Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to

Size: px
Start display at page:

Download "Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to"

Transcription

1 The NHPD Monthly Communiqué is a publication of Health Canada s Natural Health Products Directorate (NHPD), the federal department responsible for the regulation of natural health products sold in Canada. The communiqué is released to the Canadian public the first week of each month via the NHPD s electronic bulletin. Subscription to this e-bulletin is available at Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to NHPD_DPSN@hc-sc.gc.ca. ******************************************************************** TABLE OF CONTENT: Each NHPD Monthly Communiqué is separated into five sections for ease of reference. These are: Product Licensing Information, Site Licensing Information, Compliance Corner, Clinical Trial Information and Other Information. PRODUCT LICENSING INFORMATION Intent to Withdraw will no longer be sent after January 1, 2006 p. 2 Entering the Company Code in your Product Licence Application p. 2 Classification of Homeopathic product licence applications p. 2 Cover letter required for all communications with the NHPD p. 3 Common Errors and Deficiencies p. 3 SITE LICENSING INFORMATION Simply Specs-tacular p. 5 Common errors and deficiencies p. 6 Site-bite p. 6 COMPLIANCE CORNER Health Canada's compliance approach for natural health products p. 7 Frequently Asked Questions p. 7 CLINICAL TRIAL INFORMATION p. 9 OTHER INFORMATION Improper contact information in the Designated Party Authorization (DPA) Form p. 9 Page 1 of 9

2 PRODUCT LICENSING INFORMATION: Intent to Withdraw Notice will no longer be sent after January 1, 2006 Currently, when an applicant fails to respond in a timely manner to a Processing Deficiency Notice (PDN) or Information Request Notice (IRN), an Intent to Withdraw Notice is sent, providing the applicant with an additional 30 days to address the outstanding issues listed in the PDN or IRN. If the applicant does not respond within 30 days, a Notice of Withdrawal is sent and the submission is removed from the NHPD s review queue. However, this will all change in the New Year. As of January 1, 2006, the NHPD will no longer issue Intent to Withdraw Notices. Applicants who do not respond within the time frame indicated in the PDN or IRN (usually 15 to 30 business days), will receive a Notice of Withdrawal and their applications will be immediately removed from our review queue. Entering the Company Code in your Product Licence Application In Part 1 of the Product Licence Application (PLA), the field entitled Company Code refers to the five-digit code assigned by Health Canada to an applicant or licensee. When processing a company s first submission, a Company Code is assigned to the file (and indicated in the upper-right corner of the acknowledgement letter sent to the applicant). All other subsequent applications submitted by that company will be assigned the same code. If this is your first application, leave this field blank since the NHPD has not yet issued you a code. If you have already submitted an application but cannot remember your company code, please refer to the first acknowledgment letter that was sent to you. If you still cannot locate your company code, please leave the field blank on your PLA. This should not significantly slow the processing of your file. Classification of Homeopathic product licence applications For the purposes of the product licensing process, applications for homeopathic medicines are classified into one of two categories based on the product s recommended use or purpose (i.e. health claim). These are: 1. Homeopathic medicines with a non-specific recommended use or purpose: No recommended use or purpose (health claim) is permitted for these homeopathic medicines. The words Homeopathic Medicine, Homeopathic Preparation, Homeopathic Drug or Homeopathic Remedy, must appear on the label in place of any claim. These homeopathic medicines may be composed of one or more homeopathic medicinal ingredients. 2. Homeopathic medicines with a specific recommended use or purpose: Applicants may propose a specific recommended use or purpose (health claim) for their homeopathic products provided that : I. The homeopathic medicine contains two or more homeopathic medicinal ingredients, and II. The proposed health claim is supported by homeopathic references such as MATERIA MEDICA. Examples of a specific recommended use or purpose are: "For the pain, fever and irritability associated with teething" or, "To treat fever, muscle aches and chills due to the flu". Each of the two categories listed above must adhere to specific labelling requirements and parameters for the homeopathic potency. For more information, please consult the Evidence for Homeopathic Medicines Guidance Document. Page 2 of 9

3 Cover letter required for all communications with the NHPD When submitting an application package or responding to an IRN or PDN, we would ask that you please include a cover letter which explains what you are sending to us and why it is being sent. Examples: Please find attached the product licence application for Product X, manufactured by Company Y. The following is our response to the PDN issued on November 10, 2005, regarding the product licence application for Product Z (Submission # ). Including a cover letter with all communications will further assist us in tracking and processing your file in a timely manner. Please ensure that you clearly indicate your contact information as well as submission number(s) and company code (if applicable) in your cover letter. Common Errors and Deficiencies The following is a list of common errors and deficiencies found in product licence applications sent to the NHPD. These errors, though they may seem minor in some cases, can lead to major time delays and can be easily avoided if applicants take the time to properly prepare and review their applications before submitting them to the NHPD. 1. Making un-requested changes to a submission: Some applicants have been making un-requested changes to their submissions when replying to issues outlined in a PDN or IRN. Applicants should only make the requested changes. If you feel that additional changes are needed, please contact your submission coordinator directly. 2. Dosage unit vs. the recommended dose: There seems to be some confusion as to the distinction between dosage unit vs. the recommended dose. Many product licence applications received thus far, along with the proposed label text, often mix up these two terms. As indicated in the November 2005 issue of the NHPD Monthly Communiqué, the Dosage Unit is the final physical form of the natural health product that may be used by the consumer (e.g. tablet, powder, capsule, bar, etc). The Recommended Dose/Dosage Amount is the quantity of the product to be taken at one time (e.g. take 1 tablet, take 2 teaspoon, etc). Example: Product Recommended Dose as it should appear on the label Recommended Dose as it should appear in Part 4 Section 3 of the PLA form Chinese Herbal Remedy. Traditionally used to treat the symptoms of a cold. Adults: 2 tablets three times a day Sub-population Adults Amount 2 Dosage unit Tablet Frequency Three times a day Page 3 of 9

