All comments can be sent at [email protected] . Deadline of submission of comments shall be by 16 September 2021 (Friday).
I. BACKGROUND
In accordance with the provisions of the Republic Act (RA) No. 3720, Subject: Food, Drug, and Cosmetic Act, as amended by Executive Order No. 175 and RA No. 9711, subject: Food and Drug Administration Act of 2009, the FDA is mandated to cover the regulation of manufacture, distribution, sale, offer for sale, and other regulated activities and monitoring of veterinary drugs and products, veterinary biological products, device and establishments.
Previously, several issuances including the 1991 Memorandum of Agreement (MOA) and the Joint Administrative Order (JAO) No. 2013-0026 between the Department of Health – Food and Drug Administration (DOH – FDA) and Department of Agriculture – Bureau of Animal Industry (DA-BAI), allowed a shared arrangement in the regulation of veterinary drugs and products and devices between the two (2) agencies.
Following the expiration of the aforecited policies, and to ensure the continuous delivery of service, the Center for Drug Regulation and Research (CDRR) is tasked to facilitate the process for the approval of these health products and hereby provide the interim guidelines for the issuance of authorizations for veterinary products/cosmetics (non-medicated) and veterinary medical devices.
II. OBJECTIVES
This Circular aims to provide the interim guidelines for the licensing, registration and post-market surveillance (PMS), and issuance of other certifications for non-medicated veterinary products/cosmetics, medical device and establishments.
III. SCOPE
This issuance shall apply to establishments engaged in the manufacture, trade, distribution, importation, and/or exportation of non-medicated veterinary products/cosmetics and veterinary medical devices in the Philippines.
For the purposes of this Circular, Non-Medicated Veterinary Product/Cosmetics and Veterinary Device shall refer to:
Non-Medicated Veterinary Product/Cosmetics – any substance or preparation intended to be placed in contact with various external parts of the animal body or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition. This excludes products applied to eyes or the teats of animals producing milk.
Veterinary Medical Device – an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease, in animals or intended to affect the structure or any function of the body of animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of other animals and not dependent upon being metabolized for the achievement of any of its principal intended purposes.
IV. GENERAL GUIDELINES
A. Licensing Requirement
Establishments intending to manufacture, trade, distribute, import, and/or export non-medicated veterinary products and veterinary medical devices shall secure a License to Operate (LTO) with the Center for Drug Regulation and Research (CDRR) of the FDA through the procedure outlined in Section V.1. Correspondingly, establishments shall be classified as Drug Establishments (Manufacturer, Trader, Distributor, as applicable), in the interim.
B. Product Authorization Requirement
Non-medicated veterinary products/cosmetics and veterinary medical devices intended to be placed in the Philippines must be registered by a licensed establishment with FDA-CDRR, following the procedure outlined in Section V.2. Correspondingly, products shall be classified as Pharmaceutical Products or Drugs, in the interim.
C. Labeling
Such products must comply with the minimum labeling requirements provided in Annex B for non-medicated veterinary products/cosmetics, and Annex C for veterinary medical devices.
D. Post-Approval Changes
Should there be any amendment or post-approval change (PAC) either in the activity conducted by the establishments as reflected in the LTO or in the product as reflected in the corresponding CPR, the establishments shall apply for variation or notification with the FDA as may be applicable.
E. Continuous Compliance
The Market Authorization Holder (MAH) shall ensure continuous compliance with the safety, efficacy, and quality standards instituted by the FDA. Correspondingly, the MAH must adhere to the terms and conditions that are specified in all authorization granted to them.
F. Cancellation of an Authorization
Should the applicant or MAH commit violations to the FDA rules, regulations, and standards, applications may be disapproved and/or authorizations may be suspended, revoked, or cancelled. In such cases, a notice of disapproval of the application or notice of suspension, revocation, or cancellation shall clearly state the grounds for such.
G. Non-Registrable Products
The conditions for product classification of veterinary products and those that do not require registration are listed in Annex D.
The License to Operate (LTO) of the establishment shall be provided in lieu of the Certificate of Exemption at the point of entry and/or as part of bidding requirements.
H. Previously-issued Authorizations
All provisions under FDA Memorandum Circular No. 2021-001 shall remain in effect. As such, existing and valid authorizations granted by DA-BAI to establishments and products within the scope of this Circular shall be honored by FDA; while authorizations expiring from March to July 2021 shall be given an automatic validity extension of six (6) months from the date of expiry.
V. SPECIFIC GUIDELINES
1. Application for a License to Operate (LTO)
1.1 Filing of Applications
1.1.1 Applications for the issuance of LTO shall be submitted through the FDA eServices System.
1.1.2 Applicant establishments shall follow the licensing procedure as prescribed in the following issuances:
1.1.2.1 Administrative Order No. 2020-0017, subject: Revised Guidelines in the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003; and
1.1.2.2 Administrative Order No. 2020-030, subject: Guidelines in the Use of eServices Portal System for License to Operate Application of Drug Distributors, Drug Traders, Drugstores, Retail Outlets for Non-Prescription Drugs (RONPD), Clinical Research Organizations (CRO) and Sponsors.
