The document outlines statutory guidelines regarding pre-packaged commodities under the Legal Metrology Act of 2009. It discusses various rules for declarations that must be made on pre-packaged goods, including the name and address of the manufacturer/packer, generic name of product, quantity, dimensions, expiration dates and maximum retail price. Specific rules are provided for retail goods, goods manufactured and packed by a third party, and imported goods. Proper labeling helps ensure accurate information is provided to consumers of pre-packaged commodities.
This document discusses India's Legal Metrology Act of 2009. Some key points:
- The Act aims to establish standards for weights and measures and regulate trade through enforcing accurate weights/measures.
- It defines important terms like "manufacturer", "sale", "seal", "stamp", and "verification" as they relate to weights and measures.
- The Act establishes a hierarchy of standards from international down to commercial levels and requires calibration/verification of weights and measures used in transactions.
- It sets penalties for transactions that do not comply with standards or use of unverified weights and measures in trade.
There have been three significant weights and measures systems in India before the metric system. Akbar introduced a more uniform system using the barley corn but it did not replace existing systems. The British later introduced their own systems like the troy ounce. In 1956, India passed legislation to introduce the metric system for weights and measures, which was fully adopted by 1960-1962. The Legal Metrology Act of 2009 replaced earlier acts and introduced more stringent punishment for violations while protecting consumer interests.
This document summarizes key legislation and regulations regarding packaged commodities in India. It outlines the Standards of Weights and Measures Act of 1976 and 1985, as well as constitutional provisions establishing standards. The Packaged Commodities Rules of 1977 aim to regulate pre-packed trade and ensure accurate quantity information. Key terms like "pre-packed commodity", "retail package", and "wholesale package" are defined. The rules specify how declarations must be made on packages regarding name, address, quantity, and other details in a clear and prominent manner so consumers have accurate information.
The Bureau of Indian Standards Act 2016 established the Bureau of Indian Standards (BIS) as India's national standards body. The objectives of the Act are to develop standards for goods, services, and systems; enable mandatory certification regimes; provide multiple conformity assessment schemes; and boost compliance through penalties. The BIS operates several certification schemes including for products, systems, foreign manufacturers, hallmarking of precious metals, and eco-friendly products. It also establishes laboratories to test products' conformity with standards.
A presentation on weights and measures [legal metrology]Altacit Global
This document discusses India's laws and regulations around weights and measures, including:
1) The key legislation is the Legal Metrology Act of 2009, which established standards and definitions and replaced previous acts.
2) The base metric units for measurements are defined, and legal metrology officers are appointed to enforce the act.
3) Requirements are outlined for packages to display declarations and manufacturers to be licensed. Non-compliance can result in penalties.
4) Case laws provide interpretations of how the act applies, such as to advertisements using non-metric terms.
This document outlines food packaging and labeling regulations in India. It defines key terms and sets requirements for packaging materials, containers, and labels.
Chapter 1 provides general definitions for terms like date of manufacture, lot number, and vegetarian and non-vegetarian foods. Chapter 2 establishes packaging requirements, such as materials that can contact food and guidelines for canned products and drinking water.
Labeling regulations require pre-packaged foods to display information like the name, ingredients, nutrition facts, date marks, and country of origin (if imported). Special provisions address labeling of edible oils, restricting exaggerated claims. Advertising cannot mislead consumers or contradict food safety laws.
Food laws and policies in european unionAbdul Rehman
The document discusses European Union food safety laws and policies. It outlines that in 2002, the EU adopted the General Food Law to provide a comprehensive framework for food regulation based on risk assessment and management. The European Food Safety Authority was established to provide independent scientific advice on food safety issues. Key principles of EU food law include protecting human health, applying risk analysis, and ensuring traceability and strict controls on contaminants and residues throughout the food chain.
The document outlines statutory guidelines regarding pre-packaged commodities under the Legal Metrology Act of 2009. It discusses various rules for declarations that must be made on pre-packaged goods, including the name and address of the manufacturer/packer, generic name of product, quantity, dimensions, expiration dates and maximum retail price. Specific rules are provided for retail goods, goods manufactured and packed by a third party, and imported goods. Proper labeling helps ensure accurate information is provided to consumers of pre-packaged commodities.
This document discusses India's Legal Metrology Act of 2009. Some key points:
- The Act aims to establish standards for weights and measures and regulate trade through enforcing accurate weights/measures.
- It defines important terms like "manufacturer", "sale", "seal", "stamp", and "verification" as they relate to weights and measures.
- The Act establishes a hierarchy of standards from international down to commercial levels and requires calibration/verification of weights and measures used in transactions.
- It sets penalties for transactions that do not comply with standards or use of unverified weights and measures in trade.
There have been three significant weights and measures systems in India before the metric system. Akbar introduced a more uniform system using the barley corn but it did not replace existing systems. The British later introduced their own systems like the troy ounce. In 1956, India passed legislation to introduce the metric system for weights and measures, which was fully adopted by 1960-1962. The Legal Metrology Act of 2009 replaced earlier acts and introduced more stringent punishment for violations while protecting consumer interests.
