Author: FDA Admin3

FDA Advisory No. 2020-1687 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. OTC H51021671 [Label in Foreign Language]
  2. OTC Yansuan Xiujixin Pian
  3. OTC Wepon® Bromhexine Hydrochloride Tablets
  4. OTC Guo Hua® HNGH Tian Ma Shou Wu Pian
  5. Fufang Dantong Pian

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->  FDA-Advisory-No.2020-1687

FDA Advisory No. 2020-1686-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. OTC Compound Vitamin B Tablets
  2. OTC Miaoshou® Vitamin B6 Tablets
  3. Shilintongpian
  4. Zhendong® Guang An Suan Pian
  5. Lee Buan Soa Pill (Fishing Brand) 50 pills

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:->  FDA-Advisory-No.2020-1686-A

FDA Advisory No. 2020-704-A || Lifting the Advisory on the Notified Product “CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” under FDA Advisory No. 2020-704 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” Dated 16 April 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA) with Notification No. 1000006556643 has been notified by the Market Authorization Holder, Europlay Distributor Company, Inc., in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-704 and FDA Order No. 2020-445 is hereby lifted.

The public is advised to always check if a Cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the health product before purchasing. For more information or inquiries, please email us at [email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8117.

To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->  FDA-Advisory-No.2020-704-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-704-A || Lifting the Advisory on the Notified Product “CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” under FDA Advisory No. 2020-704 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” Dated 16 April 2020

FDA Advisory No. 2020-1104-A || Lifting the Advisory on the Notified Cosmetic Product “MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” under FDA Advisory No. 2020-1104 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic Product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” Dated 16 June 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM with Notification No. 1000006589658  has been notified by the Market Authorization Holder, Bee Healthy Trading & Distribution Inc., in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-1104 and FDA Order No. 2020-748 is hereby lifted.

The public is advised to always check if a Cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the health product before purchasing. For more information or inquiries, please email us at [email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8107.

 To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:–>FDA Advisory No.2020-1104-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1104-A || Lifting the Advisory on the Notified Cosmetic Product “MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” under FDA Advisory No. 2020-1104 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic Product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” Dated 16 June 2020

ANNOUNCEMENT || RESCHEDULE OF ONLINE PUBLIC CONSULTATION ON THE DRAFT GUIDELINES FOR THE REGULATION OF VAPOR PRODUCTS AND HEATED TOBACCO PRODUCTS IN RELATION TO THE PROVISIONS UNDER RA 11346, RA 11467 AND EO 106

Due to unforeseen technical issues with the registration link wherein several stakeholders are unable to access and submit the online registration form, we would like to inform all concerned stakeholders that the Online Public Consultation on the Draft Guidelines for Vapor Products and Heated Tobacco Products originally scheduled on 29  September and 01 October 2020 are moved to 06 and 08 October 2020 respectively to provide all interested stakeholders ample time to register and attend the public consultation.

All stakeholders are invited to participate by registering through the links provided below:

Vapor Product Stakeholders:

https://bit.ly/3i8pK9E

Heated Tobacco Product Stakeholders:

https://bit.ly/3mWemkH

The FDA shall accommodate a maximum of one hundred (100) participants per session and shall be on a first-come, first-served basis. To ensure that all stakeholders are given equal opportunities to attend the public consultation, only one (1) representative per company/industry association shall be allowed to register. Deadline for registration is on 04 October 2020, 4:00PM.

Below is the scheduled program for the said dates:

06 October 2020
Vapor Product Draft Regulatory Guidelines
AM Session (Batch 1)
8:00-8:15 Opening Remarks
8:16-9:15 Policy Overview and Licensing Guidelines
9:16-9:30 Break + Q&A
9:31-10:30 Product Marketing Authorization Guidelines for Vapor Products
10:31-10:45 Break + Q&A
10:46-11:45 Policy Salient Points and Product Labelling Guidelines
11:46-12:00 Q&A and Closing
PM Session (Batch 2)
1:00-1:15 Opening Remarks
1:16-2:15 Policy Overview and Licensing Guidelines
2:16-2:30 Break + Q&A
2:31-3:30 Product Marketing Authorization Guidelines for Vapor Products
3:31-3:45 Break + Q&A
3:46-4:45 Policy Salient Points and Product Labelling Guidelines
4:46-5:00 Q&A and Closing
08 October 2020
Heated Tobacco Product Draft Regulatory Guidelines
8:00-8:15 Opening Remarks
8:16-9:15 Policy Overview and Licensing Guidelines
9:16-9:30 Break + Q&A
9:31-10:30 Product Marketing Authorization Guidelines for HTPs
10:31-10:45 Break + Q&A
10:46-11:45 Policy Salient Points and Product Labelling Guidelines
11:46-12:00 Q&A and Closing

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected].

