Compliance and Best Practices. 2. Quick regulatory review. 3. Global Cosmetics Vigilance diagram, example of in-house operational logogram

Size: px
Start display at page:

Download "Compliance and Best Practices. 2. Quick regulatory review. 3. Global Cosmetics Vigilance diagram, example of in-house operational logogram"

Transcription

1 Personal Care Products Council Safety seminar Oct. 27, 2011 Cosmetics Vigilance in the EU Compliance and Best Practices 1. Introducing IRIS 2. Quick regulatory review 3. Global Cosmetics Vigilance diagram, example of in-house operational logogram 4. Focus on SUEs (Serious Undesirable Effects) 5. Case studies 6. EU Competent Authorities reports in Conclusion 2 1

2 Introducing IRIS Service provider engaged by Brands to manage their consumers health-related complaints (IRIS Call center) 1st company to offer Cosmetovigilance services (1992) Unipex group s affiliate ( Expertise in dermatology and allergy Linguistic skills (covering approx. 50 countries worldwide) Network of physicians deployed across the EU, Asia Member of Cosmetics Vigilance Task-Force group (FEBEA) CURRENT & UPCOMING COSMETIC REGULATIONS IN EUROPE MAIN COSMETICS VIGILANCE OBLIGATIONS - Directive 76/768/EEC : Register Undesirable Effects to the Product Information File and make these information easily accessible to local competent authorities and to the Public - Regulation (EC) 1223/2009 : Notify local competent authorities about any Serious Undesirable Effect occurring in Europe (applicable as from July 11, 2013) 4 articles addressing Post Market Surveillance in Reg. EC 1223/2009 Art. 10 & 11 (cosmetic product safety report appendix 1, section 9- to be kept up-to-date with CV data, Product Information File content includes this product safety report) Art. 21 (Access to information for the public) Art. 23 (Communication of serious undesirable effects) 2

3 Mail, Fax Telephone Consumers, Health Professionals, Authorities Inform the person responsible for placing the product on the market (manufacturer, distributor) about a health-related complaint Global PMS process in the EU Direct contact Undesirable event (alleged) Criteria requested to confirm a case => - Identification of the cosmetic product(s) - Identification of the notifier or consumer - Description of the undesirable event - Date of onset (undesirable event) Undesirable event (confirmed) Actions Step 1 : Data collection & analysis Step 2 : Assess the causality Tools 1. Standard questionnaire (+/- data) 2. Decision tree Undesirable effect Causality assessments = VERY LIKELY or LIKELY (??) Registration to the Product Information File Information to the public (on request) Other causality assessments To be kept May be reviewed (occurrence) Summarized step-by-step actions Upon receipt of an Undesirable Event Action 1 => Register the case under a unique reference and indicate the date of receipt Action 2 => Fill out a standard questionnaire or send this questionnaire over to the consumer (mail/ ) A standard Undesirable Event Questionnaire should at least contain : Consumer s identification & contact details Product identification Description of the Undesirable event Chronology (dates of onset, of disappearance) Information about associated factors (concomitant use of other cosmetics ) Consequences of the UE (is there any criterion of seriousness? ) Action 3 => Check if the data gathered are sufficient to confirm the Undesirable Event into an Undesirable effect Action 4 => Complementary, data deemed necessary? if not directly assess the causal relationship product/ue Next actions => Closing process (anonymize personal data), Diffusion within the company, Archiving, Data compiling & interpretation 3

4 In-house Operational Logogram (example) A Standard Operation Procedure for UEs management should detail What are these services requested to do then, when (timeframe) and how Undesirable Event Questionnaire / script 4 criteria : -Pdct identified -Cons./Not. Identified -UE described -Date of onset In-house Operational Logogram (example) Case management (which are the conditions that request further documented data ) Decision tree 4

5 In-house Operational Logogram (example) UE is NOT confirmed Closing process, Diffusion list, Personal data anonymization, Archiving, Data compiling Example of a decision tree (Colipa Guidelines, 2005) Symptoms It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology compatible Chronology not clearly compatible or unknown not performed, or not performed or Not clearly attributable Questionable Likely Very likely Likely Questionable Unlikely Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. 5

6 Focus on SUEs / Definitions, Criteria To be noted : Serious (consequences of UE) Severe (intensity of UE) Definition (cf. Regulation 1223/2009) Temporary or permanent functional incapacity Disability Hospitalisation Information to provide Duration, +/- Medical certificate, +/- expert evaluation % of disability, +/- Medical certificate, +/- expert evaluation Duration, hospital address, treatments Congenital anomalies Detected during pregnancy or after delivery, +/- expert evaluation Immediate vital risk Treatment, specific measures Death Date, diagnosis, +/- death certificate Focus on SUEs / Reporting procedure for SUEs received by RP or Distributor Initial receipt 20 calendar days Report to local Comp. Authority Level of data is complete No Yes Report mentions «Initial» and «Final» + Causality assessment Report mentions «Initial» New, relevant information No Yes Report mentions «Final» + Causality assessment Report mentions «Follow Up» OR «Final» + Causalilty assessment 6