This document summarizes key legislation and regulations regarding packaged commodities in India. It outlines the Standards of Weights and Measures Act of 1976 and 1985, as well as constitutional provisions establishing standards. The Packaged Commodities Rules of 1977 aim to regulate pre-packed trade and ensure accurate quantity information. Key terms like "pre-packed commodity", "retail package", and "wholesale package" are defined. The rules specify how declarations must be made on packages regarding name, address, quantity, and other details in a clear and prominent manner so consumers have accurate information.
The Bureau of Indian Standards Act 2016 established the Bureau of Indian Standards (BIS) as India's national standards body. The objectives of the Act are to develop standards for goods, services, and systems; enable mandatory certification regimes; provide multiple conformity assessment schemes; and boost compliance through penalties. The BIS operates several certification schemes including for products, systems, foreign manufacturers, hallmarking of precious metals, and eco-friendly products. It also establishes laboratories to test products' conformity with standards.
A presentation on weights and measures [legal metrology]Altacit Global
This document discusses India's laws and regulations around weights and measures, including:
1) The key legislation is the Legal Metrology Act of 2009, which established standards and definitions and replaced previous acts.
2) The base metric units for measurements are defined, and legal metrology officers are appointed to enforce the act.
3) Requirements are outlined for packages to display declarations and manufacturers to be licensed. Non-compliance can result in penalties.
4) Case laws provide interpretations of how the act applies, such as to advertisements using non-metric terms.
This document outlines food packaging and labeling regulations in India. It defines key terms and sets requirements for packaging materials, containers, and labels.
Chapter 1 provides general definitions for terms like date of manufacture, lot number, and vegetarian and non-vegetarian foods. Chapter 2 establishes packaging requirements, such as materials that can contact food and guidelines for canned products and drinking water.
Labeling regulations require pre-packaged foods to display information like the name, ingredients, nutrition facts, date marks, and country of origin (if imported). Special provisions address labeling of edible oils, restricting exaggerated claims. Advertising cannot mislead consumers or contradict food safety laws.
Food laws and policies in european unionAbdul Rehman
The document discusses European Union food safety laws and policies. It outlines that in 2002, the EU adopted the General Food Law to provide a comprehensive framework for food regulation based on risk assessment and management. The European Food Safety Authority was established to provide independent scientific advice on food safety issues. Key principles of EU food law include protecting human health, applying risk analysis, and ensuring traceability and strict controls on contaminants and residues throughout the food chain.
Legal Metrology Registration Weight and MeasurementASC Group
The Legal Metrology Act, 2009 (‘LMA’) was introduced in order to safeguard consumer interest and rights. Effective from April 01, 2011, LMA establishes"
For more details: https://www.ascgroup.in/service/legal-metrology-registration/
The document discusses issues with India's existing food safety regulatory regime and the need for new legislation. It outlines key aspects of the Food Safety and Standards Act of 2006, including consolidating various food laws, establishing the Food Safety and Standards Authority of India to set science-based standards, and regulating the food supply chain from manufacturing to retail. The new Act aims to ensure safe and wholesome food is available for consumers and allows for stringent enforcement including penalties for violations.
The document discusses the Food Safety and Standards Act (FSSA) 2006 and its impact on the food industry in India. It outlines some key issues with the previous multiplicity of food laws such as varied quality standards. It then summarizes some of the major features of the FSSA including provisions for licensing and registration, enforcement, adjudication, penalties, and regulations developed under the Act. Overall, the FSSA aims to establish a single reference point for all issues related to food safety and standards in India.
The document provides information about the Bureau of Indian Standards (BIS), which is the national standards body of India. It discusses the origin and establishment of BIS, its organization structure, functions, and key standards and certification schemes. Some of the main points covered are:
- BIS was established in 1986 by the BIS Act and works under the Ministry of Consumer Affairs to develop and promote standards in India.
- It has headquarters in Delhi and offices across India. BIS represents India in international standards organizations like ISO.
- Key functions include developing and enforcing standards, hallmarking, product certification, and management system certifications for standards like ISO 9001, ISO 14001, and more.
FOOD AND NUTRACEUTICALS REGULATION IN INDIAChandanBV2
This document provides an overview of regulations for nutraceuticals and functional foods in India. It discusses key terms like nutraceuticals and functional foods. It outlines the history and timeline of food regulations in India, describing various national laws established. It explains the Food Safety and Standard Act of 2006, which aims to establish a single reference point for all food safety matters. The document also discusses licensing and registration requirements for nutraceuticals under FSSAI, labeling requirements, and the regulatory requirements for entering the Indian nutraceutical market.
Vanaspati oil Act & weight and measures act.Sumit Bansal
Act to establish standards of weights and measures, to regulate trade or commerce in weights, measures and other goods which are sold or distributed by weight, measure or number, to provide
for matters connected therewith or incidental thereto.
