Falsified Medicines Directive Info session for MAHs
|
|
- Myra Davidson
- 6 years ago
- Views:
Transcription
1 Falsified Medicines Directive Info session for MAHs 25/4/ u 17u Auditorium at Wolubilis
2 Agenda Welcome MAH responsibilities in FMD Products to market Q&A Interaction with the Verification system Q&A Management of the Verification system Q&A Closing notes H. Van Eeckhout JP. Engels D. T Jampens J. Janssens P. Boudrez M. Gryseels T. Schmitz MAH Event 25/4/2017 Falsified Medicines Directive 2
3 MAH Event 25/4/2017 Falsified Medicines Directive 3
4 Falsified Medicines Directive Legal framework Directive Directive 2011/62/EU published on 1 July 2011 To be detailed via a delegated act; Obligatory safety features on the outer packaging of the medicines, Transposition by Member States into national law Transpose into national law by 2 January The transposition process is now complete. Implementation of the Falsified Medicines Directive Outlined in EU secondary legislation (Delegated Regulation) Published 09 Feb 2016 Time frame : implementation by 09 Feb Philosophy : stakeholder model - managed outsourcing by government The pharma sector will initiate, organize and finance the system Via special purpose VZW/ASBL With limited involvement of government MAH Event 25/4/2017 Falsified Medicines Directive 4
5 Basic concept: Point of dispense verification Mandated by Delegated Regulation MAH Event 25/4/2017 Falsified Medicines Directive 5
6 Basic concept: Point of dispense verification Each MAH: Adapt packs & production line Each MAH: Interaction with the Verification system MAH stakeholders: Manage the Verification system Mandated by Delegated Regulation MAH Event 25/4/2017 Falsified Medicines Directive 6
7 Medicines Verification System Manufacturer System System owner = Manufacturer Interface Man. Interf. System owner = EMVO European Hub Nat. Blue Pr. Interf. Paral. Distr. Interf. Interface Parallel Distributor System System owner = Parallel Distributor System owner = BeMVO Nat. Blueprint. Interf. National System based on blueprint standard Pharm. Interf. Interface Wholes. Interf. Interface Pharmacy System Wholesaler System EMVO European Medicines Verification Organization BeMVO Belgian Medicines Verification Organization MAH Event 25/4/2017 Falsified Medicines Directive 7
8 Tree levels of organisation HUB EMVO VZW / ASBL member: EU stakeholders association Role and Responsibility Building and exploitation of HUB Overall program management Support for scale effects Offices in Brussels Upload of product data BeMVS Verification BeMVO VZW / ASBL 7 constituencies / 8 found. Members (Pharma.be / Febelgen / BAPI / BACHI APB / Ophaco /BVZA-ABPH/ NVGV-ANGR) Role and Responsibility Building and exploitation of National MVS Overall project management Collection of membership fees & contributions BeMVO under construction COMPANY SYSTEMS STAKE- HOLDERS All companies in medicine supply chain MAH + Wholesalers +(Hosp.) Pharmacists Role and Responsibility Apply the FMD regulation Use the MVS system MAH Event 25/4/2017 Falsified Medicines Directive 8
9 Time to start NOW Project implementation Pre-pilot Pilot Ramp up Validation 2. Products to market Do I have products in Scope? Change my Artwork Submit my Variations Modify my production line Bring products to the market 3. Interaction with the Verification system Get my GTIN codes Connect to the Hub Load and manage my codes My internal processes 4. Manage the Verification system Participate in Pilot phase Contract to National system MAH Event 25/4/2017 Falsified Medicines Directive 9
10 Time to start NOW Project implementation Pre-pilot Pilot Ramp up Validation 2. Production line Do I have products in Scope? Change my Artwork Submit my Variations Modify my production line Bring products to the market 3. Interaction with the Verification system Get my GTIN codes Connect to the Hub Load and manage my codes My internal processes 4. Manage the Verification system Participate in Pilot phase Contract to National system MAH Event 25/4/2017 Falsified Medicines Directive 10
11 Bring my products to the market Dany T Jampens
12 Products to Market Scope of FMD for Belgium (*) With NCA following scope of FMD has been defined Use of the UI All medicinal products subject to prescription Plus Black List Minus White List Plus all reimbursable products in BE bearing a RIZIV/INAMI serial bar code today. Use of the ATD All medicinal products subject to prescription Plus Black List Minus White List Plus all other products on a voluntary basis based on risk assessment submission and agreement of FAGG. 2D Matrix for products out of scope The parties confirm that, for the products out of scope, the use of the 2D Matrix (without a UI) will be on a voluntary basis. For these products still without a 2D Matrix the parties advise to use the CNK. See decision table that will be published on the BeMVO website (*) based on informal agreement with Belgian National Competent Authority MAH Event 25/4/2017 Falsified Medicines Directive 12
13 Products to Market Impact of FMD on Pharmaceutical Packaging - General The Delegated act (Commission Delegated Regulation 2016/161) imposes the pharmaceutical industry to apply safety features to the medicinal products in scope of the regulation Unique Identifier (UI) Two-dimensional barcode Anti-Tampering Device Why? To allow the verification of the authenticity of medicinal products subject to prescription and protect patients and business alike from the risks of falsified medicines MAH Event 25/4/2017 Falsified Medicines Directive 13
14 Products to Market Impact of FMD on Pharmaceutical Packaging Unique Identifier Technical specifications: sequence of numeric or alphanumeric characters unique to a given pack of a medicinal product shall consist of the following data elements: a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier ( product code ) a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomisation algorithm ( serial number ) the batch number the expiry date The probability that the serial number can be guessed shall be negligible and in any case lower than one in ten thousand. The character sequence resulting from the combination of the product code and the serial number shall be unique to a given pack of a medicinal product until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution whichever is the longer period. MAH Event 25/4/2017 Falsified Medicines Directive 14
15 Products to Market Impact of FMD on Pharmaceutical Packaging UI Two-Dimensional Barcode Barcode shall be a machine-readable Data Matrix (further: 2D matrix) Carrier of the unique identifier Technical specifications for 2D matrix are presented in Delegated Act Quality of printing of 2D matrix to be verified by manufacturers MAH Event 25/4/2017 Falsified Medicines Directive 15