7 Focus on SUEs / Notification Form (for RP, Distrib.) To date, consist of a 3-page form with 13 sections to fill out (if info available) Case report Company Seriousness criteria Primary reporter End user Suspected product Description of SUE (type, location) Outcome of SUE Relevant underlying conditions ( condition, treatments ) Relevant history Case management Complementary (allergy tests ) Summary Incriminated pdct : Hair balsam Consumer : 8-year old girl Country : Denmark Case study#1 Description of UE: Itching, swelling, redness and spots in scalp + behind the ears Use of the pdct: 1 st purchase. 1 unique use Chronology: 12 hours after use. Took 1 week to settle down Consequences: Advice taken from GP and self-medication with topical dermocorticoids Medical Investigation: Positive Patch-test to finished pdct. PT with detailed ingredients showed to 1 ingredient Diagnosis: Allergic contact dermatitis 7

8 Case study#1_hair balsam Chronology compatible Symptoms Symptoms are evocative It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology not clearly compatible or unknown not performed, or not performed or Questionable Likely Very likely Likely Questionable Unlikely Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. Incriminated pdct : Lip care (balsam) Consumer : 47-year old women Country : France Case study#2 Description of UE: Feeling of swollen lips (but no visible signs). During the 3 rd week of use, she noticed the skin of her lower lip was cracking, just in the right corner. Use of the pdct: 1 st purchase. Used for approx. 3 weeks with intermittent discontinuations. Chronology: Immediate after first application. Use continued over 10 days, then stopped for 3 days and reused until cracks appeared Consequences: Attended a consultation with her GP Medical Investigation: No Diagnosis: Labial herpes 8

9 Case study#2_lip care Symptoms It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology compatible Chronology not clearly compatible or unknown not performed, or not performed or Questionable Likely Very likely Likely Questionable Unlikely Reason : labial herpes is a viral infection which cannot be caused by a cosmetic Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. Incriminated pdct : Facial skin care (anti-ageing) Consumer : 42-year old women Country : Italy Case study#3 Description of UE: Tingling sensations and itching on the entire face, together with red blotches and papules localized on right cheek only. Use of the pdct: 1 st purchase. Daily applications during 10 consecutive days. Chronology: UE occurred after 4 days. Product continued for a further 6 days before definitive discontinuation. Skin returned to normal after 6 weeks Consequences: None Medical Investigation: No 9

10 Case study#3_skin care Symptoms It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology compatible Symptoms are not evocative (visible signs localized on 1 cheek whereas pdct applied to the entire face) Chronology not clearly compatible or unknown 6 weeks to clear up after the pdct was discontinued not performed, or not performed or Questionable Likely Very likely Likely Questionable Unlikely Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. EU Competent Authorities reports in FRANCE 219 UEs notified, 13% of serious cases Population : women (71%), men (14%) and children (15%) Main cosmetic categories : Sun care, Body care (l-o), F&E makeup + removers Notifications by Health Professionals, health institutions (92%), Industry (6%) 2. THE NETHERLANDS 1250 UEs notified, no information about serious cases Population : women (90%), hardly any report involving babies/young children Main cosmetic categories : Face care, Hair care and Makeup Notifications by consumers (hotline, internet questionnaire) + Health Prof. 3. NORWAY 96 UEs notified between No information about serious cases Population : women (83%), Children up to 9 yrs old (7%) Main cosmetic categories : Moisturizers, Sun care and Hair dyes, bleaches Notifications made by Health Professionals 10

11 FRANCE, 10 days ago Conclusion To properly handle UE complaints, a company should 1. Develop an internal SOP (Standard Operation Procedure) to organize this activity 2. Inform and train all the people who may be involved in the process (distributors, in-house staff ) about what they have to do, how and when 3. Audit the system to check it duly works (ex. false cases) 4. Ensure the causality assessment is done by someone who is experienced and has appropriate professional background => reliability of the results THANK YOU 11

February 27, Human Use. Dear Sir or Madam: new data and. responded to. United States. the United products.

February 27, Human Use. Dear Sir or Madam: new data and. responded to. United States. the United products. February 27, 2012 Division of Dockets Management Food and Drug Administration 5630 Fisherss Lane Room 1061, HFA-305 Rockville, Maryland 20852 Re: Docket No. 78N-0301: External Analgesic Drug Products for

More information

Manual for Expedited Reporting of Adverse Events to DAIDS Version 2.0 January 2010

Manual for Expedited Reporting of Adverse Events to DAIDS Version 2.0 January 2010 Manual for Expedited Reporting of Adverse Events to DAIDS Version 2.0 January 2010 January 2010 Version 2.0 Table of Contents 1. INTRODUCTION...1 1.1 Scope... 1 1.2 Purpose... 1 1.3 Responsibilities...

