EMVS Stabilisation Period Recommendations. 2. Introduction Why is a Stabilisation Period needed? a. Alert Handling...

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1 1. Cntents EMVS Stabilisatin Perid Recmmendatins 2. Intrductin Why is a Stabilisatin Perid needed?... 2 a. Alert Handling... 3 b. Serialisatin... 3 c. User Cmpliance and Enfrcement What wuld the Stabilisatin Perid lk like?... 4 a. Crisis Management What must be achieved befre the end f the Stabilisatin Perid?... 4 a. Well perfrming IT Systems... 5 EU Hub and NMVS... 5 IT systems f On-Barding Partners (OBPs)... 5 IT systems f End-Users... 5 b. Trained End-Users... 5 c. Ensured data quantity and data quality... 5 T ensure data quantity:... 6 T ensure data quality:... 6 d. Refined and Adjusted Prcedures An end t the Stabilisatin Perid Cnclusins and Recmmendatins Intrductin The Eurpean Medicines Verificatin System (EMVS) is a truly transfrmative prject, and ne which is unique in its stakehlder-led mdel. The start f the Operatinal Phase f the EMVS n February 9 th is the culminatin f several years wrk by the stakehlders f the pharmaceutical supply chain, with all wrk being aimed strengthening the security f the supply chain against the ptential entry f falsified medicines. Hwever, with a prject f this size, and ne that is being implemented frm the grund-up, there are likely t be teething prblems in the initial perid f the Operatinal Phase. T address this and t ensure that there are as few as pssible disruptins in the supply chain, EMVO prmtes a s called Stabilisatin Perid; which wuld be a sft launch wrking n a case by case r market by market apprach. This apprach will ensure the stable uptake f each Natinal Medicines Verificatin System (NMVS) and will ensure an uninterrupted medicines supply thrughut the whle supply chain. During this s-called Stabilisatin Perid, certain system alerts caused, inter alia, by missing r incrrectly upladed data, scanning prducts nt in the scpe f FMD, scanning s called Indian packs, prcedural mistakes at

2 whlesale/pharmacy level leading t pack status errr alerts, etc. shuld nt be cnsidered as indicative f a ptential falsificatin by End-Users 1 but will nnetheless be visible t them, the NMVS and the NCAs. Fr the avidance f dubt, and as part f EMVO s recmmendatin, medicines shuld still be checked by the entity supplying medicines t the public and reprted t the authrities, as managed befre the Operatinal Phase frm 9th February Why is a Stabilisatin Perid needed? In the first instance, and in a purely practical sense, the EMVS is a Eurpean-wide IT prject. perating acrss the EU and EEA. Its technical establishment is a real and tangible achievement. The fact that the EMVS has been successfully established n time is remarkable when it is cnsidered that the system is cmprised f 29 natinal systems cnnecting, ver 1000 OBPs (cnnecting ver 1,500 manufacturers and parallel distributrs) via the EU Hub, and ver 150,000 End-Users which are all cnnected at natinal level. The fact that natinal systems became peratinal less than 1 year befre the deadline and that mst manufacturers and End-Users nly recently cnnected t the system has left little time at everybdy s dispsal t prperly test their cnnectin and get accustmed t using the system verall as well as irn ut the inevitable technical bugs and vercme the prcedural learning curve. Indeed, the interperating f the system has nly recently started, and the stabilisatin f the system is nging. That this perid f stabilisatin is required is clear when ne cnsiders that the Natinal Systems and the EU Hub have nly recently reached a level f maturity which is necessary t cmply with the Delegated Regulatin. We already identified sme challenges which will be faced by the EMVS during the initial perid after February 9 th. Fr instance, a number f OBPs are using incnsistent date frmats fr the expiratin date printed n the Data Matrix cde and the expiratin date upladed int the EMVS. At the same time certain IT systems (used either by OBPs r End-Users) are autmatically translating the expiry date due t their technical inability t read 00 as a data input field. End-Users will als face a particular challenge in identifying the s called Indian packs which are manufactured in India and have been serialized accrding t the Indian exprt serializatin requirements using a similar 2D Data Matrix cde. It is visible tday that Indian packs released n the EU market befre the 9 th February 2019 d nt have their crrespnding data upladed int the system. In additin t this, it is envisaged that there is an issue related t missing call-backs frm the EMVS. Fr transactins, such as data uplad, the EMVS sends back a cnfirmatin message which wuld indicate that data is valid, laded and distributed. Hwever, due t a technical miscnfiguratin these call-back messages are nt always being sent. As such, manufacturers d nt have abslute certainty that their data has been successfully upladed in the respective natinal system and may be frced t undertake a verificatin f 1 pack f thse batches (Single Market Packs nly) r re -uplad the batch (Multi-market packs nly) in the respective system, thus increasing the verall wrklad n the system. These, and ther examples, adds further weight t the case fr a perid f stabilisatin. 1 End User shall mean any whlesaler, pharmacy r ther persn authrized r entitled t supply medicinal prducts t the public as freseen under the EU Directive n Falsified Medicines and the Delegated Regulatin

