Presentation Transcript

1. X. APPLICATION FOR AMENDMENT

2. FDA shall issue a certification for those FDA licensed establishments applying for amendment during the validity of their Licenses to Operate. This certification shall form an integral part of the LTO attachment issued at the time of LTO renewal. Consequently, all amendments shall be incorporated once the LTO is re-issued for renewal. Thus, previous LTO and certifications related to amendments shall be surrendered to this Office.
3. Amendment referred hereto shall include the following: 1. Inclusion or deletion of product (finished or raw material) and/or product line 2. Inclusion or deletion of sources (including toll manufacturer/repacker, trader) 3. Change in business name/address of the source and/or manufacturer.
4. 4. Change of key personnel for Quality Assurance, Quality Control, Production Manager, Authorized Person and Pharmacist as reflected in the LTO. 5. Inclusion or deletion of activity e.g. from Manufacturer to Toll Manufacturer/Repacker/ Importer/Exporter or Trader to Trader/Importer/ Exporter (raw materials or finished bulk products)
5. Other amendments, as enumerated below, shall require re-issuance of License to Operate after the conduct of inspection as these particulars are reflected in the LTO itself:
6. 1. Change of business name, ownership and transfer of location of the establishment 2. Re-classification of the establishment (e.g. from Distributor/Importer to Distributor/Wholesaler), except for those which were reclassified into another class of establishment (e.g. from Distributor/Importer/ Wholesaler to Trader).
7. Payment for the amendments shall be collected in accordance with the existing regulations pertaining thereto. No change in the previously approved circumstances of the application of the establishment shall be effected unless proper notification and submissiono f necessary documents to the FDA and approval of such change(s) has been made.
8. NOTE: Change of address for drug manufacturer is considered opening, hence all the documentary requirements for initial application shall be submitted and payment of the initial license fee shall be made.
9. Checklist of requirements: Change of Business Name: 1.Official Letter regarding the change of business name. 2.Notarized Accomplished Petition Form Note: Notarized Certificate authorizing the person who signed behalf of the establishment/company, if he/she is not the owner or one of the incorporators as registered with DTI/SEC. 3. Joint affidavit of undertaking/Information Sheet(drugs and cosmetics only). 4.Photocopy of Business Name(DTI/SEC/Business Permit).
10. 5.ID picture(5cm X 5cm) of the owner/authorized representative and pharmacist(drugs and cosmetics only). 6.Photocopy of Contract /Agreement with Manufacturer reflecting new business name(Trader/Repacker/Distributor). 7. Surrender original LTO.
11. Change of Business Address: A. For Manufacturer/Repacker –All the genera and additional requirements for the opening. B. For Trader(Drug and Cosmetics Only) 1.Official letter regarding the change of business address 2. Photocopy of Business Name Registration (DTI/SEC/Business Permit)
12. 3.Notarized Valid Contract of lease or TCT. 4.Floor plan and location plan of the office/ storage areas. 5. Photocopy of Contract/Agreement with the Manufacturer reflecting the new address. 6. Surrender original License to Operate.
13. Change of Ownership 1.Official Letter regarding the change of ownership. 2.Notarized Accomplished Petition Form Note: Notarized Certificate authorizing the person who signed behalf of the establishment/company, if he/she is not the owner or one of the incorporators as registered with DTI/SEC. 3. Joint affidavit of undertaking/Information Sheet(drugs and cosmetics only). 4.Photocopy of Business Name(DTI/SEC/Business Permit).
14. 5.ID picture(5cm X 5cm) of the owner/authorized representative and pharmacist(drugs and cosmetics only). 6.Photocopy of Contract /Agreement with Manufacturer reflecting new business name(Trader/Repacker/Distributor). 7. Photocopy of Deed of sale/Transfer of Rights. 8. Photocopy of Contract of Lease/TCT. 9. Photocopy of Dissolution Papers from SEC(Corporation/Partnership) 10.Photocopy of Financial statement duly notarized and received by the BIR. 11. Surrender original LTO.