Brief introduction to Agmark, BIS and FSSAI
Introduction (AGMARK)
Objectives of Agmark Scheme
Requirement of Agmark Application Proceedings
Advantages of agmark
Bureau of Indian Standards (B.I.S)
Structure of BIS/ Members of BIS
OBJECTIVES and FUNCTIOS OF BIS
Food Safety and Standards Authority of India (FSSAI)
NEED OF FSSAI
Functions of fssai
FSSAI Structure
Landmark cases with FSSAI
Differences between agmark and fssai
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
This document discusses quality control testing for various packaging materials used in the pharmaceutical industry, including glass, plastic, paper/cardboard, rubber, metals and foils. It provides details on specific tests for each material. For example, for glass it describes light transmission testing, hydrolytic resistance testing and powdered glass testing. For plastic, it outlines leakage testing, collapsibility testing and water vapor permeability testing. The document aims to guide testing to ensure that packaging materials meet quality standards.
The document discusses quality management systems (QMS) and good manufacturing practices (GMP) and their benefits for businesses. It provides an overview of the key elements of a QMS and explains that a QMS establishes procedures and processes to ensure quality control across all aspects of a business. It then describes GMP guidelines which outline manufacturing and testing standards for pharmaceuticals and medical devices to ensure product quality and compliance. The document notes that many countries have legislation requiring companies to follow GMP procedures.
Standards institutes like BIS, ISO, FDA, and WHO work to improve quality of life by developing and harmonizing standards. BIS is India's national standards organization established in 1986 to facilitate standardization and quality control. It develops over 17,000 standards and certifies products and quality management systems. ISO is an international NGO with 161 member countries that develops voluntary consensus standards to facilitate global trade. FDA regulates food, drugs, medical devices and other products in the US. WHO works to attain the highest level of health globally and harmonize health standards between 194 member countries.
The document discusses food legislation and regulations in different countries. It explains that food products must comply with local laws and regulations to gain market access in a country. These laws ensure food safety and suitability for consumers. Regulations may be based on international standards set by Codex Alimentarius or a country's own rules. The document then discusses India's food laws and regulations, including the Food Safety and Standards Act of 2006, and the roles of the Bureau of Indian Standards and AGMARK in setting standards and certifying that products meet those standards. Finally, it briefly outlines the structure and responsibilities of the U.S. Food and Drug Administration and its Center for Food Safety and Applied Nutrition regarding food safety in the United States.
Presented by A.K. Singla to the ILRI workshop on safety of animal source foods with an emphasis on the informal sectors, New Delhi, India, 8 February 2011
Presentation on the World Trade Organization's Agreement on Technical Barriers to Trade.
Developed by the International Trade Team of Barral M Jorge & Associates
This document appears to be an inspection report form used by inspectors from the World Health Organization (WHO) to inspect pharmaceutical manufacturing firms and ensure compliance with Good Manufacturing Practices (GMP). The form includes sections to record details of the firm, personnel, facilities, equipment, materials, documentation, production processes, and compliance with GMP standards. Inspectors would use this form to systematically evaluate all aspects of the facility and operations during an inspection.
The document discusses specifications for raw materials, finished products, and documentation. It defines specifications and their importance in ensuring quality. Specifications include tests, acceptance criteria, and procedures for materials and products. The document outlines specifications for raw material purchasing, storage, and testing as well as finished product testing, documentation, and storage. It discusses the relationship between specifications and regulations/standards.
The Bureau of Indian Standards (BIS) is India's national standards body that was established in 1986. BIS formulates standards for various industries in India for quality control and consumer protection. It has several functions such as protecting consumers from hazardous products, promoting consumer confidence, and providing quality assurance. BIS is also involved in international standardization, product certification, hallmarking of gold and silver, operating testing laboratories, and training and consumer awareness programs.
Emma Bradley from Fera Science Ltd presented on food contact materials and migration testing. Key points included:
- Migration occurs when chemicals transfer from food packaging into food and is influenced by factors like the material, substance, food, and contact conditions.
- EU legislation establishes rules for materials, substances, testing, and compliance documentation like declarations of compliance.
- Specific rules apply to plastics, which must use authorized monomers/additives and meet migration limits through testing with food simulants intended to mimic food types.
This document discusses the requirements for food product labeling in India according to regulations from FSSAI. It outlines the key information that must be included on labels such as the product name, ingredients, nutrition facts, manufacturer details, best before/use by dates, and other specifications. Specific labeling elements are also defined, such as how to note vegetarian and non-vegetarian products, food additives, country of origin, and instructions for use. The goal of the labeling guidelines is to ensure consumers have access to comprehensive information about food products.
B.com(hons) indirect tax - central excise notesPawan Sehrawat
Central excise duty is levied on goods manufactured in India. The key points are:
1. Excise duty is governed by the Central Excise Act 1994 and is normally paid by the manufacturer at the time goods are removed from the factory.
2. Excise duty can be a basic rate of 16% or a special additional duty specified for certain goods. Duty is determined based on the transaction value or MRP of goods.
3. Manufacture is defined broadly and includes any process that produces a marketable good. The taxable event is manufacture of excisable goods in India.
Legal Metrology Registration Weight and MeasurementASC Group
The Legal Metrology Act, 2009 (‘LMA’) was introduced in order to safeguard consumer interest and rights. Effective from April 01, 2011, LMA establishes"
For more details: https://www.ascgroup.in/service/legal-metrology-registration/
The document discusses issues with India's existing food safety regulatory regime and the need for new legislation. It outlines key aspects of the Food Safety and Standards Act of 2006, including consolidating various food laws, establishing the Food Safety and Standards Authority of India to set science-based standards, and regulating the food supply chain from manufacturing to retail. The new Act aims to ensure safe and wholesome food is available for consumers and allows for stringent enforcement including penalties for violations.
