HAIFUSHENG In Paper Cup Packaging with Image of Seafood in Porridge (In Foreign Language) 4…. If the above-mentioned PPE is intended for entry to the local market for commercial use, the importer must provide two documents for customs release: a copy of the importer’s License to Operate (LTO) and proof of application for notification, such as an electronic acknowledgment. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. The public is warned to exercise extreme caution in purchasing or consuming alcoholic beverages and advised to purchase and consume only those which are registered with the FDA. FDA Consulting. OVERMANWU with Yellow/Black Colored Packaging (In Foreign Language) 3. Renewal Application – All LTO Renewal applications received from March 1- May 31, 2020 shall be given automatic extension of validity for another four (4) months after the expiration date of the LTO by virtue of the FDA Circular. We can help bridge your success. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products. 2020-2174 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. ALTER TRADE Coconut Sugar 2. Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 14 August 2019 will be in CORNER ONE EVENTS HUB, CORNER MABINI SUPERHIGHWAY, APLAYA, DIGOS CITY, DAVAO DEL SUR. Initial Application – Initial LTO application will still be processed online through the FDA ePortal System. This is in regard to companies with employees that use face masks in the performance of their jobs and are strictly for company use, but does not include medical device establishments. For the CDRRHR, the following applications will be accepted: COVID-related test kits following Memorandum No 2020-006 dated March 12 entitled ‘Issuance of Special Certification for Imported Test kits of COVID-19’ Compassionate Special Permit The circular order shall take effect immediately and until further notice. Imports of tea, coffee, and spices are subject to review by the Food and Drug Administration (FDA) and their admissibility is determined by the FDA. Methanol is a widely available chemical that has many industrial applications and is also found in household products and fuel for aircraft. By virtue of FDA Personnel Order No. B. Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX. Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on 17-18 July 2019 within Davao City shall be rescheduled to 3-4 December 2019 and GMP-FMT Seminar (Course Code: GMP-FMT-MEC) on 19 July 2019 shall be rescheduled to 5 December 2019. This is due to very low number of course participants that registered in the course. ... Customs Process in the Philippines Customs Process in the Philippines. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. As such, the agency also conducts inspections and tests to ensure the safety and quality of the above products. ZHENGLE Cola Candy with Foil Pouch Packaging Inside Carton Box (In Foreign Language) 3…. Seek medical attention immediately if you experience any side effects and report it to FDA at [email protected] or via online reporting through our website: www.fda.gov.ph. It is important to seek medical advice from doctor or pharmacist before taking medicines. Upon validation, Releasing Officer hands-over to Client the second copy as FDA’s receiving copy indicating the printed name, signature, date and time of receipt. The manufacturing facility of Juan Brewing, Inc. shall be inspected and investigated for any possibility of adulteration specifically the addition of methanol during processing. Exception to this shall be given to establishments that provide health products intended for use in the diagnosis, cure, mitigation, treatment, prevention, and provision of PPE for Covid-19, in addition to essential medicines. More about the Customs Process More about the Customs Process. Advance notice of import shipments allows the FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively. Philippines: New rules for obtaining customs clearance of radiation devices. For the mentioned medical gear, the FDA said foreign donations of such would no longer require the clearance of the agency. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. at 1-888-723-3366. If you need a professional help to ensure a fast and hassle-free release of your import goods, contact Excelsior Worldwide Logistics Corp. today at (063) 525-9775 or send an email to wecare@excelsior.ph RICHMOND RIC Canton Small 4. The Department of Health (DOH), Food and Drug Administration (FDA), and the Bureau of Customs (BOC) hereby issue thisjoint circular: 1. The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation. RICHMOND RIC Special Noodles Molo Strips White 5. The FDA hereby warns the public on the consumption of the implicated product as this is currently unregistered and has been confirmed to contain a high level of methanol. It is the FDA process of scientific and regulatory review, to help ensure that those devices are safe and effective. Duly endorsed Bill of Lading or Airway Bill, or certification by the carrier or agent of the vessel or aircraft 2. