Republic of the Philippines Department of Health

FOOD AND DRUG ADMINISTRATION

Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Fax +63 2 807 0751 Website: www.fda.gov.ph Email: info@fda.gov.ph

DRAFT VERSION FOR COMMENTS AS OF 02 JULY 2020 <Approval date >

FDA CIRCULAR No. <YYYY> - < NNN>

SUBJECT : New Normal Operational Guidelines of the Food and Drug Administration (FDA) at the Food and Drug Action Center (FDAC)

1. RATIONALE

Pursuant to DOH AO No. 2020-0015 known as “Guidelines on the Risk-Based Public Health Standards for COVID-19 Mitigation”, the FDA has been strictly implementing health protocols and minimum standards of safety to prevent the transmission of infectious diseases. The US Centers for Disease Control and Prevention Hierarchy of Controls provides a system of protecting workers from occupational hazards. Based on the hierarchy framework, eliminating or physically removing the hazard through symptom screening plus temperature check is important, inexpensive, effective and protective of workers’ health. Thus, institutionalizing occupational risk management methods (elimination control, engineering control – acrylic barrier, administrative controls – alternative work arrangements, Personal Protective equipment – PPEs) in controlling exposures to occupational hazards becomes inevitable in protecting both the employees and clients of FDA.

2. OBJECTIVES

The general objective of this Circular is to provide a clear and consistent procedure for the safety of FDA employees and clients in order to prevent the spread of infectious diseases such as COVID-19 in the workplace.

Specifically, it aims to: 2.1 Limit foot traffic; 2.2 Limit face to face interaction by encouraging online transactions.

3. SCOPE

This Circular shall cover all officials, staff of FDA and all its regulated entities.

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4. GUIDELINES

4.1 GENERAL GUIDELINES 4.1.1 OFFICE PROTOCOL PRIOR TO ENTERING FDAC

4.1.1.1 There shall be separate doors for entrance and exit. 4.1.1.2 There are floor markings for physical distancing inside and outside of the

FDAC Office with at least two (2) meters apart. 4.1.1.3 Symptom screening through the use of a health declaration form shall be

distributed by FDAC to be filled out by clients. Clients should always bring their own ball pen and a valid company and government ID.

4.1.1.4 Temperature check shall be done by the FDA security services. Clients with temperature exceeding thirty seven point five (37.5oC) degrees Celsius will be allowed to rest for five (5) minutes. If the temperature persists upon the second measurement, the client shall not be allowed inside the FDAC premises and shall be advised to seek medical assistance.

4.1.1.5 The FDA security services shall ensure that social distancing shall be implemented for those clients outside FDAC who are in line while waiting for their turn to enter the premises.

4.1.1.6 The NO FACE MASK, NO ENTRY POLICY shall be strictly enforced. 4.1.1.7 Clients should ALWAYS KEEP RIGHT. There are signages/ arrows

with one way flow scheme to prevent people from bumping into each other. 4.1.1.8 All clients shall sign in the visitor’s logbook prior to entry.

4.1.2 PERSONNEL

4.1.2.1 There shall be limited FDA staff at the frontline counters in compliance with social distancing measures.

4.1.2.2 The FDA staff shall wear face mask, face shield and gloves while on duty at FDAC.

4.1.3 OPERATIONS 4.1.3.1 The operating hours of FDAC shall be from nine (9) o’clock in the morning

until four (4) o’clock in the afternoon.4.1.3.2 Only twenty (20) clients will be allowed inside FDAC at any given time.

Seats are numbered from one (1) to twenty (20).4.1.3.3 As a general rule, online transactions are preferred.

4.1.3.3.1 For walk-in or scheduled appearance, one queue number shall be given at a time. A maximum of five (5) transactions for each queue number shall be allowed. Once a client has been served, he/she should fall in line outside of the FDAC Office if there is an additional transaction.