The document discusses the Food Safety and Standards Act (FSSA) 2006 and its impact on the food industry in India. It outlines some key issues with the previous multiplicity of food laws such as varied quality standards. It then summarizes some of the major features of the FSSA including provisions for licensing and registration, enforcement, adjudication, penalties, and regulations developed under the Act. Overall, the FSSA aims to establish a single reference point for all issues related to food safety and standards in India.
The document provides information about the Bureau of Indian Standards (BIS), which is the national standards body of India. It discusses the origin and establishment of BIS, its organization structure, functions, and key standards and certification schemes. Some of the main points covered are:
- BIS was established in 1986 by the BIS Act and works under the Ministry of Consumer Affairs to develop and promote standards in India.
- It has headquarters in Delhi and offices across India. BIS represents India in international standards organizations like ISO.
- Key functions include developing and enforcing standards, hallmarking, product certification, and management system certifications for standards like ISO 9001, ISO 14001, and more.
FOOD AND NUTRACEUTICALS REGULATION IN INDIAChandanBV2
This document provides an overview of regulations for nutraceuticals and functional foods in India. It discusses key terms like nutraceuticals and functional foods. It outlines the history and timeline of food regulations in India, describing various national laws established. It explains the Food Safety and Standard Act of 2006, which aims to establish a single reference point for all food safety matters. The document also discusses licensing and registration requirements for nutraceuticals under FSSAI, labeling requirements, and the regulatory requirements for entering the Indian nutraceutical market.
Vanaspati oil Act & weight and measures act.Sumit Bansal
Act to establish standards of weights and measures, to regulate trade or commerce in weights, measures and other goods which are sold or distributed by weight, measure or number, to provide
for matters connected therewith or incidental thereto.
Brief introduction to Agmark, BIS and FSSAI
Introduction (AGMARK)
Objectives of Agmark Scheme
Requirement of Agmark Application Proceedings
Advantages of agmark
Bureau of Indian Standards (B.I.S)
Structure of BIS/ Members of BIS
OBJECTIVES and FUNCTIOS OF BIS
Food Safety and Standards Authority of India (FSSAI)
NEED OF FSSAI
Functions of fssai
FSSAI Structure
Landmark cases with FSSAI
Differences between agmark and fssai
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
This document discusses quality control testing for various packaging materials used in the pharmaceutical industry, including glass, plastic, paper/cardboard, rubber, metals and foils. It provides details on specific tests for each material. For example, for glass it describes light transmission testing, hydrolytic resistance testing and powdered glass testing. For plastic, it outlines leakage testing, collapsibility testing and water vapor permeability testing. The document aims to guide testing to ensure that packaging materials meet quality standards.
The document discusses quality management systems (QMS) and good manufacturing practices (GMP) and their benefits for businesses. It provides an overview of the key elements of a QMS and explains that a QMS establishes procedures and processes to ensure quality control across all aspects of a business. It then describes GMP guidelines which outline manufacturing and testing standards for pharmaceuticals and medical devices to ensure product quality and compliance. The document notes that many countries have legislation requiring companies to follow GMP procedures.
Standards institutes like BIS, ISO, FDA, and WHO work to improve quality of life by developing and harmonizing standards. BIS is India's national standards organization established in 1986 to facilitate standardization and quality control. It develops over 17,000 standards and certifies products and quality management systems. ISO is an international NGO with 161 member countries that develops voluntary consensus standards to facilitate global trade. FDA regulates food, drugs, medical devices and other products in the US. WHO works to attain the highest level of health globally and harmonize health standards between 194 member countries.
The document discusses food legislation and regulations in different countries. It explains that food products must comply with local laws and regulations to gain market access in a country. These laws ensure food safety and suitability for consumers. Regulations may be based on international standards set by Codex Alimentarius or a country's own rules. The document then discusses India's food laws and regulations, including the Food Safety and Standards Act of 2006, and the roles of the Bureau of Indian Standards and AGMARK in setting standards and certifying that products meet those standards. Finally, it briefly outlines the structure and responsibilities of the U.S. Food and Drug Administration and its Center for Food Safety and Applied Nutrition regarding food safety in the United States.
Presented by A.K. Singla to the ILRI workshop on safety of animal source foods with an emphasis on the informal sectors, New Delhi, India, 8 February 2011
Presentation on the World Trade Organization's Agreement on Technical Barriers to Trade.
Developed by the International Trade Team of Barral M Jorge & Associates
This document appears to be an inspection report form used by inspectors from the World Health Organization (WHO) to inspect pharmaceutical manufacturing firms and ensure compliance with Good Manufacturing Practices (GMP). The form includes sections to record details of the firm, personnel, facilities, equipment, materials, documentation, production processes, and compliance with GMP standards. Inspectors would use this form to systematically evaluate all aspects of the facility and operations during an inspection.