3 a. Alert Handling The ultimate gal f the EMVS is t ensure that falsified medicines are kept ut f the legal supply chain and ultimately d nt reach the patient. The system is designed t trigger an alert, if a verificatin/decmmissining event reveals a suspicin that the prduct is falsified. Hwever, the current expectatin is that the number f alerts triggered by the EMVS will in n way reflect the number f falsified prducts, as alerts may be generated by technical r prcedural mistakes. A high number f alerts may lead t a disruptin f the distributin f medicines if the Delegated Regulatin (DR) is fllwed t its full extent immediately frm the 9 th f February Therefre, under Stabilisatin Perid, it is prpsed that there wuld be a plicy f flexible alert handling until the system is prperly stabilised. This is in rder t avid unnecessary disruptin t the supply chain. In additin t the prpsal n alert handling, EMVO suggests a series f initial preventative measures n alert handling t avid any ptential supply disruptins due t the full peratin f the verificatin system: a) Manufacturers wuld verify at least ne pack per batch befre release, including the Anti- Tampering Device. b) Whlesalers wuld verify at least ne pack frm each batch. If there is an alert, a deviatin investigatin wuld be initiated. In this case, the batch in questin wuld be transferred t saleable stck if the whlesaler has n dubt abut the authenticity f the prduct. c) T prevent level 5 alerts, a dwngrading wuld take place fr unknwn prduct cdes, missing batch data and expiry date mismatch. EMVO stakehlders have wrked tgether t devise practical guidelines t prevent alerts being generated in the first place (due t technical r prcedural mistake) as well as t handle the alerts generated nnetheless. The Stabilisatin Perid acknwledges that investigative actins may nt be as effective nr as fast as needed t cpe with the initially expected number f alerts, therefre supply chain actrs shuld priritise access t medicines fr patients. Hwever, the Stabilisatin Perid shuld be viewed as a waiver f ends, nt f means. That is t say that all individual stakehlders need t make an effrt and investigate the alerts in the system, but shuld the investigatin nt be successful patients shuld nt be denied access t their medicines. This prpsal n alert handling is ne which already reflects discussins internally within several participating cuntries, where flexible alert management is being taken alngside a set perid where NCAs will nt be impsing fines. b. Serialisatin An additinal factr t cnsider is that in any case there will be a perid f several years in which serialized and nn-serialized packs will be n the market and being dispensed t patients. This is cmbined with the fact that 10%-20% f packs are yet t be serialised. This phasing in f serialisatin, and the time taken frm the beginning f the Operatinal Phase t the pint at which all packs in-scpe are serialised wuld lend itself t the cnclusin that in any case a Stabilisatin Perid is taking place.

