EMA electronic Product Information (ePI) Consultation

Expert and public comments sought on ePI, open until 31/July/2021.

The EMA has opened a public consultation on the draft EU common standard for electronic product information or ePI. The consultation period is open until end of July 2021 so there is little time left to give feedback. Comments should be provided via an online form accessible here.

Consultation is sought on the following documents:

• ePI API (Application Programming Interface) specification and the associated ePI API service list;
• A FHIR (Fast Healthcare Interoperability Resources) XML (eXtensible Markup Language) template based on the QRD (Quality Review of Documents) template for human medicines.
• An instance of an ePI sample message is provided in XML and HTML (Hypertext Markup Language), along with a sample XSL (eXtensible Stylesheet Language) transformation.

All documents are available on GitHub here.

What is ePI?

EU Common Standard for electronic product information (ePI) is authorised, statutory product information for EU medicines including the summary of product characteristics or SmPC, labelling for outer and inner packing and the package leaflet in a semi-structured format. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print.

What is the ePI FHIR message template?

The objective of the ePI (FHIR) template is that it is to be used by template engines to transform PI information, in structured or semi-structured format to an ePI FHIR message.

Transformation of PI information (Source: EMA)

The resulting ePI XML message contains a FHIR resource, a Bundle of Bundles, each of which is a document having a composition, and supporting resources. The EMA will publish progress updates and details of stakeholder consultations and share these with patients, healthcare professionals, and the pharmaceutical industry.

Considerations on ePI

I believe it is important to state that the ePI initiative does not change the product information leaflet itself. It is merely a move away from a cumbersome paper-based system and an opportunity to streamline the processes of creating accurate product information leaflets on time in electronic format. The current mixture of structured and semi-structured data that we have seen in SPC documents for years does not support sophisticated data research and analysis. Maximum benefits of ePI would only be achieved via the use of electronic based package information leaflets. Updating or printing of the ever-changing leaflets would be a thing of the past, reducing the risk of having outdated package leaflets or even medicinal product recalls because of incorrect or outdated information. Professionals and the public would have instant access to the correct data online.

In summary

The ePI is well overdue, allowing the move away from outdated paper-based systems to modern electronic data management. With the envisaged use of FHIR for ePI, the path is set to modernise paper-based management of package leaflets. This more data driven approach is promising as long as it can be implemented European wide, not only at the EMA but also for national competent authorities. The benefits for professionals and the public include immediate access to the latest approved product information, availability of additional materials such as video and possible alerts informing about major leaflet updates.

The EMA has opened up a consultation period for professionals and the public alike to gather information on how best to support regulators, marketing authorisation holders, and the public using ePI, electronic product information. They need to know that the adopted Common Standard meets the needs of its future users, confirming they can access, view and disseminate product information in electronic format, ePI.

EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’

Action required: Pilot started 25/March/2021.

In March 2021 the European Commission, together with the EMA and Member States, committed to initiate a pilot to better understand the root causes of deferred market launches for centrally authorised products. The initiative has been launched with the engagement of future Marketing Authorisation Holders (MAHs).

The pilot’s overall objective is to “improve regulators’ knowledge of the planned marketing of centrally authorised medicinal products (CAPs) and on the reasons behind delayed market launch by engaging with prospective marketing authorisation holders through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorisation phase.”

Why are Marketing Authorisation Holders not launching medicinal products European wide?

MAHs are not obliged to market a medicine in all EU countries even though they have achieved approval under the Centralised Procedure (CP). The reasons could be many, for example

  • National pricing and reimbursement policies
  • Market size and hence market potential
  • Organisation of health system including distribution of medicinal products
  • Administration burden
  • Operational limitations
  • Therapeutic area and availability of specialised staff and/or infrastructure

Which products are eligible for the pilot?

It is envisaged that only certain medicinal products will take part in this pilot. These products are orphan and oncology medicines in the context of newly submitted centralised applications, as well as centralised applications under assessment. Products are identified by their link to unmet needs and high public interest.

What method will be used?

Any MAH can take part in this pilot. MAHs will supply information about planned market launch and rollout of the medicinal product. Reasons for not bringing products to market or delayed launches will help to analyse and understand any possible impact, on both the MAH and member states.