4.1.3.3.2 To avoid confusion, duplication of work, and misrouting of documents, clients shall select whether to submit online via email or in person at FDAC. Only one mode of submission shall be allowed.

4.1.3.4 All applications shall be pre-assessed by the receiving officer at FDAC based on the checklist of requirements.

4.1.3.5 Applications with drug samples, food samples, laboratory samples for analysis and product verification shall be submitted at the concerned Counters of FDAC.

4.1.3.6 FDAC shall acknowledge the submissions, issue a Document Tracking Number (DTN) and forward to the concerned offices after the applications have been paid.

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4.1.3.7 Letters of Commitment in lieu of the required notarized documents shall be submitted and included in the submission documents at FDAC during the quarantine period. Once the quarantine period is lifted, notarized documents should be sent to fdac.pacd.cdrr@fda.gov.ph to be merged with their previously submitted applications. In sending the notarized documents, the subject of the email should be as follows: Re: Notarized Document (DTN of the concerned application). [FDAC will endorse the notarized documents to the concerned Office/ Center for consolidation with the product file of their application.]

4.1.3.8 All inquiries and follow ups shall be sent through email to the concerned Offices/ Centers.

4.1.3.8.1 User Account, schedule, e-portal issues - fdac@fda.gov.ph 4.1.3.8.2 Filing of Complaints – eReport@fda.gov.ph 4.1.3.8.3 Customer Feedback – customersatisfactionteam@fda.gov.ph 4.1.3.8.4 Cashier – cashier@fda.gov.ph 4.1.3.8.5 Records Section – records-releasing@fda.gov.ph 4.1.3.8.6 Center for Drugs Regulation and Research – cdrr.od@fda.gov.ph4.1.3.8.7 Center for Food Regulation and Research – cfrr@fda.gov.ph 4.1.3.8.8 Center for Device Regulation, Radiation, Health and Research –

cdrrhr@fda.gov.ph 4.1.3.8.9 Center for Cosmetics Regulation and Research – ccrr@fda.gov.ph 4.1.3.8.10 Common Services Laboratory – csl@fda.gov.ph

4.1.3.9 As the Action Center, FDAC shall act on clients’ inquiries and follow ups by referring to the concerned FDA Office within 72 hours. In order for FDAC to be more effective and efficient in its enhanced role, it shall monitor the response and action of FDA officials/ employees and proceed accordingly.

4.1.3.10 The FDAC shall perform the following functions.4.1.3.10.1 The Public Assistance and Complaints’ Desk (PACD) shall provide

assistance to inquiries, follow ups and complaints of clients; shall receive applications on registration, compliances, and other authorizations using file-sharing platforms and shall transmit to the concerned Offices/ Centers at the FDA Central Office.

4.1.3.10.2 The phone operators shall assist clients and provide assistance to telephone callers regarding their inquiries, follow ups and complaints, and shall respond to email senders. The updated FDAC hotlines are posted at the FDA website.

4.1.3.10.3 The Accounts and Schedulers’ Team shall provide user account and appointment schedule to email requests within two (2) working days upon receipt of the request.

4.1.3.10.4 The Letters Section shall receive documents through email as well as from walk-in clients and shall transmit within one (1) working day to the concerned Offices/ Centers at FDA Central Office.

4.1.3.10.5 The Couriers Section shall receive documents/ packages sent through courier/postal service coming from the different regions and shall transmit within one (1) working day to the concerned Offices at FDA Central Office.

4.1.3.11 Cleaning and disinfection shall be in accordance with Department Memorandum No. 2020-0157 known as “DOH Guidelines on Cleaning and Disinfection in Various Settings as an Infection Prevention and Control Measure Against COVD-19”.

4.1.4 PAYMENT OF FEES

4.1.4.1 Cashless payment is encouraged.

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4.1.4.2 Contactless modes of payment such as online payment are encouraged.4.1.4.3 Over-the-Counter payments will be available at FDAC. 4.1.4.4 Cash trays shall be used to reduce touchpoints with the customer.4.1.4.5 A maximum of five (5) transactions per queue number shall be allowed.

