Category: Cosmetic Announcements

APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS/ENNDS PRODUCTS

This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph.

  1. LTO Application for E–Cigarette Establishment Documentary Requirements and Other Reminders
  2. Guidelines for Manufacturers and Traders
  3. Guidelines for Distributors
  4. Guidelines for Retailers

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.

Attachment-> : APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS-ENNDS PRODUCTS

ISSUANCE OF USER ACCOUNTS FOR LTO AND FERN APPLICATIONS FOR ENDS/ENNDS.

This is to inform all concerned stakeholders that the FDA will be accepting User Account registrations for License to Operate (LTO) and FDA Electronic Registration Number (FERN) applications for ENDS/ENNDS starting today, 05 September 2019.

The User Account Registration Form can be assessed thru: bit.ly/ePortal2.

Furthermore, an Authorization Letter must be attached to the registration form if the applicant is not the owner of the establishment. Kindly refer to the attachment below for the Authorization Letter template.

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.

Attachment-> : Authorization Letter Template
Attachment-> : ISSUANCE OF USER ACCOUNTS FOR LTO AND FERN APPLICATIONS FOR ENDS-ENNDS

LICENSING SEMINAR FOR ENDS/ENNDS MANUFACTURERS, TRADERS, DISTRIBUTORS, AND RETAILERS

This is to inform all concerned stakeholders that the FDA shall be conducting a licensing seminar for ENDS/ENNDS manufacturers, traders, distributors, and retailers on 4 and 11 September 2019, at the DOH Convention Hall, DOH, Sta. Cruz, Manila.

Please take note of the following schedule:

4 September 2019

11 September 2019

AM Session Licensing Seminar and Workshop for ENDS/ENNDS Manufacturers and Traders Licensing Seminar and Workshop for ENDS/ENNDS Retailers and Online Sellers
8:30-12:00 NN
PM Session Licensing Seminar and Workshop for ENDS/ENNDS Distributors (Importers, Exporters, and Wholesalers)
1:00-4:00 PM

Only the first one-hundred fifty (150) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue. Furthermore, due to limited slots, only one (1) representative per company will be allowed to attend the seminar.

You can register on the link provided with this announcement. 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.

Attachment-> : Licensing seminar for Manufacturers, Distributors, and Retailers

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

In the interest of the service, the Center for Cosmetics Regulation and Research (CCRR), Food and Drug Administration (FDA), shall conduct a “Cascading of the Administrative Orders on the Regulation of Electronic Nicotine and Non-Nicotine Delivery Systems (ENDS/ENNDS), Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations of RA 10620” on the following dates:

  7 August 2019 9 August 2019

AM Session

8:30-9:00 Registration
9:00-10:00 Presentation of AO on ENDS/ENNDS 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 IRR of RA10620: Toy and Game Safety Labeling Act of 2013 Presentation of AO on HUHS
2:30-4:00 Open Forum

All stakeholders are invited to attend. Registration through this link is on a first-come, first-serve basis as only the first one-hundred (100) pre-registrants (per session) shall be accommodated. To maximize the number of attendees, please limit your representative to only one (1) per company/industry association.

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).For your information and guidance.

Attachment-> : FDA Announcement re. Cascading of New Policies

/ In Cosmetic Announcements / By Administrator / Comments Off on 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