The document discusses specifications for raw materials, finished products, and documentation. It defines specifications and their importance in ensuring quality. Specifications include tests, acceptance criteria, and procedures for materials and products. The document outlines specifications for raw material purchasing, storage, and testing as well as finished product testing, documentation, and storage. It discusses the relationship between specifications and regulations/standards.
The Bureau of Indian Standards (BIS) is India's national standards body that was established in 1986. BIS formulates standards for various industries in India for quality control and consumer protection. It has several functions such as protecting consumers from hazardous products, promoting consumer confidence, and providing quality assurance. BIS is also involved in international standardization, product certification, hallmarking of gold and silver, operating testing laboratories, and training and consumer awareness programs.
Emma Bradley from Fera Science Ltd presented on food contact materials and migration testing. Key points included:
- Migration occurs when chemicals transfer from food packaging into food and is influenced by factors like the material, substance, food, and contact conditions.
- EU legislation establishes rules for materials, substances, testing, and compliance documentation like declarations of compliance.
- Specific rules apply to plastics, which must use authorized monomers/additives and meet migration limits through testing with food simulants intended to mimic food types.
This document discusses the requirements for food product labeling in India according to regulations from FSSAI. It outlines the key information that must be included on labels such as the product name, ingredients, nutrition facts, manufacturer details, best before/use by dates, and other specifications. Specific labeling elements are also defined, such as how to note vegetarian and non-vegetarian products, food additives, country of origin, and instructions for use. The goal of the labeling guidelines is to ensure consumers have access to comprehensive information about food products.
B.com(hons) indirect tax - central excise notesPawan Sehrawat
Central excise duty is levied on goods manufactured in India. The key points are:
1. Excise duty is governed by the Central Excise Act 1994 and is normally paid by the manufacturer at the time goods are removed from the factory.
2. Excise duty can be a basic rate of 16% or a special additional duty specified for certain goods. Duty is determined based on the transaction value or MRP of goods.
3. Manufacture is defined broadly and includes any process that produces a marketable good. The taxable event is manufacture of excisable goods in India.
The document provides standard operating procedures for Gap's QA process, including requirements for manufacturing ready packages, pre-production meetings, pilot runs and TOP sampling, in-process audits, and shipments audits. It details what should be included in manufacturing ready packages to provide complete production information. It also outlines procedures for pre-production meetings, including topics that should be discussed, and procedures for conducting pilot runs and collecting TOP samples to check for consistency before bulk production. In-process audits involve following up on production status and quality.
This document provides guidelines for suppliers on packing garments in boxes instead of hanging. It details the process for changing a style from hanging to boxed, including updating the UPC and contract modularity. Packing procedures are outlined such as using stockroom packs, approved carton sizes, and applying proper labels. The appendix includes references to additional documents on EDI tracking, best packing methods, and quality assurance tools related to the change to boxed shipping.
Labelling Regulatory aspects of artwork management Vicky Sharma
This document discusses the regulatory requirements for drug and cosmetic labeling in India according to the Drugs and Cosmetics Act of 1940 and Rules of 1945, as well as the Legal Metrology Act of 2009. It outlines the key information that must be included on labels such as the product name, manufacturer details, net quantity, batch number, expiration date, ingredients, and precautions. It also describes requirements for text sizes, mandatory logos, and principles for the primary display panel. Non-compliance can result in penalties like imprisonment, fines, product recalls, and blacklisting.
This document provides instructions for completing an Other Tobacco Products (OTP) Excise Tax Return and associated forms for Nevada. It explains how to calculate taxes owed on OTP sales. Line items on the return collect information on total sales, sales to out-of-state customers or tribes that are tax exempt, returned merchandise credits, and tax amounts due. Associated forms track tax-exempt OTP exports and credits for returned products to claim on the main return. Penalties are assessed for late filing or payment.
1. This Decree deals with information on goods labels, presentation thereof, and state management of labels of goods circulated in Vietnam and imported goods.
2. The following goods shall not be regulated by this Decree:
a) Real property;
b) Goods temporarily imported for re-export; goods temporarily imported for re-export after participation in fairs or exhibitions; goods in transit, goods involved in merchanting trade transactions; transshipped goods;
c) Baggage of incoming/outgoing passengers; personal belongings;
d) Confiscated goods for auction purpose;
dd) Goods being fresh, raw food, processed food without packaging and sold directly to consumers;
e) Commodities being fuel, materials (agricultural products, aquatic products, minerals), construction materials (bricks, tiles, lime, sand, stone, gravel, cement, color soil, mortar, commercial mixed concrete), scrap (in production and business) without packaging and sold directly to consumers;
g) Commodities being petrol and oil, gas (LPG, CNG, LNG), liquid, bulk cement without commercial packaging in containers, tankers;
h) Used goods;
i) Exported goods without domestic use;
k) Goods in the area of security and national defense; goods being radioactive substances, goods to be used for emergencies so as to solve problems of natural disaster, epidemic diseases; railway, waterway, airway vehicles.
This agreement is made between Advance Agrotech (Party 1) and SAFE FOOD AGRO (Party 2) on March 2012. Party 1 appoints Party 2 as the marketing agent for certain testing kits in the Dhaka division of Bangladesh. Party 2 will purchase the kits from Party 1 and sell them in the region, receiving a 30% commission. Party 1 and Party 2 agree to terms regarding forecasting, ordering, payment, quality control, dispute resolution, and termination of the agreement. The agreement is valid for 1 year and can be renewed.