MAHs should provide the following information:

  • Identification of the marketing authorisation applicant;
  • Identification of the medicinal product and its active substance;
  • Member States in which the company intends to market the product;
  • The envisioned timing of market launch per country;
  • Remarks on market launch intentions.

Templates for MAHs to notify any ‘Market Launch Intentions’ are provided by the EMA.

It is planned to run this pilot for a period of 18 months, beginning 25/March/2021. If you wish to take part, details can be found on the European Commission website here.

In summary

The aim of the pilot is to get a better understand of why MAHs that pursue the centralised procedure choose not to market their products in all European Union countries. Upon completion of the pilot, the data gathered will be analysed to see whether the reasons mentioned above (if any) are the contributing factors. Results and lessons learnt from this pilot will be published by the European Commission.

Can our four-legged friends help us get out of the COVID-19 pandemic?

Dogs are well known for their abilities to sniff out drugs even when hidden in the most concealed containers. K-9s assist humans worldwide by supporting the visually disadvantaged, hearing impaired and diabetic patients and they are well known to many of us undertaking security checks on airports. In more recent years though dogs are also assisting patients with other life-threatening health conditions.

How can K-9 be so effective?

Dogs are lucky to have about 300 million olfactory receptors in their noses, compared to a mere six million in humans. Hence dogs will be able to sniff out far more than humans will ever be able to. Furthermore, the part of a dog’s brain that is responsible for analysing smells is about 40 times larger than in humans. With that in mind, it is no wonder that dogs are able to retrace their steps for days as many of our dog walkers can relate to. There is another thing though. Dogs also have something called neophilia, which means they are attracted to new and interesting odours. Another factor many owners are far too familiar with.

Another more unknown factor is that when humans exhale through their nose, the spent air comes out in the same way it came in. In contrast, when dogs exhale, the spent air exits through the slits in the sides of the nose. This basically means, that dogs can more or less sniff continuously.

All these factors make dogs prime targets to assist in medicine by sniffing.

Any chance of K-9 assisting with fighting the COVID-19 pandemic?

In the UK, ‘Medical Detection Dogs’ has many years of experience in training dogs to detect different kinds of odours of diseases. These “bio detection dogs” are trained in a controlled environment to detect the odour of disease from samples, and then to apply that knowledge to detect certain medical conditions.

Previous work in this area has been published in the Lancet Infectious Diseases, funded by the Bill and Melinda Gates Foundation. During an earlier study, dogs were able to detect the presence of malaria with an effectiveness of over 90%.

Against COVID-19, ‘Medical Detection Dogs’ undertook a small study to assess whether four legs and a wet nose are the next weapon. The, until 01/June/2021, unpublished study found that people that were infected with the COVID-19 virus give off a distinct odour, detectable by our K-9 friends. The most accurate sniffer dog achieved 94.3% sensitivity. Comparing that with 97.2% for PCR (Polymerase chain reaction) tests, an astonishing result.

Another initiative led by the ‘National Veterinary School of Alfort’ is in line with the findings from ‘Medical Detection Dogs’, i.e. that dogs excel in the detection of COVID-19. With an efficiency of 97% based on over 300 people tested, our K-9 friends are very effective in sniffing out the true positives of the virus.

What type of dog might be suitable?

Sighthounds such as deerhounds or greyhounds are probably not a good idea as they are more interested in ‘chasing’, especially moving targets. What is needed are gundogs such as labradors, retrievers or spaniels that are best suitable as their main desire is ‘searching’, less ‘chasing’.

In summary

With K-9s being special to many individuals, by supporting people affected by diabetes or other life-threatening conditions, their support in medicines seems to be just starting. Sniffing out COVID-19 is the latest achievement our four-legged friends can assist with. And with an accuracy of over 90% in detecting COVID-19 during two independent studies that is comparable to more invasive COVID-19 tests, opportunities for support during this pandemic seem endless. Being able to sniff out the virus in airports, train stations or major events in seconds rather than waiting for a more traditional PCR test is an advantage not to be underestimated. The veterinary sector just became another important factor in beating COVID-19.

Samarind RMS is already supporting many clients in the veterinary sector, including the New Veterinary Regulations coming into effect next year.