For your information and guidance.

Procedures on the registration for the Public Consultation:

1. Please click the link provided below for the registration:
Vapor Products: https://bit.ly/3i8pK9E
Heated Tobacco https://bit.ly/3mWemkH
2. Be sure to fill out the required fields.
3. Make sure you click Submit.
4. Google Meet Link for the Public consultation will be sent to your registered email address.

/ In Cosmetic Announcements / By FDA Admin3 / Comments Off on ANNOUNCEMENT || RESCHEDULE OF ONLINE PUBLIC CONSULTATION ON THE DRAFT GUIDELINES FOR THE REGULATION OF VAPOR PRODUCTS AND HEATED TOBACCO PRODUCTS IN RELATION TO THE PROVISIONS UNDER RA 11346, RA 11467 AND EO 106

Administrative Order No. 2020-0044 || Adoption of the Collaborative Procedure for the Accelerated Registration of World of Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines

Attachment:->  Administrative Order 2020-0044

/ In General Announcements / By FDA Admin3 / Comments Off on Administrative Order No. 2020-0044 || Adoption of the Collaborative Procedure for the Accelerated Registration of World of Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines

FDA Advisory No. 2020-1757 || Public Health Warning Against the Purchase and Use of the following Non-Compliant Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following non-compliant cosmetic products imported and distributed by the Market Authorization Holder (MAH), Healthy Innovation Distribution Inc.:

1. FRESH SKINLAB 98% TOMATO GLASS SKIN WATER DROP CREAM SPF 30
2. FRESH SKINLAB 98% TOMATO GLASS SKIN SUN GEL SPF 50 PA++++
3. SUNGLOW BY FRESH TINTED LIPSCREEN SPF 50 PA++++
4. FRESH SKINLAB 98% JEJU ALOE ICE UV SUN BLOCK FOR FACE & BODY SPF 50 PA++

According to Republic Act 3720 as amended, a cosmetic shall be deemed misbranded if its labeling is false or misleading in any particular. Furthermore, the IRR of Republic Act 9711 defines “misbranding” as giving unsubstantiated claims, misinformation or misleading information on the label or other information materials.

The aforementioned cosmetic products were found non-compliant with the existing standards due to failure to substantiate the claim Sun Protection Factor (SPF) 50. Also, the MAH, Healthy Innovation Distribution Inc., has made misrepresentation and false entries in the applications for product notification based on the Centers’ post evaluation activities and product information file (PIF) audit by declaring Coreholic Co., as the manufacturer which is inconsistent from the relevant documents submitted for notification, rendering the products unauthorized.

In light of the foregoing, the public is advised not to purchase the aforementioned misbranded products. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph.) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute misbranded cosmetic products.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Attachment:-> FDA-Advisory-No.2020-1757

ANNOUNCEMENT || POSTER MAKING COMPETITION FOR 2020 NATIONAL CONSCIOUSNESS WEEK AGAINST COUNTERFEIT MEDICINES (NCWACM)

  1. BACKGROUND

By virtue of the Republic Act No. 8203 otherwise known as the “Special Law on Counterfeit Drugs” issued on the 19th of November 1996, this was established to:
1) protect and promote the right to health of the people and instill health consciousness among them as provided in Section 15 Article 11 of the constitution; and 2) to further declare the policy of the State that in order to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs.

  1. ISSUE

On 15 June 2010, Presidential Proclamation No. 2082 was issued to declare the third week of November of every year as the “National Consciousness Week against Counterfeit Medicines”. As such, it’s directed for the: 1) planning, coordination, and implementation of comprehensive public awareness programs and activities on counterfeit medicines through a collaborative inter-agency and multi-sectoral effort at all levels, and 2) to particularly ensure widespread and expeditious public information about the proliferation and dangers of counterfeit medicines.

In this regard, the FDA through the Center for Drug Regulation and Research shall be spearheading the 2020 NCWACM with the theme, “Sa Gitna ng Pandemya, Magtulungan Laban sa Pekeng Medisina” through a virtual celebration, i.e., webinar. Also, it was decided that to engage the general public, an online poster making contest is recommended.

