VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RXI) ON 22 AUGUST 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 22 August 2019 will be in GRAND REGAL HOTEL DAVAO, KM. 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

Course Assessment Slip
Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

Attachment-> : ULS DAVAO VENUE on 22 August 2019

RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC)

In order to have an efficient and orderly releasing of FDA Authorizations at the Food and Drug Action Center (FDAC), the following guidelines shall be strictly implemented:

A. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS:

Owner/President/Manager/Head of the company. Owner must submit a photocopy of his/her valid ID.
Authorized Representative.The authorized representative must present and submit the following:

Authorization letter in company letterhead;
Photocopy of valid ID of the Company’s Owner/President/Manager/Head; and
Photocopy of any of the following ID’s:

Company ID
QPIRA ID
Any government issued ID

B. RELEASING OF AUTHORIZATIONS

A Document Request Form (DRF) must be accomplished by the Client (Owner/President/Manager/Head of the company or the Authorized Representative) and submit to the Releasing Officer together with the required document/s mentioned above. Please note that photocopy of each required document is needed for every request.

2. Upon receipt of DRF, the Releasing Officer checks on the files for release. 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.

Releasing Officer releases the Authorization/s to Client.

For information and guidance.

Attachment->:ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC)

Notice of Cascading-Workshop of Center for Cosmetics Regulation and Research (CCRR) on 15 to 16 of August 2019

By virtue of FDA Personnel Order No. 2019-0523, please be advised that the Center for Cosmetics Regulation and Research (CCRR) will conduct a Cascading-Workshop on the new Administrative Orders on the Regulation of Electronic Nicotine Delivery Systems (END/ENDDS), Household Pesticide and Their Active Ingredients, Operators of Pest Control, Certification of Pesticide Handlers and Accreditation of Their Training Providers, Reinstatement of Licensing and Registration and or Notification of Household Urban Substances and Implementing Rules and Regulations of RA10620 on 15 to 16 of August 2019.On such dates, CCRR will not be able to entertain clients.

Regular transactions will resume on Monday, 19 August 2019

Attachment-> : Notice (Cascading CCRR)

CASCADING OF ADMINISTRATIVE ORDERS ON THE REGULATION OF ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEMS, HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES, HOUSEHOLD/URBAN PESTICIDES, AND PEST CONTROL OPERATORS AND PESTICIDE HANDLERS, AND IMPLMENTING RULES AND REGULATIONS OF RA 10620

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. Cruz, Manila.

Please note the following changes in schedule:

	7 August 2019	9 August 2019
AM Session
8:30-9:00	Registration
9:00-10:00	Presentation of IRR of RA10620: Toy and Game Safety Labeling Act of 2013	Presentation of AOs on HUPs and PCOs
10:00-12:00 NN	Open Forum
PM Session
1:30-2:00	Registration
2:00-2:30	Presentation of AO on ENDS/ENNDS	Presentation of AO on HUHS
2:30-4:00	Open Forum

Only the first one-hundred (100) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue.

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at fdaccrr.tru@gmail.com (for ENDS/ENNDS-related concerns) or ccrr.lrd.huhs@gmail.com (for HUHS, HUP, PCO and Toy-related concerns).

For your information and guidance.

Attachment-> : Cascading on 7 and 9 August 2019 by CCRR

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RXI) ON 14 AUGUST 2019

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.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

Course Assessment Slip
Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

Attachment-> : ULS-RXI (DIGOS)

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 NORTHVIEW HOTEL, BRGY. 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

Course Assessment Slip
Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

Attachment-> : VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019

A N N O U N C E M E N T

The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via cdrr@fda.gov.ph, and we will respond accordingly.

For your information and guidance.

Attachment-> : CDRR MEMORANDUM NO.2019-07

A N N O U N C E M E N T

Please be informed that the conduct of ULS-RII in Isabela (Course Code:ULS-RII) scheduled on 18 July 2019 shall be postponed due to Typhoon Falcon that is expected to land in Northern Luzon this week. All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar.

Rest assured that all changes and concerns of the registered participants of this seminar shall be attended to by the FDA Academy. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph.

