Capsules as Medical Devices

STRICTLY CONFIDENTIAL

Capsules as Medical Devices

Maikel HendriksPartner ProgressareCPhI October 2010

Content


Health / Medical Claims Requirements

Implement

Quality System

Implement

Technical File

Notification

(Pre Market)

Audit

Notified Body

Surveillance

(Post Market)

HEALTH / MEDICAL CLAIMS

Health Claims


Health \ Medical Claims




FOOD COS MDD PHARMA



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

http://en.wikipedia.org/wiki/Cosmetics

http://en.wikipedia.org/wiki/Anti-aging_cream



http://en.wikipedia.org/wiki/Moisturizer

http://en.wikipedia.org/wiki/Portmanteau

http://en.wikipedia.org/wiki/Cosmetic

http://en.wikipedia.org/wiki/Pharmaceutical

REQUIREMENTS


Requirements


CE-‐markering

Requirements


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


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


What is a medical device ?TEST

Requirements


Requirements


Requirements


Requirements


Requirements


Requirements


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 design examination (Annex II, 4)



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)


Requirements


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


Quality SystemDesign / Risk evaluation


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



option


Product quality assurance (Annex VI)

Production quality

assurance (Annex V)

Production quality

assurance (Annex V)


EC design examination (Annex II, 4)



Class I

Class IIb

Class IIa

Class III

Class II

Notified Body

Notified Body + Medicine Authority

ABC

ABC

ABC

MeasuringSterile



Parties involved


BIG Brother is .....watching YOU!

3. Parties involved


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


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


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


Progressare B.V.Veembroederhof 961019HC Amsterdam+31.20.3456363

Diane Bond

Capsules as Medical Devices

Health & Medicine

Capsules as Medical Devices