15. Change of Pharmacist: 1.Accomplished Notice/Affidavit for Change of Pharmacist duly notarized. 2. ID picture of the owner/authorized representative and Pharmacist (size 5cm x 5cm.) 3.Photocopy of Pharmacist’s Registration Board Certificate, PRC ID,PTR. 4. Photocopy of FDA Licensing Seminar 5. Duties and Responsibilities of the Pharmacist 6.Photocopy of the resignation letter from the previous company. 7.Pharmacist clearance.
16. XI. LICENSING PROCESS A. Filing of Applications An application, whether initial, renewal, automatic renewal or amendment, is deemed filed upon submission of duly accomplished application form and Self-Assessment Checklist (SAC) with the complete attached required documents, payment of required fees and acceptance of the authorized FDA officer. Failure to comply with the requirements within the prescribed period shall mean denial of the application.
17. Any application not pursued by the applicant within three (3) months from filing shall be deemed discarded and will be automatically cancelled and delisted from the application list.
18. B. Where to File An application shall be filed with the respective Regional Field Offices having jurisdiction over the establishment or as defined in accordance with issuance.
19. C. Period to File Initial application. It shall be filed prior to operation subject to compliance of the requirements and conduct of site inspection but in no case shall the establishment commence to operate until the issuance of the corresponding License to Operate.
20. Renewal application. Regular renewal shall be filed six (6) months prior to expiration of the original validity of the LTO. Automatic renewal shall be filed prior to the expiration of the original validity of the LTO.
21. XII. LICENSING GUIDELINES A. Place of Business, Warehouse or Plant All the office, warehouse and plant shall be covered by a single license notwithstanding their distance or different locations within one locality indicating merely their address in the license, except when any of the office, warehouse and plant carries an entirely different and complete stage of operation for different product, in which case, each shall be covered by separate license. In this instance, the principal office address shall be reflected at the front page of the LTO while the others at the back page thereof or secondary page appended thereto. The place of business should be situated in accordance with the zonal site.
22. B. Display of Signboard and License Every licensed establishment shall cause the public display the duly issued license in a conspicuous place within the premises of the establishment.
23. E. Request for Information Any request for information whether by the company or any other party shall be governed by the existing policies on disclosure.
24. XIII. LICENSE TO OPERATE A. Validity All Licenses to Operate shall have the following validity for any classification of drug establishments from the date of issuance reflected as such and renewal thereafter. a. Initial – Initial LTO issued shall be valid for one year b. Renewal- Renewed LTO shall be valid for two years In either case, the LTO shall be valid only in the address indicated therein and the warehouse or plant covered.
25. B. Lost or Destroyed LTO An LTO shall be re-issued upon the filing of request with affidavit of loss or affidavit of such destruction and other documents whenever necessary and payment of the prescribed fee. Provided that there is no change whatsoever in the establishment, otherwise the same shall be treated as amendment or initial as the case may be.
26. C. Cancellation of LTO a. Automatic. Any application for renewal of a LTO filed after one-hundred twenty (120) days after the expiration of the original validity shall be automatically considered expired and cancelled. Likewise, unrenewed LTO for successive years shall be automatically cancelled and deleted from the list of registered establishments.
27. b. Voluntary. The owner or authorized person of a licensed establishment may apply before the FDA or its regional field office having jurisdiction over the establishment for voluntary cancellation of its existing license by filing a formal notification together with the original LTO issued, or in case of loss or destruction, an appropriate affidavit therefore. Any voluntary cancellation intended to defraud the government, its creditors, and/or its workers shall not deprive FDA jurisdiction to perform acts in ensuring the safety of the public.
28. c. Involuntary- This shall be effected only on the grounds and procedures provided in the Rules of Administrative Procedure provided in the IRR OF RA 9711 or other relevant rules and regulations in case of violation or upon petition by any party. Nothing in this section shall restrict the FDA or the DOH in imposing the penalty of suspension, revocation, or cancellation of LTO or other authorization for administrative violations of any other relevant laws or their implementing rules and regulations.
29. Any notice of disapproval of applications for license or authorization or suspension, revocation, or cancellation of an existing license, or authorization must clearly state the ground/s on which the disapproval, suspension, revocation, or cancellation is based.
30. Thank You!