4 3. Unacceptable product licence submissions: Individuals and businesses applying for a product licence are required to submit all appropriate forms and documentation for assessment. The NHPD will not accept nor process product licence submissions consisting solely of the product s package and label(s) or with missing or partially completed forms and documents. The following table, which is also available on page 6 of the Product Licensing: A Step-by-Step Guide, lists which forms and documents must be submitted per type of product licence application. Applicants should review this table before submitting their final product licence application packages to ensure that all the information requirements have been fulfilled. We would also like to remind stakeholders that the Product Licensing Guidance Document as well as the Product Licensing: A Step-by-Step Guide provide all the information needed to properly prepare a product licence submission package. These documents are available on-line at: EVIDENCE REQUIREMENTS APPLICATION TYPE REQUIREMENTS Traditional Non- Traditional specific claim Homeopathic non-specific claim Compendial (NHPD Monograph) TPD Labeling Standard (LS) or Cat. IV monograph Transitional Product Licence Application Form U U U U U U U Label Text U U U U U U Most recent version of approved label Evidence Summary Report References U A U B C,D D E F Safety Summary Report U U Animal Tissue Form (if applicable) Quality Summary Report (Finished Product Specifications) U U U U U U U U U U U U U A Minimum of two traditional references (e.g. text books). Please photocopy the relevant pages, incl. cover page D One homeopathic pharmacopoeial reference per medicinal ingredient B Minimum of two pieces of evidence to support product (e.g. complete article) Please note that abstracts will not be accepted as key references, however they may be included in addition. E Attest to NHPD Monograph from the Compendium of Monographs C Minimum of two homeopathic references per medicinal ingredient F Attest to TPD Labelling Standards for Vitamin and/or Mineral Supplements or Cat. IV monograph in a cover letter Page 4 of 9

5 4. Use of prohibited health claims: Natural health products can make a wide range of health claims, provided that they are supported by adequate evidence. The only health claim restriction is with respect to Section 3 of the Food and Drugs Act, which relates to Schedule A. Schedule A is a listing of 47 diseases and disorders, ranging from alcoholism and arthritis to asthma and cancer. Section 3 of the Food and Drugs Act prohibits natural health products from being sold as treatments or cures for any of the diseases listed on Schedule A. Many product licence applicants have been seeking authority to market products with claims that are not allowed in Canada due to this restriction. We would like to remind applicants that, at the present time, authorization for sale cannot be granted to any natural health product making a Schedule A claim. Amendments regarding Schedule A You may be interested in knowing that proposed amendments were published in the Canada Gazette, Part 1 on November 19, 2005, which would allow natural health products to make Schedule A claims. However, these amendments have not yet been officially incorporated and until this occurs, current restrictions continue to apply. A copy of these proposed amendments is available on-line at *********************************** SITE LICENSING INFORMATION: Over the past two months, we have explored the importance of establishing clear and detailed Standard Operating Procedures (SOPs) and have delved further into the role of the Quality Assurance Person. This month, as part three of our educational theme-based series on site licensing, we will be discussing product specifications. Simply Specs-tacular What are specifications? Specifications are a set of complete and precise, written descriptions that outline the characteristics and quality tolerances of your raw materials, packaging materials and finished products. In terms of the requirements for finished products, it is important to note that every product manufactured for sale in Canada must have specifications that contain: Information regarding the product s purity tolerances; Information respecting the product s quantity and identity tolerances; When applicable, details regarding the product s potency tolerances; The methods used for testing the product All specifications and subsequent modifications to your specifications should be approved by your Quality Assurance Person and Standard Operating Procedures should be in place describing how to test products against their specifications. Remember, as part of your site licence application, you are required to submit details on the procedures and processes you have in place at your site for the testing of received raw and packaging materials, as well as Page 5 of 9

6 finished products. Having complete specifications in place and detailed SOPs describing them ensures that the finished products you produce are consistently safe and of the highest quality. Chapter of the Good Manufacturing Practices Guidance Document provides you with details on what Health Canada is looking for in your product specifications. When developing your specifications, you should take into account requirements such as identification, purity from unacceptable contaminants, potency (when applicable) and/or marker chemicals that would be noted on the product label (when applicable), and appropriate microbial limits, depending on the type of product you are manufacturing. The methods you choose for testing your finished products will depend on the individual product and should be included in the specifications of each product approved for sale in Canada. Every lot of your finished product must meet the requirements established in your specifications prior to being released by your Quality Assurance Person. Common Submission Deficiencies The NHPD receives many deficiencies relating to specifications. A few of these include: Lack of or inadequate specifications No process in place for the creation and maintenance of specifications No process in place for the assessment of finished product before release Ideal submissions received by the NHPD have the following: Evidence of proper specifications maintenance procedures Records showing completed finished product testing showing tolerances as described in the products specifications Samples of specifications in use at the site Site-bite Did you know? The specifications to which you compare your finished natural health products are the same as those included the Quality Summary Report of your product licence application package. BE SURE TO CHECK IN NEXT MONTH WHERE WE WILL LOOK AT STORAGE AND MAINTENCE OF YOUR FACILITIES. *********************************** Page 6 of 9

7 COMPLIANCE CORNER: In addition to authorizing the sale of natural health products, the NHPD is also responsible for coordinating compliance efforts targeted at natural health products that are not in compliance with the Natural Health Product Regulations and related policies and/or that pose an unacceptable risk to the health and safety of Canadians. Health Canada's compliance approach for natural health products The Canadian natural health products industry has grown at an extraordinary rate over the past decade. As such, when the Natural Health Products Regulations first came into effect in January 2004, several thousands of products were required by law to immediately obtain a product licence. In order to deal with this situation in a way that would ensure the health and safety of Canadians was not placed at undue risk, a unique compliance policy was developed to provide Health Canada with the means of strategically applying its compliance resources to those natural health products of greatest concern (i.e. those of greatest risk). The Compliance Policy for Natural Health Products as it is known is first and foremost a risk-based approach. Products that pose an unacceptable risk to the health of Canadians will be dealt with immediately. There are twelve criteria that Health Canada inspectors and investigators use to determine if a particular natural health product poses an unacceptable risk to health. These criteria include un-approved products destined for use by children or pregnant women. As a compliment to the risk-based approach, the Compliance Policy for Natural Health Products also outlines a product priority categorization strategy. This priority categorization sets out specific dates when compliance actions will target certain categories of natural health products. There are six priority categories. At times, the Policy may seem confusing, and the NHPD receives many questions from industry stakeholders requesting further clarification on the Policy itself as well as its application by Health Canada inspectors and investigators. The following is a list of the most frequently asked questions (FAQs) pertaining to compliance actions. Please note that there are other compliance related FAQs available on Health Canada s Web site at: Frequently Asked Compliance Questions 1. I currently have a submission number for my product. Does this constitute authorization to sell even though I am still awaiting my Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)? No. A submission number is proof of the receipt of a Product Licence Application (PLA) and it is not an authorization for sale. Under the Natural Health Products Regulations all NHPs are required to possess a valid DIN, NPN or DIN-HM in order to be lawfully sold as of January 1, As previously mentioned, Health Canada will focus its compliance efforts as per the product priority categorization approach and the risk-based approach described in the Compliance Policy for Natural Health Products. To summarize, compliance efforts will target natural health products that: i) pose an unacceptable risk to health; Page 7 of 9