SPC harmonisation: Call for Contribution to the Public Consultation of the Best Practice Guides of the CMDv

Action required: Consultation period for ‘SPC harmonisation’ ends 29/June/2021.

The CMDv (Co-Ordination Group for Mutual Recognition and Decentralised Procedure – Veterinary) is seeking feedback on its Best Practice Guides (NPGs) related to the New Veterinary Regulation (NVR), coming into effect on 28/January/2022. The Best Practice Guides have either been newly created or are updated accordingly. If you would like to get further information about the NVR itself, please refer to a previous blog here.

The CMDv published the table below, containing a list of documents and deadlines for consultation.

Please note that the CMDv will update the list of available documents as and when appropriate.

As a reminder, the initial objectives of the Regulation (EU) 2019/6 should be taken into account when commenting on the Best Practice Guides. And here more specifically the objectives of reducing administrative burden, enhancing the functioning of the internal market, increasing availability and safeguarding public health, animal health, animal welfare and the environment.

These Best Practice Guides have been prepared by the CMDv to be used during the SPC harmonisation procedures by Reference Member States (RMS), Concerned Member States (CMS) as well as the marketing authorisation holders (MAH), in order to facilitate the SPC harmonisation procedure.

What are the Harmonisation Procedure phases?

The SPC harmonisation procedure for veterinary medicinal products (VMP) can be divided into three phases:

1. Selection phase; MAH as well as Member States (MS) can suggest products to be considered.
2.A Examination phase for the reference veterinary medicinal product; determination whether the acceptance criteria to be eligible for the harmonisation procedure have been met.
2.B National phase for updating the SPC of the reference veterinary medicinal product.
3.A Harmonisation of the SPCs of generic and hybrid veterinary medicinal products.
3.B National phase for updating the SPCs of the generic and hybrid veterinary medicinal products.

According to these procedures National Competent Authorities (NCA) as well as MAHs may propose harmonisation of the SPCs of Reference Veterinary Medicinal Products (RVMPs) for which a marketing authorisation has already been granted.

A number of criteria for the prioritisation of the SPC harmonisation have been identified. However, it is probably disappointing that taking resource limitations within the agency network into account combined with untried and untested procedures, it is estimated that during the first year of implementation only 5-6 veterinary products can be short listed.

What is the impact of the SPC harmonisation on MAHs?

For products that are shortlisted by the CMDv, the CMDv working group on SPC harmonisation will first identify all MAHs with MA from the Union Product Database (UPD). VMPs should have the same active substance as those of the reference VMP. Targeted requests will be sent to MAHs concerned to provide information on the link between the MA of their product and the products identified on the CMDv shortlist.

For the reference VMPs listed in the CMDv shortlist for which the proposal for SPC harmonisation was not made by the MAH themselves, the MAH will be requested to provide the following information on their reference VMPs:

  • List of countries where the reference VMP is authorised;
  • Product name(s) and name and address of the MAH in all the countries where the reference VMP is authorised;
  • Type of marketing authorisation procedure in each of the MS where the reference VMP is authorised;
  • MRP number (if applicable);
  • MAH contact point for the SPC harmonisation (name, email and telephone number).

MSs might ask for additional information in case – for example – drug safety might be affected.

Comparative table to be submitted by the MAH

The CMDv provides further assistance (shown in the sample table below) to MAHs with regards to the information that should be provided in case the MAH (for each MS) makes a request to shortlist a reference VMP for the SPC harmonisation procedure.

Additional templates for requests are also provided. Users of the Samarind RMS solution have this information available at their fingertips, minimising time and effort spent to collect the right information from multiple sources accurately.

In summary

The Best Practice Guidance documents provide a good overview of the process to be adapted for the new SPC harmonisation procedure. Further details describe what MAH and NCA can expect and should provide. The provision of templates will simplify the process, but if you have a solution such as Samarind RMS, the information is already available at your fingertips.

Please keep in mind that the consultation deadline is 29/June/2021 if you wish to share your thoughts on the proposed SPC harmonisation guides.

EMA introduces additional measures to streamline assessments

Published by the EMA 11/May/2021.