16 Products to Market Impact of FMD on Pharmaceutical Packaging UI - Human Readable Form Content of 2D matrix must also be present in human readable format Product code Serial number Not required when sum of two longest dimensions of packaging 10cm (e.g., eye drops) When human readable required, should be adjacent to 2D matrix Always required Product Code Serial Number Only required on boxes > 10cm MAH Event 25/4/2017 Falsified Medicines Directive 16
17 Products to Market Impact of FMD on Pharmaceutical Packaging Anti-Tampering Device No specific requirements Manufacturer s choice which ATD to use Labeling (with or without perforation) Hot-Melt Gluing with perforation Self-destroying folding boxes Wrapping MAH Event 25/4/2017 Falsified Medicines Directive 17
18 Products to Market Impact of FMD on Pharmaceutical Packaging - Conclusion For all products in scope of FMD, the lay-out of the secondary packaging is about to change: Add anti-tampering device Add 2D matrix Add Product Code and Serial Number Remove linear sequential barcode MAH Event 25/4/2017 Falsified Medicines Directive 18
19 Products to Market Post-FMD Secondary Packaging Big Boxes All Data Printed On-line MAH Event 25/4/2017 Falsified Medicines Directive 19
20 Products to Market Post-FMD Secondary Packaging Big Boxes Reduced On-line Data Printing MAH Event 25/4/2017 Falsified Medicines Directive 20
21 Products to Market Post-FMD Secondary Packaging Big Boxes Too Large for Exemption, but too Small for Grouping Box too big for exemption (> 10cm), but too small to fit all the human readable version of variable text on one panel There is no obligation to place LOT and EXP adjacent to the 2D matrix The 2D matrix, PC and SN can be printed on one panel, LOT and EXP on another panel MAH Event 25/4/2017 Falsified Medicines Directive 21
22 Products to Market Post-FMD Secondary Packaging Small Boxes Only 2D matrix Human readable version of PC and SN not mandatory may if possible LOT & EXP required, as before MAH Event 25/4/2017 Falsified Medicines Directive 22
23 Products to Market Post-FMD Secondary Packaging CNK In-Scope Products MAH Event 25/4/2017 Falsified Medicines Directive 23
24 Products to Market Post-FMD Secondary Packaging CNK Out-Of- Scope Products For products not subject to FMD, CNK code still to be used on the folding box Industry associations recommend however to evolve from CNK code to 2D matrix also for products out of scope (for harmonization in market) Content of this 2D matrix will then be: PC Lot EXP No SN is allowed for exempted products! MAH Event 25/4/2017 Falsified Medicines Directive 24
25 Products to Market Regulatory Variations - Current Requirements for Packaging Changes Based on circular letter 423 (24-FEB-2003) the FAMHP requests that companies are submitting the product information as per QRD template Version 10 of QRD has been updated to include provisions for the implementation of the Falsified Medicines Directive. Following sections have been added: Section 17, UNIQUE IDENTIFIER 2D BARCODE Section 18, UNIQUE IDENTIFIER - HUMAN READABLE DATA Product Code to be identified with: PC (NL/FR/DE) Serial Number to be identified with: SN (NL/FR/DE) MAH Event 25/4/2017 Falsified Medicines Directive 25
26 Products to Market FMD Related Regulatory Variations How to submit? Combine with any variation that is to be submitted for concerned products or via Art notification Implementation period not limited to 6 months (due: Feb 9, 2019)! (1,2) Submit one variation for implementation of FMD requirements, even when there s a stepwise approach, e.g., Step 1: Add 2D matrix Step 2: add anti-tampering device Step 3: reduce blue box size (as serial barcode no longer needed) Grouping and cost of variations In discussion with FAGG Decisions to be validated by Transparency Commission (1) EMA - (2) CMDh - MAH Event 25/4/2017 Falsified Medicines Directive 26
27 Products to Market Regulatory Variations Mock-Up Needed? Impact Mock-Up Declaration Not Significant (1) NO Declaration of no significant impact on mock-up Significant (2) YES N/A (1) 2D matrix replaces CNK and no other changes to packaging (2) Impact on readability of packaging MAH Event 25/4/2017 Falsified Medicines Directive 27
28 Products to Market Pack design Important Timelines (*) Tree pack situations are possible for your convenience 1. Packs with only old serial bar code system Possible to bring old serial bar code packs on market till 08 FEB Packs with old serial bar code and new 2D matrix in parallel During transition it will be possible to bring packs on the market with both old and new code on packs Possible as from today till 09 FEB 2019 Instructions regarding pack design and variations : see 3. Packs with only new 2D matrix Packs with only 2D matrix are possible as from AUG 2018 To facilitate transition especially for smaller packs with no possibility to have both codes systems on pack For this to happen : all pharmacies and Riziv must agree and be ready to work with 2D matrix system! 4. Same rules apply to Prescription Bound & Not Reimbursed products (*) based on current views and instructions of EMVO and informal agreement with FAGG and Riziv MAH Event 25/4/2017 Falsified Medicines Directive 28
29 Products to Market Start Preparing... NOW! Artwork Analyze your artwork components Shared packs amongst countries same country requirements? If not: country specific packs? impact on supply chain (MOQ)? Space for 2D matrix, anti-tampering device? Develop a strategy for artwork changes Capacity, lead times, etc. Resources & budget!!! Anti-Tampering Device Define your standard (one or multiple) Identify supplier Testing of solution on boxes (e.g., stability study for label adhesion on boxes / compatibility with varnish) Patient testing MAH Event 25/4/2017 Falsified Medicines Directive 29
30 Products to Market Start Preparing... NOW! Production Printing of or labeling with 2D matrix, PC and SN Printing: Adapt and validate packaging lines (technical, IPC checks, data integrity) Random serial number generator needed Labeling: Which printing company can supply labels with 2D matrix, PC and SN? Data integrity throughout supply chain (how to protect serial number information) Adapt for anti-tampering device Handling of serial numbers from generation to upload in EU hub Working with contract manufacturing? Rework / Repackaging How to change leaflets in tamper-evident boxes? Release process QA/QP oversight to be defined Return process How to handle returned units? How to check whether decomissioned or not? Quality System How to operate in serialized environment? Cost-Of-Goods? MAH Event 25/4/2017 Falsified Medicines Directive 30
31 Q & A MAH Event 25/4/2017 Falsified Medicines Directive 31
32 Time to start NOW Project implementation Pre-pilot Pilot Ramp up Validation 2. Products to market Do I have products in Scope? Change my Artwork Submit my Variations Modify my production line Bring products to the market 3. Interaction with the Verification system Get my GTIN codes Connect to the Hub Load and manage my codes My internal processes 4. Manage the Verification system Participate in Pilot phase Contract to National system MAH Event 25/4/2017 Falsified Medicines Directive 32