8 ii) do not have a valid DIN, NPN or DIN-HM, or iii) have not been issued a submission number by the NHPD. Regardless of the priority listing in the NHP Compliance Policy, all natural health products identified as posing an unacceptable risk to the health of Canadians will be subject to immediate compliance action. 2. When I receive a submission number for my product, does it automatically mean that my product has met the definition of a natural health product? No, as indicated in previous monthly communiqués, when you have submitted an application for a product licence, the NHPD still has to conduct a product classification to determine whether your product meets the natural health products definition. A submission number is only proof that the NHPD has received your product licence application. 3. My product is detained at the border. What do I do? To find out about your detained product(s), please contact the Health Products and Food Branch Inspectorate (HPFBI) at: or contact your regional HPFBI Operational Centre. Contact information is available at: 4. I have a trade complaint. Who can I contact? Again, you must contact the Health Products and Food Branch Inspectorate. Please see the instructions for filing a trade complaint. 5. What kinds of compliance/enforcement actions will be taken against products without valid market authorization, found to pose an unacceptable risk to health, or without a valid submission number? Enforcement actions will be in accordance to the Health Products and Food Branch Compliance and Enforcement Policy (POL-0001). A listing of the various compliance and enforcement actions is available in Chapter 8.1: Compliance Measures Initiated by the Regulated Party of this Policy. Some of the actions required may include one of the following: i) requiring a stop sale; ii) requesting a recall of the product; iii) issuing a customs alert for imported products, or iv) issuing a public warning/advisory *********************************** Page 8 of 9

9 CLINICAL TRIAL INFORMATION: Nothing to report this month. However, keep an eye out for the winter edition of the NHPD Quarterly Report (scheduled for release in January 2006), which will include a progress report from the NHPD s Clinical Trials Unit describing some of its recent accomplishments, which include the elimination of the clinical trial application backlog. The NHPD Quarterly Report is available on-line at OTHER INORMATION: Improper contact information in the Designated Party Authorization (DPA) Form To date, many applicants have been entering the wrong contact information in the Contact Information field at the bottom of the DPA Form. You must enter the contact information for the 3rd party in this field, not the contact information for the senior official (or sponsor in the case of a clinical trial) who is authorizing the 3rd party to act on his/her behalf. The contact information for the senior official/sponsor is indicated in Part 1 of the product licence, site licence or clinical trial application form. *********************************** Page 9 of 9

NHPD Monthly Communiqué

NHPD Monthly Communiqué NHPD Monthly Communiqué Vol. 3, Issue 5 February 2008 The NHPD Monthly Communiqué is a publication of Health Canada s Natural Health Products Directorate (NHPD), the federal department responsible for

More information

Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to

Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to The NHPD Monthly Communiqué is a publication of Health Canada s Natural Health Products Directorate (NHPD), the federal department responsible for the regulation of natural health products sold in Canada.

More information

COMPENDIUM OF MONOGRAPHS NATURAL HEALTH PRODUCTS DIRECTORATE

COMPENDIUM OF MONOGRAPHS NATURAL HEALTH PRODUCTS DIRECTORATE COMPENDIUM OF MONOGRAPHS NATURAL HEALTH PRODUCTS DIRECTORATE June 13 2013 Version 3.0 i FOREWORD Guidance documents are meant to provide assistance to industry and health care practitioners on how to comply

More information

M I L L E R T H O M S O N LLP Barristers & Solicitors, Patent & Trade Mark Agents

M I L L E R T H O M S O N LLP Barristers & Solicitors, Patent & Trade Mark Agents M I L L E R T H O M S O N LLP Barristers & Solicitors, Patent & Trade Mark Agents Communiqué for Health Industry Clients on the Legal Retainer Program Canada s New Natural Health Products Regulations On

More information

Raritan Pharmaceuticals, Inc. 6/20/17

Raritan Pharmaceuticals, Inc. 6/20/17 Raritan Pharmaceuticals, Inc. 6/20/17 U.S. Food & Drug Administration Division of Pharmaceutical Quality Operations I New Jersey District 10 Waterview Boulevard, 3rd Floor Parsippany, NJ 07054 June 20,

More information

Bill C-51 and Natural Health Products - The Facts

Bill C-51 and Natural Health Products - The Facts Bill C-51 and Natural Health Products - The Facts 1. How will Bill C-51 change the way natural health products are regulated? Bill C-51 will not affect the way that natural health products are regulated

More information

Natural Health Product Raw Material Policy

Natural Health Product Raw Material Policy Natural Health Product Raw Material Policy Natural Health Products Directorate Health Products and Food Branch October 2006 Health Canada is the Federal department responsible for helping Canadians maintain

More information

THE NEW CANADIAN NATURAL HEALTH PERODUCT REGULATIONS

THE NEW CANADIAN NATURAL HEALTH PERODUCT REGULATIONS THE NEW CANADIAN NATURAL HEALTH PERODUCT REGULATIONS IMPACT AND OPPORTUNITY FOR CHINESE MEDICINE JULY 2006 Yili Bai, PhD Tel: 604-249-2896 Email: ybai@wellgenex.com Michael ZC Li, MSc, MD, MBA Tel: 604-249-2896

More information

Recall Guidelines. for Chinese Medicine Products

Recall Guidelines. for Chinese Medicine Products Recall Guidelines for Chinese Medicine Products April 2018 Recall Guidelines for Chinese Medicine Products Chinese Medicines Board Chinese Medicine Council of Hong Kong Compiled in September 2005 1 st

More information

AKA Good Manufacturing Practice (GMP) Certification Program

AKA Good Manufacturing Practice (GMP) Certification Program AKA Good Manufacturing Practice (GMP) Certification Program Preamble The American Kratom Association (AKA) is establishing this program to assure the safety and integrity of kratom dietary supplements

More information

Proposed Amendments to the Cannabis Regulations: Edible Cannabis, Cannabis Extracts and Cannabis Topicals

Proposed Amendments to the Cannabis Regulations: Edible Cannabis, Cannabis Extracts and Cannabis Topicals Proposed Amendments to the Cannabis Regulations: Edible Cannabis, Cannabis Extracts and Cannabis Topicals Health Canada s 2019 Regulatory Consultation 1 Purpose The purpose of this presentation is to provide

