falsified medicines
TRANSCRIPT
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 118
copyAegate Ltd 2011 All rights reservedISOIEC 270012005
Certificate No IS 567140
Addressing the European Legislation for
falsified medicines
Alison Williams Vice President Aegate
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 218
copyAegate Ltd 2011 All rights reserved
Discussion topics
Introductions and context of our discussion today
Requirements of the new European Directive for falsified medicines and its
impact on dispensing practice
Introduction to Aegatersquos authentication system and the additional benefits
for pharmacy practice and patient care eg New pharmacovigilance
directive patient compliance
Timings for these new Directives in Croatia
27-May-112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 318
copyAegate Ltd 2011 All rights reserved
Falsified Medicines a growing and dangerous problem
The Pharmaceutical Security Instituterecorded 196 cases of counterfeits in 2002By 2009 there had been a ten-fold increase to2003
The EU Commission estimates the rate of counterfeit medicines in the legal supplychain are growing at 10-20 per annum
The profile of medicines that are targeted ischanging
From lifestyle to life-saving drugshellipillegalto legal supply chain
Charts courtesy of PSI
27-May-113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 418
copyAegate Ltd 2011 All rights reserved
The type of products that are targeted are unpredictable
Toothpaste
euro624
Needles
Inhaler
27-May-114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 518
copyAegate Ltd 2011 All rights reserved
New EU legislation for falsified medicines
Mandatory safety features shall allow wholesale distributors pharmacists andpersons authorised to supply medicinal products to the public to
Identify individual packs by use of a unique number affixed to eachsupplied pack of medicine
Verify authenticity Verify whether the outer packaging has been tampered with
Member states must have a system in place to enable recalls to occur topatient level within 24 hours of a recall taking place
To ensure no weaknesses occur between member states Safety features formedicinal products should be harmonised in the EU
27-May-115 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 618
copyAegate Ltd 2011 All rights reserved
Medicines authentication
6
Patient
Pharmacist (or wholesaler)authenticates unique code atthe time of dispensing by
checking the numberagainst the database
Unique code placed onthe pack before
distribution and thenumber filed in the
databasePatient
ultimately knows thepack is
genuine andnot recalled
Each serialisation number is decommissioned when it leavesthe point of dispensing This way copies are detected
Less than half a second
Database
ldquoCounting offrdquo the unique number contained on the individualpack the unique number can only be valid once
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved
Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)
30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)
In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain
In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs
were recovered
27-May-117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 218
copyAegate Ltd 2011 All rights reserved
Discussion topics
Introductions and context of our discussion today
Requirements of the new European Directive for falsified medicines and its
impact on dispensing practice
Introduction to Aegatersquos authentication system and the additional benefits
for pharmacy practice and patient care eg New pharmacovigilance
directive patient compliance
Timings for these new Directives in Croatia
27-May-112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 318
copyAegate Ltd 2011 All rights reserved
Falsified Medicines a growing and dangerous problem
The Pharmaceutical Security Instituterecorded 196 cases of counterfeits in 2002By 2009 there had been a ten-fold increase to2003
The EU Commission estimates the rate of counterfeit medicines in the legal supplychain are growing at 10-20 per annum
The profile of medicines that are targeted ischanging
From lifestyle to life-saving drugshellipillegalto legal supply chain
Charts courtesy of PSI
27-May-113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 418
copyAegate Ltd 2011 All rights reserved
The type of products that are targeted are unpredictable
Toothpaste
euro624
Needles
Inhaler
27-May-114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 518
copyAegate Ltd 2011 All rights reserved
New EU legislation for falsified medicines
Mandatory safety features shall allow wholesale distributors pharmacists andpersons authorised to supply medicinal products to the public to
Identify individual packs by use of a unique number affixed to eachsupplied pack of medicine
Verify authenticity Verify whether the outer packaging has been tampered with
Member states must have a system in place to enable recalls to occur topatient level within 24 hours of a recall taking place
To ensure no weaknesses occur between member states Safety features formedicinal products should be harmonised in the EU
27-May-115 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 618
copyAegate Ltd 2011 All rights reserved
Medicines authentication
6
Patient
Pharmacist (or wholesaler)authenticates unique code atthe time of dispensing by
checking the numberagainst the database
Unique code placed onthe pack before
distribution and thenumber filed in the
databasePatient
ultimately knows thepack is
genuine andnot recalled
Each serialisation number is decommissioned when it leavesthe point of dispensing This way copies are detected
Less than half a second
Database
ldquoCounting offrdquo the unique number contained on the individualpack the unique number can only be valid once
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved
Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)
30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)
In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain
