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Capsules as Medical Devices

Maikel HendriksPartner ProgressareCPhI October 2010

Content

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Health / Medical Claims

RequirementsImplement

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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“Everything is allowed, Proof IT!”

Health \ Medical Claims

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“Globalising Health Claims”

FOOD COS MDD PHARMA

Health \ Medical Claims

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Category Europe

Food supplementsNew EU regulations make medical claims on food supplements possible. Definition: ‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, 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

CosmeticsDefinition: A “cosmetic product” shall mean any substance or preparation intended to be placed in contact with the various external 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)“medical device” means any instrument, apparatus, 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

“Free Movement of Goods”

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)

“medical device” means any instrument, apparatus, 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/ec

Annex 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)

Man

ufa

ctu

rer’

s o

pti

on

EC verification (Annex IV)

Product quality assurance (Annex VI)

Production quality

assurance (Annex V)

Production quality

assurance (Annex V)

EC verification (Annex IV)

Man

ufa

ctu

rer’

s o

pti

on

Man

ufa

ctu

rer’

s o

pti

on

Man

ufa

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rer’

s o

pti

on

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

Measuring

Sterile

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

Tech

nic

al d

ata

STED

(Te

chn

ical

do

ssie

r)

Classification

Conformity AssessmentRoute

Notification / License

Post Market Surveillance& vigilance

Au

dit

ing

–In

tern

al &

Ext

ern

al C

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fica

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nSc

op

e Fu

ll Q

ual

ity

Syst

em

Qu

alit

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stem

& R

isk

Man

agem

ent

Sco

pe

pro

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ifec

ycle

Notification Competent Authority

Product class

EC declaration of conformity (Annex VII)

EC type-examination

(Annex III)

Man

ufa

ctu

rer’

s o

pti

on

EC verification (Annex IV)

Product quality assurance (Annex VI)

Production quality

assurance (Annex V)

Production quality

assurance (Annex V)

EC verification (Annex IV)

Man

ufa

ctu

rer’

s o

pti

on

Man

ufa

ctu

rer’

s o

pti

on

Man

ufa

ctu

rer’

s o

pti

on

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

Measuring

Sterile

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

Australia

Singapore

Hong Kong

Malaisia

South-Africa

Canada (+)

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

Pharmaceuticals

Medical Devices

+ New innovations

+ Less regulations

+ BIG Marketing advantage

+ Nobody knows

+ CE = EU registration

+ New brands

- Clinical Data claims

- Nobo’s are stupid

- Inspectorates are unexperienced

- Competition crap

3Borderline

MARKETING ADVANTAGE

Less limitations in Marketing Statements (pair of glasses)

Pricing stunts

No requirements to record ingredients

Clean packaging

Identical claims as pharma

Due to physical effects, less risks on side effects

Etc

Etc

SALES ADVANTAGE

Internet

Pharmacies

Supermarkets

Reforms

Wellness

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®

SimethiconeSoft

Capsules

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 96

1019HC Amsterdam

+31.20.3456363

Diane Bond

Capsules as Medical Devices