More information

Patented Medicine Prices Review Board (PMPRB) Fasken Martineau Pharmaceutical Law Seminar April 29, 2010, Montréal

Patented Medicine Prices Review Board (PMPRB) Fasken Martineau Pharmaceutical Law Seminar April 29, 2010, Montréal Patented Medicine Prices Review Board (PMPRB) Fasken Martineau Pharmaceutical Law Seminar April 29, 2010, Montréal Overview PMPRB Origin and Mandate Price Regulatory Framework Review of Excessive Price

More information

Commercial Feed Mill Verification Task Procedures

Commercial Feed Mill Verification Task Procedures Introduction The Canadian Food Inspection Agency (CFIA) is dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada s people, environment and economy. As part

More information

RE: Permits under the Arizona Pharmacy Act should not be required for dietary supplements

RE: Permits under the Arizona Pharmacy Act should not be required for dietary supplements Board Members Arizona State Board of Pharmacy 1616 W. Adams St., Suite 120 Phoenix, AZ 85007 c/o Kam Gandhi, PharmD Executive Director Arizona State Board of Pharmacy Via email: kgandhi@azpharmacy.gov

More information

The Marketing of a Food Ingredient Understanding a System that has Worked for 105 Years

The Marketing of a Food Ingredient Understanding a System that has Worked for 105 Years The Marketing of a Food Ingredient Understanding a System that has Worked for 105 Years Gary L. Yingling Food Policy Impact December 2011 Copyright 2011 by K&L Gates LLP. All rights reserved. Brief Historical

More information

INTERIM NOTIFICATION PROGRAM LOW RISK VETERINARY HEALTH PRODUCTS OVERVIEW

INTERIM NOTIFICATION PROGRAM LOW RISK VETERINARY HEALTH PRODUCTS OVERVIEW INTERIM NOTIFICATION PROGRAM LOW RISK VETERINARY HEALTH PRODUCTS OVERVIEW Table of Contents 1.0 Purpose 2.0 Background 3.0 Scope 4.0 Definitions 5.0 Identification of a Notified Product 6.0 Requirements

More information

Food and Drug Regulations - Project Number Schedule F

Food and Drug Regulations - Project Number Schedule F Graham Spry Building 250 Lanark Avenue Address Locator: 2005D Ottawa, Ontario K1A 0K9 09-128254-482 Provincial and Territorial Deputy Ministers of Health Provincial and Territorial Drug Program Managers

More information

Understanding the New Access to Cannabis for Medical Purposes Regulations

Understanding the New Access to Cannabis for Medical Purposes Regulations Understanding the New Access to Cannabis for Medical Purposes Regulations Health Canada August 2016 Table of Contents 1. Introduction 2. Health Canada's role 3. What it means for health care practitioners

More information

Classification of Products at the Food Natural Health Product Interface: Products in Food Formats

Classification of Products at the Food Natural Health Product Interface: Products in Food Formats Classification of Products at the Food Natural Health Product Interface: Products in Food Formats Natural Health Products Directorate Food Directorate June 2010 Version 2.0 Health Canada is the Federal

More information

Ryan Smith, Community Planning Department Manager. Zoning Bylaw Text Amendment for Cannabis Production and Retail Cannabis Sales

Ryan Smith, Community Planning Department Manager. Zoning Bylaw Text Amendment for Cannabis Production and Retail Cannabis Sales Report to Council Date: August 27, 2018 File: 1250-04 To: From: Subject: Report prepared by: City Manager Ryan Smith, Community Planning Department Manager Zoning Bylaw Text Amendment for Cannabis Production

More information

Interchangeable Drug Products - Additional Criteria

Interchangeable Drug Products - Additional Criteria Interchangeable Drug Products - Additional Criteria Principle: Decisions respecting interchangeability and drug lists remain in the domain of the institution responsible for the costs of the product which

More information

GUIDANCE DOCUMENT Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard

GUIDANCE DOCUMENT Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard GUIDANCE DOCUMENT Cough and Cold Labelling Standard Published by authority of the Minister of Health Date Adopted 2015/07/09 Effective Date 2015/07/31 Health Products and Food Branch Our mission is to

More information

Health Canada Proposes New Rules to Regulate NHPs Like Drugs

Health Canada Proposes New Rules to Regulate NHPs Like Drugs Health Canada Proposes New Rules to Regulate NHPs Like Drugs Our Current System NHPs are regulated under the Natural Health Products Regulations All products are licensed by Health Canada All products

More information

Canadian Grain Commission

Canadian Grain Commission Canadian Grain Commission Licensing feed mills Discussion paper February 9, 2015 Ce document est aussi disponible en français. 1 About the Canadian Grain Commission The Canadian Grain Commission is a federal

More information

December 4, 2017 VIA ELECTRONIC SUBMISSION

December 4, 2017 VIA ELECTRONIC SUBMISSION VIA ELECTRONIC SUBMISSION December 4, 2017 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Development of a List of pre-dietary Supplement

More information

CANNABIS MANAGEMENT CORPORATION REGULATIONS

CANNABIS MANAGEMENT CORPORATION REGULATIONS c t CANNABIS MANAGEMENT CORPORATION REGULATIONS PLEASE NOTE This document, prepared by the Legislative Counsel Office, is an office consolidation of this regulation, current to August 11, 2018. It is intended

More information

REPUBLIC OF KENYA MINISTRY OF HEALTH PHARMACY AND POISONS BOARD DRAFT GUIDELINE FOR IMPORTATION OF ORPHAN MEDICINAL SUBSTANCES IN KENYA

REPUBLIC OF KENYA MINISTRY OF HEALTH PHARMACY AND POISONS BOARD DRAFT GUIDELINE FOR IMPORTATION OF ORPHAN MEDICINAL SUBSTANCES IN KENYA PPB/REG/TRA/GUD/003 REPUBLIC OF KENYA MINISTRY OF HEALTH PHARMACY AND POISONS BOARD DRAFT GUIDELINE FOR IMPORTATION OF ORPHAN MEDICINAL SUBSTANCES IN KENYA September 2015, Version 1 P.O. BOX 27663, LENANA

More information

Residual Solvents: FDA/ Regulatory Perspective

Residual Solvents: FDA/ Regulatory Perspective Rosa Motta Compliance Officer Residual Solvents: FDA/ Regulatory Perspective PDA/USP Residual Solvents Conference January 18-19, 2007 1 Outline Laws and regulations governing the compliance requirements

