This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
Teaching the history of pharmacy to young people is a challenge but it can be done if delivered in an interesting and engaging way. These slides summarize what I share with my students.
This document outlines administrative order no. 2014-0034 from the Philippines Department of Health Food and Drug Administration. It establishes rules for licensing drug establishments to ensure compliance with Good Manufacturing Practice, Good Distribution Practice, and other standards. It prescribes the use of electronic submissions and signatures. The order classifies different types of drug establishments and outlines requirements for licensing, variations, renewals, and inspections. It aims to align drug establishment operations with laws and international regulatory standards to ensure safety, efficacy and quality of drugs.
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
The document outlines the process and factors involved in good dispensing practice. It discusses receiving and validating prescriptions, interpreting prescriptions, preparing and labeling items, checking preparations, recording dispensed items, and issuing medicines to patients with instructions. Key factors that affect good dispensing include qualified staff, clean premises and equipment, and following proper procedures for each step of the dispensing cycle. The overall goal is to ensure patients receive the correct medication as prescribed.
I. This document discusses different methods of drug distribution in hospitals including individual prescription orders, floor stock systems, unit dose dispensing, and outpatient versus inpatient distribution.
II. The main types of drug distribution systems covered are individual prescription ordering, complete floor stocking, a combination of the two, and unit dose dispensing.
III. Key aspects of each system like advantages, disadvantages, and procedures are summarized.
This document provides information on drug information resources and how to evaluate them. It discusses primary sources like research studies, secondary sources like abstracts and indexes, and tertiary sources like textbooks. Primary sources provide the most current evidence but have a narrow scope, while tertiary sources have a broad scope but are often out of date. The document outlines strategies for selecting the best sources depending on the type of question, and how to critically evaluate clinical studies and other drug information.
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
Teaching the history of pharmacy to young people is a challenge but it can be done if delivered in an interesting and engaging way. These slides summarize what I share with my students.
This document outlines administrative order no. 2014-0034 from the Philippines Department of Health Food and Drug Administration. It establishes rules for licensing drug establishments to ensure compliance with Good Manufacturing Practice, Good Distribution Practice, and other standards. It prescribes the use of electronic submissions and signatures. The order classifies different types of drug establishments and outlines requirements for licensing, variations, renewals, and inspections. It aims to align drug establishment operations with laws and international regulatory standards to ensure safety, efficacy and quality of drugs.
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
The document outlines the process and factors involved in good dispensing practice. It discusses receiving and validating prescriptions, interpreting prescriptions, preparing and labeling items, checking preparations, recording dispensed items, and issuing medicines to patients with instructions. Key factors that affect good dispensing include qualified staff, clean premises and equipment, and following proper procedures for each step of the dispensing cycle. The overall goal is to ensure patients receive the correct medication as prescribed.
I. This document discusses different methods of drug distribution in hospitals including individual prescription orders, floor stock systems, unit dose dispensing, and outpatient versus inpatient distribution.
II. The main types of drug distribution systems covered are individual prescription ordering, complete floor stocking, a combination of the two, and unit dose dispensing.
III. Key aspects of each system like advantages, disadvantages, and procedures are summarized.
This document provides information on drug information resources and how to evaluate them. It discusses primary sources like research studies, secondary sources like abstracts and indexes, and tertiary sources like textbooks. Primary sources provide the most current evidence but have a narrow scope, while tertiary sources have a broad scope but are often out of date. The document outlines strategies for selecting the best sources depending on the type of question, and how to critically evaluate clinical studies and other drug information.
The highlights of this presentation covers importance of drug labeling, general labeling provisions, labeling requirements for prescription drugs and/or insulin, labeling requirements for over-the-counter (OTC) drugs, exemptions from adequate directions for use, and labeling claims for drugs in drug efficacy study.
The document discusses hospital formularies, which are lists of approved medications used in hospitals. A pharmacy and therapeutics committee is responsible for developing and revising the formulary. This includes adding and removing drugs based on efficacy, safety, and cost. The formulary provides guidelines for procuring, prescribing, dispensing, and administering drugs in the hospital. It aims to promote rational and cost-effective drug use. Restrictions may be placed on certain drugs to ensure appropriate usage. Exceptions can be made for nonformulary drugs in special cases.
This document provides the 8th edition of the Philippine National Formulary Essential Medicines List published in 2017 by the Philippine Department of Health. It contains abbreviations, measurement conversions, and lists various active pharmaceutical ingredients along with their typical routes of administration and common pharmaceutical dosage forms and strengths. The list is intended to guide procurement and use of essential medicines in public health facilities in the Philippines.
The document provides an overview of dispensing and medication counseling. It discusses the dispensing process which involves 6 steps: receiving and validating prescriptions, interpreting prescriptions, preparing and labeling items, making a final check, recording actions taken, and issuing medicine with instructions. Key aspects of each step are outlined such as selecting the proper stock, counting medications accurately, and ensuring quality control checks. The importance of environment, personnel qualifications, and following standard operating procedures are emphasized for ensuring safe and effective dispensing.
The document discusses good dispensing practices for pharmacists. It emphasizes that pharmacists have an ethical duty to ensure patients receive the right drug, dosage, and instructions to avoid harm. A good dispensing environment is clean, organized and provides a professional space for patients. When handling prescriptions, pharmacists must carefully check for completeness and accuracy before dispensing to avoid mistakes. They should also counsel patients thoroughly about their medication to ensure safe use.
Drug distribution is one of the basic service provided by the hospital pharmacy.
Drug distribution system falls in to 3 categories -
1)Ward – controlled system
2)Pharmacy controlled imprest based system
3)Pharmacy controlled patient issue system
This document provides guidelines on the establishment of procurement systems and organizations for the Department of Health (DOH) in the Philippines. It discusses the legal basis and coverage of the procurement manual. It also outlines the organizational structure for procurement, including the roles and responsibilities of key positions like the Bids and Awards Committee and Procurement Unit. Additionally, it covers important topics like procurement planning, methods of procurement, use of the Philippine Electronic Procurement System, and penalties for non-compliance. The overall aim is to customize the generic procurement manuals issued by the national government to suit DOH's specific needs and ensure transparency in public procurement.
This document discusses counterfeit medicines in the Philippines. It begins with definitions of counterfeit medicines from the World Health Organization, which can involve incorrect ingredients, insufficient ingredients, or fake packaging. It then outlines current Philippine legislation on counterfeit drugs, including Republic Act No. 8203 which prohibits activities related to counterfeit medicines. The document also discusses the local incidence of counterfeiting, particularly popular medicines, lifestyle medicines, and patented medicines. It describes the FDA's product verification process for suspected counterfeit medicines, which involves collection, evaluation including physical checks and laboratory analysis, and potential enforcement action. The goal is to increase awareness of counterfeit drugs through a national consciousness week.