33 Managing the product codes Jan Janssens
34 Connect to System GS1: Non Profit Setting Global Standards GS1 sets Standards for identification of in collaboration with business: Products: Global Trade Identification Numbers (GTIN) Company/Location: Global Location Number (GLN) Assets: Global Individual Asset Identifier (GIAI) Global Returnable Asset Identifier (GRAI) Logistics: : Serial Shipping Container Codes (SSCC) Standards in data Carriers & Barcodes: Data matrix, EAN, ITF, Standards in data exchange (EDI) MAH Event 25/4/2017 Falsified Medicines Directive 34
35 Connect to System CNK replaced by GTIN 13/14 Belgian decision Elements of GTIN 14: Country of GS1 membership(belgilux): 54 Company Prefix: length defining number of products possible and cost Article Number: 2 to 5 digits for Belgium->#codes 100 to Check Digit: check correct read out of product Indicator: identification level: e.g. tablet, blister, sales pack, bundle, carton, => ALLOCATION RULES FOR STATIC DATA SET: A GTIN in healthcare can never be re-used! MAH Event 25/4/2017 Falsified Medicines Directive 35
36 Connect to System Next step 2D Matrix: Data Matrix ECC 200 version Static data GTIN Dynamic data: Application Identifier (AI) Lot number Expiration date Production date Serial number, AI Code Pharma Data Set Format End indicator 01 PC GTIN 14 N14: 14 Numeric Values 17 Exp Expiry Date N6: 6 Numeric Values 10 Lot Batch N X..20: Up to 20 Alphanumeric Values FNC1 21 SN Serial N X..20Up to 20 Alphanumeric Values FNC1 Barcode Specifics: L-Shaped pattern Checkerboard pattern Error correction X-Dimension = one module Margins: 1 x X-dimension Default Pharma data capacity requirement Content: 24x24 => Impact size and technical requirements! MAH Event 25/4/2017 Falsified Medicines Directive 36
37 Connect to System Action Points Things to consider: GS1 Membership: Local or Global Approach Number of codes required: Company code length! Coding Database & Allocation Methodology Production: Technical Requirements & checks GTIN to CNK: Set up in discussion with Stakeholders Refunding adjust database RIZIV EDI communication set up MAH Event 25/4/2017 Falsified Medicines Directive 37
38 Time to start NOW Project implementation Pre-pilot Pilot Ramp up Validation 2. Products to market Do I have products in Scope? Change my Artwork Submit my Variations Modify my production line Bring products to the market 3. Interaction with the Verification system Get my GTIN codes Connect to the Hub Load and manage my codes My internal processes 4. Manage the Verification system Participate in Pilot phase Contract to National system MAH Event 25/4/2017 Falsified Medicines Directive 38
39 Connect to System Hub Processes for the MAH Onboarding process Managed by EMVO HUB is fully operational and tested - MAH started to upload data (3-6 mnths) Participation request Legitimacy check Contractual onboarding Technical onboarding Training video: FIRST : Check if your corporation is managing the connection with the Hub centrally for you? Yes, Principle of OnBoarding Partner group all MAH to 1 connection No, Start onboarding process with EMVO Organize your internal processes MAH Event 25/4/2017 Falsified Medicines Directive 39
40 Q & A MAH Event 25/4/2017 Falsified Medicines Directive 40
41 Time to start NOW Project implementation Pre-pilot Pilot Ramp up Validation 2. Products to market Do I have products in Scope? Change my Artwork Submit my Variations Modify my production line Bring products to the market 3. Interaction with the Verification system Get my GTIN codes Connect to the Hub Load and manage my codes My internal processes 4. Manage the Verification system Participate in Pilot phase Contract to National system MAH Event 25/4/2017 Falsified Medicines Directive 41
42 Manage the System Managing the Verification system Delegated Regulation: the Marketing Authorization Holders are responsible for implementing and managing the Verification system Set up the not-for-profit organization BeMVO Contract the IT Service Provider Implement and roll out the Verification system Assure efficient ongoing operations Successful implementation - Pilot phase Distribution stakeholders MAH Packaging & production line Connect to Hub Load data to Hub Contract BeMVO MAH Event 25/4/2017 Falsified Medicines Directive 42
43 Manage the System Pilot phase Pilot starts TODAY Because of RIZIV/INAMI readiness by 2018 selected products : Rx products, not-reimbursed MAH evaluating to participate as a Pilot can let this know to the BeMVO latest by 30/5/2017 MAH participating to the pilot will benefit from Strong support (guidelines and procedures) from the BeMVO Accelerated approval procedure at FAGG (if variation only for FMD) Extended technical support from the IT provider Additional information sessions TO DO o Select product(s) to take in Pilot o Artwork, submit variations & get approval o Production line & Bring to market o Connect to Hub and load data to Hub o Contract to BeMVO (*see further) Register NOW as Pilot candidate by mail to info@bemvo.be MAH Event 25/4/2017 Falsified Medicines Directive 43
44 Financing the BeMVO and BeMVS Pieter Boudrez
45 MAH Event 25/4/2017 Falsified Medicines Directive 45
46 Manage the System Budget criteria by BeMVO Lean and mean organisation Max 2 headcounts staff Quality, reporting, communication, link with IT-provider Low cost structure (offices, multistakeholder ) EMVS contribution Unforeseen expenses possible (quality, EMVS, blueprint deviations ) Buffer needed but will be brought to minimum reserve within first two years of operational BeMVO Discount on yearly flat fee GD Luxembourg will pay their share MAH Event 25/4/2017 Falsified Medicines Directive 46
47 Manage the System Budget buildup Constituency fees for associations full members One Off Registration fees per MAH Yearly Flat fee per MAH as of february 2019 Contributions of MAH s to be collected MAH Event 25/4/2017 Falsified Medicines Directive 47
48 Manage the System Criteria Every MAH active in Belgium (on Feb, 9th 2019) has to be contracted Every MAH active in Belgium needs to contribute directly Invoice per MAH Number of MAH s is uncertain and volatile FMD-compliant Rationalisation Auto-check of all MAH s to be in line with BeMVO obligations Check scope FMD Check structure of MAH s within corporate organisation MAH Event 25/4/2017 Falsified Medicines Directive 48
49 Manage the System Variabilities to manage in the budget Number of MAH s Contracting the MAH s Possible rationalisation Budget to be foreseen in total Risk factors Unforeseen costs Unforeseen changes on European level Payment period by MAH s IT-implementation density MAH Event 25/4/2017 Falsified Medicines Directive 49
50 Manage the System Registration process Need to register in 1 of 3 waves Added value to register quickly: Ready for testing on national level Ready for testing on European level Time to adjust internal systems and processes Lowers the cost on BeMVO level Check your MAH/corporate position right now MAH Event 25/4/2017 Falsified Medicines Directive 50