1.1.3 All applications shall be deemed filed upon payment of required fees and charges.
1.2 Documentary Requirements for Issuance of LTO
The following are the documentary requirements for the issuance of LTO, applied as initial, and for renewal:
1.2.1 Accomplished Application Form and Declaration and Oath of Undertaking (eservices.fda.gov.ph).
1.2.2 Proof of Business Name Registration shall be submitted in any of the following:
1.2.2.1 For Single Proprietorship – copy of Certificates of Business Registration issued by the Department of Trade and Industry (DTI);
1.2.2.2 For Corporation, partnership and other judicial person – Certificate of Registration issued by the Securities and Exchange Commission (SEC), and Articles of Incorporation; or
1.2.2.3 For Cooperative – Certificate of Registration issued by the Cooperative Development Authority (CDA), and Articles of Cooperation
1.2.3 Site Master File (SMF)
1.2.4 Proof of Payment based on the latest FDA issuance.
Establishments applying for variation shall follow the List of Requirement for Specific Variation in the LTO as detailed in Annex C of AO No. 2020-0017, Subject: Revised Guidelines in the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003.
1.3 Evaluation
The evaluation of all applications for LTO shall be based on satisfactory compliance to the applicable requirements or appropriate standards.
1.4 Inspection
1.4.1 Manufacturers applying for LTO shall undergo Field Regulation Operations Office (FROO) inspection prior to the issuance of initial LTO. Other covered establishments shall be inspected by FDA at any time within the validity of its license as part of its post-licensing inspection and post-marketing surveillance activities.
1.4.2 During inspection, the establishment will be required to present the following documents, as may be applicable:
1.4.2.1 Standard Operating Procedure (SOPs)
1.4.2.2 Quality Assurance / Quality Control Documents
1.4.2.3 Documents relating to the manufacture of the product
1.4.2.4 Documents relating to the distribution of the product
1.4.2.5 Contract Agreements, if applicable
1.5 Decision on Application
1.5.1 The appropriate authorization shall be issued to the applicant establishment which satisfactorily complied with all applicable requirements and standards
1.5.2 The application shall be disapproved if upon evaluation, it was found that the applicant establishment has failed to satisfactorily meet the applicable requirements and standards.
1.5.3 Applications with incomplete requirements shall automatically be disapproved and requests for reconsideration shall not be entertained.
1.5.4 The disapproval of an application is without prejudice to re-application. However, disapproval of application shall mean outright forfeiture of payment.
- Application for a Certificate of Product Registration (CPR)
2.1 Filing of Application
The guidelines on the procedures and schedules of applications indicated in the FDA Circular No. 2020-026, subject: Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the food and Drug Administration (FDA) shall be followed. Only the accepted pre-assessed application will be processed.
2.2 Guidelines for Product Registration
2.2.1 The requirements for registration of Non-medicated Veterinary Products/ Cosmetics and Veterinary Medical Devices are specified in Annex A and B.
2.2.2 An application for CPR, whether initial, renewal or variation is deemed filed after acceptance of the pre-assessed applications including payment of required fees and charges.
2.2.3 Action on registration application shall be based on the complete set of specifications of the product proposed to appear in the label, i.e. formulation, form, indications, and manufacturer. Any change in the mentioned specifications shall require a new registration.
2.2.4 A violation with any of the terms and conditions of the CPR shall likewise result in the suspension, revocation or cancellation of the CPR or disapproval of the application for renewal, after due process.
2.2.5 Post-Approval Changes (PAC)/ Variation of the product and devices shall be applied following the existing requirements for Post-Approval Changes FDA Circular No. 2014-008, subject: Application Process and Requirements for Post-Approval Changes of Pharmaceutical Products.
- Validity of Authorizations
The LTO and CPR shall be issued and shall have a validity of three (3) and five (5) years from the date of issuance respectively.
- Post-Market Surveillance of Non-Medicated Veterinary Products/Cosmetics and Veterinary Medical Devices
Non-Medicated Veterinary Products/Cosmetics and Veterinary Medical Devices shall be subject to post-marketing surveillance activities of FDA. Applicable regulatory tools shall be implemented to non-compliant and violative products/devices.
- Fees and Charges
Applications shall be charged with the fees pursuant to the schedule of fees stated in the AO No. 50 s. 2001, or its future amendments.
VI. EFFFECTIVITY
This Circular shall take effect fifteen (15) days after its publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the UP Office of the National Administrative Register until the issuance of a formal designation on the Centers to handle such products.