This document establishes the Food and Drug Administration (FDA) in the Philippines to regulate and ensure the safety of foods, drugs, and cosmetics. It creates the FDA under the Department of Health and gives it responsibilities like establishing standards, inspecting products, and enforcing laws. It also forms a Board of Food and Drug Inspection to advise the FDA and conduct investigations. The FDA was later abolished and replaced by the Bureau of Food and Drugs, which assumed its functions and additional responsibilities like monitoring product advertising claims.
Common abbreviations used in the prescriptions by great ngwaziSalum Mkata
The document provides a list of common abbreviations used in medical prescriptions. It includes abbreviations for body parts, directions, frequencies, and forms of medication. It then provides examples of prescription directions to test understanding of the abbreviations. The answers show the translations of mixing instructions, dosages, frequencies, and directions to the patient in plain English. The take home question asks for the instruction to the patient for a prescription of eye drops to be used twice daily.
The document outlines the process for generic drug dispensing. A prescription is first evaluated to determine if it is correct, erroneous, or violative/impossible. If correct, the prescription is filled and filed. If erroneous, the prescription is filled but also reported. If violative or impossible, it is not filled but still reported. The customer is then informed of generic alternatives and prices before dispensing their selection.
hospital formulary is developed under the guidance of pharmacy and therapeutic commitee of the hospital.pharmacist working in a hospital should play an important role in the preparation of the hospital formulary
OTC drugs are medicines that can be purchased without a prescription. They make up a large portion of the drug market, with over 100,000 products containing around 800 active ingredients across 80 categories. While convenient for self-treatment, they can also be misused or abused, especially by adolescents. Common OTC drugs that are misused include dextromethorphan (DXM) in cough medicines and stimulants like ephedrine. Clinicians can help prevent misuse by educating patients, reviewing all medications, and encouraging guidance from medical professionals when treating with OTC drugs.
The document discusses the regulatory requirements for package inserts in India. Package inserts are documents approved by authorities that are provided with drug packages to inform safe and effective use. In India, the Drugs and Cosmetics Act and Rules govern package inserts and require certain information under Section 6 of Schedule D, including therapeutic indications, dosage, administration method, warnings, interactions and adverse effects. Package inserts are primarily intended to inform healthcare professionals but can also include patient information leaflets in non-technical language.
The document discusses the subdivisions of hospital pharmacy. It begins with introducing hospital pharmacy and its objectives like ensuring availability of right medication. It then describes the various subdivisions like administrative service division, education and training division, in-patient services division, out-patient services division, drug information services division, departmental services division, purchasing and inventory control division, central supply services division, assay and quality control division, manufacturing and packaging division, sterile products division, radiopharmaceutical services division, and intravenous admixture division. Each subdivision is assigned specific responsibilities for efficient functioning of the hospital pharmacy.
The document provides an overview of the pharmaceutical market in the Philippines through a study conducted by Nadia Dias. It discusses the country's demographic landscape including population statistics, economic factors, healthcare system, and pharmaceutical supply chain. The market is growing at a moderate rate, with opportunities for foreign investment in manufacturing and distribution. However, poverty and access to healthcare remain challenges, especially in rural areas. Political and regulatory reforms aim to further liberalize the market while improving health outcomes for Filipinos.
The document outlines labeling requirements for pharmaceutical products in the Philippines according to Administrative Order No. 55 s. 1988. Key points include:
- The generic name must be the most prominently printed element and enclosed in an outlined box. For products with a brand name, the generic name must be above the brand name and one point size bigger.
- Labels must include the product name, dosage form and strength, category, manufacturer info, net contents, formulation, indications, warnings, batch/lot numbers, and expiration date.
- Specific formatting and font requirements are provided for different label elements and sections. Additional details may be included in package inserts.
- Biological and injectable products have additional labeling elements that
This document discusses various sources of drug information that can be classified as primary, secondary, or tertiary. Primary sources provide the most up-to-date information directly from unpublished studies and peer-reviewed journals. Secondary sources provide indexed access to primary sources through abstracting systems and databases. Tertiary sources contain well-established information that does not provide updates, including reference books, drug compendia, formularies, bulletins, and pharmacopoeias which list drugs and standards.
14ab1t0024 roles and responsibilities of hospital pharmacistRamesh Ganpisetti
Hospital pharmacists play several important roles in ensuring patients receive the most appropriate treatment. They advise patients and medical staff on all aspects of medications, including type, dosage, and administration method based on individual needs. Pharmacists can recommend the best form of medication such as tablets, injections, or inhalers. They are also seen as experts who can advise on safe drug combinations and solutions to specific patient problems. In addition, pharmacists monitor treatment effects to ensure safety, effectiveness, and appropriateness for each user.
This administrative order from the Department of Health of the Philippines establishes guidelines for the promotion and marketing of prescription pharmaceutical products and medical devices. It aims to ensure medical decisions are made in the best interest of patients and uphold patient rights and welfare. The order prescribes standards for information dissemination, advertising, and other promotional activities involving prescription drugs and medical devices. It applies to all entities engaged in promotion of these products and aims to ensure ethical interactions between industry and other stakeholders in line with principles of healthcare focus, integrity, independence, legitimacy, transparency, accountability, appropriateness, and advancement.
- The document discusses the history of pharmaceutical development in Nepal, from the establishment of the first dispensary in 1816 to the establishment of various pharmaceutical associations and universities offering pharmacy programs in recent decades.
- It outlines the development of pharmaceutical production in Nepal, from the establishment of the first pharmaceutical company in 1969 to the growth of the industry from the 1950s-2000s.
- Key acts and policies governing the pharmacy sector are summarized, including the Drugs Act of 2035 (1978) which aims to regulate drug production, marketing, and quality in Nepal.
- An overview is given of hospital pharmacy, community pharmacy, forensic pharmacy, and the roles of regulatory bodies like
The highlights of this presentation covers importance of drug labeling, general labeling provisions, labeling requirements for prescription drugs and/or insulin, labeling requirements for over-the-counter (OTC) drugs, exemptions from adequate directions for use, and labeling claims for drugs in drug efficacy study.
The document discusses hospital formularies, which are lists of approved medications used in hospitals. A pharmacy and therapeutics committee is responsible for developing and revising the formulary. This includes adding and removing drugs based on efficacy, safety, and cost. The formulary provides guidelines for procuring, prescribing, dispensing, and administering drugs in the hospital. It aims to promote rational and cost-effective drug use. Restrictions may be placed on certain drugs to ensure appropriate usage. Exceptions can be made for nonformulary drugs in special cases.
This document provides the 8th edition of the Philippine National Formulary Essential Medicines List published in 2017 by the Philippine Department of Health. It contains abbreviations, measurement conversions, and lists various active pharmaceutical ingredients along with their typical routes of administration and common pharmaceutical dosage forms and strengths. The list is intended to guide procurement and use of essential medicines in public health facilities in the Philippines.