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. Juice Drink with Picture of Pomegranate Packaging Pink in Color (In Foreign Language) 3. Guidance for Applications and Transactions at the FDA in Light of the Community Quarantine Declaration: On March 17, 2020, the FDA issued Circular 2020-006 to notify all stakeholders as well as the general public of its interim changes in work arrangements and how applications will be accepted in light of the Covid-19 outbreak, specifically for a License to Operate (LTO), Certificate of Product Registration (CPR) and Certificate of Product Notification (CPN). This is also a product of natural fermentation and is found in both alcoholic and non-alcoholic fermented beverages. Rest assured that all changes and concerns of the registered participants of this seminar shall be attended to by the FDA Academy. The FDA may allow an individual entering the U.S. to import a three-month (90-day) supply of a foreign manufactured, unapproved drug if all of the following conditions are met: The intended use of the drug is for a serious condition for which effective treatment is not available in the U.S. The FDA, in a March 20 memorandum, eased clearance guidelines for Customs to expedite the release of such medical gear as face masks including N95 masks, shoe covers, gloves, head covers, and gowns. All Local Government Units and Law Enforcement Agencies are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in NORTHVIEW HOTEL, BRGY. samp) or registered in an FDA-counterpart agency in the country of origin iii. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. Serving Filipinos through the responsible licensing and registration of quality and safe products. 2020-2172 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC), RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019, CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019, Presentation of IRR of RA10620: Toy and Game Safety Labeling Act of 2013. All confirmed participants of this seminar shall be automatically moved to the rescheduled date. The FDA oversees the production, sale, and traffic of such products in the Philippine market. In response to the limited supply of PPE in the Philippines, the FDA has issued advisory 2020-420 on March 20, 2020 outlining the procedures for FDA Clearance of imported PPE. Sorry, we weren't able to sign you up. Commercial Shipments: Imported goods brought into U.S. commerce for sale or distribution.To find out more information about the different types of entries visit our Common Entry Typespage. All concerned regulated establishments are reminded to follow and strictly comply with the FDA’s existing rules and regulations to ensure that only safe and quality products shall be made available to the public. 2020 – 1691 entitled: Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product: FDA Advisory No. Please be informed of the following changes of the FDA Academy QPIRA Seminar for Center for  Cosmetics  Regulation  and  Research  for  Mindanao  Stakeholders  (QCCRR-MIN)  and Unified  Licensing  Seminar   for  Region  X  (ULS-RX) in observance of the local holiday in Cagayan de Oro City on 28 August 2019: Our sincere apologies for any inconvenience this change in seminar schedule have cause. 2. Product registration issued by the regulatory agency or their accredited third party from the countries with established regulation such as, but not limited to, the US FDA, Therapeutic Goods Authority, European Union, Health Science Authority, Pharmaceutical and Medical Device Authority, Ministry of Food and Drug Safety (Korea), and Health Canada; or WHO pre-qualified or EUL. For your information and guidance. What are the requirements for importing tea, coffee and spices for commercial purposes? A broad range of commodities require import clearance/licenses from appropriate government agencies prior to importation into the Philippines. And the actual quantity of the face masks must be shown on the invoice. G-RUTH Peanut Butter 5. Valid License to Operate as a Medical Device Importer/Distributor/Exporter 3.) PRIOR NOTICE DEADLINES Except for food being sent by international mail (only covers foreign national mail services), Prior Notice must be submitted and the submission must be confirmed by FDA no less than: Imports of FDA-DOH -regulated products as listed below, may be brought into the Philippines without prior clearance from the Food and Drugs Administration, provided suchproducts are: a. EXCELSIOR is duly licensed as Total Logistics Company by the Bureau of Customs. All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar. Specific instructions for stakeholders of the Center for Device Regulation, Radiation, Health and Research (CDRRHR) and the Food and Drug Action Center (FDAC) in relation to medical devices are provided below. Attachment-> : ULS DAVAO VENUE on 22 August 2019. The agency aims to protect public health and safety. A medicine bought online may contain no active ingredient; too much or too little of active ingredients which may result to your condition not being treated correctly. Most questions revolve around the difference between commercial and personal shipments. 