Post on 26-May-2015
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Capsules as Medical Devices
Maikel HendriksPartner ProgressareCPhI October 2010
Content
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Health / Medical Claims Requirements
Implement
Quality System
Implement
Technical File
Notification
(Pre Market)
Audit
Notified Body
Surveillance
(Post Market)
HEALTH / MEDICAL CLAIMS
Health Claims
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Health \ Medical Claims
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Health \ Medical Claims
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FOOD COS MDD PHARMA
Health \ Medical Claims
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Category Europe
Food supplementsNew EU regulations make medical claims on food supplements possible.
y, a food or one of its constituents and health;
Claim indication: attends, support, maintains, keeps, optimizes, provides, safes, contributesClaims not allowed: cure, treats, prevents
1924/2006/ECProducts on the market must comply by 19 JAN 2010Evaluation < June 2011Claim opinions < End 2011Quality System:HACCP
Cosmeticsternal parts of the
human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.
Claimsindication: cleaning, perfuming, change appearance, correcting body odors, conditioningClaims not allowed: cure, treats, prevents
76/768/ECTechnical data:Product information packageQuality System:ISO-‐22716:2007
Medical Devices (Over-‐The-‐Counter)appliance, software, material or other article, whether used alone or in combination,
together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,investigation, replacement or modification of the anatomy or of a physiological process,control of conception, and which does not achieve its principal
Claims indication: attends, support, maintains, keeps, optimizes, provides, safes, contributes, treats, preventsClaims not allowed: cure
93/42/EC + 2004/47/ecProduct Data:Technical construction FileQuality System:ISO-‐13485:2008
Manufacturers must comply by 21 MAR 2010
PharmaceuticalDefinition: Medicinal product any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.
Claims indication: cure, treats, preventsClaims not allowed: None
2001/83 ECProduct Data:eCommon Technical DossierQuality System:GMP standard
Cosmeceuticals: cosmetic products that are claimed, primarily by those within the cosmetic industry, to have drug-like benefits. Examples of products typically labeled as cosmeceuticals include anti-aging creams and moisturizers. The word is a portmanteau of the words "cosmetic" and "pharmaceutical
REQUIREMENTS
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Requirements
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CE-‐markering
Requirements
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CE-‐mark
Jaar
1987 20 Directives
1994 Blue Guidance
1995 EffectiveMDD 93/42/ec
1998 TransferCE mandatory
21 maart 2010
Clinical Evaluation2007/47/ec
Requirements
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Medical Device definition (93/42/ec + 2007/47/ec)appliance, software,
material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,investigation, replacement or modification of the anatomy or of a physiological process,control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
Requirements
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What is a medical device ?TEST
Requirements
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Requirements
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Requirements
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Requirements
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Requirements
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Requirements
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Classification Matrix, Annex IX 93/42/ec + 2007/47/ecAnnex IX of the Medical Device Directive describes the classification rules. The manufacturer shall determine the conformity assessment route for product registration based upon this classification. A product will always be placed in the highest applicable rule.
Class I; outside body or through natural body openings, < 60 minutes min
Class IIa; Treats and prevents infections, breached skin, wounds < 30 days
Class IIb; pacemakers, monitoring equipment, wounds > 30 days
Class III; combination medical device with medicines (or animal tissue)
Market authorization:Class I: Manufacturer;
Class IIa\b: Manufacturer + Notified Body (can also be the manufacturer if QMS complies with Annex II);Class III: Manufacturer + Notified Body + Medicine Board
Notification Competent Authority
Product class
EC declaration of conformity (Annex VII)
EC type-‐examination (Annex III)
option
EC verification (Annex IV)
Product quality assurance (Annex VI)
Production quality
assurance (Annex V)
Production quality
assurance (Annex V)
EC verification (Annex IV)
EC design examination (Annex II, 4)
EC type-‐examination (Annex III)
EC declaration of conformity (Annex VII)
Class I
Class IIb
Class IIa
Class III
Class II
Notified Body
Notified Body + Medicine Board
ABC
ABC
ABC
MeasuringSterile
Full quality assurance (Annex II)
Full quality assurance (Annex II)
Requirements
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Manufacturer
Auditing
Post Market Surveillance
Distributor
Supplier / contractor
CE-declaration
Quality ManualISO Certificate
SCOPE REQUIREMENTS MAINTENANCE SURVEILLANCE
Technical Construction File
Regulations
Classification ?