4 c. User Cmpliance and Enfrcement It is anticipated that during the initial perid f the Operatinal Phase, there will be a perid in which enfrcement by Natinal Cmpetent Authrities is handled in a flexible manner. This is recgnitin f the fact that the system is new and that sme end users in sme participating cuntries are nt yet ready fr the Operatinal Phase. Indeed, it has been suggested that sme NCAs will nt enfrce fines fr a specific perid f time frm February 2019 in rder t prvide End-Users with a grace perid t cnnect t the system as sn as pssible r t becme accustmed t the EMVS. This is a key cmpnent f the Stabilisatin Perid being prpsed by EMVO and which sme participating cuntries have already embraced. 4. What wuld the Stabilisatin Perid lk like? During the Stabilisatin Perid advcated fr by EMVO: 1. All pharmaceutical cmpanies and parallel distributrs placing medicinal prducts int yur market have a cnnectin via their OBP with the EU Hub and uplad their Prduct Master Data (PMD) and Prduct Pack Data (PPD) int yur NMVS in accrdance with the Delegated Regulatin. 2. All End-Users are cnnected and are actively using yur NMVS fr verificatin and decmmissining activities, in accrdance with the Delegated Regulatin. 3. Medicines are nt unreasnably withheld in the supply chain and frm distributin t patients; unless clear indicatin is available that the pack is falsified. 4. Each NMVO mnitrs the status f the abve pints. Usage f the system is f utmst imprtance as data n the functining and effectiveness f the system will be cllected. This data can be analysed and prvide infrmatin n hw the perfrmance f each NMVS can be imprved. Once this data is cllected and analysed, crrective actins can take place. These will lead t an NMVS which filters ut suspected falsified packs with a high degree f certainty withut unnecessary bstructin f the supply f medicines. a. Crisis Management During the Stabilisatin Perid teething prblems are t be anticipated and any technical issues arising shuld be addressed as sn as pssible. In this spirit, a system f rapid crisis management is required t handle such issues during the Stabilisatin Perid. This system f crisis management begins by detecting the crisis and EMVO crdinating the rt cause analysis. Once these have been cmpleted, and the cause has been identified, fllw up actins will be cmpleted t slve the crisis. Thrughut this prcess, EMVO will maintain a cnsistent line f cmmunicatin thrugh Letters f Annuncement and the Dwntime and Disruptin Infrmatin System (DDIS). We will be transparent n ur prgress and will infrm the relevant parties nce issues have been slved. 5. What must be achieved befre the end f the Stabilisatin Perid? In rder fr this perid f stabilisatin t be judged a success, a cmbinatin f factrs is required:

5 a. Well perfrming IT Systems EU Hub and NMVS At this mment the cre Eurpean Medicines Verificatin System (which cnsists f the EU Hub and the NMVSs) is ready t meet the requirements f the Delegated Regulatin (DR). One exceptin applies t the NCA reprts which are still under develpment. These IT systems are under the respnsibility f the EMVO and the NMVO s. IT systems f On-Barding Partners (OBPs) All Marketing Authrisatin Hlders (MAHs) and parallel distributrs are t be cnnected via their OBP t the EU Hub t lad data in the EMVS. The IT systems which supprt the uplad f data frm the OBP t the EU Hub shuld meet the quality standards which have been defined in the System Develpment Kit (SDK) dcumentatin. These IT systems are under the respnsibility f the OBP s. IT systems f End-Users The IT systems f the End-Users need t cnnect securely t the NMVS while meeting the requirements f the EMVS. The NMVO shuld versee the hard- and sftware readiness f IT systems supprting the whlesalers and the pharmacists. These IT systems are under the respnsibility f the End-Users. b. Trained End-Users It is necessary that in the Stabilisatin Perid further training f On-barding Partners and End-Users takes place and experience is gained n best practices. With respect t OBPs; it is f utmst imprtance that all MAH s placing medicinal prducts in a market use the EMVS fr its intended purpse. This can nly be achieved when OBP s have sufficiently trained staff and are familiar with the EMVS prcedures. Fr End-Users training is even mre critical. It is essential that all End-Users are cnnected and use the system fr its intended purpse. The number f errrs triggered by the system caused by unintended use is a gd indicatr f the End-User training level. Unintended can be understd t be examples such as the scanning f a pack mre than nce, r cnsistently scanning packs which are nt subject t the DR. When these gals are reached, the stabilisatin perid can be ended and all alerts can be treated as ptential falsificatins. c. Ensured data quantity and data quality In rder t ensure that the necessary imprvements t the system are made, and that repeat instances f the same issue d nt ccur, the availability f data is abslutely vital. Withut the availability f reliable data, it is very difficult t wrk thrugh any technical difficulties which may arise. In irning ut the initial difficulties, and by cllecting as much reliable data as pssible, we can ensure that the end users will nt be burdened in the future by an unnecessarily high number f alerts.