The document provides an overview of dispensing and medication counseling. It discusses the dispensing process which involves 6 steps: receiving and validating prescriptions, interpreting prescriptions, preparing and labeling items, making a final check, recording actions taken, and issuing medicine with instructions. Key aspects of each step are outlined such as selecting the proper stock, counting medications accurately, and ensuring quality control checks. The importance of environment, personnel qualifications, and following standard operating procedures are emphasized for ensuring safe and effective dispensing.
The document discusses good dispensing practices for pharmacists. It emphasizes that pharmacists have an ethical duty to ensure patients receive the right drug, dosage, and instructions to avoid harm. A good dispensing environment is clean, organized and provides a professional space for patients. When handling prescriptions, pharmacists must carefully check for completeness and accuracy before dispensing to avoid mistakes. They should also counsel patients thoroughly about their medication to ensure safe use.
Drug distribution is one of the basic service provided by the hospital pharmacy.
Drug distribution system falls in to 3 categories -
1)Ward – controlled system
2)Pharmacy controlled imprest based system
3)Pharmacy controlled patient issue system
This document provides guidelines on the establishment of procurement systems and organizations for the Department of Health (DOH) in the Philippines. It discusses the legal basis and coverage of the procurement manual. It also outlines the organizational structure for procurement, including the roles and responsibilities of key positions like the Bids and Awards Committee and Procurement Unit. Additionally, it covers important topics like procurement planning, methods of procurement, use of the Philippine Electronic Procurement System, and penalties for non-compliance. The overall aim is to customize the generic procurement manuals issued by the national government to suit DOH's specific needs and ensure transparency in public procurement.
This document discusses counterfeit medicines in the Philippines. It begins with definitions of counterfeit medicines from the World Health Organization, which can involve incorrect ingredients, insufficient ingredients, or fake packaging. It then outlines current Philippine legislation on counterfeit drugs, including Republic Act No. 8203 which prohibits activities related to counterfeit medicines. The document also discusses the local incidence of counterfeiting, particularly popular medicines, lifestyle medicines, and patented medicines. It describes the FDA's product verification process for suspected counterfeit medicines, which involves collection, evaluation including physical checks and laboratory analysis, and potential enforcement action. The goal is to increase awareness of counterfeit drugs through a national consciousness week.
This document establishes the Food and Drug Administration (FDA) in the Philippines to regulate and ensure the safety of foods, drugs, and cosmetics. It creates the FDA under the Department of Health and gives it responsibilities like establishing standards, inspecting products, and enforcing laws. It also forms a Board of Food and Drug Inspection to advise the FDA and conduct investigations. The FDA was later abolished and replaced by the Bureau of Food and Drugs, which assumed its functions and additional responsibilities like monitoring product advertising claims.
Common abbreviations used in the prescriptions by great ngwaziSalum Mkata
The document provides a list of common abbreviations used in medical prescriptions. It includes abbreviations for body parts, directions, frequencies, and forms of medication. It then provides examples of prescription directions to test understanding of the abbreviations. The answers show the translations of mixing instructions, dosages, frequencies, and directions to the patient in plain English. The take home question asks for the instruction to the patient for a prescription of eye drops to be used twice daily.
The document outlines the process for generic drug dispensing. A prescription is first evaluated to determine if it is correct, erroneous, or violative/impossible. If correct, the prescription is filled and filed. If erroneous, the prescription is filled but also reported. If violative or impossible, it is not filled but still reported. The customer is then informed of generic alternatives and prices before dispensing their selection.
hospital formulary is developed under the guidance of pharmacy and therapeutic commitee of the hospital.pharmacist working in a hospital should play an important role in the preparation of the hospital formulary
OTC drugs are medicines that can be purchased without a prescription. They make up a large portion of the drug market, with over 100,000 products containing around 800 active ingredients across 80 categories. While convenient for self-treatment, they can also be misused or abused, especially by adolescents. Common OTC drugs that are misused include dextromethorphan (DXM) in cough medicines and stimulants like ephedrine. Clinicians can help prevent misuse by educating patients, reviewing all medications, and encouraging guidance from medical professionals when treating with OTC drugs.
The document discusses the regulatory requirements for package inserts in India. Package inserts are documents approved by authorities that are provided with drug packages to inform safe and effective use. In India, the Drugs and Cosmetics Act and Rules govern package inserts and require certain information under Section 6 of Schedule D, including therapeutic indications, dosage, administration method, warnings, interactions and adverse effects. Package inserts are primarily intended to inform healthcare professionals but can also include patient information leaflets in non-technical language.
The document discusses the subdivisions of hospital pharmacy. It begins with introducing hospital pharmacy and its objectives like ensuring availability of right medication. It then describes the various subdivisions like administrative service division, education and training division, in-patient services division, out-patient services division, drug information services division, departmental services division, purchasing and inventory control division, central supply services division, assay and quality control division, manufacturing and packaging division, sterile products division, radiopharmaceutical services division, and intravenous admixture division. Each subdivision is assigned specific responsibilities for efficient functioning of the hospital pharmacy.
The document provides an overview of the pharmaceutical market in the Philippines through a study conducted by Nadia Dias. It discusses the country's demographic landscape including population statistics, economic factors, healthcare system, and pharmaceutical supply chain. The market is growing at a moderate rate, with opportunities for foreign investment in manufacturing and distribution. However, poverty and access to healthcare remain challenges, especially in rural areas. Political and regulatory reforms aim to further liberalize the market while improving health outcomes for Filipinos.
The document outlines labeling requirements for pharmaceutical products in the Philippines according to Administrative Order No. 55 s. 1988. Key points include:
- The generic name must be the most prominently printed element and enclosed in an outlined box. For products with a brand name, the generic name must be above the brand name and one point size bigger.
- Labels must include the product name, dosage form and strength, category, manufacturer info, net contents, formulation, indications, warnings, batch/lot numbers, and expiration date.
- Specific formatting and font requirements are provided for different label elements and sections. Additional details may be included in package inserts.
- Biological and injectable products have additional labeling elements that
This document discusses various sources of drug information that can be classified as primary, secondary, or tertiary. Primary sources provide the most up-to-date information directly from unpublished studies and peer-reviewed journals. Secondary sources provide indexed access to primary sources through abstracting systems and databases. Tertiary sources contain well-established information that does not provide updates, including reference books, drug compendia, formularies, bulletins, and pharmacopoeias which list drugs and standards.
14ab1t0024 roles and responsibilities of hospital pharmacistRamesh Ganpisetti
Hospital pharmacists play several important roles in ensuring patients receive the most appropriate treatment. They advise patients and medical staff on all aspects of medications, including type, dosage, and administration method based on individual needs. Pharmacists can recommend the best form of medication such as tablets, injections, or inhalers. They are also seen as experts who can advise on safe drug combinations and solutions to specific patient problems. In addition, pharmacists monitor treatment effects to ensure safety, effectiveness, and appropriateness for each user.