2.) These guidelines are listed below: A. The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products: 1. ITACS allows the Import Trade Community to: 1) Check status of Entries 2) Input Line Availability 3) Submit Requested Documents To get started, at a minimum please enter an Entry Number. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. This is in consideration to the reinstatement of the HUHS licensing and notification requirements. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. On 30 June 2019, the Food and Drug Administration (FDA) received a report on an incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’ and exhibited signs and symptoms related to methanol intoxication which include headache, vomiting, abdominal pain, and affected vision. Upon receipt of DRF, the Releasing Officer checks on the files for release. Laboratory testing of the product is also being undertaken to check if the methanol content is compliant. Status of applications may still be viewed via the FDA website Document Tracking Status and respective e-Portal accounts. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). The Premarket Approval (PMA) is another important part of the FDA customs clearance process when it comes to the Class III medical devices. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. Applications for variations of CPRs for medical devices and in-vitro diagnostic devices 5.) HAOHUANLUO Liuzhou Snail Rice Noodles Instant Noodles in Foil Pouch with Violet Packaging 300g (In Foreign Language) 2. This is to inform all concerned stakeholders that the Cascading activities shall push through on 7 & 9 August 2019 at the DOH Convention Hall, DOH, Sta. Said procedures shall be in effect until otherwise lifted. With the expanding global outbreak of respiratory illness caused by COVID-19, the CDRRHR shall be issuing a special certificate for imported in-vitro diagnostic (IVD) kits used for diagnosis and screening of COVID-19. 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR. In the Philippines, the License Holder must be involved in importing the customs clearance process for medical and IVD devices for which it holds the Import License. 1. Buying medicines over the internet can pose serious health risk. Blindness can also happen in severe cases. Due to the rapid spread of COVID-19, the following measures are being adopted for the expedient release of certain PPE within the jurisdiction of the Bureau of Customs. HAIFUSHENG In Paper Cup Packaging with Image of Porridge (In Foreign Language) 3. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected]. In response to the limited supply of PPE in the Philippines, the FDA has issued advisory 2020-420 on March 20, 2020 outlining the procedures for FDA Clearance of imported PPE. Regular transactions will resume on Monday, 19 August 2019. Attachment-> : CDRR MEMORANDUM NO.2019-07. Renewal Application – All CPR & CPN applications received from March 1- May 31, 2020 shall be given an automatic extension of validity for another four (4) months after the expiration date of the CPR or CPN. For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected] (for ENDS/ENNDS-related concerns) or [email protected] (for HUHS, HUP, PCO and Toy-related concerns). We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. Letter of intent regarding exemption of the device/product from registration 2.) Attachment-> : RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR. You may want to contact the FDA to obtain instructions on how to label the products (i.e., ingredients, nutrition, content etc.) In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. Cruz, Manila. Instant Noodles in Bluegreen Pouch Packaging (In Foreign Language) 3. Sorry, we weren't able to sign you up. Protecting the public health through the enforcement of its standards. 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE. Special certificates/import clearance/permit depending on the nature of goods being shipped and/or requested by the importer/bank (see below); Commercial Invoice of Returned Philippine Goods. