Presentation on theme: "Revised Regulations for the Licensing of Drug establishments and outlets and for other purposes. Revised AO 56."— Presentation transcript:
1 Revised Regulations for the Licensing of Drug establishments and outlets and for other purposes. Revised AO 56
2 RationaleSection 15 Article II of the 1987 Constitution-protect and promote the right to health of the people and instill health consciousness among them.RA 3720 as amended by RA 9711and A 7394= to ensure safe and good quality of food, drug, and cosmetics and to regulate the production sale and traffic of the same to protect the health of the people.RA Electronic commerce Act of To facilitate domestic and international dealings. Transactions, arrangements, agreements, contracts and exchanges and storage of information through the utilization of electronic medium or mode.
3 RA Universally Accessible Cheaper and quality Medicines Act of Provides the policy of the state that when the interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to provide and ensure access to affordable quality pharmaceutical products for all through an effective competition policy in the supply and demand.
4 The streamlined regulatory approaches in licensing of drug establishments, Provision of faster access of pharmaceutical products to the publicAnd promote transparency through the universal use of electronic transaction in the government and the general public.
5 Bases of authoritySection 26 of RA 3720 as amended by RA 9711 ( FDA Act of 2009)RA Consumers Act of the PhilippinesRA Universally Accessible cheaper and Quality Medicines Act of 2008.RA Generics Act of 1988RA The Pharmacy LawSection 27 Part IV of RA Electronic commerce Act of 2000.
6 Objectives1. Further amend the existing rules and regulations in the licensing of drug establishments to align with recently promulgated laws and adopted policies affecting drug establishments.2. Ensure the public that establishments licensed by FDA comply with current regulatory standards.( GMP,GDP,GSP, GPP,GDP)3.Prescribe the use and implementation of new innovations such as but not limited to Electronic data messages, electronic submission of documents.
7 Scope This Order shall apply to : all drug establishments, including local government units ,government owned and controlled corporations,non government organizations ,other government offices and instrumentalities engaged in the manufacture, importation, exportation, sale, offer for sale, distribution in wholesale and/ or retail basis and transfer of pharmaceutical products.
8 Entities engaged in the activities such as donation,promotion,advertising,or sponsorship of pharmaceutical products shall be responsible therefor and shall secure an authorization.
9 General Provisions1.No drug establishments shall manufacture, import , export ,sell , offer for sale, distribute, transfer, promote, advertise and/ or sponsor any activity that involves pharmaceutical product without a license or appropriate authorization from FDA pursuant to this order.2.The recipient of donated products whether foreign or locally manufactured for purpose of either medical missions or other health related programs shall secure a special permit prior to product's distribution.
10 3. Any pharmaceutical product sold in its original packaging ( container) , the seal of which has not been broken or tampered with, the liability of ensuring its safety, efficacy, quality, and/ or purity rests upon all the stakeholders involved in the supply chain .4. All drug distributors shall not sell directly to the general public or consumer, unless they have license as a retailer.5. The application must meet the required documentary and/ or technical requirements or appropriate standards.
11 6. Misrepresentation, false entries, or withholding of any relevant data contrary to the provisions of the law, rules and regulations or appropriate standards shall mean disapproval of the application.7. A violation of any of the term and conditions of its license shall likewise result in the disapproval of the application.8. Application may also be disapproved for similar causes as determined by FDA.
12 9. All licensed drug establishments must continuously comply with the existing requirements, regulations and standards, otherwise the establishment may be ordered close or their license suspended or revoked motu proprio or upon petition by any person.10. Any pharmaceutical product o imported or offered for import, the sale or use of which has been banned or withdrawn for health and safety reasons in the country of manufacture or country of origin, shall likewise be banned and refused admission in the Philippines.
13 11. Any pharmaceutical product that is declared by the secretary of health or the FDA Director General to be imminently injurious , unsafe or dangerous shall be ordered for their immediate recall, seizure or banning from public sale or distribution.12. All entities, whether government or non-government offices, that regularly procure medicines on wholesale basis from any FDA authorized drug establishments for use of their constituents must be licensed as drugstore /pharmacy or distributor. ( Sec. 25 of RA 5921 and RA 3720)
14 13.Institutional Pharmacies procuring medicines on a wholesale basis from any FDA authorized drug establishments for use of their employees and dependents must likewise be licensed as drugstore/ pharmacy.14. Every pharmacy, drugstore, institutional or hospital pharmacy whether owned by the government, or a private person or firm shall at all times when open for business be under the supervision of a registered pharmacist except otherwise allowed by pertinent law.
15 15. All establishments applying for a license to manufacture, import, distribute, sell vaccines and other biological products are hereby directed to comply with Cold Chain Management requirements. Likewise existing establishments handling the same shall upgrade their cold chain management capabilities.16. FDA shall have the authority to verify all original or authenticated copies of the submitted documents for LTO. ( Sec. 27,26 of RA 3720)
16 17. FDA shall endeavor to integrate all electronic submission or processes into electronic format pursuant RA 8792 or the Electronic Commerce Act of 2000.18 . Rule 17 non discriminatory clause of IRR of RA 9502.
17 33. Non-Discriminatory Clause 33. Non-Discriminatory Clause. - It shall be unlawful for any retail drug outlet to refuse to carry either by sale or by consignment, or offer for sale drugs and medicines brought into the country, as allowed under Section 7 of this Act which amends Section 72.1 of the Intellectual Property Code of the Philippines or Republic Act No. 8293, by the government or authorized third party which have been previously approved for distribution or sale by the Bureau of Food and Drugs. For this purpose, the said products shall be displayed with equal prominence as all other products sold in the establishment.
19 Article- XIV- Violations and Administrative sanctions Violations and administrative sanctions shall be covered by separate issuance.A. Re-application after disapprovalThe disapproval of an application is without prejudice to re-application. However, disapproval of application shall mean outright forfeiture of payment.
20 B. Resumption after Suspension The lifting of the order of suspension and the resumption of the operation of an establishments that have been issued a suspension of its LTO, shall take effect only after due application and satisfactory compliance of the deficiencies for which it was suspended.C. Re-application after RevocationUnless permanently barred, any establishment whose LTO have been revoked may apply for initial application after three years from date of revocation.
21 Schedule of FEESUpon application for license to operate, the drug establishment shall be charged with the corresponding non- refundable fees for each type of activity or classification. The fees shall be based on the existing Administrative Order on schedule of fees including any applicable amendment thereto.