This administrative order from the Department of Health of the Philippines establishes guidelines for the promotion and marketing of prescription pharmaceutical products and medical devices. It aims to ensure medical decisions are made in the best interest of patients and uphold patient rights and welfare. The order prescribes standards for information dissemination, advertising, and other promotional activities involving prescription drugs and medical devices. It applies to all entities engaged in promotion of these products and aims to ensure ethical interactions between industry and other stakeholders in line with principles of healthcare focus, integrity, independence, legitimacy, transparency, accountability, appropriateness, and advancement.
- The document discusses the history of pharmaceutical development in Nepal, from the establishment of the first dispensary in 1816 to the establishment of various pharmaceutical associations and universities offering pharmacy programs in recent decades.
- It outlines the development of pharmaceutical production in Nepal, from the establishment of the first pharmaceutical company in 1969 to the growth of the industry from the 1950s-2000s.
- Key acts and policies governing the pharmacy sector are summarized, including the Drugs Act of 2035 (1978) which aims to regulate drug production, marketing, and quality in Nepal.
- An overview is given of hospital pharmacy, community pharmacy, forensic pharmacy, and the roles of regulatory bodies like
This document is the Republic Act No. 6675, an act passed by the Philippine Congress in 1988 to promote the use of generic drug names. It declares the state policy to encourage generic drug use to ensure adequate supply of medicines at lowest cost. It defines key terms like generic name, essential drugs list. It requires all government agencies and medical professionals to use generic names in purchasing, prescribing and dispensing drugs. It also mandates drug companies to produce and distribute generic versions of their medicines. Penalties are prescribed for violations of the act.
1. This Circular provides for:
a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;
b) Required clinical data for assurance of safety and efficacy in the application;
c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;
d) Rules for validation of marketing authorization applications (hereinafter referred to as “marketing application”) for drugs/medicinal materials, renewal and revision thereof;
đ) Rules for validation of applications for license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as “Decree No. 155/2018/ND-CP”);
e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);
g) Procedures for validation of marketing applications, renewal and revision thereof; Procedures for validation of applications for the license to import unapproved drugs.
This document from the World Health Organization provides an update to the United Nations Consolidated List of pharmaceutical products that have been banned, withdrawn, severely restricted, or not approved by governments. It summarizes regulatory actions taken by 38 governments on 99 pharmaceutical products from 2009-2010 and earlier years. For each product, it provides the chemical name and CAS registry number if available, a summary of regulatory measures, and references to supporting documentation. The list is intended to promote safe and rational use of medicines and complement other WHO publications on drug safety.
This document discusses regulatory affairs related to pharmacy practice in India. It outlines several key laws that pharmacists must adhere to, including the Drugs and Cosmetics Act of 1940, the Narcotic Drugs and Psychotropic Substances Act of 1985, the Drugs Price Control Order of 1995, and the Consumer Protection Act of 1986. The document also describes legal aspects of dispensing medications, such as prescription requirements, medication schedules, emergency supplies, and record keeping. Overall, it emphasizes that following all applicable laws is essential for pharmacists to provide safe and effective healthcare while protecting patient safety.
This document outlines exemptions and provisions for advertisements related to drugs and remedies under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954. It lists 5 classes of advertisements that are exempt from being prohibited, including those printed by the government, sent confidentially to doctors, or relating to books on diseases. It also describes conditions for certain exempted advertisements, such as those in medical journals only including therapeutic information. Penalties are described for violating the Act, including fines or imprisonment. Authorities may also scrutinize misleading drug advertisements and require information from manufacturers.
The document summarizes key provisions of the Drug Act 2035 and Rules made thereunder in Nepal. It outlines the objectives of controlling and regulating drugs to ensure they are safe, effective and of standard quality. It describes the various chapters that establish committees to advise on drugs, regulate research and production, and enforce standards. The act defines important terms, requires licenses and permits for manufacturing, import, sale and clinical trials of drugs, and prohibits misuse, adulteration and sale of expired drugs.
Regulatory affairs professionals play a crucial role in ensuring pharmaceutical products meet regulatory standards for safety, efficacy and quality. They provide strategic guidance to various departments on regulatory requirements and work to obtain approvals from regulatory authorities. Key responsibilities include filing product registrations, tracking legal changes, and facilitating clinical trials and product approvals. Regulatory affairs has become increasingly important given historical issues that prompted stronger drug regulations to protect public health.
This document provides an overview of pharmacy law and regulatory affairs in the United Arab Emirates (UAE). It includes the table of contents for an orientation course on pharmacy law, which covers topics like the UAE Federal Law on pharmaceutical professions and institutions, guidelines for good pharmacy practice, codes of conduct, and policies from the Health Authority of Abu Dhabi. The document provides details on licensing requirements for pharmacists, assistants, pharmacies, drug stores, medicine factories and scientific offices. It also outlines regulations regarding prescriptions, controlled substances, and the duties and prohibited acts of pharmacists.
This document provides information about the US Food and Drug Administration (FDA). It describes the organization and responsibilities of the FDA, including protecting public health by regulating food, drugs, medical devices, and other products. It also summarizes key FDA centers like the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The document introduces the Pharmaceutical Inspection Convention, its objectives to harmonize good manufacturing practices among countries.
The Ministry of Health and Social Protection of Colombia passed Resolution XX of 2014 to increase transparency regarding relationships between actors in the health sector and the pharmaceutical industry. It establishes a two-stage process for mandatory registration of payments from pharmaceutical companies to health professionals, organizations, and institutions. The first stage requires voluntary reporting of aggregate payment amounts. The second stage mandates identifying individual recipients to allow analysis of potential influences on prescribing decisions and costs. The resolution aims to promote rational drug use and address conflicts of interest through public disclosure.
This document from Medsafe provides guidance on how to categorize products in New Zealand based on their ingredients, purpose of use, and presentation. It outlines that products are categorized as dietary supplements, foods, cosmetics, or medicines/medical devices. Medicines achieve their purpose through pharmacological means while medical devices do not. It includes a table showing example products and their categories, and information on how to request a product categorization from Medsafe.
This document establishes new regulations for the registration of biological medicinal products in Argentina. It defines biological products and outlines specific requirements and procedures for their registration, including information that must be included in registration certificates. Evaluation and approval of registration applications will ensure biological products have favorable benefit-risk ratios, sufficient therapeutic efficacy, adequate quality and composition supported by application materials.
Medical devices are regulated under the Medical Device Rules published in 2017 and effective in 2018 in India. They include any instrument or material intended for human or animal use for diagnosis, treatment or prevention of disease. The Central Drugs Standard Control Organization regulates medical devices and some are notified under the Drugs and Cosmetics Act. There have been efforts to improve regulation of medical devices in India to focus on safety and appropriate use.
