenses and Authorizations for the Establishment and Operation of a Bulk Import, Fill and Finish Local Coronavirus Disease 2019 Vaccine Manufacturing Facility and For the Registration for Availment of Incentives” states that manufacturing facilities will follow the bulk import, fill, and finish model.
“Bulk supplies of vaccines will be imported from abroad and the local companies will fill and package vials locally for distribution,” the JMC read.
Agencies involved in the permitting process such as the FDA shall follow the green lane’s guidelines “for the use of facilitated registration and evaluation pathway for permits, licenses, and authorizations” including applications for Emergency Use Authorization (EUA).
With this, the FDA will have to identify a dedicated staff for licensing, authorization, and/or registration to assist applicants throughout the entire process.
“Interaction with the applicant in the processing of the applications covered herein shall not be considered a violation of the Zero-Contact Policy when the inspection or meeting with the applicant is an integral part of the application process for a complex or highly technical transaction or when such interaction was done upon the written request of the applicant,” the document clarified.
The green lane mandates that applications for a License to Operate (LTO) as a vaccine manufacturer shall take no more than 20 working days.
It also enables pharmaceutical companies to put up manufacturing facilities within 10 months.
Through the DTI-BOI, local vaccine manufacturers may avail of the incentives applicable per Republic Act No. 11534 or the “Corporate Recovery and Tax Incentives for Enterprises Act” (CREATE Law) and other applicable laws and implementing rules and regulations.
“DTI-BOI, through its Investments Assistance Service, shall provide assistance to the applicant by facilitating the immediate resolution of issues and concerns relating to the establishment and operation of a Covid-19 vaccine manufacturing facility including those related to applicable administrative processes of the Bureau of Customs (BOC) and other concerned government institutions, agencies, and LGUs),” the JMC added.
A Joint Oversight Committee, composed of ARTA, FDA, DOH, DTI-BOI, DOST, NTF Covid-19, and the Office of the Presidential Adviser on Streamlining of Government Processes (OPASGP), is tasked to monitor the implementation of the JMC.
An advanced market commitment for the Covid-19 vaccine will be addressed in a separate Memorandum of Agreement between the local Covid-19 vaccine manufacturers and the concerned agencies.
The JMC institutionalizing the green lane is a response to President Rodrigo Duterte’s directive to lessen the Philippines’ dependence on Covid-19 vaccine importation and capacitate the country in developing its own vaccines. (PNA)