6 T ensure data quantity: T avid the system triggering unnecessary errr messages, all packs which are physically in the market shuld be reflected by Prduct Pack Data in yur NMVS. T ensure data quality: The Prduct Master Data (PMD)and Prduct Pack Data (PPD) available in yur NMVS shuld meet the EMVS data quality requirements. Incrrect data may accidentally pass the data validatin checks f manufacturers internal systems, and subsequently may lead t false errr messages and alerts. d. Refined and Adjusted Prcedures As yur NMVS is a cmplete new system, n large scale experience culd yet be gained n its use and management. Prcedures which are currently in place are expected t be refined and adjusted. Once the updated prcedures are mature and embedded in the daily habits f NMVS users, the system will be perceived as stable. 6. An end t the Stabilisatin Perid By September 2019 (i.e. rughly 8 mnths after the entry int frce f the Delegated Regulatin) EMVO, EMVO stakehlders and the Eurpean Cmmissin (at EU level) and NMVOs, natinal stakehlders and Natinal Cmpetent Authrities (at natinal level) will undertake a thrugh assessment f the status f stakehlder cmpliance with DR requirements as well as the status f vercming the challenges identified in this paper. This assessment shuld end the Stabilisatin Perid enabling the return t business as usual fr all supply chain stakehlders as well as the prper investigatin f all alerts generated by the system, with all the slemnity implied by the very generatin f the respective alerts. 7. Cnclusins and Recmmendatins In shrt, EMVO s prpsal fr the Stabilisatin Perid frm 9 th February 2019 cvers a perid t ensure a cntrlled applicatin f the NMVS and an uninterrupted medicines supply. In the prpsed Stabilisatin Perid there shuld be: Flexible alert handling; Enfrcement and inspectins nly n a case by case (market by market) basis with a staged implementatin f NCA reprting; Cmpletin f serializatin; Increase f EMVS stability/perfrmance, i.e. Well perfrming EU Hub and NMVS (data quantity & data quality f utmst imprtance) Well perfrming IT systems f On-Barding Partners (including trained OBPs) Well perfrming IT systems f End-Users (including trained End-Users) Effective crisis management, which will maintain trust in the system s added value;

7 The EMVS is a cmpletely new system. As such, n large-scale experience culd yet be gained n its use and management. It is t be expected that prcedures which are currently in place will need t be refined and adjusted. Once the updated prcedures are mature and embedded in the daily habits f NMVS users, the system will be perceived as stable. This must be the respnsibility f all f thse invlved in the peratin f the EMVS, as we must ensure a stable verificatin system t meet ur gal f enhancing patients access t safe medicines. Frm EMVO s discussins with the Eurpean Cmmissin, it is clear that they are fully appreciative f the prblems which will arise frm implementing such a cmplex and interperable system. Based upn this, the Eurpean Cmmissin accept the cncept f the Stabilisatin Perid as laid ut in this dcument. In rder t realise this prpsal, specific and measurable indicatrs are needed t track prgress during the Stabilisatin Perid, during which time the Eurpean Cmmissin wuld liaise directly with Natinal Cmpetent Authrities n crisis management and stabilisatin within each Member State. Furthermre, the EMVS is a demanding but highly valuable prject fr all f thse invlved, and fr patients acrss Eurpe. It is therefre vital that we maintain trust in the system and that its added value is recgnised. It is therefre EMVOs recmmendatin that this Stabilisatin Perid is enacted in rder t ensure that these aims are met.