The last queue number shall be issued no later than 3 p.m. of each working day.

4.1.4.6 All payments shall conform with the current prescribed schedule of fees.

4.1.5 RECORDS RELEASING 4.1.5.1 Clients within the National Capital Region (NCR) may pick up their FDA

Authorizations at the FDAC Records Releasing Section in accordance with FDA Advisory dated 30 July 2019 on “Releasing of FDA Authorizations at the Food and Drug Action Center (FDAC)”. If for whatever reason the client was unable to pick up the Authorization within ten (10) working days upon receipt by FDAC, it shall be sent through courier to the registered mailing address of the company.

4.1.5.2 The FDA Records Section shall mail the FDA Authorizations through courier services to the concerned FDA Regional Field Office (RFO) which has jurisdiction over clients residing outside of NCR.

4.1.5.3 The database shall be kept updated for systematic filing and easy retrieval of records.

4.1.5.4 The status of mailing and/or printing of the Certificate can be tracked at https://www.fda.gov.ph/fda-kiosk/

4.2 SPECIFIC GUIDELINES

There shall be a schedule in submission of applications and procedural guidelines to provide quality, effective and efficient frontline services.

4.2.1 CDRR Applications and Compliance Documents

Applications under CDRR shall follow the prescribed schedule indicated in Annex-A: Schedule of Submissions Concerning CDRR.

4.2.1.1 The subject of the email shall comply with the following format: 4.2.1.1.1 For Registration Applications:

[Application Type] Generic Name (Brand Name) Dosage Form and Strength. E.g. [Initial – OTC] Paracetamol (Brand Name) 500 mg Tablet.

4.2.1.1.2 For GMP Applications [Application Type] Manufacturing Site Name (Market Authorization Holder) E.g. [Initial Foreign cGMP] ABC Manufacturing (MAH Name)

4.2.1.1.3 For Clinical Trial and Related Applications [Application Type] Study Title/Subject Request E.g. [Compassionate Special Permit] Request for CSP for Patient (Patient Name)

4.2.1.2 Procedural guidelines on the submission of product dossier pursuant to

FDA Circular No. 2014-003. 4.2.1.2.1 The client shall secure a schedule of appointment/ submission to

FDAC.

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4.2.1.2.2 The client shall submit the application dossier on the assigned scheduled date.

4.2.1.2.3 FDAC shall forward the application to the pre-assessment team for appropriate action.

4.2.1.2.4 FDAC shall release the results of the pre-assessment within the given processing days upon receipt of the application.

4.2.1.2.5 An email shall be sent to the company and an update at the DocTrack System informing them of the results of the pre-assessment and instruction to proceed with payment. If the application did not satisfactorily pass the pre-assessment, the applicant will be advised to secure a new appointment schedule to submit the application for pre-assessment.

4.2.1.2.6 Non-acceptable dossiers will be immediately deleted in the FDA servers.

4.2.1.2.7 Documents for submission should adhere to the following. a. Each section of the dossier corresponding to a specific

documentary requirement shall be properly labelled and bookmarked.

b. The files should be saved in PDF format and readable even with 100x magnification.

4.2.1.3 Email to fdac.pacd.cdrr@fda.gov.ph through file-sharing platforms. 4.2.1.3.1 Registration Application – every Tuesday and Wednesday 4.2.1.3.2 Sales Promo Permit – every Friday 4.2.1.3.3 Compliance – any working day 4.2.1.3.4 Additional Documents pertaining to safety updates shall be

accepted by FDAC regardless of the decking status of the application.