In the process of streamlining assessment for medicinal products during the COVID-19 pandemic, the EMA is implementing additional temporary measures in the European medicines regulatory network . This should allow assessors to concentrate on the ever-increasing volume of COVID-19-related applications, whether vaccines or treatments. The focus will be on vaccines and therapeutics and – of course – safety monitoring of vaccines already given.

To ensure high standards of scientific evaluations during this pandemic, when the EMA has to dedicate resources specifically to COVID-19, the EMA has agreed a number of measures with the Management Board as outlined below. These measures complement the arrangements prioritising COVID-19 procedures that are already in place.

Temporary measures, starting from May 2021 for initial marketing authorisations, include:

For pre-authorisation procedures (text from the EMA website)

• All initial marketing authorisation applications (MAAs) for COVID-19 vaccines and therapeutics will continue to be given first priority. There will continue to be two independent, simultaneous scientific assessments with separate initial reports for these procedures, with no change to the current responsibilities of the rapporteur and co-rapporteur at EMA’s human medicines committee (CHMP).
• For initial MAAs for non-COVID-19 products, unless they are advanced therapy medicinal products (ATMPs) or other very complex medicines to be considered by the CHMP, the co-rapporteur will no longer provide a separate assessment report to the rapporteur in the first phase of the evaluation. Instead, he or she will review the submitted data and give a detailed critique of the rapporteur’s assessment report. These measures will free up some of the co-rapporteur resources to focus on COVID-19 activities.
• For all applications, there will temporarily no longer be a separate, formally appointed peer reviewer, but the assessment will rely on the intrinsic peer review that is part of the CHMP’s role in the evaluation process. In the case of COVID-19 products, there are additional reviews by the COVID-19 EMA pandemic Task Force (COVID-ETF).

It is anticipated, that the responsibilities for rapporteur and co-rapporteur will not change though.

For post-authorisation procedures (text from the EMA website)

Currently, the involvement of co-rapporteurs in the assessment of post-authorisation procedures to extend indications and extension applications (so-called line extensions) depends on the complexity of the file. The approach to these procedures is being temporarily amended as follows:

• For COVID-19 products, the co-rapporteur will be systematically involved in all such procedures; however, the need for two separate assessment reports, or for providing a detailed critique of the rapporteur’s assessment report, will depend on the complexity of the application.
• For non-COVID 19 products, when the co-rapporteur is involved, the co-rapporteur will produce comments on the rapporteur’s assessment report but will not draft a full separate report in the first phase of the evaluation.

These changes will also take effect from May 2021.

Additional activities will be implemented as needed, here specifically to facilitate the appointment of any rapporteur or co-rapporteur. The EMA will, in agreement with the CHMP and the Management Board, regularly review the measures if required and further support by the EMA might be available.

New EMA veterinary product information template

Action required: The EMA invites comments for the new product information template by 14/May/2021.

The EMA just released a new product information template for public consultation. Besides smaller adjustments, the template mainly addresses changes required in line with the New Veterinary Regulations (NVR) that is coming into effect January 2022. Although no firm date for implementation has been provided for the new template, the EMA will inform Marketing Authorisation Holders (MAHs) when to start using the new template after the NVR comes into force.

What does the new template contain?

The new template contains the following:

• a new structure of the SPC and package leaflet; MAHs have to adjust their own templates accordingly to stay compliant;
• Simplification of outer and immediate labelling by providing information only in the package leaflet;
• a consolidated section on ‘minimum particulars to appear on small immediate packaging units’;
• a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines;
• standard text for marketing authorisations granted for veterinary limited markets and under exceptional circumstances;
• reference to national collection systems for disposal of waste veterinary medicines;
• guidance on specific content for novel therapies.

The EMA also simplified the SPC and package leaflet sections on frequency and seriousness of adverse events.

Changes to be considered by Marketing Authorisation Holders (MAHs)

The main purpose of the new template is to be compliant with the NVR and hence it is now based on “Article 35 of Regulation (EU) 2019/6” instead of “Article 14 of Directive 2001/82/EC”.

Another update MAHs will notice is the link to EMA’s SPOR, or better to the Referentials of SPOR. Here MAHs can already benefit from solutions such as Samarind RMS, providing an interface to SPOR and therefore minimising list management and eliminate data entry mistakes. The EMA changed template references accordingly from “Target species: according to the target species CTL on the EUTCT website” to “Target species: according to the target species list under “Referentials” on the SPOR website.