Essential Requirements
Appllying the Regulations
RequirementsIntended use
Product LifecycleSTART
Design input /specifications
Design
Design verification
Pilotproduction
Validation
Production
Placed on the Market
Results
Product LifecycleEND
Surveillance
Definitions
Essential Requirements
Quality SystemDesign / Risk evaluation
Essential Requirements
LabelingQuality System / GMP
Quality SystemRisk evaluation
Process validationClinical Evaluation
Quality System / GMP
Quality System Service
Technical data
STED
(Techn
ical dossier)
Classification
Conformity AssessmentRoute
Notification / License
Post Market Surveillance& vigilance
Aud
iting Internal & External Certification
Scop
e Full Quality System
Quality System
& Risk Managem
ent
Scop
e prod
uct Life
cycle
Notification Competent Authority
Product class
EC declaration of conformity (Annex VII)
EC type-‐examination (Annex III)
option
EC verification (Annex IV)
Product quality assurance (Annex VI)
Production quality
assurance (Annex V)
Production quality
assurance (Annex V)
EC verification (Annex IV)
EC design examination (Annex II, 4)
EC type-‐examination (Annex III)
EC declaration of conformity (Annex VII)
Class I
Class IIb
Class IIa
Class III
Class II
Notified Body
Notified Body + Medicine Authority
ABC
ABC
ABC
MeasuringSterile
Full quality assurance (Annex II)
Full quality assurance (Annex II)
Parties involved
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BIG Brother is .....watching YOU!
3. Parties involved
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Manufacturer
Notified Body
Competent authority
Medicine Authority
Notification class I MDD
Verify class IIa\b and III MDDAudit Technical FilesAudit Quality System
Verify drug substance class III MDDReview Borderline products
Ministry of Health
Policies / surveillanceFree of Sales Certificates
Health Claim authority
Verify Health Claim
Farmatec
IGZ
KOAGKAGCBG
DEKRA
VWSBSI
MDD
Marketing Authorisation > EU
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Mutual Recognition
AustraliaSingaporeHong KongMalaisiaSouth-AfricaCanada (+)India (+)
25
MARKET CHANGE NEW CATEGORY OTC
94 % 6 %TodaySource IMS
85 % 30 %2015- Stronger regulations- Movement Claim regulations- Homeopathic / herbal drugs regulations- Missing eCTD
PharmaceuticalsMedical Devices
+ New innovations+ Less regulations+ BIG Marketing advantage+ Nobody knows+ CE = EU registration+ New brands
- Clinical Data claims-- Inspectorates are unexperienced- Competition crap
3Borderline
MARKETING ADVANTAGE
Less limitations in Marketing Statements (pair of glasses)Pricing stuntsNo requirements to record ingredientsClean packaging
Identical claims as pharmaDue to physical effects, less risks on side effects
EtcEtc
SALES ADVANTAGE
InternetPharmaciesSupermarketsReformsWellness
Queensday on the street (NL only)
Everywhere
Capsule Developments
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Pellets in Licaps®
Cap in Licaps®
Pellet in Cap in Licaps®
Licaps®Simethicone
SoftCapsules
Tablets
Time
SUMMARY
User Perspective: Health claim identical to Pharma< side effects
Distributor / manufacturer: > distribution points> marketing advantage> less regulations
IP: > patent applications> protection
NEW as a MEDICAL DEVICE
3. Contact us
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Progressare B.V.Veembroederhof 961019HC Amsterdam+31.20.3456363
Diane Bond
Capsules as Medical Devices