This document provides instructions for the process of importing a new vendor's products into Korea. It outlines 10 key steps: 1) checking documents, 2) market research, 3) ingredient lists, 4) nutrition facts, 5) flow chart, 6) laboratory tests, 7) negotiation, 8) official purchase order, 9) customs clearance, and 10) delivery to the EMART DC Center. For each step, it provides detailed guidelines on what information and samples are required from the vendor to ensure compliance with Korean import regulations.
Australia medical device registration and approval process - EMERGOEMERGO
1. To register a medical device in Australia, manufacturers must first determine the device's classification using Australia's regulations and submit an application through an Australian sponsor.
2. The sponsor will submit the application along with supporting documents to the Therapeutic Goods Administration (TGA) for review and approval.
3. If approved, the TGA will provide an Australian Register of Therapeutic Goods (ARTG) listing number allowing marketing in Australia. Listings do not expire as long as annual fees are paid and the device is not changed.
Medical device authority re registration shareslide 110621Peggy
This document provides information about the medical device re-registration process in Malaysia. It discusses that re-registration is similar to renewal and requires documents to be submitted to the Conformity Assessment Body before submitting for re-registration. It also outlines the documents needed at different stages, including the Conformity Assessment Body verification, uploading to Medcast 2.0, and common issues like an expired certificate during the re-registration review process. Contacting the officer directly via phone or email is recommended if review is not completed before expiry.
This document discusses registration requirements and procedures under the Central Excise Act. It states that manufacturers, dealers, importers and others must register if their turnover exceeds a certain threshold or they engage in other specified activities. The penalties for non-registration include confiscation of goods, fines, and imprisonment. It provides details on the registration application process, separate registration requirements for multiple premises, and introduces the new 15-digit Excise Control Code used for identification.
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.
Unit 5 consumer protection and introduction to cyber lawGanesha Pandian
This document provides an overview of the Consumer Protection Act of 1986 and introduces cyber law in India. It discusses key aspects of the Consumer Protection Act including its aims to better protect consumer interests, establish quasi-judicial machinery for disputes, and salient features. It also covers consumer rights and duties. The document then provides an introduction to cyber law in India through the Information Technology Act of 2000, highlighting several chapters related to digital signatures, electronic governance, and certifying authorities.
The document discusses the Consumer Protection Act and introduction of cyber laws in India. It provides an overview of the key aspects of the Consumer Protection Act 1986 including its aims and objectives, salient features, consumer rights and duties. It also discusses the need for consumer protection, redressal machinery under the act and procedures for filing complaints. The document then provides an introduction to cyber laws in India, highlighting the key provisions and chapters of the Information Technology Act 2000 which provides the legal framework for e-commerce and electronic records.
B PHARAM 6TH SEM
PHARAMACEUTICAL QUALITY ASSURANCE
COMPLAINT
Reasons
Types of Complaint
Steps involved in Handling of complaints
Product Complaint Data Sheet
Complaint Record
Regulatory Guidelines
SOP on Complaint Handling
RECALL
Reasons
Types of Recall
Recall Classification
Levels of Recall
How to Recall the Product?
How To Notify The Consumers?
Regulatory Guidelines
SOP on Product Recall
DRUG RECALL IN 2013 AND 2014
This document provides an overview of the Consumer Protection Act 1986 and introduction to cyber laws in India. It discusses key aspects of the Consumer Protection Act including its aims and objectives, salient features, consumer rights and duties. It also covers the need for consumer protection, definitions, complaints process and the 3-tier consumer grievance redressal system. The document then provides an introduction to cyber laws in India, highlighting the Information Technology Act 2000 and aspects such as digital signatures and electronic governance.
1. The document provides instructions for installing and operating a Smart Combustible Gas Sensor.
2. It detects gas leaks and connects to a Z-Wave network to transmit notifications and alarms.
3. The sensor has a green LED that indicates normal operation and a red LED and buzzer for alarms.
Manual Smart combustible gas sensor Z-Wave Plus -ZipatoDomotica daVinci
This document provides installation and operation instructions for a smart combustible gas sensor. It can be installed 0.3-1m from the floor or ceiling, within 1.5m of a gas source. The sensor has a 5 year lifespan and uses Z-Wave wireless technology. To install it, the device must pre-heat for 3 minutes before inclusion into a Z-Wave network. It detects gas leaks and sends notifications. The sensor works between -10°C and 50°C and has a wireless range of under 100m.
This document provides an overview of central excise law in India, including:
1. It defines manufacture and excisability under central excise law, outlining key concepts like actual substantive manufacture and deemed manufacture. Leading court cases that define manufacture are also discussed.
2. It covers the basic ingredients required for excisability - fact of manufacture, entry availability in the tariff, and marketability.
3. Key valuation concepts like transaction value, valuation rules, and exclusions/inclusions from value are explained. Special valuation situations like job work and MRP-based valuation are also covered.