MAHs that are more focused on regional markets will also notice the addition of the national procedure.

More subtle changes are for specific field formats such as the expiry date, changing from “EXP {month/year}” now to “Expiry dates should be expressed with the month given as 2 digits and the year as 4 digits. e.g.02/2007”. Another example is the manufacturing batch number, which previously was given as “<Batch> <Lot> <BN> {number}”, now defined in a new format as “Lot {number}”.

In summary

Although some changes are more subtle with only minor impact on the actual content of the veterinary product information template, MAHs still need to address any alterations to stay compliant. This of course brings further demands on MAHs in the veterinary space. With the deadline of the NVR looming in January 2022, and a deadline for comments on the veterinary product information template coming up imminently, MAHs do not have much time to get involved. However, SPOR Referentials should help to simplify reference data management significantly.

EMA’s PRIME draft toolbox: Consultation ends July 2021

Action required: Consultation for the EMA PRIority MEdicine (PRIME) draft toolbox guidance closes 31st July 2021.

What is PRIME about?

The European Medicines Agency (EMA) launched the PRIority MEdicines (PRIME) scheme in March 2016. The scheme was launched to provide early and enhanced scientific and regulatory support for medicines that target an unmet medical need. PRIME focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without any treatment options.

PRIME benefits

PRIME aims to bring promising innovative medicines to patients faster by optimising and supporting medicine development. PRIME benefits patients, but also the industry.

Benefit for patients:

  • PRIME is driven by patients’ needs
  • PRIME focuses on medicines to address unmet needs and rare diseases
  • PRIME helps to translate research into development while meeting regulatory requirements
  • PRIME brings promising treatment to patients earlier

Benefit for industry

  • PRIME assists development of promising medicines
  • PRIME fosters early dialog with the EMA to facilitate robust data collection
  • PRIME supports creation of high-quality Marketing Authorisation Applications
  • PRIME aims to speed up the evaluation process
  • PRIME encourages developers to focus on medicines that are likely to make a real difference


Experience to date has shown that applicants face challenges to complete quality, manufacturing development and data requirements during development of medicines for early access. Initiatives such as the ‘rolling review’ are trying to address such challenges for promising or urgently required medicines.

How does the PRIME process work?

Data from the EMA shows that only just over 20% of PRIME requests are actually granted. However, once a candidate medicine has been selected, the Agency:

  • appoints a rapporteur from the Committee for Medicinal Products for Human Use (CHMP) or from the Committee for Advanced Therapies (CAT), to provide continuous support and help to build knowledge ahead of Marketing Authorisation Application (MAA);
  • organises a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts from relevant EMA scientific committees and working parties;
  • issues guidance on a company’s overall development plan and regulatory strategy;
  • offers a dedicated EMA contact person;
  • provides scientific advice at key development milestones, involving additional stakeholders as needed.

It is important to note that medicinal products eligible for PRIME are potentially eligible for accelerated assessment during the Marketing Application process, a benefit not to be underestimated.

EMA’s PRIME toolbox

Until 31/July/2021 the EMA is now looking for feedback on their PRIME toolbox (reference EMA/CHMP/BWP/QWP/IWG/694114/2019, 02/February/2021). Consultation is sought on this ‘toolbox style’ document that provides guidance by summarising scientific elements and regulatory tools, available in the existing EU regulatory framework. It is seen as support for the development and completion specifically of Module 3 quality data packages in the preparation of MAAs. It is hoped, that a well-prepared Module 3 will support timely access to the medicine whilst providing assurance that product quality, efficacy and safety are not compromised.

The document includes two major sections:

Scientific tools

Referring to scientific concepts, principles or technologies used for development, manufacture and quality risk management of medicinal products. These might include modelling, analytical or platform technologies.

Regulatory tools

The EMA seeks to support the medicinal product development process early on and to offer regulatory mechanisms to help a ‘faster time to market’ approach without compromising quality, safety or efficacy. This process for example includes giving scientific advice during medicinal product development.