In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs
were recovered
27-May-117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 318
copyAegate Ltd 2011 All rights reserved
Falsified Medicines a growing and dangerous problem
The Pharmaceutical Security Instituterecorded 196 cases of counterfeits in 2002By 2009 there had been a ten-fold increase to2003
The EU Commission estimates the rate of counterfeit medicines in the legal supplychain are growing at 10-20 per annum
The profile of medicines that are targeted ischanging
From lifestyle to life-saving drugshellipillegalto legal supply chain
Charts courtesy of PSI
27-May-113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 418
copyAegate Ltd 2011 All rights reserved
The type of products that are targeted are unpredictable
Toothpaste
euro624
Needles
Inhaler
27-May-114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 518
copyAegate Ltd 2011 All rights reserved
New EU legislation for falsified medicines
Mandatory safety features shall allow wholesale distributors pharmacists andpersons authorised to supply medicinal products to the public to
Identify individual packs by use of a unique number affixed to eachsupplied pack of medicine
Verify authenticity Verify whether the outer packaging has been tampered with
Member states must have a system in place to enable recalls to occur topatient level within 24 hours of a recall taking place
To ensure no weaknesses occur between member states Safety features formedicinal products should be harmonised in the EU
27-May-115 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 618
copyAegate Ltd 2011 All rights reserved
Medicines authentication
6
Patient
Pharmacist (or wholesaler)authenticates unique code atthe time of dispensing by
checking the numberagainst the database
Unique code placed onthe pack before
distribution and thenumber filed in the
databasePatient
ultimately knows thepack is
genuine andnot recalled
Each serialisation number is decommissioned when it leavesthe point of dispensing This way copies are detected
Less than half a second
Database
ldquoCounting offrdquo the unique number contained on the individualpack the unique number can only be valid once
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved
Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)
30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)
In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain
In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs
were recovered
27-May-117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 418
copyAegate Ltd 2011 All rights reserved
The type of products that are targeted are unpredictable
Toothpaste
euro624
Needles
Inhaler
27-May-114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 518
copyAegate Ltd 2011 All rights reserved
New EU legislation for falsified medicines
Mandatory safety features shall allow wholesale distributors pharmacists andpersons authorised to supply medicinal products to the public to
Identify individual packs by use of a unique number affixed to eachsupplied pack of medicine
Verify authenticity Verify whether the outer packaging has been tampered with
Member states must have a system in place to enable recalls to occur topatient level within 24 hours of a recall taking place
To ensure no weaknesses occur between member states Safety features formedicinal products should be harmonised in the EU
27-May-115 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 618
copyAegate Ltd 2011 All rights reserved
Medicines authentication
6
Patient
Pharmacist (or wholesaler)authenticates unique code atthe time of dispensing by
checking the numberagainst the database
Unique code placed onthe pack before
distribution and thenumber filed in the
databasePatient
ultimately knows thepack is
genuine andnot recalled
Each serialisation number is decommissioned when it leavesthe point of dispensing This way copies are detected
Less than half a second
Database
ldquoCounting offrdquo the unique number contained on the individualpack the unique number can only be valid once
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved
Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)
30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)
In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain
In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs
were recovered
27-May-117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 518
copyAegate Ltd 2011 All rights reserved
New EU legislation for falsified medicines
Mandatory safety features shall allow wholesale distributors pharmacists andpersons authorised to supply medicinal products to the public to
Identify individual packs by use of a unique number affixed to eachsupplied pack of medicine
Verify authenticity Verify whether the outer packaging has been tampered with
Member states must have a system in place to enable recalls to occur topatient level within 24 hours of a recall taking place
To ensure no weaknesses occur between member states Safety features formedicinal products should be harmonised in the EU
27-May-115 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 618
copyAegate Ltd 2011 All rights reserved
Medicines authentication
6
Patient
Pharmacist (or wholesaler)authenticates unique code atthe time of dispensing by
checking the numberagainst the database
Unique code placed onthe pack before
distribution and thenumber filed in the
databasePatient
ultimately knows thepack is
genuine andnot recalled
Each serialisation number is decommissioned when it leavesthe point of dispensing This way copies are detected
Less than half a second
Database
ldquoCounting offrdquo the unique number contained on the individualpack the unique number can only be valid once
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved
Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)
30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)
In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain