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

PHARMACOVIGILANCE GLOSSARY

PHARMACOVIGILANCE GLOSSARY PHARMACOVIGILANCE GLOSSARY Section 1 Section 2 Section 3 Section 4 Definitions of terminology used for side effects Definitions of drug safety terms Definitions of risk terminology Definitions of general

More information

KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE

KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE RNI Conseil 2017 Tous droits réservés Toute reproduction interdite sans l'autorisation de l'auteur. KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE Anne Laure TARDY, PhD

More information

Adverse Event Reporting Programme for Veterinary Medicines

Adverse Event Reporting Programme for Veterinary Medicines Adverse Event Reporting Programme for Veterinary Medicines ACVM guideline for registrants 1. Introduction 2. Statutory basis for adverse event reporting 3. Definitions 4. Statutory obligations 5. Information

More information

Active TB drug-safety management & monitoring

Active TB drug-safety management & monitoring Active TB drug-safety management & monitoring Global TB Programme, WHO, Switzerland 6 August 2015 Pharmacovigilance: definition of science and activities relating to the detection, assessment, understanding

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT ADVERSE REACTION REPORT CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200326 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Anaphylaxie Stufe II nach

More information

Research & Development. J H Pacynko and J Illingworth. Research, pharmacy and R&D staff

Research & Development. J H Pacynko and J Illingworth. Research, pharmacy and R&D staff Department Title of SOP Research & Development Safety reporting SOP SOP reference no: R&D GCP SOP 07 Authors: Current version number and date: J H Pacynko and J Illingworth Version 9, 31.01.18 Next review

More information

FoodDrinkEurope Position on GLP studies

FoodDrinkEurope Position on GLP studies FoodDrinkEurope Position on GLP studies Content of the presentation Introduction to GLP Importance of GLP for the food industry Use of GLP based on the example of novel foods Conclusions GLP what is it?

More information

SAE håndtering i protokol CC MM-001

SAE håndtering i protokol CC MM-001 SAE håndtering i protokol CC-92480-MM-001 An SAE is any AE occurring at any dose that: Results in death; Is life-threatening (ie, in the opinion of the Investigator, the subject is at immediate risk of

More information

CHAPTER 4 POST-MARKETING SURVEILLANCE OF DRUGS

CHAPTER 4 POST-MARKETING SURVEILLANCE OF DRUGS CHAPTER 4 POST-MARKETING SURVEILLANCE OF DRUGS Post-marketing surveillance (PMS) to assure the quality, efficacy and safety of drugs after they go on the market and to establish proper methods of use of

More information

NEHSNORTH EASTERN HEALTH SPECIALISTS

NEHSNORTH EASTERN HEALTH SPECIALISTS COSMETIC DERMATOLOGY NEHSNORTH EASTERN HEALTH SPECIALISTS nehs.com.au CONSENT FORM VASCULAR Treatment with BBL & LASERS I, DOB:, of authorize of North Eastern Health Specialist to perform hair removal

More information

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014 Good Laboratory Practice EU-Serbia screening meeting Brussels, 19 June 2014 Table of contents 1. Background information on the principles of GLP 2. EU legal basis for GLP 3. Role of Member States 4. Role

More information

Drugs Regulatory Unit Ministry of Health PHARMACOVIGILANCE GUIDELINES

Drugs Regulatory Unit Ministry of Health PHARMACOVIGILANCE GUIDELINES Drugs Regulatory Unit Ministry of Health PHARMACOVIGILANCE GUIDELINES THIRD EDITION 2017 0 CONTENTS Introduction 2 Definition and Terminologies..3 Rationale of ADR Monitoring.4 Pharmacovigilance...4 Reporting

More information

ORDER of the Minister of Health No. 269/2017 of 14 March 2017 on mandatory provision of medicinal product adequate and continuous supplies

ORDER of the Minister of Health No. 269/2017 of 14 March 2017 on mandatory provision of medicinal product adequate and continuous supplies ORDER of the Minister of Health No. 269/2017 of 14 March 2017 on mandatory provision of medicinal product adequate and continuous supplies ISSUING BODY: The Ministry of Health published in: the Official

More information

Counterfeit Medicinal Products. FINLAND Roschier, Attorneys Ltd.