  1. FINDINGS/COMMENTS/ANALYSIS

In line with the abovementioned proposed poster making contest, the technical working group for the observance of the 2020 NCWACM proposes the following:

  1. The contest is open to all ages.
    1. The poster must illustrate, interpret, and emphasize the theme of the 2020 NCWACM.
    2. The poster must be in PNG format, 24 x 36 size, and with 4000 pixels by 6000 pixels.
    3. All entries must be submitted on 25 to 30 September 2020 only to [email protected] with the subject of e-mail as “2020 NCWACM Poster” and the body of the e-mail containing your full name, complete address, and contact details.
    4. There shall be a preliminary judging of all the submitted entries by the FDA through dissemination of the google form link through e-mail using the following criteria:
    • Relevance to the theme: 30%
    • Creativity & Presentation: 30%
    • Originality: 30%
    • Compliance with Requirements: 10%
    1. The finalists shall be uploaded to the FDA Facebook for online voting and online voting shall be open on 03 to 18 October 2020 only. A system shall be used for the awarding of points to each entry wherein one (1) point shall be given for every “Like” or thumbs-up and three (3) points for every “Share” of the entry;
    2. The top six (6) entries shall be awarded with the following prizes:
    • Grand Prize (One Entry) = 15,000
    • 1st Runner-Up = 12,000
    • 2nd Runner-Up = 10,000
    • 3rd Runner-Up = 8,000
    • 4th Runner Up = 5,000
    • 5th Runner Up = 3,000

     

    Furthermore, the top six (6) entries shall become the properties of Food and Drug Administration, which shall be used as Information, Education, and Communication (IEC) materials.

    1. RECOMMENDATION

     

    1. To launch an online poster making competition to allow the general public to showcase their creativity while participating in our cause amidst the pandemic.
    2. To allow the posting of the announcement for poster making contest in the FDA website and FDA Facebook.

 

Attachment:->  POSTER MAKING COMPETITION FOR 2020 NATIONAL CONSCIOUSNESS WEEK AGAINST COUNTERFEIT MEDICINES (NCWACM)

FDA Advisory No. 2020-1686 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. OTC Compound Vitamin B Tablets
2. OTC Miaoshou® Vitamin B6 Tablets
3. Shilintongpian
4. Zhendong® Guang An Suan Pian
5. Lee Buan Soa Pill (Fishing Brand) 50 pills

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2020-1686

FDA Advisory No. 2020-1685-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

1. OTC Inosine Tablets
2. OTC Yuanhu Zhitong Pian
3. H44023966 [Label in Foreign Language]
4. Moroxydine Hydrochloride Tablets 0.1g
5. OTC Vitamin C Tablets

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:->  FDA-Advisory-No.2020-1685-A

FDA Advisory No. 2020-1685 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. OTC Inosine Tablets
2. OTC Yuanhu Zhitong Pian
3. H44023966 [Label in Foreign Language]
4. Moroxydine Hydrochloride Tablets 0.1g
5. OTC Vitamin C Tablets

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->  FDA-Advisory-No.2020-1685

FDA Advisory No. 2020-1684-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. OTC Miaoshou® Vitamin B2 Tablets
2. OTC Z35020252 [Label in Foreign Language]
3. WY® Metamizole Sodium Tablets 0.5g
4. OTC Houtoujun Pian
5. OTC Cimetidine Tablets

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa  [email protected]  Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:->  FDA-Advisory-No.2020-1684-A

FDA Advisory No. 2020-1684 ||Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. OTC Miaoshou® Vitamin B2 Tablets
2. OTC Z35020252 [Label in Foreign Language]
3. WY® Metamizole Sodium Tablets 0.5g
4. OTC Houtoujun Pian
5. OTC Cimetidine Tablets

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected] You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2020-1684

FDA Advisory No. 2020-1683-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. OTC Chlorphenamine Maleate Tablets
2. Cusuan Ponisong Pian
3. Nysfungin Tablets
4. OTC H21022140 [Label in Foreign Language]
5. SPH Ding Lu Brand® Haizhu Chuanxiding Pian