51 Manage the System After registration Phase till 9 february 2019 One off registration fee in 3 waves After 31 may 2018: registration fee of admin cost for those already active in Belgium After 9 february 2019 New MAH: one off registration fee of /MAH Yearly flat fee to be paid per MAH to cover operational costs Amount to be calculated Q If substantial reserves on BeMVO-level discount on yearly flat fee for first 2 years will be applied MAH Event 25/4/2017 Falsified Medicines Directive 51
52 Manage the System Wrap up Action points - registration process Letter of invitation to registration will be sent to all MAH All MAH known by FAGG (name, address, ) Check if your MAH will act within scope of FMD in Belgium on FEB, 9th 2019 Sign up and indicate what wave you prefer to register into BeMVO Lines open as of 2 may via info@bemvo.be Complete, sign the contract and return to BeMVO ( ) Template will be provided via website and been pushed through umbrella organisations Signature by authorized persons Invoice will be sent to MAH Remember: Auto control responsiblity If no contract and/or no payment received on FEB 9th, 2019 Registration fee at + full rate Potentially No access to FMD Belgium/BeMVO MAH Event 25/4/2017 Falsified Medicines Directive 52
53 Q & A MAH Event 25/4/2017 Falsified Medicines Directive 53
54 Key takeaways Overall responsibility of the MAH in the FMD stakeholder model Check if you are concerned by the scope Modify your pack layout and bring new designed packs to the market Connect to the Verification System via the Hub Manages your codes (GTIN and serial number) and reorganize internal processes Participate in the Pilot for a fluent start Take your responsibility towards the management and financing of the Verification System START NOW! MAH Event 25/4/2017 Falsified Medicines Directive 54
55 Closing Remarks M. Gryseels T. Schmitz MAH Event 25/4/2017 Falsified Medicines Directive 55
56 Addenda MAH Event 25/4/2017 Falsified Medicines Directive 56
57 Your To Do s check list 1 General 1. Do I have products if scope of FMD? If one product in scope on Belgian market => be FMD compliant Scope definition : see Addendum slide p59 2. Register yourself and sign contract with BeMVO Make yourself visible towards the BeMVO All MAH should sign contract with BeMVO to access the system Will be the only basis for invoicing of contributions Process : see slide Pay your One-Off Registration Fee A first financial contribution is foreseen to cover costs of investment and operations before FEB 2019 Process, timing and fee levels : see slide Evaluate opportunity to joint the pilot projects We work with fazed implementation and well defined pilot projects Process, timing, criteria and benefits to participate in pilots : see slide 42 MAH Event 25/4/2017 Falsified Medicines Directive 57
58 Your To do s check list 2 Your workstreams 1. What is the process of onboarding? All requested information should be uploaded via EU Hub This must be done by you or your OBP Before uploading you need to onboard in the HUB For instructions of onboarding : see slide GTIN For Belgian : we will work with GTIN for product identification More information : see slides Adapted pack design and (cost of) variations Implementation of FMD will require Adaptation the pack design Submission of variations All information about process and design rules :see slides Impact assessment on your organization Start as soon as possible the impact assessment Potential domains : ICT functions / access management process / warehousing / transport / MAH Event 25/4/2017 Falsified Medicines Directive 58
59 Scope for FMD in Belgium Rx - product NON Rx - product on white list not on white list not on black list CHARACTERISTICS (8) reimbursable not reimbursable reimbursable not reimbursable reimbursable on black list not reimbursable reimbursable not reimbursable FMD SCOPE case number Compulsory ATD? (0) Compulsory 2D-Matrix with UI? For FMD packs - Should Human readable PC and SN be on pack? Is pack > 10 cm? (3) Is pack < or = 10 cm? (3) Possible to put adjacent (5)? => PC and SN adjacent ==> Obliged to put on pack Not possible to put adjacent (5)? => free to put on wathever place/panel (3) ==> Not obliged to put on pack No obligation but if possible and willing to do => free to put on whatever place/panel Can I put a Can I put a 2D-Matrix liniair code? without UI? FOR non FMD PACKS GTIN OR CNK (6) COMPULSORY ACCORDING TO RIZIV RULES not bearing code today 1 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y COMPULSARY bearing code today (7) 2 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y COMPULSARY not bearing code today 3 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREE bearing code today (7) 4 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREE not bearing code today 5 Y Y N Y IS AN FMD PACK bearing code today (7) 6 Y Y N Y IS AN FMD PACK not bearing code today 7 Y Y N Y IS AN FMD PACK bearing code today (7) 8 Y Y N Y IS AN FMD PACK not bearing code today 9 Y Y N Y IS AN FMD PACK bearing code today (7) 10 Y Y N Y IS AN FMD PACK not bearing code today 11 Y Y N Y IS AN FMD PACK bearing code today (7) 12 Y Y N Y IS AN FMD PACK not bearing code today 13 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREE bearing code today (7) 14 VOL Y N Y IS AN FMD PACK not bearing code today 15 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREE bearing code today (7) (8) 16 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREE (0) VOL = voluntary (1) N = NO Y=YES (3) Is the sum of the two largest dimensions of the pack >10 cm? (4 )Is the som of the two largest dimension of the pack > or = 10 cm? (5) Adjacent = just above, left, right or under the 2D matrix (6) For non FMD packs recommanded to evolve from CNK code and liniair bar code to GTIN and 2D matrix for harmonisation in the market. => content of 2D martrix will be : PC + LOT +EXP. Remark : SN is NOT allowed out of scope products. (7) Denomination 'bearing code today' will evolve in the futur to 'bearing a public price" (8) Some cases / combinations are be purely theoritical MAH Event 25/4/2017 Falsified Medicines Directive 59
The Blueprint approach
the way to comply with FMD and its Delegated Regulation: The Blueprint approach Johan Verhaeghe (FMD Project Manager) Frankfurt, 16 February 2016 EGA Vision 2020 To provide sustainable access to high quality
More informationFalsified Medicines Directive: Irish Medicines Verification Organisation (IMVO) update for HPRA GMP Conference LEONIE CLARKE - 7 TH FEBRUARY 2017
Falsified Medicines Directive: Irish Medicines Verification Organisation (IMVO) update for HPRA GMP Conference LEONIE CLARKE - 7 TH FEBRUARY 2017 Safety Features Falsified Medicines Directive(2011/62/EU)
More informationUpdate Version 1.0 Based on the information available at that date of NCA.