For inquiries and other concerns, you may reach the FDA Academy thru:

Telephone Number: (02) 877 0259
Email Address: e-nroll@fda.gov.ph and enroll.fdaacademy@gmail.com

Please be guided accordingly.

Attachment-> : ULS-RII POSTPONEMENT ON JULY 18 2019

UPDATES ON THE ISSUE FOLLOWING THE INCIDENT INVOLVING THE CONSUMPTION OF “COSMIC CARABAO GIN”

In light of the developments on the investigation of the Food and Drug Administration (FDA) with regards to the incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’, this Office shall order the seizure and/or confiscation of the product as the samples collected and subjected to FDA analysis were found positive for methanol.

Methanol is a widely available chemical that has many industrial applications and is also found in household products and fuel for aircraft. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. This is also a product of natural fermentation and is found in both alcoholic and non-alcoholic fermented beverages. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. Blindness can also happen in severe cases.

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. 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. Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals.

In the interest of public protection, the Field Regulatory Operations Office inspectors and Regulatory Enforcement Unit officers of FDA shall seize and/or confiscate all Cosmic Carabao Gin products available in the market. 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.

For more information and inquiries, please e-mail us at info@fda.gov.ph. To report continuous sale or distribution of the above unregistered food product, e-mail us via report@fda.gov.ph, or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.

Attachment-> : FDA Advisory No. 2019-188

UNSAFE USE OF GLUTATHIONE AS SKIN LIGHTENING AGENT

The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione.

In the Philippines, several health and beauty salons, wellness spa and beauty clinics are offering all kinds of beauty enhancements, services and skin treatments. It is alarming that they also offer services such as intravenous drip or infusion using skin lightening agents including reduced glutathione, vitamin C and other injections.

To date there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. There are also no published guidelines for appropriate dosing regimens and duration of treatment. The FDA has not approved any injectable products for skin lightening. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy.

Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. Also of concern is the possibility of Stevens Johnson Syndrome. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. Large doses of Vitamin C have resulted in hemodialysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

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.

Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility.

To assure that your skin conditions are treated, consult only a board-certified dermatologist. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products.

Seek medical attention immediately if you experience any side effects and report it to FDA at pharmacovigilance@fda.gov.ph or via online reporting through our website: www.fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596.

Attachment-> :FDA Advisory No.2019-182

STATEMENT ON THE ISSUE FOLLOWING THE INCIDENT INVOLVING THE CONSUMPTION OF “COSMIC CARABAO GIN”

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.

With this, the FDA commenced its own investigation on the implicated product ‘Cosmic Carabao Gin’ which is a locally manufactured alcoholic beverage. Currently, this product is not registered with the FDA. The manufacturing facility of Juan Brewing, Inc. shall be inspected and investigated for any possibility of adulteration specifically the addition of methanol during processing. Laboratory testing of the product is also being undertaken to check if the methanol content is compliant.

Further, the FDA has requested the assistance of the Epidemiology Bureau of the Department of Health to ensure that proper information from the patients relative to this incident is collected and verified. The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation.

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. 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.

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. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations.

Attachment-> : FDA Advisory No.2019-181

A N N O U N C E M E N T

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:

ACTIVITY TITLE	FROM (ORIGINAL SCHEDULE)	TO (NEW SCHEDULE)
Center for Cosmetics Regulation and Research QPIRA Seminar for Mindanao (Cagayan de Oro)	28-29 August 2019	29-30 August 2019
Unified Licensing Seminar for Region X (Iligan City)	28 August 2019	29 August 2019
Unified Licensing Seminar for Region X (Cagayan de Oro City)	29 August 2019	30 August 2019

Our sincere apologies for any inconvenience this change in seminar schedule have cause.

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at enroll.fdaacademy@gmail.com.

Please be guided accordingly.

Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX

A N N O U N C E M E N T

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.

All confirmed participants of this seminar shall be automatically moved to the rescheduled date.

For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph.

Attachment-> : RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR

A N N O U N C E M E N T

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 shall be rescheduled to 3-4 October 2019. This is in consideration to the reinstatement of the HUHS licensing and notification requirements.

All confirmed participants of this seminar shall be automatically moved to the rescheduled date.