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-1683-A

FDA Advisory No. 2020-1683 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. OTC Chlorphenamine Maleate Tablets
2. Cusuan Ponisong Pian
3. Nysfungin Tablets
4. OTC H21022140 [Label in Foreign Language]
5. SPH Ding Lu Brand® Haizhu Chuanxiding Pian

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2020-1683

FDA Advisory No. 2020-1682-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. OTC She Dan Chuan Bei Ye 10mL
2. Zhennaoning Jiaonang
3. OTC Compound Flavescent Sophora and Salicylic Acid Powder Fufang Kushen Shuiyangsuan San [as reflected in the secondary packaging]
4. Sanqi Shangyao Pian
5. Coenzyme A for Injection

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-1682-A

FDA Advisory No. 2020-1592-A || Lifting the Advisory of the Registered Food Product BINGO Corned Beef Tipid Pack Ready to Eat under FDA Advisory No. 2020-1592 Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products”

The Food and Drug Administration (FDA) informs the public that the food product BINGO Corned Beef Tipid Pack Ready to Eat is registered by the Market Authorization Holder, CDO FOODSPHERE INC.under the National Meat Inspector Service (NMIS).

1.BINGO Corned Beef Tipid Pack

The product is registered under NMIS with Registration Number 13-LM-0578 valid until 22 December 2020.

Accordingly, the list released in FDA Advisory No. 2020-1592 is hereby updated to remove the aforementioned food product.

The public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

To report any sale or distribution of unregistered food product, kindly email us through [email protected].

The public health warning imposed on the remaining product listed in FDA Advisory No. 2020-757 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1592-A

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1592-A || Lifting the Advisory of the Registered Food Product BINGO Corned Beef Tipid Pack Ready to Eat under FDA Advisory No. 2020-1592 Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products”

FDA Advisory No. 2020-1682 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. OTC She Dan Chuan Bei Ye 10mL
2. Zhennaoning Jiaonang
3. OTC Compound Flavescent Sophora and Salicylic Acid Powder Fufang Kushen Shuiyangsuan San [as reflected in the secondary packaging]
4. Sanqi Shangyao Pian [as reflected in the package insert]
5. Coenzyme A for Injection

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2020-1682

FDA Advisory No. 2020-1681-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. Citiconline Sodium Injection 2ml:0.25g
2. Xian Zhu Li 15mL
3. Shenmai Zhusheye 10mL [as reflected in the package insert]
4. [Label in Foreign Language]
5. Hasen® Cimetidine Injection 2ml:0.2g

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-1681-A

FDA Advisory No. 2020-1681 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. Citiconline Sodium Injection 2ml:0.25g
2. Xian Zhu Li 15mL
3. Shenmai Zhusheye 10mL [as reflected in the package insert]
4. [Label in Foreign Language]
5. Hasen® Cimetidine Injection 2ml:0.2g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA-Advisory-No.2020-1681

 

FDA Advisory No. 2020-1680-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1.CISEN® Fluconazole and Sodium Chloride Injection 100ml:0.2g:0.9g
2. OTC Loratadine Syrup 60mL
3. OTC Chuanbei Qingfeitangjiang
4. Lysine Acetylsalicylate for Injection 0.9g
5. Raceanisodamine Hydrochloride Injection 1ml : 10mg

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-1680-A

FDA Advisory No. 2020-1738 || Public Health Warning Against the Purchase and Use Non-Compliant Cosmetic Products

The Food and Drug Administration (FDA) warns the public from purchasing and using the following non-compliant cosmetic products imported and distributed by the Market Authorization Holder (MAH), Healthy Innovation Distribution Inc., (Refer to the image provided in the attached annex):