Update 05.2017 Version 1.0 Based on the information available at that date of NCA. 1 Check if your company is affected: check the scope of the Falsified Medicines Directive (FMD) = Download general presentation
More informationThe European Stakeholder Model A Medicines Verification System for Europe (ESM)
The A Medicines Verification System for Europe (ESM) Fighting g counterfeit medicines to ensure patient safety in Europe Martin Friedrich, i Andreas Walter ESM Stakeholders 2013-07-03 European Medicines
More informationEU IDMP Taskforce Falsified Medicines Directive and European Medicines Verification System Update
EU IDMP Taskforce Falsified Medicines Directive and European Medicines Verification System Update 19 th February 2016 EMA London Falsified Medicines February 9 th 2016 Delegated Regulation (EU) 2016/161
More informationEU Falsified Medicines Directive. Gareth Jones
EU Falsified Medicines Directive Gareth Jones Why is it important to NPA Members? Will require new processes within community pharmacy from Feb 2019 (barcode scan and tamper check) Requires new IT systems
More informationRecommendations on a harmonised implementation of the EU Falsified Medicines Directive using GS1 standards
Executive Summary The EU Falsified Medicines Directive 2011/62/EU (FMD) and the supplementing Commission Delegated Regulation 2016/161 require the interoperability of product verification repositories
More informationInside EU FMD and the Delegated Acts A Compliance Primer
Inside EU FMD and the Delegated Acts A Compliance Primer TABLE OF CONTENTS 01 02 03 04 05 06 EU FMD And Delegated Acts Requirements How Is EU FMD Governed? What Are The Roles For Different Supply Chain
More informationGS1 Ireland Healthcare User Group (HUG) Information Day
GS1 Ireland Healthcare User Group (HUG) Information Day Overview on EU FMD regulation and unique identification requirements Geraldine Lissalde-Bonnet, GS1 Global Office 28 th March 2017 Overview on EU
More informationImplementation of the safety features in medicinal products for human use
Circular published on the INFARMED I.P website in 4 th Sept.2017 Translation of the responsibility of APIFARMA (not official) Information Circular N. º 108/CD/100.20.200 Date: 01/09/1017 Subject: For:
More informationVerification of Pharmaceutical Products at the Point of Dispense. Status of the EFPIA Project
Verification of Pharmaceutical Products at the Point of Dispense Speaker : Grant Courtney Status of the EFPIA Project Event: GS1 Global Forum - São Paulo 1 Who is EFPIA? The European Federation of Pharmaceutical
More informationVerification of Pharmaceutical Products at the Point of Dispense. An EFPIA update
Verification of Pharmaceutical Products at the Point of Dispense Speaker : Grant Courtney Event: GS1 Global Conference Location: Washington An EFPIA update 1 Who is EFPIA? The European Federation of Pharmaceutical
More informationBackground to the Falsified Medicines Directive and the Delegated Regulation. Susan Grieve, Principal Pharmacist, Department of Health 12 April 2016
Background to the Falsified Medicines Directive and the Delegated Regulation Susan Grieve, Principal Pharmacist, Department of Health 12 April 2016 Background to the Falsified Medicines Directive and the
More informationVerification processes in the supply chain. Workshop for MAHs, Helsinki, 18 Sep 2018 Teijo Yrjönen, FiMVO
Verification processes in the supply chain Workshop for MAHs, Helsinki, 18 Sep 2018 Teijo Yrjönen, FiMVO Legislative background Directive 2011/62/EU (Falsified Medicines Directive) Commission Delegated
More informationSafety features for medicinal products for human use. Questions & Answers. 1. Document history
Safety features for medicinal products for human use Questions & Answers This document sets out frequently-asked 'questions and answers' regarding the implementation of the rules on the safety features
More informationManufacturers serialisation challenges with FMD & DR implementation
Manufacturers serialisation challenges with FMD & DR implementation Mike Rose Vice President, Supply Chain Visibility, Johnson & Johnson Supply Chain Chairman of EFPIA s Supply Chain WG & FMD Implementation
More informationSafety features for medicinal products for human use
Safety features for medicinal products for human use Questions & Answers This document sets out frequently-asked 'questions and answers' regarding the implementation of the rules on the safety features
More informationImplementation of the safety features in medicinal products for human use
Translation of the responsibility of APIFARMA (not official) Information Circular N.º XXX/CD/cód. class. Date: DD/MM/YYYY Subject: For: Implementation of the safety features in medicinal products for human
More informationJerome Lepeintre. Delegation of the European Union to China and Mongolia
Jerome Lepeintre Delegation of the European Union to China and Mongolia EU Falsified Medicine Directive Jerome Lepeintre, Minister Counsellor for Health and, Delegation of the European Union to China and
More informationHow to start implementing traceability in a country
How to start implementing traceability in a country Ask the expert Grant Courtney April 2016 Introduction Grant Courtney Member of GS1 Healthcare Leadership Team 21 Years experience in Healthcare - GSK
More informationFMD edusammud ja väljakutsed. Mai 26, 2017 Tartu. Ravimiameti infopäev. Mart Levo REKS Eesti.
FMD edusammud ja väljakutsed Ravimiameti infopäev Mai 26, 2017 Tartu Mart Levo REKS Eesti Mart.Levo@reks.ee EU-FMD Safety Features EMVO, EMVS and NMVOs REKS, soovitused MAH dele EU-FMD Timeline 2011 2012
More informationHealth systems and products Medical products quality, safety and innovation VERSION 8
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and products Medical products quality, safety and innovation SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS
More informationMAHs and CMOs considerations and objectives to meet upcoming regulations in 2019
ARVATO SYSTEMS MAHs and CMOs considerations and objectives to meet upcoming regulations in 2019 Pascal Leppich, Arvato Systems Joseph Tshimbalanga, Systec & Services Abcoude, 22 June 2017 The WINDOW is
More informationFalsified Medicines Directive Procedure for managing Alerts generated by the verification system
I. PURPOSE The objective of this document is to clarify the procedures that the different stakeholders, involved in the process of medicines verification, have to follow. Important to note that this version
More informationSafety Features Required by the Falsified Medicines Directive 2011/62/EU
TOPRA Annual Human Medicines Symposium 2017 Safety Features Required by the Falsified Medicines Directive 2011/62/EU Syed Qadri, Global Regulatory Affairs Strategy EU/ROW Jazz Pharmaceuticals Syed.Qadri@jazzpharma.com
More informationBelgian Medicines Verification Organisation. End User Implementation
Belgian Medicines Verification Organisation End User Implementation End User implementation Agenda Project planning and status End user FMD activity Controlled on boarding for early bird end users End
More informationGUIDANCE ON IMPLEMENTATION OF IDENTIFICATION AND BARCODING OF MEDICINAL PRODUCTS FOR HUMAN USE
T.C. TURKISH MINISTRY OF HEALTH G.D. OF PHARMACEUTICALS AND PHARMACIES GUIDANCE ON IMPLEMENTATION OF IDENTIFICATION AND BARCODING OF MEDICINAL PRODUCTS FOR HUMAN USE Version 1.4 Ankara, 2011 Index Index...
