Capsules as Medical Devices


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Capsules as Medical Devices

  1. 1. Capsules  as  Medical  Devices Maikel  Hendriks Partner  Progressare CPhI  October  2010 STRICTLY CONFIDENTIAL
  2. 2. Content Health  /   Implement Implement Notification   Audit   Surveillance     Requirements Medical  Claims Quality  System Technical  File (Pre  Market) Notified  Body (Post  Market) STRICTLY CONFIDENTIAL
  4. 4. Health   Medical  Claims STRICTLY CONFIDENTIAL
  6. 6. Health Medical Claims Category Europe Food  supplements 1924/2006/EC Products  on  the  market  must   New  EU  regulations  make  medical  claims  on  food  supplements  possible.   comply  by    19  JAN  2010 y,  a  food  or  one  of  its   Evaluation  <  June  2011 constituents  and  health; Claim  opinions  <  End  2011 Quality  System: Claim  indication:    attends,  support,  maintains,  keeps,  optimizes,  provides,  safes,  contributes HACCP Claims  not  allowed:  cure,  treats,  prevents Cosmetics 76/768/EC Technical  data: ternal  parts  of  the   Product  information  package human  body  (epidermis,  hair  system,  nails,  lips  and  external  genital  organs)  or  with  the  teeth  and  the  mucous  membranes  of  the  oral  cavity  with   Quality  System: a  view  exclusively  or  mainly  to  cleaning  them,  perfuming  them,  changing  their  appearance  and/or  correcting  body  odors  and/or  protecting  them   ISO-­‐22716:2007 or  keeping  them  in  good  condition. Claimsindication:    cleaning,  perfuming,  change  appearance,  correcting  body  odors,  conditioning Claims  not  allowed:    cure,  treats,  prevents Medical  Devices  (Over-­‐The-­‐Counter) 93/42/EC  +  2004/47/ec Product  Data: appliance,  software,  material  or  other  article,  whether  used  alone  or  in  combination,   Technical  construction  File together  with  any  accessories,  including  the  software  intended  by  its  manufacturer  to  be  used  specifically  for  diagnostic  and/or  therapeutic   Quality  System: purposes  and  necessary  for  its  proper  application,  intended  by  the  manufacturer  to  be  used  for  human  beings  for  the  purpose  of:   ISO-­‐13485:2008 diagnosis,  prevention,  monitoring,  treatment  or  alleviation  of  disease, diagnosis,  monitoring,  treatment,  alleviation  of  or  compensation  for  an  injury  or  handicap, Manufacturers  must  comply  by  21   investigation,  replacement or  modification of  the  anatomy  or  of  a  physiological  process, MAR  2010 control  of  conception,  and  which  does  not  achieve  its  principal Claims  indication:    attends,  support,  maintains,  keeps,  optimizes,  provides,  safes,  contributes,  treats,  prevents Claims  not  allowed:    cure Pharmaceutical 2001/83  EC Product  Data: Definition:  Medicinal  product  any  substance  or  combination  of  substances  presented  for  treating  or  preventing  disease  in  human  beings.  Any   eCommon  Technical  Dossier substance  or  combination  of  substances  which  may  be  administered  to  human  beings  with  a  view  to  making  a  medical  diagnosis  or to restoring,   Quality  System: correcting  or  modifying  physiological  functions  in  human  beings  is  likewise  considered  a  medicinal  product. GMP  standard Claims  indication:    cure,  treats,  prevents Claims  not  allowed:  None 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 STRICTLY CONFIDENTIAL
  8. 8. Requirements CE-­‐markering STRICTLY CONFIDENTIAL
  9. 9. Requirements CE-­‐mark Jaar 1987 20 Directives 1994 Blue  Guidance 1995 Effective MDD  93/42/ec 1998 Transfer CE mandatory 21 maart   Clinical Evaluation 2010 2007/47/ec STRICTLY CONFIDENTIAL
  10. 10. 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 STRICTLY CONFIDENTIAL
  11. 11. Requirements What  is  a  medical  device  ? TEST STRICTLY CONFIDENTIAL
  12. 12. Requirements STRICTLY CONFIDENTIAL
  13. 13. Requirements STRICTLY CONFIDENTIAL
  14. 14. Requirements STRICTLY CONFIDENTIAL
  15. 15. Requirements STRICTLY CONFIDENTIAL
  16. 16. Requirements STRICTLY CONFIDENTIAL
  17. 17. Requirements 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 IIab: Manufacturer + Notified Body (can also be the manufacturer if QMS complies with Annex II); Class III: Manufacturer + Notified Body + Medicine Board STRICTLY CONFIDENTIAL