1. FRESH SKINLAB 98% TOMATO GLASS SKIN SUGAR LIP SCRUB
2. FRESH SKINLAB 98% TOMATO GLASS SKIN VITAMIN C SERUM SHEET MASK
3. FRESH SKINLAB 98% TOMATO GLASS SKIN VITAMIN C SERUM SOAP
4. FRESH SKINLAB 98% TOMATO GLASS SKIN MAKEUP CLEANSING BALM
5. FRESH SKINLAB 98% TOMATO GLASS SKIN GENTLE FOAMING FACIAL CLEANSER
6. FRESH SKINLAB 98% TOMATO GLASS SKIN LIP THERAPY MASK
7. FRESH SKINLAB 98% TOMATO SUN GEL SPF50
8. FRESH SKINLAB 98% TOMATO GLASS SKIN SPF 50 FACE & BODY MIST
9. FRESH SKINLAB 98% TOMATO GLASS SKIN SLEEPING PACK
10. FRESH SKINLAB 98% TOMATO GLASS SKIN SPF 30 WATER DROP CREAM
11. FRESH SKINLAB 98% TOMATO GLASS SKIN SOOTHING GEL LOTION
12. FRESH SKINLAB 98% TOMATO GLASS SKIN pH 5.5 HYDRATING TONER
13. FRESH SKINLAB WATERMELON YOUTHFUL GLOW JELLY TONER MIST
14. FRESH SKINLAB 98% ALOE VERA SPF 50 FACE & BODY MIST
15. FRESH SKINLAB MILK WHITE BRIGHTENING JELLY PEEL
16. FRESH SKINLAB MILK WHITE TONE UP SUN CREAM SPF 30
17. FRESH SKINLAB MILK WHITE WHIP FOAMING FACE AND BODY SOAP
18. FRESH SKINLAB JEJU ALOE ICE COOLING FACIAL SHEET MASK
19. FRESH SKINLAB JEJU ALOE ICE pH 5.5 TONER
20. FRESH SKINLAB JEJU ALOE ICE FACE AND BODY MIST
21. FRESH SKINLAB JEJU ALOE ICE SOOTHING GEL
22. FRESH SKINLAB JEJU ALOE ICE WHIP FOAMING FACE & BODY SOAP
23. FRESH SKINLAB 98% JEJU ALOE ICE FOAM WASH
24. FRESH SKINLAB 98% JEJU ALOE ICE FACIAL SCRUB
25. FRESH JEJU ALOE ICE MAKEUP CLEANSING BALM
26. FRESH JEJU ALOE ICE UV SUN BLOCK SPF 50
27. FRESH SKINLAB CALAMINE ANTIBLEMISH CALMING TONER
28. FRESH SKINLAB CALAMINE ANTIBLEMISH CALMING SPOT CREAM
29. FRESH SKINLAB CALAMINE ANTIBLEMISH CALMING FOAM WASH
30. FRESH SKINLAB GREEN TEA & CUCUMBER ACNE CARE JELLY TONER MIST
31. FRESH SKINLAB COLLAGEN SPF 50 FACE AND BODY MIST
32. FRESH SKINLAB ARGAN OIL IN WATER FACE AND BODY MIST
33. FRESH SKINLAB OLIVE OIL IN WATER FACE AND BODY MIST
34. FRESH SKINLAB BEAUTY WATER
35. FRESH SKINLAB ACNE CARE LOTION
36. FRESH SKINLAB PORE REDUCING CREAM
37. FRESH SKINLAB LIGHTENING GEL
38. FRESH SKINLAB ALOE VERA FACE MIST
39. FRESH SKINLAB COLLAGEN FACE MIST
40. FRESH SKINLAB LIFTING EYE GEL
41. SUNGLOW BY FRESH TINTED LIPSCREEN SPF 50
42. SUNGLOW BY FRESH TINTED SUNSCREEN SPF50
43. SUNGLOW BY FRESH SUN MIST SPF 50
44. SUNGLOW BY FRESH SET AND FIX MATTIFYING SUNSCREEN POWDER
45. HELLO KITTY CHARCOAL PEEL OFF MASK
46. HELLO KITTY APPLE PEELING GEL
47. HELLO KITTY FACE MIST
48. CHERIMOA PANDA FACE MASK
49. CHERIMOA GHOST FACE MASK
50. CHERIMOA PENGUIN FACE MASK

The abovementioned products was verified NON-COMPLIANT by FDA through postmarketing surveillance pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” provides for the relevant functions, powers and duties of the FDA, including conduct of post-market surveillance system in monitoring health products.

Attachment:->FDA-Advisory-No.2020-1738

FDA Advisory No. 2020-1680 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. CISEN® Fluconazole and Sodium Chloride Injection 100ml:0.2g:0.9g
2. OTC Loratadine Syrup 60mL
3. OTC Chuanbei Qingfeitangjiang
4. Lysine Acetylsalicylate for Injection 0.9g
5. Raceanisodamine Hydrochloride Injection 1ml : 10mg

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachement–>FDA-Advisory-No.2020-1680

FDA Circular No. 2020-015-B || Further Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

On 21 April 2020, FDA Circular No. 2020-015 was issued to provide interim measures to ensure access to vitamin drug products during the Coronavirus Disease 2019 (COVID-19) Pandemic. Subsequently, FDA Circular No. 2020-015-A was issued to extend the validity of said Circular.

