PFDA released two consecutive guidelines, FDA Circular No. 2020-0024 and FDA Circular No. 2020-0026, to update existing regulation for the transactions allowed during the quarantine period and to finalize previously drafted regulation for the new normal operations.
Under FDA Circular No. 2020-0024, the following guidelines were mentioned:
- 1) License to Operate (LTO) applications were resumed but priority will be given to establishments that will cater products related to COVID-19.
- 2) Certificate expiry and Product Renewal: An automatic 4 months extension was granted to LTOs, CPRs and CPNs expiring on 01-Jul-20 to 31-Dec-20. During importation and securing clearances with Bureau of Customs, a copy of the circular must be attached after the LTO or CPR/CPN expiry.
- 3) PFDA Payments: Over-the-counter payments were suspended. Applicants must use other payment channels such as On-Coll payment or online payment.
- 4) Certificate Release: Copies of certificates will be sent to registered e-mail address of the authorized representative per company while the hard copies will be mailed to respective company office.
FDA Circular No. 2020-0026, on the other hand, provide the specific details initially mentioned by 2020-024. In this document, online transactions became the mode of transacting with PFDA until further notice. All face-to-face transactions were suspended until further notice. Here are the other guidelines discussed in this announcement:
1) Specific details on the e-mail format for inquiries, applications and compliances were also given.
2) Renewal, amendment and correction of CPRs were also resumed. However, for ever company, renewal applications are limited to 5 per week while amendment and correction is 2 per week.
3) Non-COVID-19-related CMDR applications will only be entertained starting September 17.
Both guidance effectively repeals the previously released FDA Circular No. 2020-006 and its amendments.
FDA Circular No. 2020-024