Counterfeit Medicinal Products. FINLAND Roschier, Attorneys Ltd. Counterfeit Medicinal Products FINLAND Roschier, Attorneys Ltd. CONTACT INFORMATION Mikael Segercrantz Robert Hagelstam Roschier, Attorneys Ltd. Keskuskatu 7 A 00100 Helsinki, Finland 358.20.506.6000 mikael.segercrantz@roschier.com

More information

Adverse Events Monitoring (aka Pharmacovigilance)

Adverse Events Monitoring (aka Pharmacovigilance) Adverse Events Monitoring (aka Pharmacovigilance) Presentation to American Conference Institute s FDA Boot Camp William W. Vodra May 16, 2007 Agenda What is pharmacovigilance (PV)? How does PV use adverse

More information

Update on Australian regulatory framework for medical devices

Update on Australian regulatory framework for medical devices MTAA Update on Australian regulatory framework for medical devices Val Theisz, MSc, RAC Director Regulatory Affairs, MTAA April 2017 Who is MTAA? The Medical Technology Association of Australia (MTAA)

More information

RESULTS AT A GLANCE. FDA Oversight of Tobacco Manufacturing Establishments. HHS OIG Data Brief August 2017 OEI

RESULTS AT A GLANCE. FDA Oversight of Tobacco Manufacturing Establishments. HHS OIG Data Brief August 2017 OEI HHS OIG Data Brief August 2017 OEI-01-15-00300 FDA Oversight of Tobacco Manufacturing Establishments RESULTS AT A GLANCE The Tobacco Control Act authorized FDA to regulate domestic tobacco manufacturers

More information

MOTION FOR A RESOLUTION

MOTION FOR A RESOLUTION EUROPEAN PARLIAMT 2009-2014 Plenary sitting 07.3.2012 B7-0000/2012 MOTION FOR A RESOLUTION further to Question for Oral Answer B7-0000/2012 pursuant to Rule 115(5) of the Rules of Procedure on Defective

More information

The Telecommunications Act of 1996

The Telecommunications Act of 1996 The Telecommunications Act of 1996 [Editor s note: This article was originally written in 2004 and may have outdated content. Please refer to the DCMP s Clearinghouse of Information for updated information

More information

Guidelines to Commission Regulation (EU) No 655/2013. laying down common criteria for the justification of claims used

Guidelines to Commission Regulation (EU) No 655/2013. laying down common criteria for the justification of claims used Ref. Ares(2015)5892153-16/12/2015 Version July 2013 Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT ADVERSE REACTION REPORT CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17233171 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10042646): Swallowing disorder

More information

Adult Patient Information and Consent Form

Adult Patient Information and Consent Form The ROAM Trial Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial

More information

EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines

EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines International Conference organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council

More information

PROFICIENCY TESTING POLICY

PROFICIENCY TESTING POLICY Supersedes Prepared by: APPROVALS in this section Approved by: Date: Laboratory Director RECORD OF REVIEWS Date Signature Title Procedural Changes/Review VERSION HISTORY Revision # 0 Section #/Changes

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT ADVERSE REACTION REPORT CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17359392 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE [ MedDRA 20.0 LLT (10013968):

More information

CERTIFICATION COURSES Information and Application

CERTIFICATION COURSES Information and Application CERTIFICATION COURSES Information and Application Why take a course through the World Trichology Society? The World Trichology Society is an organization dedicated to raising the standards and improving

More information

Market surveillance of medical devices

Market surveillance of medical devices Market surveillance of medical devices A joint action on market surveillance of medical devices to reinforce public health protection Information for healthcare professionals Introduction The European

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure Clinical Study Synopsis for Public Disclosure These results are supplied for informational purposes only in the interest of scientific disclosure. The synopsis may include approved and non-approved uses,

More information

Clinical Study Report SLO-AD-1 Final Version DATE: 09 December 2013

Clinical Study Report SLO-AD-1 Final Version DATE: 09 December 2013 1. Clinical Study Report RANDOMIZED, OPEN, PARALLEL GROUP, PHASE IIIB STUDY ON THE EVALUATION OF EFFICACY OF SPECIFIC SUBLINGUAL IMMUNOTHERAPY IN PAEDIATRIC PATIENTS WITH ATOPIC DERMATITIS, WITH OR WITHOUT

More information

Lead-up to REACH Pre-Registration

Lead-up to REACH Pre-Registration Lead-up to REACH Pre-Registration Steptoe REACH Advisory Services -- What, and Who, are covered By James REACH? Searles (and what to do about it) All Attorney Lunch Meeting Jim Searles 26 April 2007 REACH

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Have a Voice in Your Choice!

