The Cometic registration and Import registration process as per regulations in India. CliniExperts Services Pvt. Ltd. provides consultation services in Cosmetic Registration since the import registration of cosmetics came into existence and became mandatory. For further assistance or queries please contact us at contact@cliniexperts.com or visit our website www.cliniexperts.com
Cosmetics regulatory: includes Regulatory provision relating to manufacture of cosmetics, Schedule M (II) of D & C rule 1945 deals with requirements for the factory premises for the manufacture of cosmetic, requirement of plant & equipment, conditions of licencing, regulatory provision on sale of cosmetics, loan licence, Regulatory provision relating to import of cosmetics, offences & penalties, List of amending Act and adaptation orders.
The Cometic registration and Import registration process as per regulations in India. CliniExperts Services Pvt. Ltd. provides consultation services in Cosmetic Registration since the import registration of cosmetics came into existence and became mandatory. For further assistance or queries please contact us at contact@cliniexperts.com or visit our website www.cliniexperts.com
Cosmetics regulatory: includes Regulatory provision relating to manufacture of cosmetics, Schedule M (II) of D & C rule 1945 deals with requirements for the factory premises for the manufacture of cosmetic, requirement of plant & equipment, conditions of licencing, regulatory provision on sale of cosmetics, loan licence, Regulatory provision relating to import of cosmetics, offences & penalties, List of amending Act and adaptation orders.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
ย
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Definition of cosmetic products as per Indian regulation. Indian regulatory requirements for labeling of cosmetics .Regulatory provisions relating to import of cosmetics ,Misbranded and spurious cosmetics. Regulatory provisions relating to manufacture of cosmetics โ Conditions for obtaining license, prohibition of manufacture and sale of certain cosmetics, loan license, offences and penalties.
The Regulation requires all cosmetic products (except where specific exceptions apply โ see below) to have clearly and indelibly marked on their container and packaging the following information: name and address of the Responsible Person. country of origin for imported products.
In this presentation I have mentioned whatever the possible relevant content required for the title.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
ย
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
To import Cosmetics into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
INDIAN REGULATORY REQUIREMENTS FOR LABELING OF COSMETICSPV. Viji
ย
INDIAN REGULATORY REQUIREMENTS FOR LABELING OF COSMETICS , IMPORTANCE OF LABELING , LABELING REQUIREMENTS , Common or generic name of the product. , Product function , Use instruction , Name & address of Manufacturer , Country of manufacture , Manufacture Date , Expiry date , Net Quantity , Retail Sale Price , Storage condition , Barcodes , Batch number , Warning or Caution if hazard exists , Manufacturing License Number , Ingredients , Registration Certificate Number (RCN) , Consumer Care Details , Using Stickers , Brown/Red or green dot , Not a standard pack size under Legal Metrology(Packaged commodities) Rules
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
ย
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Definition of cosmetic products as per Indian regulation. Indian regulatory requirements for labeling of cosmetics .Regulatory provisions relating to import of cosmetics ,Misbranded and spurious cosmetics. Regulatory provisions relating to manufacture of cosmetics โ Conditions for obtaining license, prohibition of manufacture and sale of certain cosmetics, loan license, offences and penalties.
The Regulation requires all cosmetic products (except where specific exceptions apply โ see below) to have clearly and indelibly marked on their container and packaging the following information: name and address of the Responsible Person. country of origin for imported products.
In this presentation I have mentioned whatever the possible relevant content required for the title.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
ย
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
To import Cosmetics into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
INDIAN REGULATORY REQUIREMENTS FOR LABELING OF COSMETICSPV. Viji
ย
INDIAN REGULATORY REQUIREMENTS FOR LABELING OF COSMETICS , IMPORTANCE OF LABELING , LABELING REQUIREMENTS , Common or generic name of the product. , Product function , Use instruction , Name & address of Manufacturer , Country of manufacture , Manufacture Date , Expiry date , Net Quantity , Retail Sale Price , Storage condition , Barcodes , Batch number , Warning or Caution if hazard exists , Manufacturing License Number , Ingredients , Registration Certificate Number (RCN) , Consumer Care Details , Using Stickers , Brown/Red or green dot , Not a standard pack size under Legal Metrology(Packaged commodities) Rules
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
Want to know how to start a cosmetic manufacturing company in India. Have a look here this information will give excellent guidance on starting your own venture in cosmetic range.
Similar to COSMETIC REGISTRATION IN INDIA ppt (20)
CDSCO & Central Bureau of Narcotics are the two organizations which regulate Narcotic Drugs.