This document summarizes the Drugs and Magic Remedies Act 1954 which aims to control advertisements of drugs and prohibit advertisements for remedies claiming magic qualities. Some key points:
- It defines terms like advertisement, drug, and magic remedy. Advertisements of certain drugs are prohibited for diseases like AIDS that require medical consultation.
- Advertisements cannot be misleading or make false claims. Advertising magic remedies for treating diseases is also prohibited.
- Some exemptions exist like signs by doctors, scientific books, and ads to doctors if following certain conditions.
- Offences can be punished by imprisonment up to 6 months or 1 year for subsequent offences. Forfeiture of unlawful advertisements and protection from legal
Laws Regulating Drugs and Medical DevicesAshish vishal
This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/
This document discusses the labeling and advertising requirements for drugs. It covers topics such as the definitions of drugs and different drug types (OTC and prescription), labeling requirements, information that must be included on labels, and regulations regarding advertising. It also discusses the roles of regulatory bodies like the FDA and FTC in overseeing drug labeling and advertising.
This document outlines guidelines for filing applications using an Integrated Application Form adopted by the Philippines' Food and Drug Administration (FDA) to streamline the application process. The form was created to comply with laws mandating improved efficiency and accountability in government services. It consolidates requirements for various FDA authorizations like licenses and permits onto a single electronic form. Applicants must submit documentary requirements digitally, pay fees, and provide hard copies of certain documents to complete the application process based on a scheduled intake procedure.
This document discusses good practices for storing pharmaceutical products in pharmacies. It emphasizes that medicines must be stored properly under the correct conditions to ensure their potency does not expire before the listed expiry date. Every pharmacy needs systems for secure, clean storage with accurate record keeping and stock rotation. Key requirements include preventing access from moisture, light, heat, pests and proper refrigeration. Standard operating procedures should be established in writing for all storage activities.
This document provides information and instructions for using the Electronic Drug Price Monitoring System (EDPMS). It summarizes the laws requiring drug price monitoring, outlines the EDPMS process for uploading price data, and details the forms and support available. Pharmaceutical suppliers are mandated to regularly upload price and inventory data to the EDPMS website to participate in government drug biddings and avoid administrative sanctions for noncompliance.
The document discusses good dispensing practices for pharmacists. It emphasizes that pharmacists have an ethical duty to ensure patients receive the right drug, dosage, and instructions to avoid harm. A good dispensing environment is clean, organized and provides privacy for patients. When handling prescriptions, pharmacists must verify the prescription is legal, legible and complete before dispensing to avoid mistakes. Pharmacists should also counsel patients on how to take their medications and possible side effects.
This document discusses good practices for storing pharmaceutical products in pharmacies. It emphasizes that medicines must be stored properly under the correct conditions to ensure their potency does not expire early. Every pharmacy needs systems for secure, clean storage with accurate record keeping and stock rotation. Key requirements include preventing access from moisture, light, heat, pests and proper refrigeration. Standard operating procedures should specify activities, timing, locations and responsibilities for consistent operations.
This document provides information and instructions for using the Electronic Drug Price Monitoring System (EDPMS), which monitors drug prices and inventories in the Philippines. It summarizes the laws requiring EDPMS reporting, the EDPMS reporting process, sanctions for non-compliance, and contact information for technical support. Pharmaceutical suppliers must upload drug price and inventory data monthly to EDPMS to participate in government drug procurement bids. The document provides step-by-step instructions for downloading, installing, and using the standalone EDPMS software to enter and upload local data files.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
2. SUBJECT: Rules and Regulations on the Licensing
of Drug Establishments and Other Related
Authorizations Further Amending for this Purpose
Administrative Order No. 56 s. 1989 on the
“Revised Regulations for the Licensing of Drug
Establishments and Outlets,” and for other
Purposes
3. A.O. 56 s. 1989
Pursuant to Section 26(a) in relation
to Section 21(a) and 11(k) of
Republic Act No. 3720, known as the
Foods, Drugs and Devices, and
Cosmetics Act as amended by
Executive Order No. 175 s. 1987 and
consistent with Republic Act No.
6675, known as the Generic Act of
1988, the following regulations are
hereby promulgated governing drug
establishments and drug outlets
under the Bureau of Food and Drugs
(BFAD).
Revised Guidelines
I. RATIONALE
II. AUTHORITY/BASES
III. OBJECTIVES
IV. SCOPE
…
4. I. RATIONALE
Section 15, Article II of the 1987 Constitution
declared it the policy of the State to protect and promote
the right to health of the people and instill health
consciousness among them. The Constitution also
mandates the State to adopt an integrated and
comprehensive approach to health development which
shall endeavor to make essential goods, health and other
social services available to all the people at affordable cost
(Section 11, Article XIII).
5. I. RATIONALE
Republic Act No. 3720 as amended by RA 9711 and
its implementing rules and regulations, and RA 7394, in
implementing the above Constitutional policy, declares
further as a policy of the State to insure safe and good
quality of food, drugs, and cosmetics, and to regulate the
production, sale, and traffic of the same to protect the
health of the people. In so doing, the same laws, empower
the Food and Drug Administration to issue licenses to
establishments manufacturing and/or distributing
pharmaceutical products.
6. I. RATIONALE
Republic Act No. 8792 or the “Electronic Commerce Act of
2000” declares it as an objective to facilitate domestic and
international dealings, transactions, arrangements, agreements,
contracts and exchanges, and storage of information through the
utilization of electronic, optical and similar medium, mode,
instrumentality and technology to recognize the authenticity and
reliability of electronic documents related to such activities and to
promote the universal use of electronic transaction in the
government and general public. The above objective of RA 8792
and its Implementing Rules and Regulations mandate the use of
electronic data messages, electronic document and electronic
signatures in government transactions.
7. I. RATIONALE
Republic Act No. 9502, otherwise known as the
“Universally Accessible Cheaper and Quality Medicines Act
of 2008” and its Implementing Rules and Regulations
provides as a policy of the State that when the public
interest or circumstances of extreme urgency so require, it
shall adopt appropriate measures to promote and ensure
access to affordable quality pharmaceutical products for all
through an effective competition policy in the supply and
demand thereof.
8. I. RATIONALE
Therefore, pursuant to the foregoing, to streamline
regulatory approaches in licensing of drug establishments;
provide faster access of pharmaceutical products to the
public; and promote transparency through the universal
use of electronic transaction in the government and general
public, the following rules and regulations in the licensing
of drug establishments as provided below are hereby
adopted and prescribed for the information and
compliance of all concerned.
9. II. AUTHORITY/BASES
This Order is issued by virtue under:
•Section 26 of Republic Act No. 3720 as amended by Republic Act 9711
otherwise known as “FDA Act of 2009”;
•Republic Act No. 7394 or the “Consumer Act of the Philippines”;
•Republic Act No. 9502, otherwise known as the “Universally Accessible
Cheaper and Quality Medicines Act of 2008”;
•Republic Act No. 6675 or the “Generics Law of 1988” as amended;
•Republic Act No. 5921 or “The Pharmacy Law” as amended;
•Executive Order No. 292 or the Administrative Code of 1987;
•and Section 27, Part IV of Republic Act No. 8792 or the “Electronic
Commerce Act of 2000.”