4. Refunds and rebates under central excise law are briefly discussed.
Similar to Legal Metrology Act - Anas Shaikh - 13FET1006 (20)
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2. Introduction
Ministry of Consumer Affairs, Food & Public Distribution
--(Department of Consumer Affairs)
Central
Government
Legal Metrology Act 2009, (1 of
2010)
Section 52
Sub-section (1) Sub-section (2)
Clause (j) & (q)
Jointly read for exercise of powers
G. S. R. 202( E )
(Legal Metrology (Packaged Commodities) Rules,
2011
Enforcement Date: 1st April, 2011
3. Applicability
Every Other Packaged
Commodity
Packaged
Commodities for
Institutional
Consumers
Packages with
qty > 25kg or
25L
Packaged
Commodities for
Industrial
Consumers
Transportation,
Airways, Railways
Hotels
Hospitals Any Institution buying
pg’s from manu.
Industry
(For Industrial Use)
Packaged
Commodities
Manu.
Institutional
Consumers
Industrial
Consumers
4. Permission
for Pre-
packing, Sale,
etc
Pre-Packing Permitted only
with
Delivery
Distribution
Sale
Declarations
LabelBearing on
Material
Not Permitted
Otherwise
Manufacturer’s
Premises (within)
No Label
permitte
d
(outsid
e)
-------
--
-------
Label
required
5. Recommende
d Standard
Packages for
Specific
Commodities
Schedule II
If not as
per
Schedule
II
Prominent
declaration on
Label
‘Not a standard pack
size under the Legal
Metrology
(packaged
commodities) Rules,
2011’
‘Not a standard size
under the Legal
Metrology
(packaged
commodities) Rules,
2011’
6. Declarations
to be made
on every
package
1) Bearing/ Label with definite, plain & conspicuous declaration of:
a) Name & Address of Manufacturer
Or Name & Address of Manufacture & Packer (if M/=P)
And Name & Address of Importer (for imported packages)
*For food articles: PFA, 1954(37 of 1954)
b) Common/ Generic names of commodity
Name & Number or Qty, of each product on package (for more than
1 product)
c) Net Quantity (Std unit of Wt/Measure; # of commodities)
d) Month & Year of Manufacturing, Pre-packing & Importing
Exemptions:
For food articles: PFA, 1954(37 of 1954)
For seeds: Seeds Act, 1966(54 of 1966)
Rubber stamp w/o overwriting
7. Declarations
to be made
on every
package
e) Retail sale price of package
Exemptions: Alcoholic beverages/ Spirituous liquor State Excise
Laws
f) Commodity Size (If relevant):
Same dimensions Mention
Different dimensions of different pieces Specify for each piece
g) Such other matter as are specified in this rules
Exemptions:
1) No declaration of Month & Year Bidi & Incense sticks
2) Exhaustion date of packaging material (Al foil) with bearing
8. Declarations
to be made
on every
package
Packaging Material
(Date of Packaging)
If not exhausted during that month
Can be used for next succeeding
month
Exemptions:
1) If Central Govt. is satisfied about non-exhaustion Extension of
period
2) For food products: Not applicable where ‘Best before or Use before’
period is less than 90 days or less from date of manufacturing or
packaging’
3) No declaration of retail sale price for bidi
9. Declarations
to be made
on every
package
2. For Consumer Complaints Name, Address, Telephone No., E-mail
address of person or office
3. No Individual Stickers for altering or declaring as per rules
Exemption: Reducing MRP Sticker with ‘Revised lower MRP (inclusive of
all taxes)’ then that on label not applicable
4. Stickers Allowed for declarations other than rules
5. Multiple pack
Label
Label
LabelLabel
Or
But if each counterpart sold individually then
(a)
(a)
(b)
10. Principal
Display Panel-
Its Area, Size
& Letter, etc.
1. Capacity <= 5 cc Card/ Taped affixed firmly with
required information
2. Numeral Height: Specified in Table 1 (wrt Wt/ Vol) & Table
2 (wrt Length, Area or Number)
3. Letter Height: NLT 1 mm ; NLT 2 mm (if blown, formed,
molded, embossed, perforated)
4. Numeral/ Letter Width: NLT (1/3rd * Height) except
Numeral ‘1’ & Letters (i), (I) and (l)
5. Exemptions: If any other law also specifies PDP regulations
11. Declaration,
where to
appear
1. PDP
Area around Qty declared – Free from printed declaration
Above/ Below – Space >= Height of Number
Left/ Right – Space >= Twice Height of Number
2. Soft Drink/ RTS Beverage/ the-like (returnable bottles)
Either or both on Crown and Bottle
Form: ‘MRP Rs_ _ _’
12. Manner in
which
declarations
shall be made
1. Legible & Prominent; Numerals of RSP & Net Qty
printed/painted/inscribed conspicuously contrast color with
background
Exception:
Blown/formed/moulded on glass/plastic – No need of contrasting
colors
Printed as Hand-writing or Hand-script – Clear, unambiguous &
legible
2. Declaration to be read along a liquid commodity Not allowed
3. Boxed commodities
Inner & Outer Declarations – Both required;
Inner Decl. NMT Outer Decl.