ACCREDITED CONSULTANTS PVT LTD
info@acplgroupindia.co.in
+919310040434
To import Diagnostics into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Recruiting in the Digital Age: A Social Media MasterclassLuanWise
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In this masterclass, presented at the Global HR Summit on 5th June 2024, Luan Wise explored the essential features of social media platforms that support talent acquisition, including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok.
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Learn how to use Binance Savings to expand your bitcoin holdings. Discover how to maximize your earnings on one of the most reliable cryptocurrency exchange platforms, as well as how to earn interest on your cryptocurrency holdings and the various savings choices available.
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Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
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Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
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Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
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In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
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2. The Objective of a Drug Regulatory in India are to ensure the
medicinal, Medical Devices and Cosmetics products are acceptable on
the of Quality, Safety and Efficacy.
Drug Controller General of India-the head of Central Drug Standard
Control Organisation, regulates Cosmetics, Devices & Drugs in India.
The Drugs & Cosmetics Act and Rules are the governing regulations in
India.
Accredited Consultants Pvt. Ltd.
3. Central Drug Standards Control
Organization is the Regulatory
authority for the approval of New
Drug, Import Registration of Drugs,
Medical Devices and Cosmetics.
Accredited Consultants Pvt. Ltd.
4. As in the case of USFDA regulation or
any other country regulation in India
also there are possibilities of
categorisation of product in different
ways, depending upon various
parameters.
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5. FLOW CHART FOR REGISTRATION
OF COSMETICS
Legal Documents Regulatory documents Technical Documents
Form 42 POA, DIII Product Testing
(From Indian Agent) Specification Method, COA,
Label/IFU
Manufacturing License, GMP, Free Sale Certificates, Standards
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6. ๏ฝ Drugs & Cosmetic Act defines โcosmeticโ means any article intended
to be rubbed, poured, sprinkled or sprayed on, or introduced into, or
otherwise applied to, the human body or any part thereof for
cleansing, beautifying, promoting attractiveness, or altering the
appearance, and includes any article intended for use as a component
of cosmetic.
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7. ๏ฝ Domestic Manufacturing of Cosmetic already regulated in India
๏ฝ As per Notification GSR 426(E) in 2010 the Drugs & Cosmetics
Act amended required Registration prior to importation of
Cosmetics to India.
๏ฝ Though it is extended for some time now it is mandatory from
1st April 2013
REQUIREMENTS FOR IMPORT OF
COSMETICS
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8. ๏ฝ Other Documents required are Manufacturing License, GMP if any,
Free Sale Certificate, etc.
๏ฝ The products should not contain prohibited items (such as mercury,
lead & prohibited colors) & it should comply to the standards of
either Bureau of Indian Standards or of International Cosmetics
Standards.
๏ฝ Government Fee by TR Challan as applicable.
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9. Labels and inserts
๏ฝ Product labels should show the address of manufacturer, manufacturing &
expiry date, importer name and address, import license no., indications &
cautions or contra indications (if any)
Product inserts should describe the brief description of the product and its
intended use.
๏ฝ Company Profile
๏ฝ Product specification and testing protocol
๏ฝ List of Ingredients with details of strength of each ingredient used in the
products to be registered
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10. Documents To be submitted by Indian agent
๏ฝ Form 42- It should be signed and stamped by Indian agent.
Documents To be submitted by Manufacturer
๏ฝ POA- Power of attorney should be Appostilised or Consularized
from Indian embassy of the country of origin, and should be
co-jointly signed by both the parties i.e. Manufacturer and
Indian Agent in the given format.
๏ฝ Schedule DIII- They should be signed and stamped by
Manufacturer in the given format.
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11. ๏ฝ The total fee depends upon the no. of brands. The cosmetics must
be categorized into brands.
๏ฝ A "Brand" will mean each category of cosmetic products as
mentioned in Column 3 of Annexure (enclosed in โGuidelines on
Registration of Import of Cosmeticsโ).
๏ฝ Government Fees as TR Challan of USD 250 or its equivalent Indian
rupees is required for each brand.
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12. ๏ฝ After ensuring all documents correctly as per the requirements of
FDA, they are submitted. It generally takes about 2-3 months to
scrutinize these documents by Technical Data Associates/Drug
inspectors of CDSCO and during this period clarification if any,
required by them are answered and thereafter we get the
Registration Certificate (RC) in Form 43.
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13. State Drug authorities of Respective States are responsible to issue
manufacturing Licenses.
Application in Form 31 with Govt. Fees of Rs3500.
List of Equipments, Manufacturing Facility details with minimum area
of 15 Sq. Meters, Technical Competent personnel details, Relevant
Sops are required for obtaining manufacturing permissions. The
specifications should comply the BIS standards if applicable or else
acceptable International Standards. Presently Trials are not required.
A proposal to include the definition of New cosmetics are on cards.
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