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. The following applications are hereby suspended for application until further notice: 1.) To report continuous sale or distribution of the above unregistered food product, e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105. – Initial LTO applications from manufacturers of health products must await a pre-license inspection schedule which will be released as soon as the community quarantine in Luzon and/or the respective Local Government Unit of the establishment is lifted. Center for Cosmetic Regulation and Research, Center for Device Regulation Radiation Health and Research, Licenses To Operate and Products Registered, OUR FIGHT AGAINST COUNTERFEIT CONTINUES TO KEEP THE PUBLIC SAFE AND SECURE, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019, Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in, We advise our clients to kindly send all queries and concerns via, For more information and inquiries, please e-mail us atÂ, Seek medical attention immediately if you experience any side effects and report it to FDA at, Center for Cosmetics Regulation and Research QPIRA Seminar  for Mindanao (Cagayan de Oro), Unified Licensing Seminar for Region X (Iligan City), Unified Licensing Seminar for Region X (Cagayan de Oro City), For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email atÂ, Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on, Please be informed that the conduct of Center for Cosmetics Regulation and Research (CCRR) QPIRA Seminar for Household and Urban Hazardous Substance (Course Code: QCCRR-HUHS) on 16-17 July 2019 within Muntinlupa City, Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in, Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in. – All expiring LTO must still apply for their renewal using the FDA ePortal System. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. Q10 Fertility Gel Food Supplement 2. Please note that photocopy of each required document is needed for every request. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations. Also of concern is the possibility of Stevens Johnson Syndrome. Enle 500ml Green Bottle with…. Given that glutathione affects the production of melanin (the pigment that gives the human skin, hair and eyes their color) — there are theoretical concerns about the long term skin cancer risk. with expiry date less than six (6) months upon arrival 3. The importer will not distribute the drug commercially The PPE includes: 1) Face masks including N95 masks 2) Shoe covers 3) Gloves 4) Head covers, and 5) Gowns. 2020-2173 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Food Products: FDA Advisory No. Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals. To report continuous unauthorized sale or distribution of drug products, kindly email us via [email protected], or through the online reporting facility, eREPORT, at www.fda.gov.ph/ereport. The Philippine Food and Drug Administration (FDA) is the country’s official government arm that protects the health of the public by assuring safe, efficient, and quality drugs, food products, food supplements, cosmetics, household hazardous products, household urban hazardous products, and medical devices. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. 2. Philippines Import Shipments Clearance Tips This information is provided as guidance only. To assure that your skin conditions are treated, consult only a board-certified dermatologist. The National Food Authority (NFA) is the sole importer of rice and continues to be involved in the importation of corn. License to Operate (LTO) 1.) Discretionary licensing arrangements are in place for rice imports. Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Website: www.fda.gov.ph Fax +63 2 807 0751 Email: info@fda.gov.ph For your guidance. FDA Import Program Web Site Landing Page, importing fda products into the US, regulated products, ITACS, submission of fda regulated products actions and enforcement, fda import contacts Initial application of CPR for medical devices, in-vitro diagnostic devices, water purification systems and healthcare waste systems 4.) For personal use; b. TÙVRheinland ERTIFIEO Management System Eje.é.. 9105073396 Civic Drive, Filinvest City. – For transactions with the BOC, please provide this Circular as an attachment in support of the expired CPR or CPN. 3.) This Circular shall apply to all establishments importing drug, foreign drug manufacturers and concerned Offices of FDA. The Food and Drug Administration (FDA) Philippines (previously called Bureau of Food and Drugs) is responsible for safeguarding public health and safety through enforcing its standards on all products relating to food, drugs, cosmetics, medical devices, and household hazards that are available in the Philippine market. REWEL’S Peanut Butter 2. Fruits Blend 30% 500ml Juice with Picture of Fruits (In Foreign Language) 2. The confirmed participant of this seminar will be transferred to the next available seminar schedule. The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. Drink in Pet Bottle with Black and Gold Packaging (In Foreign Language) 3. For foreign donations of the same PPE to a company, clearance from the FDA is not necessary. FDA issues rules on clearance of personal ... the Philippine Food and Drug Administration (FDA) ... head covers and protective gowns, so as to expedite their customs release. The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products: 1. 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