But if outside packaging is transparent Outer declaration
Not needed
4. Hindi (Devnagri script) ; English ; Other language (if not
prohibited)
13. Declaration of
Name &
Address of
Manufacturer
As per Rule 4
<= 5 cc. capacity – Identifiable
Commodities manufactured outside India & packed in India
Also mention packer/ importer in India
Complete address (postal of factory location & city & state of
business carried by manufacturer or packer)
Name of Manufacturer/Packer/Importer
Actual corporate name
If not Inc. : Name under which such business is conducted by
M/P/I in India
14. General
Provisions
relating to
declaration of
Quantity
Net Wt of Commodity excludes wt of wrappers/ packaging materials
Commodity Wt/ Measure not varied by environment
Net Qty on pack == Net Qty received by consumer
Not qualified by words ‘when packed’
Commodity Wt/ Measure varied by environment – Variation is
negligible
Net Qty on pack == After considering the variation
Not qualified by words ‘when packed’
Commodity Significant variation
Qualified by words ‘when packed’
Schedule III
15. Manner in
which
declaration of
Quantity shall
be made
1. Wt/ Measure/ Number/ Combination Accurate & Adequate
Info
2. Except for Schedule IV commodities declaration of quantity shall
be wrt:
Mass (Solid, Semi-solid, Viscous, Mixture of solid & liquid)
Length (Sold by Linear measure)
Area (Sold by Area measure)
Volume (Liquid/ sold by cubic measure)
Number (Sold by Number)
3. Mass declaration # of commodities declaration (optional)
4. When Mass, Measure or Number insufficient wrt dimensions
and/or numbers accompany info on dimensions and/or
number
5. Any additional info necessary to consumers Same panel as that
of other info on panel
6. Exaggerated, Misleading, Inadequate impressions Not Allowed
7. Capacity <= 5 cc Declaration – Tag, Card, Tape, Similar device
that can’t be removed w/o opening the container Every tag,
card, tape or device contain declaration
16. Statement of
Units of
Weight,
Measure &
Number
For Qty
less
than
1 kg 1 g
1 m 1 cm
1 m2 1 dm2
1 m3 1 cm2
1 dm3 1 cm3
1 L 1 mL
For Qty equal to
or more than
1 kg 1 kg
1 m 1 m
1 m2 1 m2
1 m3 1 m3
1 L 1 L
Any fraction of said units shall be
expressed in terms of decimal sub-
multiple of that unit
Examples:
500 g
7.3 L
1.1 kg
1 kg
1000 g
X 0.5 kg
• Dozen, Score, Gross & Great gross Not
Allowed
• Symbols: International System of Units
• For items sold by number: Symbols N or U
17. Declarations
N/A to Foods
Dimensions of certain commodities
Dimensions of container type commodities
Unstable sheets (Al foil, waxed paper)
18. Provisions wrt
Wholesale &
Retail dealers
Tax Revision
No sale with previous sale
Manu. must inform packer [Newspaper, Notices to dealers,
Director in Central Govt., Controllers of LMA in States & UT’s]
If packed before revision then marking necessary
Dealers can’t tamper price of M/P
M/P/I can’t alter price after printing & packing
Retailers under VAT or TOT:
Electronic Weighing Machine (Class III) with smallest division of
>=1
Facility (free of cost) & (proper place) Printed Receipt of Gross
Qty & Price
Consumers can check Qty.
19. Inspection of
Quantity &
Error in
packages at
the Premises
of the
Manu./Packer
Sampling – Schedule V
Tests – Schedule VI
Form – Schedule VII (with sign of M/P)
Report on Findings
-- Stat avg of Net Qty < Qty on pack/labels
-- Error in deficiency > Maximum permissible error
Request with apt reason Conduct fresh survey (Rs. 2500 from
M/P)
No selling of previous tests’ samples if Non- compliance until:
1) 100% check by Manu.
2) Dir/C/LMO satisfied & authorize to sell
Release of articles only after compliance if non-compliance was
found
20. Action to be
taken on
completion of
inspection of
packages at
the premises
of
Manu./Packer
Seize packets
Disposal as per Code
of Criminal
Procedure, 1973 (2
of 1974)
Fresh Test on
Request
21. Inspection of
Quantity &
Error in
packages at
the premises
of the
Wholesale or
Retail dealer
On Complaint (Tampered package) – By Dir/ Contr/ LMO
Deficiency of Error > MPE Seize packet & take action as per
Act Except: ‘When packed’ – No punitive action
Conforms – Can sell but based on Qty found on test
Deficiency but Error < MPE – Can sell but based on Qty found
on test
During inspection, packet decl. non-compliance then further
investigation of source
22. Establishment
of MPE on
packages
Schedule I
Due account of following variations:
-- Unavoidable deviation in weighing, measuring & counting
(GPP)
-- Climate, Transport & Storage (GDP)
-- Due to Nature of packaging material/ container
Dir/ Contr/ LMO – shall determine reasonable variations due
to environment for ‘when packed’ commodities
23. Deceptive
packages to
be repacked
or in default
to be seized
Deceptive: Misleading, Exaggerated, etc.
Deceptive: Bigger dimensions, except when justified by
packaging machine
Re-pack If not done Punitive action
If seized commodities (speedy or natural decay) disposed
off by by LMO/Contr/Dir