More information

Trademark Use Guidelines for Certified Products and Related Advertising

Trademark Use Guidelines for Certified Products and Related Advertising Trademark Use Guidelines for Certified Products and Related Advertising Version 2.0. Updated March 2017 2017 CSA Group 1 Introduction CSA Group has developed a significant reputation and goodwill in its

More information

Policy Options for the Regulation of Electronic Cigarettes

Policy Options for the Regulation of Electronic Cigarettes Policy Options for the Regulation of Electronic Cigarettes Consultation submission This submission was completed by: (name) Position (if applicable): Evon Currie General Manager, Community and Public Health

More information

EVIDENCE FOR SAFETY AND EFFICACY OF FINISHED NATURAL HEALTH PRODUCTS NATURAL HEALTH PRODUCTS DIRECTORATE

EVIDENCE FOR SAFETY AND EFFICACY OF FINISHED NATURAL HEALTH PRODUCTS NATURAL HEALTH PRODUCTS DIRECTORATE EVIDENCE FOR SAFETY AND EFFICACY OF FINISHED NATURAL HEALTH PRODUCTS NATURAL HEALTH PRODUCTS DIRECTORATE December 2006 Version 2.0 Our mission is to help the people of Canada maintain and improve their

More information

WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS

WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS SEPTEMBER 23, 2009 COUNCIL OF THE CONVENTION SECTION ON THE QUALITY OF FOOD INGREDIENTS AND DIETARY SUPPLEMENTS INTRODUCTION The 1994 Dietary Supplement

More information

Guidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

Guidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry DRAFT GUIDANCE This guidance

More information

Classification of Products at the Cosmetic-Drug Interface

Classification of Products at the Cosmetic-Drug Interface Health Canada Santé Canada Your health and safety our priority. Votre santé et votre sécurité notre priorité. GUIDANCE DOCUMENT Classification of Products at the Cosmetic-Drug Interface Health Canada is

More information

Claims about health in ads for e-cigarettes. CAP and BCAP s regulatory statement

Claims about health in ads for e-cigarettes. CAP and BCAP s regulatory statement Claims about health in ads for e-cigarettes CAP and BCAP s regulatory statement Contents 1. Executive Summary... 2 2. Policy background and the decision to consult... 4 3. Decisions... 6 4. Consequence

More information

GUIDANCE DOCUMENT Non-prescription Oral Adult Nasal Decongestant Labelling Standard

GUIDANCE DOCUMENT Non-prescription Oral Adult Nasal Decongestant Labelling Standard GUIDANCE DOCUMENT Decongestant Labelling Standard Published by authority of the Minister of Health Date Adopted 2015/12/17 Effective Date 2015/12/31 Health Products and Food Branch Our mission is to help

More information

SECTION PRESCRIPTIONS

SECTION PRESCRIPTIONS SECTION.1800 - PRESCRIPTIONS 21 NCAC 46.1801 EXERCISE OF PROFESSIONAL JUDGMENT IN FILLING PRESCRIPTIONS (a) A pharmacist or device and medical equipment dispenser shall have a right to refuse to fill or

More information

B.C. Cannabis PRIVATE RETAIL LICENSING GUIDE Applications and Operations

B.C. Cannabis PRIVATE RETAIL LICENSING GUIDE Applications and Operations B.C. Cannabis PRIVATE RETAIL LICENSING GUIDE Applications and Operations Copyright February 2018, Province of British Columbia. All rights reserved. This material is owned by the Government of British

More information

CHE8000 Major Research Project A. The Complementary Medicines Reforms and Its Impact to the Complementary Medicine Industry and the Consumer

CHE8000 Major Research Project A. The Complementary Medicines Reforms and Its Impact to the Complementary Medicine Industry and the Consumer CHE8000 Major Research Project A The Complementary Medicines Reforms and Its Impact to the Complementary Medicine Industry and the Consumer Completed by: Lina Karlina (ID: 2067226) Lina Karlina (2067226)

More information

Notice of Modification Lists of Permitted Food Additives Reference Number: NOM/ADM November 20, 2012

Notice of Modification Lists of Permitted Food Additives Reference Number: NOM/ADM November 20, 2012 Notice of Modification to the List of Permitted Preservatives to Enable the Addition of Potassium Lactate and Sodium Lactate to Standardized Meat Products and Poultry Meat Products Notice of Modification

More information

Talon Compounding Pharmacy 10/3/17

Talon Compounding Pharmacy 10/3/17 Talon Compounding Pharmacy 10/3/17 Office of Pharmaceutical Quality Operations, Division II 4040 N. Central Expressway, Suite 300 Dallas, Texas 75204 October 3, 2017 CMS Case # 522630 VIA UPS EXPRESS WARNING

More information

LAW ON MINERAL FERTILIZERS. Official Gazette of Bosnia and Herzegovina, 46/04

LAW ON MINERAL FERTILIZERS. Official Gazette of Bosnia and Herzegovina, 46/04 LAW ON MINERAL FERTILIZERS Official Gazette of Bosnia and Herzegovina, 46/04 Pursuant to Article IV.4.a) of the Constitution of Bosnia and Herzegovina, the Parliamentary Assembly of Bosnia and Herzegovina,

More information

Food Directorate Update: Supplemented Foods and Nutrition Labelling

Food Directorate Update: Supplemented Foods and Nutrition Labelling Food Directorate Update: Supplemented Foods and Nutrition Labelling Dr. William Yan Bureau of Nutritional Sciences, Food Directorate, Health Canada Canadian Health Food Association Expo West Regulatory

More information

Recognized Pharmacopoeia in Registration system

Recognized Pharmacopoeia in Registration system Recognized Pharmacopoeia in Registration system Mrs. Prapassorn THANAPHOLLERT Acting Director, Bureau of Control Food and, THAILAND What is pharmacopoeia? Legal basis Outline Recognized Official Pharmacopoeia

More information

MODIFICATION OF APPLICATION TO BECOME A LICENSED PRODUCER UNDER THE ACCESS TO CANNABIS FOR MEDICAL PURPOSES REGULATIONS

MODIFICATION OF APPLICATION TO BECOME A LICENSED PRODUCER UNDER THE ACCESS TO CANNABIS FOR MEDICAL PURPOSES REGULATIONS MODIFICATION OF APPLICATION TO BECOME A LICENSED PRODUCER UNDER THE ACCESS TO CANNABIS FOR MEDICAL PURPOSES REGULATIONS (ACMPR) (Disponible en français) This form should be used if you already submitted