10. III. OBJECTIVES
1. Further amend the existing rules and regulations in the
licensing of drug establishments to align with the
recently promulgated laws and adopted policies
affecting drug establishments;
2. Ensure the public that establishments licensed by FDA
comply with current regulatory standards such as, but
not limited to, Good Manufacturing Practice (GMP),
Good Distribution Practice (GDP), Good Storage Practice
(GSP), Good Pharmacy Practice (GPP) and Good
Dispensing Practice.
11. III. OBJECTIVES
3. Prescribe the use and implementation of new
innovations, such as but not limited to, electronic data
messages, electronic submission of documents and
electronic signatures in the Food of Drug Administration
pursuant to Republic Act No. 8792 or the “Electronic
Commerce Act of 2000.”
12. IV. 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
product.
– Entities engaged in the activities such as donation, promotion,
advertising, or sponsorship of pharmaceutical product shall be
responsible therefor and shall secure an authorization.
13. A.O. 56 s. 1989
In accordance with Section 3 Paragraph
5 & 6 of RA 6675, any organization,
company or business establishments in the
pharmaceutical industry shall fall under the
following general classifications;
I. Drug Establishment means any
organization or company involved in the
manufacture, importation,
repacking and/or distribution of drugs or
medicines. This is covered by Chapter I
below.
II. Drug Outlet means drugstore,
pharmacy, and other business
establishment which sells drugs or
medicines. This is covered by Chapter II
below.
Revised Guidelines
V. DEFINITION OF TERMS
VI. GENERAL PROVISION
14. V. DEFINITION OF TERMS
As used in this Order, the following words, phrases or terms shall have
the following meaning:
1. FDA – shall refer to the Food and Drug Administration
2. Drug Establishment – a sole proprietorship, a partnership, a
corporation, an institution, an association, or an organization
engaged in the manufacture, importation, exportation, sale,
offer for sale, distribution in wholesale and/or retail basis,
donation, transfer, use, testing, promotion, advertising, or
sponsorship of pharmaceutical product including the facilities
and installations needed for its activities
15. V. DEFINITION OF TERMS
As used in this Order, the following words, phrases or terms shall have
the following meaning:
3. PIC/S – means Pharmaceutical Inspection Co-operation
Scheme
4. Pharmaceutical products – are the same as drug or
medicinal products as defined in AO 2012-0008 “Adoption
and Implementation of PIC/S Guides for the Good
Manufacturing Practice for Medicinal Products
16. V. DEFINITION OF TERMS
As used in this Order, the following words, phrases or terms shall have
the following meaning:
5. License to Operate (LTO) – is an authorization or permission
embodied in a document granted by FDA to any natural or
juridical person engaged in the manufacture, importation,
exportation, sale, offer for sale, distribution, and transfer of
pharmaceutical products
6. Professional Regulation Commission (PRC)- is a national
government agency created by Presidential Decree (P.D.) No.
223 dated June 22, 1973
17. V. DEFINITION OF TERMS
As used in this Order, the following words, phrases or terms shall have
the following meaning:
7. Special Permit- is a form of authorization granted to
national government, local government unit, non-government
organization and other entities that procures
medicines for use of their constituents, medical missions and
other health programs, and other purposes such as donation,
promotion, advertising, or sponsorship of pharmaceutical
product
18. V. DEFINITION OF TERMS
As used in this Order, the following words, phrases or terms shall have
the following meaning:
8. Pharmacy Compounding - is a practice in which a licensed
pharmacist combines, mixes, or alters ingredients in response
to a prescription to create a medication tailored to the
medical needs of an individual patient
19. V. DEFINITION OF TERMS
As used in this Order, the following words, phrases or terms shall have
the following meaning:
9. Specialty pharmaceuticals - generally defined as products
used to treat chronic, high-cost, or rare diseases and can be
injectable, infusible, oral, or inhaled medications
20. VI. GENERAL PROVISIONS
A. No drug establishment 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.
B. The recipient of donated pharmaceutical products, whether
foreign or locally manufactured, for purposes of either medical
missions or other health related programs, shall secure a special
permit prior to the product’s distribution. The products covered
herein shall not be available for sale in the market.
21. VI. GENERAL PROVISIONS
C. 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 shall be held liable thereof.
D. All drug distributors shall not sell directly to the general public
or consumer, unless they have license as a retailer.
E. The application must meet the required documentary and/or
technical requirements or appropriate standards.
22. VI. GENERAL PROVISIONS
F. Misrepresentations, 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.
G. A violation with any of the terms and conditions of its license
shall likewise result in the disapproval of the application.
H. Applications may also be disapproved for similar causes as
determined by the FDA.
23. VI. GENERAL PROVISIONS
I. All licensed drug establishments must continuously comply with
the existing requirements, regulations and standards, otherwise
the establishment may be ordered close or their licenses
suspended or revoked motu proprio or upon petition by any
person.
J. Any pharmaceutical product 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.
24. VI. GENERAL PROVISIONS
K. 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.
L. All entities, whether government or non-government offices,
that regularly procure medicines on wholesale basis from any
FDA authorized drug establishment for use of their constituents
must be licensed as a drugstore/pharmacy or distributor (see
Sec. 25 of RA 5921 and RA 3720)
25. VI. GENERAL PROVISIONS
M.Institutional Pharmacies procuring medicines on a wholesale
basis from any FDA authorized drug establishment for use of
their employees and dependents must likewise be licensed as
drugstore/ pharmacy.
N. 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 personal
and immediate supervision of a registered pharmacist except
otherwise allowed by pertinent laws.
26. VI. GENERAL PROVISIONS
O.All establishment applying for a license to manufacture, import,
distribute, sell vaccines and other biological products are
hereby directed to comply with the Cold Chain Management
requirement. Likewise, existing establishment handling the
same shall upgrade their cold chain management capabilities.
P. The FDA shall have the authority to verify all original or
authenticated copies of the submitted documents for LTO (See
Sec 27 & 28 of RA 3720).
27. VI. GENERAL PROVISIONS
Q. The FDA shall endeavor to integrate all electronic submissions
or processes into electronic format pursuant to Republic Act
No. 8792 or the “Electronic Commerce Act of 2000”
R. Rule 17. Non-Discriminatory Clause of IRR of RA 9502:
Section 1. General Rule
Section 2. Patented Drugs
Section 3. Permit to Import and Distribute
Section 4. Requirements for Request for Mandatory Carry
Section 5. Mandatory Carry
Section 6. Refusal to Sell Drugs and Medicines
28. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
29. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
31. VII A. Drug Manufacturer
A.O. 56 s. 1989
any establishment engaged in operations
involved in the production of a drug,
including propagation, processing,
compounding, finishing, filling, packing,
repacking, altering, ornamenting and
labelling with the end in view of
storage, distribution or sale of the
product: provided that for the purpose
of this regulation the compounding
and filling of prescriptions in
drugstores and hospital pharmacies
shall not be considered as production
operations.