Have a Voice in Your Choice! Have a Voice in Your Choice! BLU-U Blue Light Photodynamic Therapy The LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is

More information

Medication Information for Parents and Teachers

Medication Information for Parents and Teachers Medication Information for Parents and Teachers Modafinil Provigil Armodafinil Nuvigil General Information About Medication Each child and adolescent is different. No one has exactly the same combination

More information

Serious Adverse Event (SAE) Form Clinical Trials

Serious Adverse Event (SAE) Form Clinical Trials Protocol Code number: LP0162-1325 1. Trial information: Subject ID: Site No.: Country: If blinded trial, was the study treatment unblinded? Yes No Is this the initial report of an SAE or a follow-up? Initial

More information

EU Regulatory Requirements Update, the latest news and developments. Hans-Heiner Junker TÜV SÜD Product Service GmbH October 2013

EU Regulatory Requirements Update, the latest news and developments. Hans-Heiner Junker TÜV SÜD Product Service GmbH October 2013 EU Regulatory Requirements Update, the latest news and developments Hans-Heiner Junker TÜV SÜD Product Service GmbH October 2013 Folie 1 Content Two groups of Notified Bodies Designation process with European

More information

NEHSNORTH EASTERN HEALTH SPECIALISTS

NEHSNORTH EASTERN HEALTH SPECIALISTS COSMETIC DERMATOLOGY NEHSNORTH EASTERN HEALTH SPECIALISTS nehs.com.au CONSENT FORM TREATMENT OF PIGMENTATION BBL BroadBand Light I, DOB:, of authorize of North Eastern Health Specialist to perform acne

More information

LEAF Marque Assurance Programme

LEAF Marque Assurance Programme Invisible ISEAL Code It is important that the integrity of the LEAF Marque Standard is upheld therefore the LEAF Marque Standards System has an Assurance Programme to ensure this. This document outlines

More information

COMPETENT AUTHORITY (UK) MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES

COMPETENT AUTHORITY (UK) MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES COMPETENT AUTHORITY (UK) 10 EC MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES (CUSTOM MADE DEVICES) Updated March 2008 CONTENTS PAGE Introduction 3 Definition of dental

More information

PROPECIA is prescribed for individuals with male pattern baldness.

PROPECIA is prescribed for individuals with male pattern baldness. MK 0906 PAGE 1 PROPECIA (FINASTERIDE 0.2 AND 1 MG) VI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Male pattern baldness is a common type of hair loss that develops in many men

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

PHYSIOTHERAPY ACT AUTHORIZATION REGULATIONS

PHYSIOTHERAPY ACT AUTHORIZATION REGULATIONS c t PHYSIOTHERAPY ACT AUTHORIZATION REGULATIONS PLEASE NOTE This document, prepared by the Legislative Counsel Office, is an office consolidation of this regulation, current to July 11, 2009. It is intended

More information

Medication Information for Parents and Teachers

Medication Information for Parents and Teachers Medication Information for Parents and Teachers General Information About Medication Melatonin Each child and adolescent is different. No one has exactly the same combination of medical and psychological

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT ADVERSE REACTION REPORT CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16395978 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 38 DA MO YR (Year)

More information

Introduction. Doc-Biocides-2002/01 Version

Introduction. Doc-Biocides-2002/01 Version Doc-Biocides-2002/01 Version 08.01.2008 Guidance document agreed between the Commission services and the competent authorities of the Member States for the Biocidal Products Directive 98/8/EC and for the

More information

Table of Contents. Injectable Gel with 0.3% Lidocaine

Table of Contents. Injectable Gel with 0.3% Lidocaine Patient Brochure Table of Contents About Restylane-L 4 Safety 6 Post-Marketing Surveillance 9 About the Procedure 10 Troubleshooting 11 Injectable Gel with 0.3% Lidocaine 2 3 About Restylane-L Q What is

More information

We get your personal data from the following sources (examples detailed below are not exhaustive):

We get your personal data from the following sources (examples detailed below are not exhaustive): Novo Nordisk Limited processes (e.g. collects, uses, stores, and shares) personal data for different reasons (purpose) and uses a number of legal bases to process that personal data. This Notice explains

More information

(Adopted by the Committee of Ministers on 19 January 2011 at the 1103rd meeting of the Ministers Deputies)

(Adopted by the Committee of Ministers on 19 January 2011 at the 1103rd meeting of the Ministers Deputies) Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (Adopted by the Committee of Ministers on 19 January

More information

National nutrivigilance scheme

National nutrivigilance scheme National nutrivigilance scheme Review of nutrivigilance in 2016 March 2017 French Agency for Food, Environmental and Occupational Health & Safety, 14 rue Pierre et Marie Curie, 94701 Maisons-Alfort Cedex

More information

POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC PUBLIC CONSULTATION DOCUMENT

POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC PUBLIC CONSULTATION DOCUMENT POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC DG SANCO 2010 PUBLIC CONSULTATION DOCUMENT Answer given by the General Direction of Public Health of the Spanish Ministry of Health and Social

More information

SOP 17 BLOOD BANK. 3. Overall Responsibility: Blood Bank In-Change/Pathologist.

SOP 17 BLOOD BANK. 3. Overall Responsibility: Blood Bank In-Change/Pathologist. SOP 17 BLOOD BANK 1. Purpose: To ensure the availability of safe blood unit with facility for compatibility testing, storage and issue of blood in an aseptic environment on 24*7 basis trough trained professionals.