  18. 18. Notification  Competent  Authority Class I EC  declaration  of  conformity  (Annex  VII) Measuring Sterile Notified  Body Full  quality  assurance  (Annex  II) EC  verification   EC  declaration   (Annex  IV) of  conformity   Class IIa (Annex  VII) Production   quality   assurance   (Annex  V) EC  type-­‐ ABC Product class Class II Class IIb examination   Product  quality   (Annex  III) assurance   (Annex  VI) Full  quality  assurance  (Annex  II) ABC Notified  Body  +  Medicine  Board EC  design   examination   EC  verification   (Annex  II,  4) (Annex  IV) Class III option EC  type-­‐ Production   examination   quality   ABC (Annex  III) assurance   (Annex  V)
  19. 19. Requirements SCOPE REQUIREMENTS MAINTENANCE SURVEILLANCE Supplier / contractor Regulations Technical CE-declaration Auditing Construction File Classification  ? Manufacturer Post Market Quality Manual Surveillance Essential ISO Certificate Requirements Distributor STRICTLY CONFIDENTIAL
  20. 20. Appllying  the  Regulations Product  Lifecycle START Requirements Definitions Classification Intended  use Design  input  / Essential  Requirements specifications Quality  System STED  (Technical  dossier) Design Design  /  Risk  evaluation Auditing   Internal  &  External  Certification Technical  data Quality  System  &  Risk  Management Design   Essential  Requirements verification Scope  Full  Quality  System Scope  product  Lifecycle Labeling Pilot Quality  System    /  GMP production Quality  System Risk  evaluation Validation Process  validation Clinical  Evaluation Conformity  Assessment Quality  System  /  GMP Production Route Notification  /  License Placed  on  the  Market Post  Market  Surveillance Quality  System  Service Results &  vigilance Surveillance Product  Lifecycle END
  21. 21. Notification  Competent  Authority Class I EC  declaration  of  conformity  (Annex  VII) Measuring Sterile Notified  Body Full  quality  assurance  (Annex  II) EC  verification   EC  declaration   (Annex  IV) of  conformity   Class IIa (Annex  VII) Production   quality   assurance   (Annex  V) EC  type-­‐ ABC Product class Class II Class IIb examination   Product  quality   (Annex  III) assurance   (Annex  VI) Full  quality  assurance  (Annex  II) ABC Notified  Body  +  Medicine  Authority EC  design   examination   EC  verification   (Annex  II,  4) (Annex  IV) Class III option EC  type-­‐ Production   examination   quality   ABC (Annex  III) assurance   (Annex  V)
  22. 22. Parties  involved BIG Brother is ..... watching YOU! STRICTLY CONFIDENTIAL
  23. 23. 3.  Parties  involved Farmatec Competent   authority DEKRA IGZ MDD Notification  class  I  MDD Notified   Ministry  of   Body Health VWS BSI Verify  class  IIab  and  III  MDD Policies  /  surveillance Audit  Technical  Files Free  of  Sales  Certificates Audit  Quality  System Manufacturer CBG KOAGKAG Medicine   Health  Claim   Authority authority Verify  drug  substance  class  III  MDD Verify  Health  Claim Review  Borderline  products STRICTLY CONFIDENTIAL
  24. 24. Marketing  Authorisation    >  EU Mutual  Recognition Australia Singapore Hong Kong Malaisia South-Africa Canada (+) India (+) 25 STRICTLY CONFIDENTIAL
  25. 25. MARKET  CHANGE     NEW  CATEGORY  OTC Today 94  % 6  % Source IMS Borderline 2015 85  % 3 30  % - Stronger regulations + New innovations - Movement Claim regulations + Less regulations - Homeopathic / herbal drugs regulations + BIG Marketing advantage - Missing eCTD + Nobody knows + CE = EU registration + New brands - Clinical Data claims - Pharmaceuticals - Inspectorates are unexperienced Medical Devices - Competition crap
  26. 26. 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
  27. 27. SALES  ADVANTAGE     Internet Pharmacies Supermarkets Reforms Wellness Queensday on the street (NL only) Everywhere
  28. 28. Capsule  Developments   Pellets in Licaps® Pellet in Cap in Licaps® Cap in Licaps® Licaps® Simethicone Soft Capsules Tablets Time STRICTLY CONFIDENTIAL
  29. 29. 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
  30. 30. 3.  Contact  us Progressare B.V. Veembroederhof 96 1019HC Amsterdam +31.20.3456363 Diane Bond Capsules as Medical Devices STRICTLY CONFIDENTIAL