More information

TSDR Pharmacy Inc. dba brandmd Skin Care 11/9/17

TSDR Pharmacy Inc. dba brandmd Skin Care 11/9/17 TSDR Pharmacy Inc. dba brandmd Skin Care 11/9/17 Division of Pharmaceutical Quality Operations IV 19701 Fairchild, Irvine, CA 92612-2506 Telephone: 949-608-2900 Fax: 949-608-4417 WARNING LETTER VIA SIGNATURE

More information

Agency Information Collection Activities; Submission for Office of Management and Budget

Agency Information Collection Activities; Submission for Office of Management and Budget This document is scheduled to be published in the Federal Register on 01/28/2016 and available online at http://federalregister.gov/a/2016-01690, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

AGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION. (Moscow, 23 December 2014)

AGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION. (Moscow, 23 December 2014) AGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION (Moscow, 23 December 2014) Member States of the Eurasian Economic Union, hereinafter referred

More information

Guideline on the Regulation of Therapeutic Products in New Zealand

Guideline on the Regulation of Therapeutic Products in New Zealand Guideline on the Regulation of Therapeutic Products in New Zealand Part 10: Requirements for information for prescribers and consumers Edition 7.0 January 2016 Section 1: Legislation Section summary This

More information

Animal Products Notice

Animal Products Notice Animal Products Notice Labelling Requirements for Exports of Dairy Based Infant Formula Products and Formulated Supplementary Food for Young Children 18 December 2014 An animal products notice issued under

More information

SUMMARY: The Food and Drug Administration (FDA) is requesting public input on updated

SUMMARY: The Food and Drug Administration (FDA) is requesting public input on updated This document is scheduled to be published in the Federal Register on 11/22/2017 and available online at https://federalregister.gov/d/2017-25245, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

GOVERNMENT OF REPUBLIC OF TRINIDAD AND TOBAGO MINISTRY OF HEALTH CHEMIST- FOOD AND DRUGS DIVISION NEW DRUG SUBMISSION FORM

GOVERNMENT OF REPUBLIC OF TRINIDAD AND TOBAGO MINISTRY OF HEALTH CHEMIST- FOOD AND DRUGS DIVISION NEW DRUG SUBMISSION FORM GOVERNMENT OF REPUBLIC OF TRINIDAD AND TOBAGO MINISTRY OF HEALTH CHEMIST- FOOD AND DRUGS DIVISION NEW DRUG SUBMISSION FORM Guidelines: In order to expedite the processing of your New Drug Submissions,

More information

Town and Country Compounding and Consultation Services, LLC 10/17/17

Town and Country Compounding and Consultation Services, LLC 10/17/17 Town and Country Compounding and Consultation Services, LLC 10/17/17 Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973)

More information

American Emu Association. Certified Emu Oil Program

American Emu Association. Certified Emu Oil Program Table of Contents Part 1. Frequently Asked Questions... 3 Part 2. AEA Certified Fully Refined Seal & Verbiage Usage Requirements... 5 Section A. Program Requirements... 5 Section B. Product Labeling Requirements...

More information

https://www.businesscompanion.info/en/quick-guides/food-and-drink

https://www.businesscompanion.info/en/quick-guides/food-and-drink https://www.businesscompanion.info/en/quick-guides/food-and-drink Food & drink In the guide Food hygiene & safety Food safety: quality & composition Food safety: quality & labelling Prepacked food Best

More information

Consultation: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)

Consultation: Discontinuing pre-market evaluation of Herbal Component Names (HCNs) Complementary Medicines Australia submission to the Therapeutic Goods Administration Consultation: Consultation: Discontinuing pre-market evaluation of Herbal Component Names (HCNs) 12 January 2018 To:

More information

CHILD AND ADULT CARE FOOD PROGRAM ADMINISTRATIVE REVIEW PROCEDURES

CHILD AND ADULT CARE FOOD PROGRAM ADMINISTRATIVE REVIEW PROCEDURES CHILD AND ADULT CARE FOOD PROGRAM ADMINISTRATIVE REVIEW PROCEDURES The regulations and guidelines of the Child and Adult Care Food Program (CACFP or Program) under the Food and Nutrition Service (FNS)

More information

Environmental, Health and Safety

Environmental, Health and Safety Environmental, Health and Safety Codes of Practice The Environmental, Health and Safety (EHS) Codes of Practice set forth Zimmer EHS requirements for our business functions and facilities worldwide. In

More information

Availability of FSIS Compliance Guidelines for Allergens and. Ingredients of Public Health Concern: Identification, Prevention

Availability of FSIS Compliance Guidelines for Allergens and. Ingredients of Public Health Concern: Identification, Prevention This document is scheduled to be published in the Federal Register on 11/16/2015 and available online at http://federalregister.gov/a/2015-28935, and on FDsys.gov Billing Code 3410-DM-P DEPARTMENT OF AGRICULTURE

More information

QUESTIONS AND ANSWERS Access to Drugs in Exceptional Circumstances

QUESTIONS AND ANSWERS Access to Drugs in Exceptional Circumstances QUESTIONS AND ANSWERS Access to Drugs in Exceptional Circumstances Published by authority of the Minister of Health Date Adopted 2017/06/09 Effective Date 2017/06/28 Health Products and Food Branch Our

More information

The Nutrition (Amendment) (EU Exit) Regulations 2018

The Nutrition (Amendment) (EU Exit) Regulations 2018 The Nutrition (Amendment) (EU Exit) Regulations 2018 A public consultation Contents Introduction... 3 Why we are consulting... 4 Nutrition and Health Claims... 6 Proposals... 6 Vitamins, minerals, and

More information

Guidance Document The Use of Probiotic Microorganisms in Food

Guidance Document The Use of Probiotic Microorganisms in Food Guidance Document The Use of Probiotic Microorganisms in Food Food Directorate Health Products and Food Branch Health Canada April 2009 Page 1 of 8 I. Introduction Purpose 1. The purpose of this Guidance

More information

The proposed rule is significant, and the requirements and exceptions are complex. Key provisions of the proposal are described below.