More information

Planning For The FDA s 'Deeming Rule' For E- Cigarettes

Planning For The FDA s 'Deeming Rule' For E- Cigarettes Law360, New York (September 21, 2015, 3:39 PM ET) -- The 2009 Family Smoking Prevention and Tobacco Control Act (TCA)[1] gave the U.S. Food and Drug Administration the authority to oversee the manufacture,

More information

Quality Management System Certification. Understanding Quality Management System (QMS) certification

Quality Management System Certification. Understanding Quality Management System (QMS) certification Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality

More information

MS Society Safeguarding Adults Policy and Procedure (Scotland)

MS Society Safeguarding Adults Policy and Procedure (Scotland) MS Society Safeguarding Adults Policy and Procedure (Scotland) Safeguarding Adults Policy The phrase adult support and protection is used instead of safeguarding in Scotland. However for consistency across

More information

PATIENT INFORMATION LEAFLET. Naseptin Nasal Cream chlorhexidine dihydrochloride and neomycin sulfate

PATIENT INFORMATION LEAFLET. Naseptin Nasal Cream chlorhexidine dihydrochloride and neomycin sulfate PATIENT INFORMATION LEAFLET Naseptin Nasal Cream chlorhexidine dihydrochloride and neomycin sulfate Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need

More information

Urgent field safety notice

Urgent field safety notice Accu-Chek Aviva Urgent field safety notice May 2018 Important information on selected lots of Accu-Chek Aviva (50s, 10s) potentially showing an increased number of strip errors prior to dosing or biased

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT ADVERSE REACTION REPORT CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17085373 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 67 DA MO YR (Year)

More information

Medication Information for Parents and Teachers

Medication Information for Parents and Teachers Medication Information for Parents and Teachers General Information About Medication Gabapentin Neurontin, Gralise, Gralise Starter Each child and adolescent is different. No one has exactly the same combination

More information

Pharmacovigilance Methods and Post-Authorisation Safety Studies

Pharmacovigilance Methods and Post-Authorisation Safety Studies Pharmacovigilance Methods and Post-Authorisation Safety Studies Alex Dodoo Director, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance Accra, Ghana Objectives At the end of this module

More information

POLICIES AND PROCEDURES

POLICIES AND PROCEDURES Managing Allergies Policy Author Susan Bradley Version 2 Approved at team meeting (date) 12/04/16 Cross Reference CYP Registration Form, Annual Medication Review Form Purpose of this document To inform

More information

APOC-5FU Cream Fluorouracil

APOC-5FU Cream Fluorouracil APOC-5FU Cream Fluorouracil Consumer Medicine Information For a copy of a large print leaflet, Ph: 1800 195 055 What is in this leaflet This leaflet answers some common questions about APOC-5FU. It does

More information

Consumer Perception of Thresholds

Consumer Perception of Thresholds Consumer Perception of Thresholds IFST Spring Conference 2015 Lynne Regent Anaphylaxis Campaign CEO @LynneRegentAC What I will cover Who we are Background to a global survey on consumer perception of thresholds

More information

GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT MEMBER STATES

GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT MEMBER STATES EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 5 November 2008 ENTR/F/2/SF D(2008) 34957 GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON

More information

Use of abatacept in rheumatoid arthritis - patient information

Use of abatacept in rheumatoid arthritis - patient information Practical management of patients receiving abatacept 1 Use of abatacept in rheumatoid arthritis - patient information Evidence-based Medicine Official Recommendations Expert opinion Key points 1. Abatacept

More information

The Chartered Society of Physiotherapy Complaints Procedure

The Chartered Society of Physiotherapy Complaints Procedure 14 Bedford Row, London WC1R 4ED Tel +44 (0)20 7306 6666 Web www.csp.org.uk The Chartered Society of Physiotherapy Complaints Procedure issuing function Chief Executives Office date of issue May 2009 The

More information

Regulatory scientific significance of Japan s ADR relief system

Regulatory scientific significance of Japan s ADR relief system Regulatory scientific significance of Japan s ADR relief system Toshi TOMINGA, Ph.D. Associate Executive Director Pharmaceuticals and Medical Devices Agency (PMDA) 1 Disclaimer The views and opinions expressed

More information

HUMAN PHOTOTOXICITY AND PHOTOALLERGENICITY TEST. April, 2006

HUMAN PHOTOTOXICITY AND PHOTOALLERGENICITY TEST. April, 2006 HUMAN PHOTOTOXICITY AND PHOTOALLERGENICITY TEST April, 2006 Protocol Number: Title: Objective: Human Phototoxicity and Photoallergenicity Test The objective of the test is to assess the potential of a

More information

Enhanced Continuing Professional Development and Personal Development Planning

Enhanced Continuing Professional Development and Personal Development Planning Enhanced Continuing Professional Development and Personal Development Planning Aims: To make participants aware of the current General Dental Council (GDC) Continuing Professional Development (CPD) requirements

More information

PROTECT YOURSELF FROM TYPE I ALLERGIES.