Revised Guidelines
any establishment engaged in any and all
operations involved in the production of
pharmaceutical products including
preparatory processing, compounding,
formulating, filling, packaging,
repackaging, altering, ornamenting,
finishing and labeling with the end in view
of its storage, sale or distribution;
provided, that the term shall not apply to
the compounding and filling of
prescriptions in drugstores and hospital
pharmacies.
32. VII A. Drug Manufacturer
a “DRUG MANUFACTURER” can be further classified into the following:
•DRUG MANUFACTURER-REPACKER
•DRUG MANUFACTURER-PACKER
•DRUG MANUFACTURER-TRADER
Drug Trader under A.O. 56 is now classified as a drug
manufacturer
33. VII A. Drug Manufacturer
a “DRUG MANUFACTURER” can be further classified into the following:
•DRUG MANUFACTURER-REPACKER
refers to any establishment that repacks a finished drug product into smaller
quantities in a separate container and/or into secondary packaging,
including but not limited to
•Relabeling
•Stickering
•bundling for promo packs
with the end view of storage, distribution, or sale of the product. Provided, it shall
not cover repacking of drugs at the time of purchase for purposes of dispensing.
34. VII A. Drug Manufacturer
a “DRUG MANUFACTURER” can be further classified into the following:
•DRUG MANUFACTURER-REPACKER
•DRUG MANUFACTURER-PACKER
refers to any establishment that packages a bulk drug product into its immediate
container with the end view of storage, distribution, or sale of the product.
35. VII A. Drug Manufacturer
a “DRUG MANUFACTURER” can be further classified into the following:
•DRUG MANUFACTURER-REPACKER
•DRUG MANUFACTURER-PACKER
•DRUG MANUFACTURER-TRADER
refers to any establishment which is a registered owner of a pharmaceutical product
and the formulation and procures the raw materials and packing components, and
provides the production monographs, quality control standards and procedures, but
subcontracts the manufacture of such product to a licensed manufacturer.
In addition, a trader may also engage in the distribution and or marketing of its
products. A trader shall be categorized as a manufacturer.
36. VII B. Drug Distributor/Exporter
A.O. 56 s. 1989 Revised Guidelines
any drug establishment
that exports raw materials,
active ingredients and/or
finished products to another
country
any establishment that
exports raw materials, active
ingredients and finished
products for distribution to
other drug establishments
outside the country.
37. VII C. Drug Distributor/Importer
A.O. 56 s. 1989 Revised Guidelines
any establishment that
imports raw materials, active
ingredients and/or finished
products for its own use or
for wholesale distribution to
other drug establishments
or outlets
any establishment that
imports raw materials, active
ingredients and/or finished
products for wholesale
distribution to other local
FDA- licensed drug
establishment.
38. VII D. Drug Distributor-Wholesaler
A.O. 56 s. 1989 Revised Guidelines
any drug establishment
that exports raw materials,
active ingredients and/or
finished products from local
establishments for local
distribution on wholesale
basis.
any establishment that
procures raw materials,
active ingredients and/or
finished products from a
local FDA licensed drug
establishment for local
distribution on wholesale
basis.
39. VII E. Drugstore/Pharmacy/Botica and similar outlets
such as Hospital Pharmacy and Institutional Pharmacy
A.O. 56 s. 1989 Revised Guidelines
a drug outlet where
registered drugs, chemical
products, active principles,
proprietary medicines or
pharmaceutical specialties
and dental medicinal,
galenical or veterinary
preparations are compounded
and/or dispensed.
drug establishment where
registered drugs, chemical
products, specialty pharmaceutical
and dental, medicinal and
household remedies are dispensed
directly to the general public on a
retail basis.
Botika ng Barangay and its variants
that sell prescription product shall
be reclassified and required to
secure LTO as a drugstore.
40. VII F. Retail Outlet for Non-Prescription Drugs
(RONPD)
A.O. 56 s. 1989 Revised Guidelines
including non-traditional outlets such as
supermarkets and stores, means a drug
outlet where registered non-prescription
or Over-the-Counter (OTC) drugs are sold
in their original packages, bottles or
containers or in smaller quantities not in
their original containers
drug establishments such as
supermarkets, convenient stores and other
similar retail establishments licensed to sell
registered non-prescription or Over-the-
Counter (OTC) drugs which are sold in
their individual original and primary
packaging and are dispensed directly to
the general public on a retail basis.
Botika ng Barangay and its variants that
sell non-prescription or OTC product only
shall be reclassified and required to secure
LTO as a RONPD.
41. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII.Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
42. VIII. Requirements for Securing an LTO
Any qualified natural or juridical person
desiring to engage or operate in the
manufacture, packing, repacking, importation,
exportation, sale, offer for sale, distribution or
transfer of pharmaceutical products shall
comply with the requirements that FDA is
authorized to promulgate through the
appropriate issuance including amendments
thereto.
43. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
44. IX. Renewal of LTO
A.O. 56 s. 1989
The License to Operate shall have
the following validities for all
categories of drug establishments:
•Initial Application- 1 year
•Renewal Application- 2 years
At least one month prior to the
expiration of the LTO, drug
establishments shall apply to renew
their license.
In considering the renewal application,
BFAD shall ascertain the continued
compliance by the establishment with
the standards and requirements (General
and Specific requirements)
Revised Guidelines
Stipulated in Section XIII
Application for regular renewal of
license may be filed within six months
from its expiration.
Applications for Automatic Renewal
Detailed in Sections VIII, X, XI, XII, XIII
45. IX. Renewal of LTO
A.O. 56 s. 1989
In case of renewal of LTO, the
drug outlet must have a history of
satisfactory performance, consistent
with BFAD standards and
requirements, without any cases of
serious violation of laws, rules and
regulations
Revised Guidelines
Detailed in Sections VIII, X, XI, XII, XIII
46. IX. Renewal of LTO (A)
Application for regular renewal of license may be filed within six
months from its expiration.
An application received after expiration of the LTO shall be subject to a
surcharge or penalty equivalent to twice the renewal licensing fee and
an additional ten percent (10%) per month or a fraction thereof of
continuing non-submission of such application up to a maximum of
one hundred twenty (120) days.
OLD AO56:
A surcharge of fifty percent (50%) of the above fees shall be issued on
application for renewal filed after the validity of the license has lapsed. (AO 56
Chapter 2, Section 6)
47. IX. Renewal of LTO (A)
Any application for renewal of license filed beyond the 120 days after
the original expiration shall be considered expired and shall be subject
to a fee equivalent to the total surcharge or penalty plus the initial
license fee. Such application shall undergo the initial filing and
evaluation procedure.