4.2.1.3.5 Other Authorizations (e.g. Certificate of Pharmaceutical Product; Generic Labeling Exemption; Certificate of Free Sale) – any working day

4.2.1.4 Email to fdac.letters.cdrr@fda.gov.ph. 4.2.1.4.1 Minor Variation – Notification – every Tuesday and Wednesday

only. Refer to Annex – B: Receiving of CDRR Applications for Variation-Notification

4.2.1.4.2 Foreign cGMP Clearance – every Tuesday and Wednesday only 4.2.1.4.3 Local GMP Certificate – any working day 4.2.1.4.4 Reconstruction – any working day 4.2.1.4.5 Animal Feeds Certification – any working day 4.2.1.4.6 Clinical Trial Applications – every Tuesday and Wednesday 4.2.1.4.7 Post Marketing Study Protocol – every Tuesday and Wednesday 4.2.1.4.8 Protocol Amendment – every Tuesday and Wednesday

4.2.1.5 Email directly to clinicalresearch@fda.gov.ph. 4.2.1.5.1 Compassionate Special Permit (CSP) – any working day 4.2.1.5.2 BOC Clearance – any working day

4.2.1.6 All follow ups and inquiries shall be emailed to cdrr.od@fda.gov.ph.

4.2.2 CFRR Applications and Compliance Documents4.2.2.1 Email to fdac.pacd@fda.gov.ph

4.2.2.1.1 Food Supplement Samples for submission – any working day 4.2.2.1.2 Sales Promo Permit – every Friday

4.2.2.2 Email to fdac.letters@fda.gov.ph 4.2.2.2.1 BOC Clearance/Import Permit – any working day 4.2.2.2.2 HACCP Certificate – any working day 4.2.2.2.3 Sangkap Pinoy Seal – any working day

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4.2.3 CCRR Applications and Compliance Documents

4.2.3.1 Email to fdac.pacd@fda.gov.ph 4.2.3.1.1 Registration Applications for Household Urban Pesticides (HUP)

– every Thursday from 9 a.m. to 12 noon only. All emails received after 12 noon shall be acted upon on the next working day.

4.2.3.1.2 Certificate of Free Sale (CFS) – any working day 4.2.3.1.3 Compliance – any working day 4.2.3.1.4 Sales Promo Permit – every Friday

4.2.3.2 Email to fdac.letters@fda.gov.ph 4.2.3.2.1 Local GMP – any working day 4.2.3.2.2 Bureau of Customs (BOC) Clearance for special cases – any

working day

4.2.4 CDRRHR Applications and Compliance DocumentsThe CDRRHR email template below shall be strictly followed for a successful online submission. Refer to Annex – C: Schedule of Submissions Concerning CDRRHR.

SUBJECT: Type of Application – CDRRHR LRD/ RRD (for example: Compliance, Sales Promo Permit, COVID-19 Test Kits) BODY OF EMAIL:

Name of Applicant: Last Name, First Name, Middle Initial COMPANY NAME LTO Number DTN (when applicable)

4.2.4.1 For Medical Device, email the following to fdac.pacd@fda.gov.ph. 4.2.4.1.1 Certificate of Product Registration – Licensing and Registration

Division (CPR-LRD) Compliance – any working dayAll Notice of Deficiencies (NOD) for Certificate of Product Registration (Initial, Renewal, Variation) of Medical Devices shall be extended for one (1) month from the end of their compliance period.

4.2.4.1.2 Sales Promo Permit – every Friday4.2.4.2 For Medical Device, email the following to fdac.letters@fda.gov.ph.

4.2.4.2.1 Certificate of Medical Device Listing (CMDL) – any working day 4.2.4.2.2 Applications related to COVID-19 (Test Kits, Clinical

Thermometer, Sterile Surgical Gloves) – any working day 4.2.4.2.3 Compassionate Special Permit (CSP) – any working day 4.2.4.2.4 Certificate of Free Sale (CFS) – any working day 4.2.4.2.5 Notification of Sources (no payment required) – any working day4.2.4.2.6 Application for Good Manufacturing Practice (GMP) – any

working day4.2.4.2.7 Renewal Applications for Medical Devices and In-vitro Diagnostic

Devices (IVD)a. Company names starting with numbers and letters A to M –

every Thursdayb. Company names starting with letters N to Z – every Fridayc. Maximum of only five (5) applications per company d. Multiple Certificates of Product Registration (CPR) should be

applied as one (1) application. Failure to comply with this requirement shall result to the automatic disapproval of the applications done individually.