Considering that there are regular updates on the quarantine status of different localities in the country, the validity of the provisions of this Circular should remain unaffected to ensure access to vitamin drug products during the COVID-19 pandemic.

Hence, FDA Circular No. 2020-015 shall be valid until 31 December 2020, regardless of the level of the imposed quarantine restriction, and subject to extension upon the review of this Office.

Attachment–>FDA-Circular-No.2020-015-B

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-015-B || Further Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

FDA Circular No.2020-007-B || Further Amendment to FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

On 17 March 2020, FDA Circular No. 2020-007 was issued providing guidelines for the implementation of the use of electronic means of prescription for drugs for the benefit of individuals vulnerable to COVID-19. Thereafter, on 26 August 2020, FDA Circular No. 2020-007-A was issued to extend the validity of said Circular.

Considering that there are regular updates on the quarantine status of different localities, the validity of the provisions of this Circular should remain unaffected to ensure access to drugs for the benefit of vulnerable individuals to COVID-19.

Hence, FC No. 2020-007 shall be valid until 31 December 2020, regardless of the level of the imposed quarantine restriction, and subject to extension upon the review of this Office.

Attachement–>FDA-Circular-No.2020-007-B

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No.2020-007-B || Further Amendment to FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

FDA Circular No. 2020-028 || Reissuance of the Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)

I. RATIONALE

On 02 April 2020, FDA Circular No. 2020-012 was issued to provide guidelines for the registration of Drug Products Under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19). Said Circular was further amended by FDA Circular Nos. 2020- 012- A and 2020-012-B on 27 July 2020 and 26 August 2020, respectively.

The global search for an effective treatment against this emerging disease continues until today. The clinical management for treatment of suspected or confirmed cases is continuously being updated based on the Philippine Society for Microbiology and Infectious Diseases (PSMID) for the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection. Also, R.A. No. 11494, otherwise known as the “Bayanihan to Recover As One Act” (“Bayanihan 2” for brevity) authorizes necessary and proper exercise of powers to ensure the availability of medicines in the supply chain [Section 4(dd)]. Thus, there is a need to reissue and update current regulations on the registration of drug products under emergency use to ensure access to the same at all times, regardless of the imposed quarantine restrictions. The need of the public for access to quality, safe, and effective medicines for the COVID-19 disease remains.

II. OBJECTIVE

This Circular aims to provide streamlined requirements and application process for the registration of Drug Products under Emergency Use (DEU) for COVID-19.

III. SCOPE AND COVERAGE

This Circular shall be applicable to all Marketing Authorization Holders (MAH) intending to manufacture and import/distribute the drug products listed in the PSMID Interim Guidelines on the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection. These are the only considered Drug Products under Emergency Use (DEU) for the pandemic:

The drug product eligible for registration under DEU is as follows:

Generic Name Dosage Form and Strength
Tocilizumab 400 mg/ 20 mL Concentrate Solution for I.V. Infusion
200 mg/ 10 mL Concentrate Solution for I.V. Infusion
80 mg/ 4 mL Concentrate Solution for I.V. Infusion
162 mg/ 0.9 mL Solution for Injection (S.C.)

New applications for the registration of Chloroquine, Hydroxychloroquine, and Lopinavir + Ritonavir under DEU registration shall no longer be accepted.

Current stocks at the manufacturing level of those issued with Certificate of Product Registration (CPR) shall be exhausted for their approved indications within the given validity. No further extension shall be granted. Furthermore, the inventory of stocks on hand shall be submitted as required under FDA Circular No. 2020-013.

The list shall be updated following any change/s in the above-stated treatment guidelines.

IV. GUIDELINES

A. Eligibility Criteria

The DEU shall be locally manufactured or imported and distributed for the management of COVID-19 patients during the pandemic, following the PSMID Interim Guidelines.