More informationExperience with Serialization Implementation as one powerful measure to protect our patients. Françoise Hirth
Experience with Serialization Implementation as one powerful measure to protect our patients Françoise Hirth Objectives 1 2 3 Supply Chain integrity & product security A worldwide concern Pharma Industry
More informationNMVO on-boarding presentation
NMVO on-boarding presentation Please check https://www.emvo-medicines.eu/ for the latest version of this presentation and the on-boarding guideline. European Medicines Verification Organisation (EMVO)
More informationWhat To Do or Not To Do? Utility of Medication Traceability to the Patient
What To Do or Not To Do? Utility of Medication Traceability to the Patient Melsen Kwong, Pharm.D. Associate Director Department of Pharmacy Services Cedars-Sinai Medical Center, Los Angeles, CA, USA Objectives
More informationSupply chain integrity Fighting counterfeiting in healthcare
Supply chain integrity Fighting counterfeiting in healthcare The increasing, global threat of counterfeiting in healthcare What is the problem? Counterfeit drugs may harm the patient. Often impossible
More informationHealth systems and products Medical products quality, safety and innovation
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and products Medical products quality, safety and innovation SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS
More informationMHRA GDP Symposium. Novotel London West, London 8 & 10 December #GMDPevents
MHRA GDP Symposium Novotel London West, London 8 & 10 December 2015 Enforcement activities - Impact of the falsified medicines directive Presented by: Peter Blundell, GDP Inspector Impact of the falsified
More informationGuideline for EMVO and NMVO stakeholders: recommendations for alert handling and prevention process. January 2019
Guideline for EMVO and NMVO stakeholders: Recommendations for alert handling and prevention process Document Number Version Effective Date Page No EMVO_0306 1.0 09/FEB/2019 1 of 21 Guideline for EMVO and
More informationThe Global Language of Business. Guide to Encode the Unique Identifier on Medicinal Products
The Global Language of Business Guide to Encode the Unique Identifier on Medicinal Products Introduction The Directive 2011/62/EU Falsified Medicines Directive aims to establish the safety features necessary
More informationFMD Implementation Status Report
FMD Implementation Report Country: Responsible personnel: Czech Republic [Pavlína Štisová, Project Manager] Date: [June 18 th, 2018] Overall country readiness: [Main Stream] This report covers initial
More informationHealthcare. Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA
Healthcare Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA Release 1.0, May 23 2017 Table of Contents 1 Introduction... 7 2 IDENTIFY: Questions about GS1
More informationFMD Implementation Status Report
FMD Implementation Report Country: Responsible personnel: Czech Republic [Pavlína Štisová, Project Manager] Date: [February 20 th, 2018] Overall country readiness: [On the same level as Mainstream] This
More informationSerialisation. GS1 Standards in Healthcare. Standards Certification Education & Training Publishing Conferences & Exhibits
Serialisation GS1 Standards in Healthcare Standards Certification Education & Training Publishing Conferences & Exhibits Siobhain Duggan Director of Innovation and Healthcare at GS1 Ireland Siobhain is
More informationA closer look at the EU- FMD Safety Features Delegated Act: 10 things pharma manufacturers need to consider
August 2015 A closer look at the EU- FMD Safety Features Delegated Act: 10 things pharma manufacturers need to consider It is the general consensus amongst close observers that the draft of the EU- Falsified
More informationOfficial Journal of the European Union. (Non-legislative acts) REGULATIONS
9.2.2016 L 32/1 II (Non-legislative acts) REGULATIONS COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by
More informationFalsified Medicines Directive Procedure for managing Alerts generated by the verification system
I. PURPOSE The objective of this document is to clarify the procedures that the different stakeholders, involved in the process of medicines verification, have to follow. Important to note that this version
More informationThe role of the European Commission during the FMD implementation phase Agnès Mathieu DG SANTE European Commission
The role of the European Commission during the FMD implementation phase Agnès Mathieu DG SANTE European Commission 1st EMVO-MS Workshop 13 December 2016 Delegated Regulation on the Safety Features Adoption
More informationFMD error and alert messages guidance notes To accompany FMD scanning and alert messages chart (v7) December 2018 UPDATED GUIDANCE
Falsified Medicines Directive FMD error and alert messages guidance notes To accompany FMD scanning and alert messages chart (v7) December 2018 UPDATED GUIDANCE These guidance notes accompany the FMD error
More informationGlobal Serialisation Developments and the Need for Convergence. Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015
Global Developments and the Need for Convergence Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015 Developments across the world Regulatory bodies need to address Public Health issues one
More informationMarking Pharmaceuticals & Medical Devices for the 2012 GTIN Sunrise EXPECTATIONS FOR 2012 AND BEYOND
Marking Pharmaceuticals & Medical Devices for the 2012 GTIN Sunrise EXPECTATIONS FOR 2012 AND BEYOND Contents EXECUTIVE OVERVIEW... 4 DOCUMENT INFORMATION... 5 PURPOSE... 5 AUDIENCE... 5 SCOPE... 5 2012
More informationTop 15 Questions and Answers. EU FMD Safety Features and Verification
Top 15 Questions and Answers EU FMD Safety Features and Verification Now set for early 2019, the Delegated Act on safety features for the European Union (EU) Falsified Medicines Directive (FMD) has pharmaceutical
More informationHealth systems and products Medical products quality, safety and innovation
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and products Medical products quality, safety and innovation SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS
More informationGS1 Ireland Healthcare User Group (HUG) Information Day
GS1 Ireland Healthcare User Group (HUG) Information Day FMD Implementation challenges for the manufacturers Joan Cahill, Pfizer 28 th March 2017 FMD Implementation Challenges Industry Perspective Joan
More informationEuropean Union (EU) Falsified Medicines Directive
European Union (EU) Falsified Medicines Directive Mr. Mike Rose, Vice President, Supply Chain Visibility Johnson & Johnson 18 October 2017 GS1 2017 The Promise of Serialization EU Falsified Medicines Directive
More informationGS1 Identification System. 1. What is GS1 Identification system?