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4.2.4.2.8 Renewal Applications for Water Purification Devices/ System and Equipment/ Devices Used to Treat Sharps, Pathological and Infectious Wastes – every Thursday

4.2.4.2.9 Schedule of application for renewal of all products covered by the CDRRHR and other considerations. a. The following schedule of submission for renewal applications

shall apply based on the validity of the CPR.

Validity of CPR Ending Month of Application March 2020 01 July – 31 July 2020 April and May 2020 01 August – 31 August 2020 June and July 2020 01 September – 30 September

2020 August and September 2020

01 October – 31 October 2020

October and November 2020

01 November – 30 November 2020

b. The validity of the CPRs for renewal shall be extended for

another three (3) months to ensure that the CPR remains valid while the renewal process is ongoing. For example, CPRs which are expiring in March 2020, will be extended until October 2020.

c. A corresponding penalty shall be imposed on companies who fail to renew their CPRs during the period stated above.

4.2.4.2.10 Variation Applications for Medical Devices and In-vitro Diagnostic Devices a. Company names starting with numbers and letters A to M –

every Thursdays b. Company names starting with letters N to Z – every Fridays c. Maximum of only two (2) applications per company

4.2.4.2.11 The Certificate of Medical Device Notification (CMDN) shall be applied through the e-portal.

4.2.4.2.12 The manual application for initial Certificate of Medical Device Registration (CMDR) of Classes B, C and D are suspended. Acceptance of application shall resume on 01 September 2020.

4.2.4.3 Radiation Facility Application and Compliance Documents

4.2.4.3.1 The acceptance of the following applications are still suspended until further notice.a. Applications for the issuance of initial authorization for medical

and non-medical radiation facilitiesb. Radiofrequency Radiation (RFR) evaluation report for RFR

facilities4.2.4.3.2 The following applications shall be emailed to

cdrrhr.rrd@fda.gov.ph. The emailed application and its attachments must be in PDF file format with appropriate file name.a. Application for the issuance of renewal authorization of

medical and non-medical radiation facilitiesb. Clearance for Customs Release (CFCR) of radiation emitting

devicesc. Application for issuance of authorization for hospital based x-

ray facilities using mobile x-ray devices intended for use in the

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diagnosis of COVID-19 patients in need of medical imaging procedure

4.2.5 CSL Applications and Compliance Documents

Refer to Annex-D: Schedule of Submissions Concerning CSL 4.2.5.1 Submission of Food Export Certificate and Food Commodity Clearance by

food manufacturers/ traders/ exporters will be accommodated online through csl@fda.gov.ph, from 9 a.m. to 3 p.m., Mondays to Fridays. Applications received after 3 p.m. will be treated as submitted on the next working day. Failure to submit the mandatory documentary requirements and submission of incorrect and misleading information shall be grounds for denial of the application. Once denied, applicant company shall submit new application together with the required documents.

4.2.5.2 Pre-assessment and acceptance of applications for Lot Release Certificate will be accommodated online through cslvbu@fda.gov.ph from 8 a.m. to 3 p.m., Mondays to Fridays. Applications received after 3 p.m. will be assessed on the next working day. Applicants who are unable to avail the online pre-assessment service, may submit their application directly at FDAC-CSL Counter on Mondays and Fridays only from 9 a.m to 11 a.m., subject to pre-assessment prior to acceptance.