PROTECT YOURSELF FROM TYPE I ALLERGIES. PROTECT YOURSELF FROM TYPE I ALLERGIES. 1 PROTECT YOURSELF FROM TYPE I ALLERGIES. Occasionally wearing glove products can cause issues with the health of our skin. This predominantly manifests itself in

More information

RECERTIFICATION PROGRAMME FOR CONTINUING PROFESSIONAL DEVELOPMENT OF OPTOMETRISTS

RECERTIFICATION PROGRAMME FOR CONTINUING PROFESSIONAL DEVELOPMENT OF OPTOMETRISTS RECERTIFICATION PROGRAMME FOR CONTINUING PROFESSIONAL DEVELOPMENT OF OPTOMETRISTS Background The principal purpose of the Health Practitioners Competence Assurance Act 2003 (Act) is to protect public health

More information

HELP RESTORE A MORE YOUTHFUL LOOK

HELP RESTORE A MORE YOUTHFUL LOOK HELP RESTORE A MORE YOUTHFUL LOOK Get the lift you want with RADIESSE and smooth those etched-in lines and wrinkles with BELOTERO BALANCE What are RADIESSE and BELOTERO BALANCE? RADIESSE and BELOTERO BALANCE

More information

patients and family NEMOS for treatment of epilepsies

patients and family NEMOS for treatment of epilepsies patients and family NEMOS for treatment of epilepsies Transcutaneous Vagus Nerve Stimulation (t-vns ) with NEMOS a promising treatment option No surgery No hospitalisation Minor side effects Self-administered

More information

Draft Guidelines on the Sale and Supply of Non- Prescription Medicinal Products from a Retail Pharmacy Business

Draft Guidelines on the Sale and Supply of Non- Prescription Medicinal Products from a Retail Pharmacy Business Draft Guidelines on the Sale and Supply of Non- Prescription Medicinal Products from a Retail Pharmacy Business To facilitate compliance with Regulations 5(1)(d), 5(1)(h) and 10 of the Regulation of Retail

More information

Reports of Adverse Drug Reactions, etc. of Pharmaceuticals

Reports of Adverse Drug Reactions, etc. of Pharmaceuticals (Attachment) Reports of Adverse Drug Reactions, etc. of Pharmaceuticals 1 GLOSSARY (1) Drugs, quasi-drugs, and cosmetics -1- Related to Article 228-20, paragraph 1, item 1 of the Enforcement Ordinance

More information

Lidocaine PATIENT INFORMATION GUIDE

Lidocaine PATIENT INFORMATION GUIDE Lidocaine PATIENT INFORMATION GUIDE Table of Contents GLOSSARY............................................. 3 ABOUT RADIESSE (+)................................... 4 SAFETY INFORMATION.................................

More information

Medical Devices. UKRAINE Magisters

Medical Devices. UKRAINE Magisters Medical Devices UKRAINE Magisters CONTACT INFORMATION Oleg Boichuk, Senior Associate Oleksandr Liulkov, Associate Magisters 38 Volodymyrska St., Kyiv, Ukraine +38044 492 82 82 www.magisters.com 1. Definition

More information

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Ginkgoforce Memory & Circulation Ginkgo Tablets Extract (as dry extract) from fresh leaves of Ginkgo biloba (Ginkgo

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT ADVERSE REACTION REPORT CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17338368 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE [ MedDRA 20.0 LLT (10008641):

More information

Diphencyprone (DPC) treatment for Alopecia Areata

Diphencyprone (DPC) treatment for Alopecia Areata University Teaching Trust Diphencyprone (DPC) treatment for Alopecia Areata Irving Building Dermatology 0161 206 1846 All Rights Reserved 2017. Document for issue as handout. What is diphencyprone treatment?

More information

HUMAN REPEAT INSULT PATCH TEST

HUMAN REPEAT INSULT PATCH TEST HUMAN REPEAT INSULT PATCH TEST Prepared For: 024 Zone Richard Weise TABLE OF CONTENTS Page PURPOSE...3 GENERAL INFORMATION...3 SUMMARY...4 STORAGE, HANDLING, AND DOCUMENTATION OF TEST MATERIALS...5 TEST

More information

ADT Booster (ay-dee-tee boo-ster)

ADT Booster (ay-dee-tee boo-ster) ADT Booster (ay-dee-tee boo-ster) Diphtheria and Tetanus Vaccine, Adsorbed Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about ADT Booster. It does not

More information

Serious Adverse Event (SAE) Form Clinical Trials

Serious Adverse Event (SAE) Form Clinical Trials Protocol Code number: LP0162-1334 1. Trial information: Subject ID: Site No.: Country: Is this the initial report of an SAE or a follow-up? Initial Follow-up, follow up no. In which period of the trial