GS1 Identification System 1. What is GS1 Identification system? The GS1 Identification System provides two types of identifiers. The first or primary identifiers are called GS1 Keys like the Global Trade
More informationMedicines Barcoding and Serialization Guideline. National Health Regulatory Authority (NHRA) Kingdom of Bahrain
edicines Barcoding and Serialization Guideline National Health Regulatory Authority (NHRA) Kingdom of Bahrain August 2018 Version 1.0 Chief of Pharmaceutical Product Regulation: Dr / Roaya Al Abbasi Date:
More informationFalsified Medicines Directive: Overview from the Irish Medicines Verification Organisation (IMVO) LEONIE CLARKE - 28 TH MARCH HUG
Falsified Medicines Directive: Overview from the Irish Medicines Verification Organisation (IMVO) LEONIE CLARKE - 28 TH MARCH 2017 - HUG EU requirements * for repositories of unique identifiers Every MS
More informationNational Blueprint System Slovakia Kick-Off Meeting
National Blueprint System Slovakia Kick-Off Meeting Bratislava November 22th, 2017 Nov. 22th, 2017 Kick-Off SOOL 1 Agenda Arvato Architecture NMVS Web Service Interface Important Business Processes Project
More informationHealthcare Sector. - Upcoming legislations - GS1 standards. Ann Luyckx Healthcare Manager. Phi Data Event 2018
Healthcare Sector - Upcoming legislations - GS1 standards Ann Luyckx Healthcare Manager Phi Data Event 2018 Anti-trust GS1 Belgium & Luxembourg will not enter into any discussion, activity or conduct that
More informationMass Serialization and Traceability Implementation in the Pharma Industry. Mathieu Aman, Global Program Lead F. Hoffmann-La Roche Ltd, Switzerland
Mass Serialization and Traceability Implementation in the Pharma Industry Mathieu Aman, Global Program Lead F. Hoffmann-La Roche Ltd, Switzerland What drives the industry towards more traceability Strategic
More informationFIMVO END USER AND ISV WORKSHOP. Paul Mills - EMVO
FIMVO END USER AND ISV WORKSHOP Paul Mills - EMVO AGENDA I EMVS System Overview What the Hub does (and how) Master Data Multi-Market Data Inter-Market Transactions FIMVO OBP WORKSHOP 2 AGENDA II Connection
More informationPosition paper on the identification of the primary package level of drugs
Position paper on the identification of the primary package level of drugs This position paper provides good practice recommendations that enable enhanced medication administration processes in care settings
More informationThe new European Regulations the Importance of GS1 standards in the Healthcare sector
The new European Regulations the Importance of GS1 standards in the Healthcare sector Safer, more efficient care starts with a simple scan Ulrike Kreysa, Senior Vice-President Healthcare, GS1 Global Office
More informationFrequently Asked Questions Secondary care services and the Falsified Medicines Directive (FMD)
Medicines are the most common intervention made across the NHS. It is essential that patient can have confidence in the medicines they are supplied and that systems are in place to prevent counterfeit
More informationGS1 Healthcare - Discussion paper on multi-market packs for pharmaceutical products
Purpose This GS1 Healthcare paper has been written to help demonstrate ways in which GS1 bar codes can be used to minimise the need for multiple bar codes to appear on product packaging while still enabling
More informationManufacturing Intelligence: Serialization to Improve Processes. Presented By Jean Pierre Allard Serialization Product Manager Optel Vision
Manufacturing Intelligence: Serialization to Improve Processes Presented By Jean Pierre Allard Serialization Product Manager Optel Vision INTRODUCTION Agenda Standards Overview General Solution Architecture
More informationGlobal Track & Trace requirements for better and safer Healthcare
Global Track & Trace requirements for better and safer Healthcare Ulrike Kreysa, VP Healthcare, GS1 Global Office Riyadh, 6 th December 2016 Counterfeiting - The Impact According to Interpol more than
More informationPharmaceutical Serialization in Brasil. 12 Mar 2015
Pharmaceutical Serialization in Brasil 12 Mar 2015 Agenda Introduction Serialization Supply Chain Overview Global Regulatory Snapshot Discussion and Comparison of RDC No. 54 (Brasil Law) Key Impact Considerations
More informationA FREQUENTZ WHITE PAPER: Meeting Traceability Regulations In The World s Two Largest Pharmaceutical Markets Frequentz. All rights reserved.
Meeting Traceability Regulations In The World s Two Largest Pharmaceutical Markets Introduction John Schultz john.schultz@frequentz.com Regulations mandating the serialization and tracing of pharmaceuticals
More informationTHE HOME DEPOT. Barcode Specifications Carton and Shipment Barcode Identification April 2017
THE HOME DEPOT Barcode Specifications Carton and Shipment Barcode Identification April 2017 Contents INTRODUCTION... 3 Purpose... 3 Methods to Print Barcode Symbols... 3 GS1 DATA STRUCTURES... 3 GTIN Identification...
More informationRegulatory Update: The US Drug Supply Chain Security Act (DSCSA) December 2017
Regulatory Update: The US Drug Supply Chain Security Act (DSCSA) December 2017 Regulatory Agency Regulation Name or System Name Compliance Dates U.S. Department of Health and Human Services (HHS), Food
More informationHI, emvo. Author's Signature. Approver's Signature. ROnoMnP TO NMVO AND NMVS IUPITUENTATION. Interim General Manager. Interim Quality Assurance
HI, emvo Roadmap to NMVO and NMVS Implementation Document Number Version Effective Date Paqe No EMVO OO2B 1.0 Ll3l20L6 LofZ ROnoMnP TO NMVO AND NMVS IUPITUENTATION Author's Signature Authored by: Markus
More informationConnecting dots Can we collaborate better on digital health?
Connecting dots Can we collaborate better on digital health? EU activities in digitising medicines Authorisation Clinical trials EMA Medicines portal Monitoring Falsified medicines Online pharmacies Pharmacovigilance
More informationGLOBAL STANDARDS TECHNICAL IMPLEMENTATION GUIDELINE
USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM PR O CURE ME NT AND S UPPLY MANAGEMENT GLOBAL STANDARDS TECHNICAL IMPLEMENTATION GUIDELINE Product and Location Identification, Labeling, and Data Exchange Version
More informationGuidelines for the Serialisation of Medicinal Products
GS1 Standards Guidelines for the Serialisation of Medicinal Products With a Focus on Labelling and Identification Application recommendation Table of Contents Table of figures... 6 1 The role of the PZN
More informationIdentification and Marking of multi-market packs
Identification and Marking of multi-market packs Ask the expert Grant Courtney April 2015 Introduction Grant Courtney - Member of GS1 Healthcare Leadership Team - Co-author of the GS1 discussion paper
More informationBeing Prepared for Track and Trace: DSCSA 101
Being Prepared for Track and Trace: DSCSA 101 Susanne Somerville, Founder The LinkLab Eric Garvin, Founder, The LinkLab Brian Daleiden, VP Industry Marketing and Co-Founder, TraceLink Objective of Today
More informationEuropean Medicines Verification Organisation: Requirements for the European Medicines Verification System URS Lite
EMVO_0020 3.0 7/3/2017 1 of 51 European Medicines Verification Organisation: Requirements for the European Medicines Verification System URS Lite Copyright 2017 EMVO All rights reserved. Reproduction in
More informationThe Journey
FMD @PHOENIX: The Journey Dr. Tikesh Ramtohul Interim Head of PHOENIX Corporate Serialization Implementation 6 th October 2018 14 th Symposium of the Medicines and Medical Devices Agency, SERBIA EU FMD
More informationMembership Registration Form. Company Details
Membership Registration Form This form allows you to become a voting or non-voting member of GS1 Healthcare, the global healthcare user group. GS1 Healthcare welcomes the following stakeholders as voting
More informationNew product code functionality starting Multiple product codes for each article number
To our submitters of medicines New product code functionality starting 1.1.2018 Multiple product codes can be added to each article number in VareWeb Product codes for inner packs can be registered in
More informationAgenda. The Past: 1990 s. Healthcare. Supply Efficiencies Pallet Through Retail Packages The Present:
Agenda The Past: 1990 s Supply Efficiencies Pallet Through Retail Packages The Present: 2000-2005 Prevention of Dispensing Errors Unit Dose and Unit of Use Packages The Future: 2005 Forward Counterfeit
More informationPharmaceutical Serialisation and Traceability
Pharmaceutical Serialisation and Traceability Panel Discussion Wednesday 11 th April 2018-14:15 15:30 Pharmaceutical Serialisation and Traceability Panelists Scott Mooney (chair) Vice President Distribution
More informationAction plan: serialisation of Nordic packages focus on Product Codes
14.3.2017, version 2 Action plan: serialisation of rdic packages focus on Product Codes The aim of this document is to help pharma companies to prepare for product code changes and to be able to maintain
More informationEMVO FMD Workshop Brussels 13. December 2016
EMVO FMD Workshop Brussels 13. December 2016 Supervision by National Competent Authorities and Access to Data Andreas Walter & Paul Mills dd/mm/yyyy FMD & DR objectives (1) FMD - purpose of the SF Art.