4.2.5.3 Batch Notification4.2.5.3.1 On-site submission of applications will be accepted at FDAC CSL

Counter from 9 a.m. to 2 p.m., Monday to Wednesday.4.2.5.3.2 Post-submission of previous online applications will be accepted at

FDAC CSL Counter from 9 a.m. to 2 p.m., Monday to Wednesday.4.2.5.3.3 Online submissions through cslbn@fda.gov.ph will be accepted

from 8 a.m. to 5 p.m., Wednesday to Friday.4.2.5.4 Acceptance of Request for Laboratory Analysis together with the samples

from walk-in clients shall be from 9 a.m. to 3 p.m., any working day.

4.2.6 Application for Certifications and Compliance Documents to the Regional Field Office (RFO) – Refer to Annex-E: Regional Field Office Contact Details

4.2.6.1 Clients may email to fdac.pacd@fda.gov.ph upon the instruction of the RFO/inspector within their area of jurisdiction.

4.2.6.1.1 Corrective Action and Preventive Action (CAPA) Plan and corresponding objective evidences

4.2.6.2 Clients may email the following applications for Certification with its corresponding Letter of Intent and complete requirements to fdac.letters@fda.gov.ph upon the instruction of the RFO/inspector within their area of jurisdiction.

4.2.6.2.1 Hazard Analysis Critical Control Points (HACCP)4.2.6.2.2 Sangkap Pinoy Seal Application4.2.6.2.3 Foreign Drug Manufacturer Good Manufacturing Practice (GMP)

Inspection Application 5. SEPARABILITY CLAUSE

The provisions of this Circular are hereby declared to be separable. In the event that one or more of its provisions are held to be invalid, the validity of the other provisions shall not be affected thereby.

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6. REPEALING CLAUSE

This Circular repeals Section III. C. Electronic Filing of Applications for Certain FDA Certificate and Permits of FDA Circular No. 2020-006-A known as “Amendment to FDA Circular No. 2020-006 Entitled Guidance for Applications and Transactions at the Food and Drug Administration in Light of the Community Quarantine Declaration” dated 2 April 2020.

7. EFFECTIVITY

This policy shall be effective immediately.

ROLANDO ENRIQUE D. DOMINGO, MD

Director General

*01234567890123*

`

Office ORIGINATING

OFFICE CLEARING

OFFICE ODDG-FROO ODDG-IM ODG

Initial

______________ FDAC

_____________ PPS/ LSSC (if

applicable)

_____________ DDG-FROO

_______________ DDG-IM/ AFS

______________ Head Executive

Assistant

Date:

Office CDRR CFRR CCRR CDRRHR CSL

Initial

_______________

Director IV

_______________

Director IV

_______________

Director IV

________________

Director IV

__________________

Director II

Date:

Keywords New Normal Guidelines, FDAC Related issuances, laws, directives from other government agencies

DOH AO 2020-0015, DOH DM 2020-0157, FDA Circular No. 2020-006 and its Amendments

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DRAFT VERSION FOR COMMENTS AS OF 02 JULY 2020

ANNEX – A: SCHEDULE OF SUBMISSIONS CONCERNING CDRR

To be Received on TUESDAYS

To be Received on WEDNESDAYS

To be Received on FRIDAYS

To be Received DAILY

Initial (except Vaccines and Biologicals)

Initial (except Vaccines and Biologicals)

Sales Promo COPP

Monitored Release (except Vaccines and Biologicals)

Monitored Release (except Vaccines and Biologicals)

CFS

Major Variation and Minor Variation – Prior Approval (except Vaccines and Biologicals)

Major Variation and Minor Variation – Prior Approval (except Vaccines and Biologicals)

Animal Feeds Certificate

BioVac – Initial / MR COE BioVac – Variations CSP Foreign GMP Clearance Foreign GMP Clearance DEU Regular Renewal Regular Renewal Foreign

Donations PCPR / CLIDP PCPR / CLIDP BOC Clearance

(for registration samples, BE samples)

