17.10.2023
EU Hub Release 1.14: Planned deployment dates for ITE, IQE & PRD
EMVO officially announces the deployment dates for Release 1.14 of the EU Hub:
- ITE currently planned for 20th October 2023
- IQE currently planned for 27th October 2023
- PRD currently planned for 27th January 2024; this date could change following the outcome of the Interoperability testing (IOT).
10.07.2023
New
EMVO Webcast Series Episodes
EMVO shares two new episodes
of the EMVO Webcast series – a series of remote training sessions and webcasts
aimed at providing you with useful information on a diverse set of topics
related to the EMVS. Read more about it here.
26.06.2023
EAMS EU HUB Release 1.13: Confirmation of deployment to PRD
EMVO officially announce that Release 1.13 was successfully deployed to PRD on Saturday 24th June 2023. Read more about it here.
16.06.2023
EAMS Upcoming Releases in 2023 – AMS Cybersecurity 1
EMVO confirms the deployment date of the upcoming AMS Cybersecurity 1 (HUB V3.0.0 – Portal V2.3.0) Release and provide further details:
- PRD currently planned for June 27, 2023
Read more about it here.
14.06.2023
EAMS Upcoming Releases in 2023 – AMS Clementine
EMVO announces the deployment dates of the next planned AMS Clementine (HUB V4.0.0 – Portal V3.0.0) Release and provide further details:
- IQE currently planned for October 19, 2023
- PRD currently planned for November 17, 2023
Read more about it here.
31.05.2023
Consequences of product withdrawal & batch recall
EMVO once again highlights the consequences following Product Withdrawal and Batch recall and remind you that these are irreversible actions. Read more about it here.
12.05.2023
Changes to the NMVO Observers
EMVO officially EMVO would like to congratulate the new members of the NMVO Observers within EMVO's Board for 2023. Iwona McManus (from KOWAL) will take over from Philippe Gendre (from France MVO) and Inese Erdmane from (LZVO) will replace Hjörleifur Thoranisson (from ICEMVO), while Kristina von Sydow (from e-VIS) has been re-elected for another year.
EMVO would like to thank Philippe and Hjörleifur for the knowledge and experience they brought during their mandates and welcomes Iwona and Inese into their new role.
02.05.2023
EAMS Upcoming Releases in 2023
EMVO officially announces the 2023 releases of the EAMS!
- AMS Cybersecurity 1 (HUB V3.0.0 - Portal V2.2.0): June 27th, 2023
- AMS Clementine (HUB V4.0.0 - Portal V3.0.0): Q3 of 2023
- AMS Cybersecurity 2: Q4 of 2023
28.03.2023
Static IP addresses for the EU HUB
The benefit of the new system improvement to the EU HUB is that Outbound IP addresses (HUB to OBP) for the different environments (ITE, IQE and PRD) will become static, meaning they will never change. Read more about it here.
24.03.2023
Removal of old ciphers with EU Hub Release 1.13
The successful deployment of Release 1.12 in PRD introduced new ciphers for all three environments (ITE, IQE & PRD) which further increase the security of the EU HUB by replacing older ciphers. Read more about it here.
01.03.2023
EAMS officially live & upcoming releases
Following the "go-live" of the European Alert Management System (EAMS) Hub, it came to EMVO's attention that some improvements are required. Based on these findings, EMVO deployed a new version of the AMS HUB on Friday 24th of February and is working on new versions of the AMS Portal and the AMS Hub which will be released soon. Read more about it here.
01.03.2023
Changes to EMVO's Board of Directors
EMVO congratulates the EMVO’s Board members for their appointment in new functions within the Board and for the renewal of their two-year mandate for the term 2023-2025. Read more about it here.
09.02.2023
EAMS
officially live & next steps
EMVO confirms that the
European Alert Management System (EAMS) HUB is officially live. All interested
OBPs and NMVOs using the system can start connecting from now onwards.Read more about it here.
09.02.2023
EMVO marks the 4th anniversary of EMVS
The European Medicines Verification System (EMVS) celebrates its 4th anniversary on February 9, 2023.
Along with all NMVOs, this was marked. Read more about the last 4 years of work with FMD, and statements from EMVOs General Manager Andreas Walther, and DMVOs Director Tina Hou Marer here.
06.02.2023
EAMS "Go-live"
EMVO is launching EAMS, the European Alert Management System, and connection is possible for OBPs and NMVOs on 9th of February, 2023 and onwards.
22.12.2022
EMVO notice update of OBP Divestiture & Acquisition (D&A) Guide.For more see here.
22.12.2022
EMVO sends out 2022 holiday bulletin. For more see here.
07.04.2022
EMVO informes about renewal EU Hub certificates and alert points. For more see here.
07.04.2022
EMVO informes about whitelist additional EU Hub IP adresses in your firewall. For more see here.
21.03.2022
EMVO celebrates the EMVS third anniversary on February 9th 2022. For more see here.