More information

Managing Allergens within a manufacturing context. Helen Brown CampdenBRI Chipping Campden

Managing Allergens within a manufacturing context. Helen Brown CampdenBRI Chipping Campden Managing Allergens within a manufacturing context Helen Brown CampdenBRI Chipping Campden Food Allergens An unusual food safety issue Harmless natural substances however In allergic individuals cause reactions,

More information

FSE s approach to novel foods BELFRIT List

FSE s approach to novel foods BELFRIT List International Conference on Novel Foods FSE s approach to novel foods BELFRIT List Prague 19-20 June 2018 Patrick Coppens Director Scientific and Regulatory Affairs Food Supplements Europe International

More information

PUBLIC CONSULTATION DOCUMENT

PUBLIC CONSULTATION DOCUMENT EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate C Public Health and Risk Assessment POSSIBLE REVISION OF THE TOBACCO PRODUCTS DIRECTIVE 2001/37/EC PUBLIC CONSULTATION DOCUMENT

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

CONSENT FOR FACE-LIFT SURGERY (RHYTIDECTOMY)

CONSENT FOR FACE-LIFT SURGERY (RHYTIDECTOMY) CONSENT FOR FACE-LIFT SURGERY (RHYTIDECTOMY) Patient s Name Date Please initial each paragraph after reading. If you have any questions, please ask your doctor BEFORE initialing. I have been informed that

More information

RECERTIFICATION PROGRAMME FOR CONTINUING PROFESSIONAL DEVELOPMENT OF OPTOMETRISTS

RECERTIFICATION PROGRAMME FOR CONTINUING PROFESSIONAL DEVELOPMENT OF OPTOMETRISTS RECERTIFICATION PROGRAMME FOR CONTINUING PROFESSIONAL DEVELOPMENT OF OPTOMETRISTS Background The principal purpose of the Health Practitioners Competence Assurance Act 2003 (Act) is to protect public health

More information

A world leader in allergy immunotherapy

A world leader in allergy immunotherapy A world leader in allergy immunotherapy Company presentation Per Plotnikof, VP Corporate Communications and IR 1 I ALK at a glance Commercial leader and foremost innovator within respiratory allergies

More information

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Venaforce Varicose Veins gastro-resistant tablets Dry extract from fresh Aesculus hippocastanum L., semen (Horse Chestnut

More information

I_HeERO Ostrava 30 th October Andy Rooke Technical Implementing Officer I_HeERO ERTICO

I_HeERO Ostrava 30 th October Andy Rooke Technical Implementing Officer I_HeERO ERTICO I_HeERO Ostrava 30 th October 2017 Andy Rooke Technical Implementing Officer I_HeERO ERTICO Agenda I_HeERO Member State Update Where could ecall go? Is technology an Issue? It s a brave new world! Where

More information

Overview of thoughts on skin testing

Overview of thoughts on skin testing Overview of thoughts on skin testing Social Dialogue, 9 February 2016 COIFFURE EU - Miet Verhamme Coiffure EU Working group skin testing (23 June 2015) group skin testing within CEU (23 June 2015) 7 countries:

More information

PATIENT STUDY INFORMATION LEAFLET

PATIENT STUDY INFORMATION LEAFLET PATIENT STUDY INFORMATION LEAFLET BOOKLET 1 You are invited to take part in this research study. Before you decide, it is important for you to understand why the research is being done and what it will

More information

Establishing Enforcement Remit

Establishing Enforcement Remit Consumer Protection Establishing Enforcement Remit Definition of a Consumer, someone who acquires goods or services for direct use or ownership rather than for resale or use in production/ manufacturing.

More information

8.0 ADVERSE EVENT HANDLING

8.0 ADVERSE EVENT HANDLING 8.0 ADVERSE EVENT HANDLING In accordance with the U.S. Code of Federal Regulations governing IND safety reports (Code of Federal Regulations 21, 312.32), adverse events (AEs) are reported from research

More information

Understanding Adverse Events

Understanding Adverse Events The Fundamentals of International Clinical Research Workshop Understanding Adverse Events Deborah Hilgenberg Family Health International Goals of the Presentation Definition of Adverse Event (AE) Definitions

More information

Other EU Activities Contributing to Harmonization of Labeling

Other EU Activities Contributing to Harmonization of Labeling Other EU Activities Contributing to Harmonization of Labeling Dr Laurent Brassart European Medicines Agency Medical Information Sector DIA Labeling Harmonisation 2011 Workshop October 13-14. 2011 Disclaimer

More information

Self-declaration of Belgium regarding the recovery of the HPAI free status in poultry

Self-declaration of Belgium regarding the recovery of the HPAI free status in poultry Self-declaration of Belgium regarding the recovery of the HPAI free status in poultry Declaration sent to the OIE on October 11, 2017 by Dr. Jean-François Heymans, Chief of Veterinary Services of the Belgian

More information