Automatic Renewal Automatic Renewal CPR Extension

Minor Variation – Notification

Minor Variation – Notification

Local GMP Certificate

Clinical Trial Application & CT Notification

Clinical Trial Application & CT Notification

Compliance

Protocol Amendment Protocol Amendment GLE Product Classification Product Classification Reconstruction CT – Import License and IL - Notification

CT – Import License and IL – Notification

LEGEND: BE – Bioequivalence; BOC – Bureau of Customs; COE – Certificate of Exemption; CFS – Certificate of Free Sale; COPP – Certificate of Pharmaceutical Product; CLIDP – Certificate of Listing of Identical Drug Product; CT – Clinical Trial; CSP – Compassion Special Permit; CPR – Certificate of Product Registration; DEU – Drug for Emergency Use; GLE – Generic Labeling Exemption; GMP – Good Manufacturing Practice; LTO – License to Operate; MR – Monitored Release; PCPR – Principal Certificate of Product Registration

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ANNEX – B: RECEIVING OF CDRR APPLICATIONS FOR VARIATION-NOTIFICATION

All applications for Minor Variation – Notification (MiV-N) shall be processed as follows.

1. RECEIVING OF APPLICATIONS AT FDAC 1.1 Applications shall be received by a Food and Drug Action Center (FDAC) Officer at

the Letters Section of FDAC every Tuesdays and Wednesdays from 9 a.m. to 12 noon, without need for prior appointment.

1.2 All applications received (walk-in or email) after 12 noon shall be acted upon on the next working day.

1.3 Upon receipt of the application, a Document Tracking Number (DTN) and Acknowledgement Receipt shall be issued to the applicant as proof of acceptance of the notification.

1.4 The application shall be endorsed to Center for Drug Regulation and Research (CDRR) for post-acknowledgement evaluation.

2. The following are the requirements that shall be submitted. Soft Copy 2.1 Scanned copy of Notarized Annex-B 2.2 Scanned copy of proof of payment (Official Receipt or Oncoll payment slip indicating

the DTN) 2.3 Portable Document Format (PDF) copy of signed Integrated Application Form (IAF) 2.4 IAF in Microsoft Excel format 2.5 Declaration signed by the Head of Regulatory Office, that there is/ are no other

change(s) except for the proposed variation 2.6 Scanned copy of the Certificate Product Registration (CPR) and/or proof of renewal 2.7 For Certificate of Listing of Identical Drug Product (CLIDP), a copy of Principal CPR

(PCPR) variation approval (whenever applicable)

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ANNEX – C: SCHEDULE OF SUBMISSIONS CONCERNING CDRRHR

To be Received on THURSDAYS

To be Received on FRIDAYS To be Received DAILY

Sales Promo Permit CPR Compliance Renewal of Medical Devices and IVD: Company Names starting from A-M

Renewal of Medical Devices and IVD: Company Names starting from N-Z

CMDL

Variation – Medical Devices and IVD: Company Names starting from A--M

Variation – Medical Devices and IVD: Company Names starting from N-Z

COVID-related

Renewal of Water Purification Devices/ System and Equipment/ Devices Used to Treat Sharps, Pathological and Infectious Wastes

CSP

CFS GMP CMDN through e-Portal

To start on 01 September 2020 (to be emailed to fdac.letters@fda.gov.ph) Initial applications of Medical Devices and IVD: Company Names starting from A-M (Issuance of DTN and Order of Payment. Documents shall be submitted through Google Drive)

Initial applications of Medical Devices and IVD: Company Names starting from N-Z (Issuance of DTN and Order of Payment. Documents shall be submitted through Google Drive)

Initial application for Water Purification Devices/ System and Equipment/ Devices Used to Treat Sharps, Pathological and Infectious Wastes (Issuance of DTN and Order of Payment. Documents shall be submitted through Google Drive)

For Radiation Facilities (to be emailed at cdrrhr.rrd@fda.gov.ph) Renewal / Amendment of