For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph.

For inquiries and other concerns, you may reach the FDA Academy thru:

Telephone Number: (02) 877 0259
Email Address enroll.fdaacademy@gmail.com

Please be guided accordingly.

Attachment-> : QCCRR-HUHS POSTPONEMENT

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in HOTEL GUILLERMO, RIZAL AVENUE, PAGADIAN CITY.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

Course Assessment Slip
Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

Attachment:->VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019

INTERNET SALES AND ACCESS TO SAFE MEDICINE

The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines.

Unlike other consumer products purchased over the internet, medicines have the potential to cause serious side effects and health problems if not used and stored properly. It is important to seek medical advice from doctor or pharmacist before taking medicines.

Buying medicines over the internet can pose serious health risk. You will never know what exactly you are getting. Even if the medicines bought online looks the same; there is no guarantee that it is genuine. 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. Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions.

In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA.

The FDA recommends purchase of medicines from licensed pharmacies near you and seek advice from your community pharmacist on the proper and safe use of medicines.

To report continuous unauthorized sale or distribution of drug products, kindly email us via report@fda.gov.ph, or through the online reporting facility, eREPORT, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-154

VENUE FOR UNIFIED LICENSING SEMINAR
(ULS –RXII) ON 3 & 4 JULY 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RXII) on 3 & 4 July 2019 will be in GREENLEAF HOTEL, SAN MIGUEL STREET CORNER J. CATOLICO AVENUE, LAGAO, GENERAL SANTOS CITY.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:
Course Assessment Slip
Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019

CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019

Please be informed that the conduct of ULS-ARMM in Cotabato City (Course Code:ULS-ARMM) scheduled on 2 July 2019 is cancelled due to very low number of course participants that registered in the seminar. The confirmed participant of this seminar will be transferred to the next available seminar schedule.

For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph.

For inquiries and other concerns, you may reach the FDA Academy thru:

Telephone Number: (02) 877 0259
Email Address enroll.fdaacademy@gmail.com

Please be guided accordingly.

Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RV) ON 19-20 JUNE 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in LA VENEZIA HOTEL & SPA, INC., RENAISSANCE GARDENS, WASHINGTON DRIVE, LEGAZPI CITY, ALBAY.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

Course Assessment Slip
Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RV) ON 19-20 JUNE 2019

CDRRHR Downloadables

Medical Device Licensing Establishment Requirements

Medical Device Registration Requirements

Checklist

Forms

Site Master File

AO 2018-002 Requirements

X-Ray Facilities Requirements

Magnetic Resonance Imaging Facility

Health Related Devices

Information Sheet and Mechanics of the Sales Promotion

RFR Evaluation Report Requirements

Technical Specification for the following Machine

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RXI) ON 22 AUGUST 2019

RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC)

Notice of Cascading-Workshop of Center for Cosmetics Regulation and Research (CCRR) on 15 to 16 of August 2019

CASCADING OF ADMINISTRATIVE ORDERS ON THE REGULATION OF ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEMS, HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES, HOUSEHOLD/URBAN PESTICIDES, AND PEST CONTROL OPERATORS AND PESTICIDE HANDLERS, AND IMPLMENTING RULES AND REGULATIONS OF RA 10620

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RXI) ON 14 AUGUST 2019

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019

A N N O U N C E M E N T

A N N O U N C E M E N T

UPDATES ON THE ISSUE FOLLOWING THE INCIDENT INVOLVING THE CONSUMPTION OF “COSMIC CARABAO GIN”

UNSAFE USE OF GLUTATHIONE AS SKIN LIGHTENING AGENT

STATEMENT ON THE ISSUE FOLLOWING THE INCIDENT INVOLVING THE CONSUMPTION OF “COSMIC CARABAO GIN”

A N N O U N C E M E N T

A N N O U N C E M E N T

A N N O U N C E M E N T

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019

INTERNET SALES AND ACCESS TO SAFE MEDICINE

VENUE FOR UNIFIED LICENSING SEMINAR
(ULS –RXII) ON 3 & 4 JULY 2019

CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RV) ON 19-20 JUNE 2019