48. IX. Renewal of LTO (A)
For applications for renewal filed within one hundred twenty (120) days
from its original expiry, the LTO shall be considered valid and existing
until a decision or resolution by the FDA is rendered on the application
for renewal.
49. IX. Renewal of LTO (B)
The Automatic Renewal
Automatic renewal shall apply to the following conditions:
1. The application is filed before the expiration date;
2. The prescribed renewal fee is paid upon filing of the application;
3. A sworn statement indicating no change or variation whatsoever in
the establishment is attached to the application.
50. IX. Renewal of LTO (C)
In considering both renewal application, FDA shall ascertain the
continued compliance by the establishment with the existing standards
and requirements. In either case above, the instances provided in Section
4, Article I, Book II of the IRR of RA 9711(Paragraph E, Item VI above) shall
be grounds for non-renewal of application.
“Paragraph E, Item VI
E. The application must meet the required documentary and/or technical
requirements or appropriate standards.”
51. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
52. Standards and Requirements for
License to Operate ( AO56 )
Documentary requirements specified in Sections I.2 and
II.2 “Standards and Requirements” in AO 56 are
transfered in the proposed FDA Circular:
Guidelines on the Implementation of Rules and Regulations on
the Licensing of Drug Establishments and Other Related
Authorizations Further Amending for this Purpose
Administrative Order No. 56 s. 1989 on the “Revised
Regulations for the Licensing of Drug Establishments and
Outlets,” and for other Purposes
53. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
54. X. Application for Amendment
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.
55. X. Application for Amendment
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. 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)
56. X. Application for Amendment
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:
•Change of business name, ownership and transfer of location of
the establishment
•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).
57. X. Application for Amendment
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.
58. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
60. 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.
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.
61. XI. Licensing Process
A. Filing of Applications
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.
62. XI. Licensing Process
A. Filing of Applications
B. Where to File
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.
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.
63. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
64. XII. Licensing Guidelines
A. Place of Business, Warehouse or Plant
B. Display of Signboard and License
C. Request for Information
65. 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.
66. XII. Licensing Guidelines
A. Place of Business, Warehouse or Plant
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.
67. XII. Licensing Guidelines
A. Place of Business, Warehouse or Plant
B. Display of Signboard and License
C. Request for Information
Any request for information whether by the company or any
other party shall be governed by the existing policies on
disclosure.
68. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
69. 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.
70. XIII. License to Operate
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.
71. XIII. License to Operate
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.
72. XIII. License to Operate
C. Cancellation of LTO
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.
73. XIII. License to Operate
C. Cancellation of LTO
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.
74. XIII. License to Operate
C. Cancellation of LTO
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.
75. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
76. XIV. Violations and Administrative Sanctions
A.O. 56 s. 1989 Revised Guidelines
CHAPTER I - DRUG ESTABLISHMENTS
4.1. Grounds for Revocation of LTO
4.2. Grounds for Suspension of LTO
CHAPTER II - DRUG OUTLETS
4.1. Temporary Closure
4.2. Suspension of License to Operate
4.3. Revocation of License to Operate
Violations and administrative
sanctions shall be covered by a
separate issuance.
A.Re-application after Disapproval
B.Resumption after Suspension
C.Re-application after Revocation
77. XIV. Violations and Administrative Sanctions
Violations and administrative sanctions shall be
covered by a separate issuance.
A.Re-application after Disapproval
B.Resumption after Suspension
C.Re-application after Revocation
78. XIV. Violations and Administrative Sanctions
A. Re-application after Disapproval
The disapproval of an application is without
prejudice to re-application. However,
disapproval of application shall mean outright
forfeiture of payment.
79. XIV. Violations and Administrative Sanctions
B. Resumption after Suspension
The lifting of the order of suspension and the
resumption of the operation of an
establishment 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.
80. XIV. Violations and Administrative Sanctions
C. Re-application after Revocation
Unless permanently barred, any establishment
whose LTO have been revoked may apply for
initial application after three years from date of
revocation.
81. A.O. 56 s. 1989 Revised Guidelines
… I. Drug Establishments
1. Definition
2. Standards and Requirements for
License to Operate (LTO)
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
II. Drug Outlets
1. Definition
2. Standards and Requirements for
LTO
3. Renewal of LTO
4. Administrative Sanctions
5. Schedule of Fees
....
VII. Classification of Drug
Establishments
VIII. Requirements for Securing an LTO
IX. Renewal of LTO
X. Application for Amendment
XI. Licensing Process
XII. Licensing Guidelines
XIII. License to Operate
XIV. Violations and Administrative
Sanctions
XV. Schedule of Fees
82. XV. Schedule of Fees
A.O. 56 s. 1989 Revised Guidelines
Chapter I
Chapter II
Upon application for license to
operate, the drug establishment shall
be charged with the corresponding
non-refundable fees for each type of
activity or classification that it will
engage into. The fees shall be based
on the existing Administrative Order
on schedule of fees including any
applicable amendment thereto.
83. XVI. Separability Clause
If any of the provisions of this administrative order is found by a court of
competent jurisdiction to be void or unenforceable, in whole or in part,
such provision shall be deemed deleted from this Order but the remaining
provisions thereof shall remain in full force and effect.
XVII. Repealing Clause
All provisions of existing administrative orders, circulars, regulations and other
issuances inconsistent with this Order are hereby repealed or amended
accordingly.
XVIII. Effectivity Clause
This Order shall take effect after fifteen (15) days following its publication in a
newspaper of national circulation and upon submission to the University of
the Philippines Law Center;This AO is subject for review after 2 years from
Editor's Notes
In accordance with Section 3 Paragraphs 5 and 6 of R.A. 6675, any organization, company or business establishments in the pharmaceutical industry shall fall under the following general classification:
I. Drug Establishment means any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines. This is covered by Chapter I below.
II. Drug Outlet means drugstore, pharmacy, and other business establishment which sells drugs or medicines. This is covered by Chapter II below.
In accordance with Section 3 Paragraphs 5 and 6 of R.A. 6675, any organization, company or business establishments in the pharmaceutical industry shall fall under the following general classification:
I. Drug Establishment means any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines. This is covered by Chapter I below.
II. Drug Outlet means drugstore, pharmacy, and other business establishment which sells drugs or medicines. This is covered by Chapter II below.
Explain: Drug outlets is considered as drug establishment; use of terminologies
?? Why started in G?
- The Standards part was divided into different clauses
- The Standards part was placed into a different clause
The TURNED initial ( does not appear in AO 56)
Not mentioned in AO 56. references?
- The Standards part was placed into a different clause
- The Standards part was placed into a different clause
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 submission of necessary documents to the FDA and approval of such change(s) has been made.