In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs
were recovered
27-May-117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 618
copyAegate Ltd 2011 All rights reserved
Medicines authentication
6
Patient
Pharmacist (or wholesaler)authenticates unique code atthe time of dispensing by
checking the numberagainst the database
Unique code placed onthe pack before
distribution and thenumber filed in the
databasePatient
ultimately knows thepack is
genuine andnot recalled
Each serialisation number is decommissioned when it leavesthe point of dispensing This way copies are detected
Less than half a second
Database
ldquoCounting offrdquo the unique number contained on the individualpack the unique number can only be valid once
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved
Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)
30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)
In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain
In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs
were recovered
27-May-117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved
Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)
30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)
In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain
In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs
were recovered
27-May-117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 818copyAegate Ltd 2011 All rights reserved
Authentication of the unique identity closes the loop
The process of authentication at the pointof dispense cancels the unique identity
As a result any copies that appear in themarket will be detected
Verification within the wholesaleenvironment permits sample checking
or returned goods to be checked
27-May-118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 918copyAegate Ltd 2011 All rights reserved
An authentication system makes the following checks
Every time a pack is dispensed we check the product is-
Not a copy
ie a serialisation number that we have already read
Not suspicious
ie a pack with no number or the wrong number placed on the wrongbatch
Not recalled
Not expired
Not short expiry
If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack
27-May-119 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1018copyAegate Ltd 2011 All rights reserved
In Europe Aegate have
Completed installations with 30 different pharmacy software systems which
represent 40000 of Europersquos 160000 pharmacies
Installed systems into pharmacies in four countries operating in 5 different
languages
Currently we are scanning more than 28 million packs per month
Tested a verification system in a first wholesaler (in Belgium)
27-May-1110 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1118copyAegate Ltd 2011 All rights reserved
Aegatersquos Authentication Service
In 2010 in Europe we-
Alerted the pharmacist to 55759 recalled packs which were
identified before dispensing
Alerted the pharmacist to check the batch numbers of a further
155523 packs that may be recalled
Altered the pharmacist to 3282 expired packs
Informed the pharmacist of 6907 packs that were short expiry
Investigated with the regulatory authorities and manufacturers two
incidents of suspicious packs
27-May-1111 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1218copyAegate Ltd 2011 All rights reserved
Governance is an important aspect of the system
We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system
Pharmacists maintain ownership of data generated by the system Aegate
has a written agreement with every pharmacy as well as the national
pharmacy association and pharmacy software providers
Aegatersquos security management system is operated to ISO 270001
Independently validated that the system is robust External Audit 2008
27-May-1112 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1318copyAegate Ltd 2011 All rights reserved
We also provide a portal for national pharmacyassociations
To add information that supports pharmacy practice
Pharmacovigilance
Recalls (instructions)
Regulatory changes
Past Expiry date or soon to expire
Pharmacy practice advice
Patient advice
Disease monitoring eg flu
Adherence to treatments
27-May-1113 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1418copyAegate Ltd 2011 All rights reserved
Pack or tablet changes communicated with visual images
Images canalso be used tosupportcounterfeit
detection
27-May-1114 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1518copyAegate Ltd 2011 All rights reserved
Treatment reminders via SMS
27-May-1115
Both the pharmacist and the patient benefit
Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1618copyAegate Ltd 2011 All rights reserved
93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating
This is currently avoluntary system
The PharmacyAssociation havesecure access toinput recalls and
other safetyinformation
15 million packsauthenticated perday
Less than half asecond responsetime
27-May-1116 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1718copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Timings
From the date of official publication (May 27th 2011 approval in EU Council )
November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation
May 2013 articles relating to control of imports and exports and activesubstances must be implemented
Following the delegated acts member states must implement
Within 12 months controls relating to internet pharmacy and an EU logo
Within 36 months unique identification authentication and tamperevidence
27-May-1117 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential
842019 Falsified Medicines
httpslidepdfcomreaderfullfalsified-medicines 1818copyAegate Ltd 2011 All rights reserved
Implementation of the EU Directive Other
A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology
The time to implementation for the pharmacovigilance directive is 18
months from the date of official publication (June 2011)
The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features
27-May-1118 Confidential