B. Documentary Requirements

Only the following requirements shall be submitted by the MAHs:

1. Integrated Application Form (in excel and in pdf format)
2. Letter of Intent
3. Valid License to Operate of Drug Manufacturer/Repacker/Packer/Trader (for locally manufactured products) or Drug Importer (for imported products)
4. Certificate of Pharmaceutical Product or Certificate of Free Sale (for imported products)
5. List of countries where the product is marketed (for biologicals)
6. Certificate of Foreign Good Manufacturing Practice (GMP) Clearance duly issued by this Office and/or GMP Certificate issued by the national regulatory authority or other competent regulatory authority (for imported products)
7. Labeling Materials
8. Generic Labeling Exemption may be granted for products exceeding 12,000 units.
9. Product Composition/Formulation (Unit Dose and Batch Formulation)
10. Finished Product Technical Specifications
11. Finished Product Certificate of Analysis (CoA) and Batch Analysis
12. Stability Studies
13. Drug products with no stability studies shall be given an interim shelf-life of 6 months.
14. Proof of Payment (Official Receipt or Landbank Oncoll Payment Slip)

C. Application Process

There shall be no need for the scheduling of submission of applications under this Circular. Applications for the registration shall be under Emergency Use Classification and shall be submitted at the Food Drug Action Center (FDAC). Submission of applications may be done either:

Manual submission to FDAC. Submit the requirements in a flash drive at the FDAC – PACD. An Acknowledgement Receipt with a corresponding Document Tracking Number shall be issued to the applicant.

E-mail submission. The applicant shall submit the application through [email protected] Guidance for e-mail submission shall be specified in a separate issuance.

D. Fees

The appropriate fees as prescribed under existing regulations shall apply, including the Legal Research Fund (LRF).

Application Type Fees
Emergency Use Registration Php 5,000.00 + LRF
Brand Name (if any) Php 500.00 + LRF per brand name

E. Validity of the Certificate of Product Registration (CPR)

The CPR shall be valid for one (1) year under Emergency Use Registration Status and is not subject for renewal registration. Automatic revocation of the CPR shall be imposed at the end of the pandemic.

F. Post-Approval Compliance

Post-Approval Compliance to the CPR shall be strictly required from the MAHs.

1. Post-Approval Commitments – shall be submitted within the CPR validity, or as prescribed below:

a. Post-Approval Stability Data of Commercial Batch/es for products without stability data submitted upon its registration
b. Commercial sample from the first batch of manufacture (local) or importation shall be submitted to this Office prior to distribution
c. Reference standards of the Active Pharmaceutical Ingredient/s (API) – submission shall be within five (5) working days from the CPR issuance

2. Post-Market Surveillance (PMS)

Health institutions (Hospitals, other Health Facilities) and Healthcare Professionals that shall use the products approved under this Circular shall be coordinate and submit to the respective suppliers/MAH for Adverse Drug Reaction (ADR) reports. The MAH shall be responsible for the submission of the ADR reports consistent with the latest issuance with this Office.

The MAH shall undertake the PMS activities in a separate issuance.

G. Supplemental Information

As interim measures for applications and transactions during the community quarantine, electronic signatures in documents shall be temporarily allowed. The requirement for notarized documents shall also be temporarily suspended. Instead, the applicant shall be required to submit a commitment letter for the submission of the notarized documents once available.

V. REPEALING CLAUSE

In the event that any provision or part of this Circular is declared unauthorized or rendered invalid by any court of law, those provisions not affected by such declaration shall remain valid and effective.

VI. EFFECTIVITY

This Circular shall take effect immediately and shall be effective until 31 December 2020, regardless of the level of the imposed quarantine restrictions due to COVID-19.

Attachment–>FDA-Circular-No.2020-028

/ In Circular / By FDA Admin3 / Comments Off on FDA Circular No. 2020-028 || Reissuance of the Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)

FDA Advisory No. 2020-1696 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal for License to Operate (LTO) Application for Food Product Establishments

The Food and Drug Administration (FDA) is currently developing the FDA eServices Portal System – an online platform for a streamlined License to Operate (LTO) application of FDA-regulated establishments.

In this regard, FDA is issuing this Advisory to inform all stakeholders that the application for eLTO for Food Product Establishments within National Capital Region (NCR) is now on its pilot implementation. The eServices Portal is accessible through this link http://eservices.fda.gov.ph/, with the scope of the application is limited for the time being:

FDA eServices Portal for LTO Application for Food Establishments
Location of Establishment National Capital Region (Metro Manila)
LTO Establishment Application Distributor (Wholesaler, Importer, Exporter), and Trader of Processed Food Products, Food Supplements, Bottled Water, and Iodized Salt
Type of LTO Application

Initial

Fees to be Paid Based on current issuance on Fees and Charges (Reference: DOH Administrative Order No. 50 s. 2001)
Validity of Initial LTO Two (2) years
Start of Pilot Implementation 31 August 2020

 

For this Pilot Run, applications for Renewal and Variation in the LTO using the eServices Portal are only functional if the approved initial LTO is applied using the eServices Portal.