LTO / COC CFCR COR for MRI Facilities Letters / Compliance

Documents Note: Incomplete submission based on the existing checklist shall result to outright disapproval. LEGEND: CFCR – Clearance for Customs Release; CMDL – Certificate of Medical Device Listing; CMDN – Certificate of Medical Device Notification; COC – Certificate of Compliance; COR – Certificate of Registration; IVD – In-Vitro Diagnostic Device

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ANNEX – D: SCHEDULE OF SUBMISSIONS CONCERNING CSL

To be Received on MONDAYS

To be Received on TUESDAYS

To be Received on

WEDNESDAYS

To be Received on

THURSDAYS

To be Received on FRIDAYS

To be Received DAILY

Food Export Certificate and Food Commodity Clearance

Request for Laboratory Analysis

Lot Release Certificate (On-site & online)

Lot Release Certificate (Online)

Lot Release Certificate (Online)

Lot Release Certificate (Online)

Lot Release Certificate (On-site & online)

Batch Notification (On-site)

Batch Notification (On-site)

Batch Notification (On-site & online)

Batch Notification (Online)

Batch Notification (Online)

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ANNEX – E: REGIONAL FIELD OFFICE CONTACT DETAILS

FDA Regional Field

Office

Email Regional Supervisor

1. RFO I rfoi@fda.gov.ph Veronica F. Obille

2. RFO II rfoii@fda.gov.ph Alegria G. Ong

3. RFO III rfoiii@fda.gov.ph Virginia P. Timbol

4. RFO CAR rfocar@fda.gov.ph Saturnina O. Pandosen

5. RFO NCR rfoncr@fda.gov.ph Carolyn P. Custodio

6. RFO IV-A rfoiv-a@fda.gov.ph Ma. Luisa L. De Sagun

7. RFO IV-B rfoiv-b@fda.gov.ph Luzvimin G. Atienza

8. RFO V rfov@fda.gov.ph Evangelina T. Lozada

9. RFO VI rfovi@fda.gov.ph Ma. Lexia T. Jancorda

10. RFO VII rfovii@fda.gov.ph Rica Reina C. Aumentado

11. RFO VIII rfoviii@fda.gov.ph Benczinct Benedikt C. Ortega

12. RFO IX rfoix@fda.gov.ph Sharon Rose P. Garcia

13. RFO X rfox@fda.gov.ph Merla K. Araña

14. RFO XI rfoxi@fda.gov.ph Arnold G. Alindada

15. RFO XII rfoxii@fda.gov.ph Nicanora D. Rabara

16. RFO XIII rfoxiii@fda.gov.ph Perla B. Alvizo

FDA Regional Field

Office

Email Regional Supervisor

1. RFO I rfoi@fda.gov.ph Veronica F. Obille

2. RFO II rfoii@fda.gov.ph Alegria G. Ong

3. RFO III rfoiii@fda.gov.ph Virginia P. Timbol

4. RFO CAR rfocar@fda.gov.ph Saturnina O. Pandosen

5. RFO NCR rfoncr@fda.gov.ph Carolyn P. Custodio

6. RFO IV-A rfoiv-a@fda.gov.ph Ma. Luisa L. De Sagun

7. RFO IV-B rfoiv-b@fda.gov.ph Luzvimin G. Atienza

8. RFO V rfov@fda.gov.ph Evangelina T. Lozada

9. RFO VI rfovi@fda.gov.ph Ma. Lexia T. Jancorda

10. RFO VII rfovii@fda.gov.ph Rica Reina C. Aumentado

11. RFO VIII rfoviii@fda.gov.ph Benczinct Benedikt C. Ortega

12. RFO IX rfoix@fda.gov.ph Sharon Rose P. Garcia

13. RFO X rfox@fda.gov.ph Merla K. Araña

14. RFO XI rfoxi@fda.gov.ph Arnold G. Alindada

15. RFO XII rfoxii@fda.gov.ph Nicanora D. Rabara

16. RFO XIII rfoxiii@fda.gov.ph Perla B. Alvizo