More informationNational Blueprint System Slovakia Kick-Off Meeting
National Blueprint System Slovakia Kick-Off Meeting Bratislava November 22th, 2017 Nov. 22th, 2017 Kick-Off SOOL 1 Agenda Arvato Architecture NMVS Web Service Interface Roles and Rights Onboarding Project
More informationDC Labeling Implementation Guide
DC Labeling Implementation Guide DC Labeling Implementation Guide 1 Revision date: June 14, 2006 Table of Contents 1 Labeling Requirements for Non-Rx Vendors... Page 3 1.1 Pallet Labeling Requirements
More informationImplementation Reality - Traceability
Implementation Reality - Traceability GS1 Healthcare Global Conference San Francisco, California, USA Wednesday 2 nd October 2013 Agenda Introduction Case Studies Janice Kite, GS1 Global Office Manufacturer
More informationPractical implementation of the Falsified Medicines Directive
Practical implementation of the Falsified Medicines Directive Belén Escribano Romero Head of Pharmaceutical Inspection and Enforcement Department AEMPS 1 Content Development of the Directive Overview of
More informationFalsified Medicines Directive (FMD) Leyla Hannbeck MRPharmS, MBA, MSc, MA NPA Chief Pharmacist and Director of Pharmacy
Falsified Medicines Directive (FMD) Leyla Hannbeck MRPharmS, MBA, MSc, MA NPA Chief Pharmacist and Director of Pharmacy Falsified medicines: the facts Falsified medicines may: Be fraudulently mislabelled
More informationIMPLEMENTAÇÃO DA DIRETIVA DOS MEDICAMENTOS FALSIFICADOS E ATOS DELEGADOS. Pedro Ferreira ANF
IMPLEMENTAÇÃO DA DIRETIVA DOS MEDICAMENTOS FALSIFICADOS E ATOS DELEGADOS Pedro Ferreira ANF What are falsified medicines? Growing threat to public health and safety in Europe Counterfeit medicines seized
More informationComplying with barcoding
Complying with barcoding requirements of DGFT GS1 India 8 9 0 1 0 1 6 0 0 0 5 0 8 890 indicates India as country of origin GS1 India is a Standards based not-for-profit organisation set up by the Ministry
More informationGS1 Guide on Unique Device Identification (UDI) implementation
GS1 Guide on Unique Device Identification (UDI) implementation This document aims at providing clarification to questions raised by the industry as well as implementation guidance on the use of GS1 standards.
More informationSerialisation: The Great Challenge for the Pharmaceutical Industry Considerations on China
Packaging Serialisation: The Great Challenge for Pharmaceutical Industry Considerations on China The pharmaceutical industry, as we knew it, appears to be over. The high guaranteed margins in a relatively
More informationEMVO ON-BOARDING HOW TO CONNECT TO THE EU HUB? VERSION OCTOBER 2017
EMVO ON-BOARDING HOW TO CONNECT TO THE EU HUB? VERSION5.0 18 OCTOBER 2017 www.emvo-medicines.eu helpdesk@emvo-medicines.eu Please check www.emvo-medicines.eu for the latest version of this presentation
More informationFMD Workshop 27 June 2016
FMD Workshop 27 June 2016 Meeting outcome Presented by Paolo Alcini Head of Data Standardisation and Analytics Service An agency of the European Union Point Discussed during the WS Review of draft agenda
More informationSerialisation End User View
Serialisation End User View Agenda What is serialisation? Why do we serialise? Regulatory landscape and challenges Approaches to serialisation WHAT IS SERIALISATION? Packaging Levels Lowest saleable unit
More informationThe Falsified Medicines Directive. What pharmacy teams need to do
The Falsified Medicines Directive What pharmacy teams need to do Overview Explain the FMD requirements How the authenticity of products will be checked The implications of Brexit The responsibilities of
More informationThe Danish Generic Medicines Industry Association (IGL)
The Danish Generic Medicines Industry Association (IGL) comments on the concept paper on the delegated act for a unique identifier for medicinal products for human use, and its verification. The Danish
More informationSaudi Drug Code (SDC), and Drug Barcoding Specifications
Drug Sector Licensing Executive Directorate Guidance for Industry Saudi Drug Code (SDC), and Drug Barcoding Specifications This document outlines the SDC and the new drug barcode requirements for pharmaceuticals.
More informationDelegated Act on the detailed rules for a unique identifier for medicinal products for human use, and its verification
Delegated Act on the detailed rules for a unique identifier for medicinal products for human use, and its verification Doc.-Ref. Sanco ddg1.d.3(2011) 1342823 (18/11/2011) COMMENTS FROM: Name of Organisation
More informationFederal agency for medicines and health products. Seminar LM4: Falsified Medicines Directive - Did they forget the hospital pharmacy?
Federal agency for medicines and health products Seminar LM4: Falsified Medicines Directive - Did they forget the hospital pharmacy? Philippe De Buck 23-24 march 2017 22 nd Congress of the European Association
More informationImproving Patient Safety and Supply Chain Efficiency with GS1 Standards in HEALTHCARE
Improving Patient Safety and Supply Chain Efficiency with GS1 Standards in HEALTHCARE 1 GS1 STANDARDS IN HEALTHCARE Together, we re making it possible to follow drugs and medical devices from the manufacturer
More informationSerialization a global approach. Emanuele Tellaroli Key Account Manager ANTARES VISION
Serialization a global approach Emanuele Tellaroli Key Account Manager ANTARES VISION Beirut 02 June 2016 Serialization concept THE SMALLEST ITEM PUT ON SALE (selling unit) IS IDENTIFIED BY THE COMBINATION
More information