10.09.2021
Mandatory conformity to Transport Layer Security (TLS) 1.2 or higher. To ensure the security of the EMVS, EMVO would like to inform you that when the EU Hub Release 1.10 will be deployed in IQE and PRD by the end of the year, it will no longer accept connections with Transport Layer Security (TLS) versions prior to 1.2. For more, pls. see here
10.09.2021
Webcast Series Launch – EU FMD Designated Wholesaler Webcast Series. EMVO is announcing the launch of the EMVO Webcast series – a series of remote trainings and webcasts aimed at providing you with useful information on a diverse set of topics related to the EMVS. The recording is accessible here and on EMVO’s website (Knowledge Database -> Videos).
25.06.2021
EMVO is regularly monitoring the EMVS security infrastructure to protect it from
cyber security hazards. A disruptive test will be executed on the EU Hub in the Integrated Quality Environment (IQE) on the following dates:
29th June from 10:00 CEST to 18:30 CEST
30th June from 10:00 CEST to 18:30 CEST
1st July from 10:00 CEST to 18:30 CEST
25.06.2021
EMVO informs you that the Guideline on "Best Practice on Alert Handling" has been approved by EMVO´s Board and is now available here
15.06.2021
EMVO communicates about decommissioning of products: use of correct statuses. For more see here
01.06.2021
EMVO communicates about the next update on the Hub release 1.9.
05.05.2021
EMVO communicates about the Alert Management System (AMS) project, which ultimate goal is to maximise the efficiency of alert management in the EMVS. See more
here
03.02.21
EMVO has updated the Brexit "Q&A" article, which outlines frequently asked questions regarding Brexit. For more pls. see
here
03.02.21
EMVO has created a guide describing how Covid-19 vaccines are handled in the national systems. For more, kindly see
here
03.03.21
EMVO has developed a description on how to investigate Intermarket Transactions. For more, pls. see
here
10.11.20
Letter of Announcement from EMVO
EMVO has been working to manage the implications of Brexit (the UK’s departure from the EU Internal Market rules) for the EMVS and its users. This was undertaken in close collaboration with concerned authorities and stakeholders, including the European Commission, as well as the most impacted National Medicines Verification Organisations (NMVOs). Although the final Brexit negotiations continue, EMVO is working to ensure that as from 1 January 2021 the operation of the EMVS is adapted to the EU-UK Withdrawal Agreement and Northern Ireland Protocol (included as an Annex thereto) that makes certain provisions of EU law applicable “to and in the United Kingdom in respect of Northern Ireland”. Read more
here
10.09.20
Letter of Announcement from EMVO
EMVO has developed a cross-departmental strategy to ensure that the relevant information is provided to all OBPs and Stakeholders promptly. We have created a Communication Matrix to streamline our internal workflows to allow the right teams to react quickly to future situations. Read more
here
24.04.20
Letter of announcement from EMVO
Based on a new system improvement to the EU Hub, EMVO would like to advise you to whitelist the following IP addresses in your network (and internal firewall) settings. The benefit of this update is that Outbound IP addresses (Hub to OBP) for the different environments (ITE, IQE and PRD) will become static, meaning they will never change. We strongly recommend that you update your whitelist and firewall settings as soon as possible. Read more here
24.04.20
Letter of announcement from EMVO
Regarding the recent EU Hub outage, EMVO plan to keep you informed regularly as they progress with the root cause analysis process. Read more here
15.04.20
Letter of announcement from EMVO
Withdrawal of a product code (SKU) affects all packs of all batches in the transaction specified markets. The status “Withdrawn” prevents the uploading of additional batches to the system for the affected markets. Additionally, the end-user of the affected markets will not be able to decommission the packs in the EMVS. EMVO would like to remind once more that the withdrawal of data and batch recall within the EMVS are irreversible actions. For more pls. see here
13.03.20
Letter of announcement from EMVO
EMVO took the decision to allow its employees to work remotely, from home, until further notice. EMVO will ensure that its support and assistance to OBPs will be provided as far as possible. Please note that the usual channel of communication remains at your disposal: Email: EMVO Helpdesk helpdesk@emvo-medicines.eu Phone: +32 (0)2 657 00 08
This measure is taken by EMVO and does not bind any National Medicines Verification Organisation (NMVO). In order to know the applicable measures per country, please consult the relevant NMVO.