For those with existing LTO application via ePortal, you may opt to apply to the eServices Portal for a new fee. Previous payment will be forfeited as the application has already been processed.

The implementation of eServices Portal for Manufacturers, including Repackers/Packers of all health products shall be on November 2020.

Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, and Annex B for the Step-by-Step Guide in applying via eServices Portal and the procedure for checking of application status.

Attachement–>FDA-Advisory-No.2020-1696

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1696 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal for License to Operate (LTO) Application for Food Product Establishments

FDA Advisory No. 2020-1655 || Pilot Implementation of the Food and Drug Administration (FDA) Food Product Registration Portal V. 2 for Certificate of Product Registration (CPR) Application of Food Products

The FDA, with its aim to streamline submissions of’ all market authorization applications and to provide efficient public service, is currently enhancing the Electronic Portal tor FDA food product registration. This revised online platform shall be used in securing Certificate of Product Registration (CPR) and amended thereof The Food Product Registration Portal v.2  for CPU application is accessible to stakeholders for pilot testing (dry run) on 15 September 2020. Pilot testing or dry run is important to address glitches, loopholes, technical concerns or problems that may be encountered.

In this regard, all stakeholders within the National Capital Region (NCR) who intend to apply for CPR of food products are encouraged to use the new FDA Food Product Registration Portal v. 2 through this link https://eportal.fda.gov.ph/.

FDA Food Product Registration Portal v. 2

Establishment Activities Manufacturer, Distributor (Importer, Exporter, and

Wholesaler), and Trader of Food Products

Type of CPR  Application Initial, Amendment, Renewal, and Re-Application
Fees to be Paid Based on Current Issuance on Fees and Charges (DOH Administrative Order No.50 s. 2001)
Validity of CPR Based on Current Issuance on Fees and Charges (DOH Administrative Order No.50 s. 2001)

Please follow Annex A & B of this Advisory for the Step-by-Step Guide in applying in the FDA Food Product Registration Portal V.2. and Checklist of’ Requirements.

The regulatory requirements for CPR application of food products shall still follow  the provisions of DOH Administrative Order No. 2014-0029 entitled  “Rules  and  Regulations  tin the Licensing ot’ Food Establishments and Registration o1’ Processed Food, and other Food Products, and for Other Purposes” and FDA Circular 2016-014.

For compliance.

Attachment:->FDA-Advisory-No.2020-1655

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1655 || Pilot Implementation of the Food and Drug Administration (FDA) Food Product Registration Portal V. 2 for Certificate of Product Registration (CPR) Application of Food Products

FDA Advisory No. 2020-1596 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food Supplements:

1. JARROW FORMULAS ® ACETYL L-CARNITINE 250 (250MG) DIETARY SUPPLEMENT
2. SPRING VALLEY WHOLE HERB GINGER ROOT 550MG – DIEGSTIVE HEALTH DIETARY SUPPLEMENT
3. SPRING VALLEY FOLIC ACID 400MCG DIETARY SUPPLEMENT – HEART HEALTH
4. SPRING VALLEY RAPID-RELEASE COQ10 100MG DIETARY SUPPLEMENT – HEART HEALTH
5. LIFE EXTENSION 5-LOX INHIBITOR WITH APRESFLEX 100MG – NEXT GENERATION BOSWELLIA EXTRACT DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->  FDA-Advisory-No.2020-1596

FDA Advisory No. 2020-1595 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food Supplements:

1. LIFE EXTENSION Boron 3mg – Advance Chelate Complex Dietary Supplement
2. LIFE EXTENSION Sea-Iodine 1000mcg with Sea Plant Complex Dietary Supplement
3. LIFE EXTENSION Melatonin 10mg – Promotes Optimal Sleep Dietary Supplement
4. LIFE EXTENSION Florassist Balance – Dual Encapsulated Probiotic Blend for Overall Health Dietary Supplement
5. LIFE EXTENSION Pomegranate Fruit Extract – Pomegranate Polyphenols Dietary Supplement

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->  FDA-Advisory-No.2020-1595

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