The proposed rule is significant, and the requirements and exceptions are complex. Key provisions of the proposal are described below. ADVISORY Food & Drug FDA ISSUES PROPOSED RULE TO ESTABLISH A UNIQUE DEVICE IDENTIFICATION SYSTEM FOR MEDICAL DEVICES July 16, 2012 On July 11, 2012, the Food and Drug Administration (FDA) published in

More information

TGA: the current regulatory reform agenda

TGA: the current regulatory reform agenda TGA: the current regulatory reform agenda ASMI 2012 Conference: 13 November 2012 Future proofing the consumer healthcare industry Dr John Skerritt, National Manager The Therapeutic Goods Administration

More information

USP Perspective on Atypical Actives November 29, 2017

USP Perspective on Atypical Actives November 29, 2017 USP Perspective on Atypical Actives November 29, 2017 USP Excipients Stakeholder Forum USP Perspective on Atypical Actives Catherine Sheehan, M.S., M.S. Senior Director, Science Excipients Outline Role

More information

July 11, Dear Mr. Derfler:

July 11, Dear Mr. Derfler: July 11, 2005 Mr. Philip Derfler Assistant Administrator Office of Policy, Program and Employee Development Food Safety and Inspection Service Room 350 Administration Building U.S. Department of Agriculture

More information

STAFF REPORT City of Lancaster NB 2

STAFF REPORT City of Lancaster NB 2 STAFF REPORT City of Lancaster NB 2 12/13/16 MVB Date: December 13, 2016 To: From: Subject: Mayor Parris and City Council Members Mark V. Bozigian, City Manager Allison E. Burns, City Attorney Ordinance

More information

Guidelines for Product Recall or Withdrawal

Guidelines for Product Recall or Withdrawal REPUBLIC OF KENYA PHARMACY AND POISONS BOARD Guidelines for Product Recall or Withdrawal Edition 1 Date of release for publication June 2006 Date of implementation June 2006 This document has been prepared

More information

COUNCIL OF THE EUROPEAN UNION. Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DENLEG 51 CODEC 893

COUNCIL OF THE EUROPEAN UNION. Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DENLEG 51 CODEC 893 COUNCIL OF THE EUROPEAN UNION Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DLEG 51 CODEC 893 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: Common Position with

More information

Guideline for the Rational Use of Controlled Drugs

Guideline for the Rational Use of Controlled Drugs Guideline for the Rational Use of Controlled Drugs Ministry of Health Male' Republic of Maldives April 2000 Table of Contents Page Introduction.. 2 1. Procurement and Supply of Controlled Drugs 3 1.1 Import

More information

British American Tobacco Snus Marketing Standards

British American Tobacco Snus Marketing Standards British American Tobacco Snus Marketing Standards British American Tobacco p.l.c. believes there is sufficient scientific evidence to support a less restrictive regime for the advertising and promotion

More information

Complainant v. the College of Dental Surgeons of British Columbia

Complainant v. the College of Dental Surgeons of British Columbia Health Professions Review Board Suite 900, 747 Fort Street, Victoria, BC V8W 3E9 Complainant v. the College of Dental Surgeons of British Columbia DECISION NO. 2015-HPA-221(a) September 13, 2016 In the

More information

BACKGROUNDER What s special about Théra Wise product ingredients? Barley Beta Glucan concentrate Argan Oil Tea Tree oil Honeysuckle extract

BACKGROUNDER What s special about Théra Wise product ingredients? Barley Beta Glucan concentrate Argan Oil Tea Tree oil Honeysuckle extract What s special about product ingredients? Ninety nine percent of ingredients have natural healing properties. Olive oil derivatives are used as a base in all products because olive oil s fatty acids are

More information

PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES

PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 040-1 3 Appendices 1 January 2019 PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES PIC/S January 2019 Reproduction

More information

HILLSBOROUGH COUNTY AVIATION AUTHORITY AIRPORT BOARD OF ADJUSTMENT RULES OF PROCEDURE

HILLSBOROUGH COUNTY AVIATION AUTHORITY AIRPORT BOARD OF ADJUSTMENT RULES OF PROCEDURE HILLSBOROUGH COUNTY AVIATION AUTHORITY AIRPORT BOARD OF ADJUSTMENT RULES OF PROCEDURE PURPOSE AND AUTHORITY Adopted May 6, 2010 Revised June 2, 2016 The Hillsborough County Aviation Authority Airport Board

More information

Amy Larrick Chavez-Valdez, Director, Medicare Drug Benefit and C & D Data Group

Amy Larrick Chavez-Valdez, Director, Medicare Drug Benefit and C & D Data Group DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850 CENTER FOR MEDICARE TO: FROM: SUBJECT: All Part D Sponsors Amy Larrick

More information

Republika e Kosovës Republika Kosovo - Republic of Kosovo Kuvendi - Skupština - Assembly

Republika e Kosovës Republika Kosovo - Republic of Kosovo Kuvendi - Skupština - Assembly Republika e Kosovës Republika Kosovo - Republic of Kosovo Kuvendi - Skupština - Assembly Law No. 04/L-114 ON FLOUR FORTIFICATION Assembly of Republic of Kosovo; Based on Article 65 (1) of the Constitution

More information

Inspections, Compliance, Enforcement, and Criminal Investigations

Inspections, Compliance, Enforcement, and Criminal Investigations Page 1 of 6 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations A Nelson & Co.,

More information

Dietary Supplement Health and Education Act of 1994 Public Law rd Congress

Dietary Supplement Health and Education Act of 1994 Public Law rd Congress Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements,

More information

1 of 6 8/7/17, 10:45 AM January 15, 2017 By Katie Burns Posted Jan. 4, 2017 A third of all U.S. households with dogs use supplements, as do about a fifth of households with cats, according to a report

More information

Presentation to Parliamentary Portfolio Committee on Health

Presentation to Parliamentary Portfolio Committee on Health Presentation to Parliamentary Portfolio Committee on Health Bill 6 of 2014 Medicines and Related Substances Amendment Bill Presented by: Anele Vutha South African Medical Device Industry Association 29

More information

TOBACCO PRODUCT OR MEDICAL PRODUCT?