09.03.20
SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE
EMVO has released a new version of frequently-asked 'questions and answers' regarding the implementation of the rules on the safety features for medicinal products for human use. For more pls. see here
06.03.20
Letter of announcement from EMVO
EMVO has created a document to provide further information on how versioning and the retrospective data upload work. For more pls. see here
02.03.20
Letter of announcement from EMVO
EMVO would like to provide you with additional information related to the next EU Hub Release 1.7 and the allocated testing period. Please note that three weeks will be granted for testing in the IQE environment, planned to start end of March/ early April 2020. For more pls. see here
25.02.20
Letter of announcement from EMVO
EMVO would like to inform you that the latest update of the Fee Models overview of NMVOs has been published on the EMVO website. For more pls. see here
20.01.20
Letter of announcement from EMVO
The 2016 schema of the OBP Interface will no longer be supported as of EU Hub release 1.7 planned for mid-April 2020. If you are still using the 2016 schema, please switch to the 2018 schema before mid-April 2020 in order to be able to remain connected to the EU Hub. For more pls. see here
26.11.19
Letter of announcement from EMVO
New contact number for EMVO Helpdesk will be activated: +32 2 657 00 08. For more see here
21.11.19
Letter of announcement from EMVO
It has been noted that a number of end user systems are misconfigured and are not correctly announcing that the data has been entered manually. For more pls. see here
05.11.19
Letter of annoucement from EMVO
EMVO would like to announce that Release 1.6.02 of the EU Hub was successfully deployed to the Production Environment (PRD) on Saturday 2nd November. For more pls. see here
31.10.19
Letter of announcement from EMVO
Due to the need to undertake maintenance and renew an SSL certificate, there will be a downtime of the EMVO Gateway PRD for approximately 3 hours on Friday 8th November. The downtime will begin at 5pm (CET). For more, pls. see here
17.10.19
Letter of announcement from EMVO
EMVO has been informed about a large number of alerts currently being caused due to incorrect actions in the event of a batch recall.
According to Article 40 (c) of the Delegated Regulation (EU) 2016/161, a batch recall must be reflected within the EMVS. (EU Hub and National Systems). For more, pls. see here
15.10.19
Letter of announcement from EMVO
EMVO would like to remind OBPs that for Multi-Market Packs (MMPs), the master, batch and pack data must be loaded to all of the markets within the defined cluster, i.e. for all markets to which the MMP can be distributed. See more here
27.09.19
EMVO Newsletter
A new medicines safety verification system has been successfully implemented in Latvia. There are almost 40 million active packs in the Latvian repository. For more, pls. see here
26.09.19
Letter of announcement from EMVO
In order to reduce the number of alerts, EMVO recommends that wholesalers verify one pack per batch (released after 9th February) upon receipt. For more, pls. see here
05.09.19
Letter of announcement from EMVO
EMVO is aware that some OBPs investigate alerts by verifying a Unique Identifier (UI) to better understand the root cause of an alert. The action of performing individual pack verification for alert investigation purposes is considered as an acceptable divergence from the general statement regarding the pack being ‘at hand’. Read more here
10.09.19
Letter of announcement from EMVO
EMVO can now officially announce Release 1.6 of the EU Hub, which is planned to be available in IQE in mid-October, and in PRD in mid-November. The new realease will bring new functionalities. For more, pls. see here
21.08.19
Letter of announcement from EMVO
Since the latest release of the national systems in July, OBPs are receiving alert messages in a new format. During calendar week 36 this new format will also be sent from the national systems of FI and ES. For more see here
19.07.19
EMVO Newsletter
Katriina NewtonKolehmainen, Communications Assistant at FimVO, the Finnish Medicines Verification Organisation who shares with us an insight the situation on Finland. Read more here
15.07.19
Q&A V.15.0 - Safety Features for Medical Products for human use
The European Commision has published an updated version of Q&As. For more see here
12.07.10
Letter of announcement from EMVO
EU Hub Release 1.5 has now been deployed in the IQE environment. EMVO recommends that all OBPs conduct IQE testing - preferably before the 25th of July - to ensure that all call-backs are correctly received from these national systems. More info here
05.07.19
EMVO Newsletter
This week´s NMVO contribution comes from Mitja Pirman, managing director at ZAPAZ, the Slovenian medicines verification organisation, who gives an insight into the situation in Slovenia. Read more here.
21.06.19
EMVO Newsletter
In this week´s letter, insights have been provided by Nadine Bourg & Claude Farrugia from MaMVO, who give an overview of the FMD implementation in Malta. Read more here.
20.06.19
Letter of Announcement from EMVO
This communication provides clear guidance on subscripting to notifications for national systems from the European Medicines Verification System Information (EVI) tool on the EMVO website.
19.06.19
Letter of Announcement from EMVO
The intention of the communication is to provide clear guidance for the completion of Product Master Data that Parallel Distributors must undertake in order to be compliant as errors have been uncovered by EMVO. Read more here.
07.06.19
EMVO Newsletter
Leonie Clarke, the General Manager of MVO Ireland, gives an insight to the situation in Ireland. Read more here.
24.05.19
EMVO Newsletter
Ricardo Valente, the General Manager of MVO Portugal, gives an insight to the situation in Portugal. Read more here.
10.05.19
EMVO Newsletter
This week, Kristina von Sydow, General Manager of e-VIS, provides an update on FMD implementation in Sweden. Read more here.
29.04.19
Released: EMVO bi-weekly newsletter
EMVO is pleased to announce that from this April onwards, EMVO will be issuing a newsletter every two weeks informing you about the activities of EMVO. Read more here.
08.04.19
Letter of Announcement from EMVO
All OBPs must ensure that the representation of the expiry date in the Data Matrix Code printed upon the pack is identical to that which is loaded to the EMVS via the EU Hub. Read more here.
05.04.19
Letter of Announcement from EMVO
EMVO advises all OBPs to directly contact the relevant NMVO when they experience an alert which they suspect is related to End-User software or scanner misconfiguration. Read more here.