TOBACCO PRODUCT OR MEDICAL PRODUCT? TOBACCO PRODUCT OR MEDICAL PRODUCT? Priscilla Callahan-Lyon, MD Deputy Director Division of Individual Health Science Office of Science, CTP Grail Sipes, JD Director Office of Regulatory Policy, CDER Disclaimer:

More information

MEDICINES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF FOOD/NUTRITIONAL/DIETARY SUPPLEMENTS IN THE GAMBIA

MEDICINES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF FOOD/NUTRITIONAL/DIETARY SUPPLEMENTS IN THE GAMBIA MEDICINES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF FOOD/NUTRITIONAL/DIETARY SUPPLEMENTS IN THE GAMBIA Document No.: MCA/NSG/17/11/01 Date of Adoption: 20 th January 2017 Date of Issue: 25 th July 2017

More information

Health Canada s Proposed Approach to Managing Caffeinated Energy Drinks

Health Canada s Proposed Approach to Managing Caffeinated Energy Drinks Health Canada s Proposed Approach to Managing Caffeinated Energy Drinks October 2011 Food Directorate, Health Products and Food Branch 1 Table of Contents Background... 3 Assessment of the Potential Health

More information

MEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA

MEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA MEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA Document No.: MCA/HMPG/17/12/01 Date of Adoption: 20 th January 2017 Date of Issue: 25 th July 2017 Version

More information

Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability

Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability This document is scheduled to be published in the Federal Register on 04/16/2018 and available online at https://federalregister.gov/d/2018-07836, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

NDI: LOOKING BACK & AHEAD

NDI: LOOKING BACK & AHEAD NDI: LOOKING BACK & AHEAD Chi Hee Kim D i r e c t o r, W o r l d w i d e R e g u l a t o r y, G o v e r n m e n t a n d I n d u s t r y A f f a i r s H e r b a l i f e I n t e r n a t i o n a l o f A m

More information

Final Rule for Preventive Controls for Animal Food

Final Rule for Preventive Controls for Animal Food Final Rule for Preventive Controls for Animal Food http://www.fda.gov/fsma THE FUTURE IS NOW 1 Background Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food

More information

Second Regular Session Seventieth General Assembly STATE OF COLORADO INTRODUCED

Second Regular Session Seventieth General Assembly STATE OF COLORADO INTRODUCED Second Regular Session Seventieth General Assembly STATE OF COLORADO INTRODUCED LLS NO. 1-0.01 Michael Dohr x HOUSE BILL 1-1 HOUSE SPONSORSHIP Pabon, Conti, Court, Foote, Garnett, Kagan, Priola, Roupe,

More information

ORDINANCE NO

ORDINANCE NO ORDINANCE NO. 01-2017 AN ORDINANCE OF THE CITY COUNCIL OF THE CITY OF SEMINOLE, FLORIDA, REGARDING MEDICAL CANNABIS; IMPOSING A TEMPORARY MORATORIUM ON THE SALE OF MEDICAL CANNABIS AND ON THE ESTABLISHMENT

More information

5.I.1. GENERAL PRACTITIONER ANNOUNCEMENT OF CREDENTIALS IN NON-SPECIALTY INTEREST AREAS

5.I.1. GENERAL PRACTITIONER ANNOUNCEMENT OF CREDENTIALS IN NON-SPECIALTY INTEREST AREAS Report of the Council on Ethics, Bylaws and Judicial Affairs on Advisory Opinion 5.I.1. GENERAL PRACTITIONER ANNOUNCEMENT OF CREDENTIALS IN NON-SPECIALTY INTEREST AREAS Ethical Advertising under ADA Code:

More information

Research: Medical Cannabis

Research: Medical Cannabis Research: Medical Cannabis Background The hemp plant Cannabis sativa (cannabis) is commonly known as marijuana and can be used as a therapy to alleviate symptoms such as pain and fatigue caused by chronic

More information

June 9, U.S. Food and Drug Administration Division of Dockets Management, HFA Fishers Lane, Room 1061 Rockville, MD 20852

June 9, U.S. Food and Drug Administration Division of Dockets Management, HFA Fishers Lane, Room 1061 Rockville, MD 20852 June 9, 2014 U.S. Food and Drug Administration Division of Dockets Management, HFA-305 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Implementation of the Food and Drug Administration Food Safety

More information

Disclosure. Objectives. Objectives. Introduction. Introduction. Non-Sterile Compounding/Calculations

Disclosure. Objectives. Objectives. Introduction. Introduction. Non-Sterile Compounding/Calculations 49th Annual Meeting Non-Sterile Compounding/ Sunil Jambhekar, B. Pharm., M.S., Ph.D Professor, Pharmaceutical Sciences LECOM Bradenton, School of Pharmacy Bradenton, FL 34211 Disclosure I do not have a

More information

METROLINX ADMINISTRATIVE FEE DISPUTE RESOLUTION PROCESS RULES OF PRACTICE

METROLINX ADMINISTRATIVE FEE DISPUTE RESOLUTION PROCESS RULES OF PRACTICE METROLINX ADMINISTRATIVE FEE DISPUTE RESOLUTION PROCESS RULES OF PRACTICE Overview The Metrolinx Act, 2006, gives Metrolinx ( Metrolinx ) the authority to establish a system of administrative fees to ensure

More information

San Francisco Department of Public Health

San Francisco Department of Public Health San Francisco Department of Public Health Barbara A. Garcia, MPA Director of Health City and County of San Francisco Edwin M. Lee, Mayor San Francisco Department of Public Health Policy & Procedure Detail*

More information

Personal Importation Policy (PIP)

Personal Importation Policy (PIP) Personal Importation Policy (PIP) CDR Paras Patel, R.Ph., MBA US Food & Drug Administration Center for Drug Evaluation and Research Drug Shortage Staff Objectives Describe the purpose of the Personal Importation

More information

City of Watsonville Public Works Department M E M O R A N D U M

City of Watsonville Public Works Department M E M O R A N D U M CITY COUNCIL 9.B.1 Public Works Department M E M O R A N D U M DATE: January 9, 2017 TO: FROM: SUBJECT: Charles Montoya, City Manager Steve Palmisano, Director Public Works & Utilities Michelle Templeton,

More information

COMMISSION OF THE EUROPEAN COMMUNITIES REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT

COMMISSION OF THE EUROPEAN COMMUNITIES REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 5.12.2008 COM(2008) 824 final REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on the use of substances other than vitamins

More information

Food Fortification Regulations, 2016 (Gazetted on 24 October, 2016) ARRANGEMENT OF SECTIONS PART I PRELIMINARY

Food Fortification Regulations, 2016 (Gazetted on 24 October, 2016) ARRANGEMENT OF SECTIONS PART I PRELIMINARY Statutory Instrument 120 of 2016 Food Fortification Regulations, 2016 (Gazetted on 24 October, 2016) [Cap 15:05 Section 1 Title 2 Interpretation ARRANGEMENT OF SECTIONS PART I PRELIMINARY 3 Inspection

More information