In summary

EMA’s ‘PRIME toolbox’ document outlines the available support from the Agency with scientific and regulatory tools, easing the way for the industry to be able to gain quicker market access for medicinal products addressing unmet medical needs. Action is required as comments are required by 31/July/2021.

FDA Adverse Event Reporting System (FAERS)

FDA launches FAERS public dashboard for COVID-19 emergency use authorization products.

Covid-19 is currently in the news worldwide and that on a daily basis. With vaccinations now becoming more widely available, not only healthcare professionals are interested in post vaccination information. The public too is getting hungrier not only for information on vaccination success, but also on possible side effects even though these are minimal.

With that in mind, the US Food and Drug Administration (FDA) has launched a new public dashboard, allowing tracking of adverse event reporting for drugs treating Covid-19. The FAERS public dashboard is a highly interactive web-based solution, allowing extensive querying functionality. The FDA acknowledges though that there are limitations. One being that a report in FAERS does not necessarily mean that the drug in question actually caused the side effect. Other limitations include

  • FAERS can include duplicates and incomplete reports
  • Reports reflect only the reporter’s opinion and are not necessarily linked to the cause of the drug event as the event could have been triggered by other reasons.
  • Reports and their content have not been (medically) verified.
  • Rates of occurrence cannot be established with reports.

Despite these limitations, the FDA emphasises that improving data access and transparency were core concepts that drove FAERS development. The FDA anticipates that increased transparency will lead to more detailed and complete report submissions by health care professionals and the public.

The dashboard itself provides the ability to display data according to regions, seriousness, age group and others. The below example shows a report by report type.

Another example shows a report by age group (data view as of March 11, 2021).

An easier representation of the same data is also available in graphic view (data as of March 11, 2021):

The user interface is very flexible and allows further drill down into the data, such as viewing of a specific age group or year.

In summary

FDA’s Adverse Event Reporting System (FAERS) is a good example of how agencies can increase transparency of adverse event reporting for medical professionals as well as the public. The FDA states that “Complete and detailed reports are immensely helpful to the agency when identifying safety signals”. Sharing additional information during difficult times such as the Covid-19 pandemic will be appreciated and can only lead to better safety monitoring and ultimately to better medicinal products, benefiting all patients.

New EMA’s Union Product Database production release

The EMA released version 01.02 of the Union Product Database on 16th March 2021.

As part of the New Veterinary Regulations (NVR) implementation, the EMA is developing a Union Product Database (UPD) to allow the management of veterinary medicinal products in the EU. The UPD has been welcomed by many and will certainly improve the safety, availability and maintenance of veterinary medicinal products. In a previous blog we looked at the UPD, how it impacts Marketing Authorisation Holders (MAHs) and to better understand purpose and advantages.

Today though, I shall look at the latest UPD product release version 01.02 that contains additional functionality compared to its previous releases. But there are also some alarming uncertainties that require urgent attention.

The important updates

The new UPD version 01.02 provides the following additions:

  • Additional functionality compared to release 01.00 (core UPD Repository and Application Programming Interface (API), including document management and validation).
  • The first version of the National Competent Authority (NCA) User Interface (UI), providing search, view and create functionality.

It should be noted though, that this release is limited to centrally and nationally authorised products with functionality for DCP and MRP to be provided in the release scheduled for July 2021.

The important notes

Besides not supporting DCP and MRP, it is important to understand that this new UPD version is compliant with the EU implementation guide dated back to 2020. It is not compliant with the more recent guidance published in January 2021 for which the consultation period just closed. This however highlights at least one major challenge for all stakeholders: any new implementation guide might require changes to the underlying data structure of the UPD. This by itself brings another challenge as the data already entered into the UPD might not be retainable. The notification from the EMA is clear: “… we do not recommend to use this release of the UPD for production purposes yet.” Considering the tight timetable for implementation, this will be a further blow to outside stakeholders such as the Marketing Authorisation Holders (MAHs) and solution providers who eagerly await a stable data structure and API. According to the EMA, more functionality will be made available gradually between now and January 2022 but for a successful interaction with the UPD, stable APIs and data structure are a must.

The changes

The new UPD version 01.02 provides mainly four areas of improvements via the User Interface (UI) for National Competent Authorities (NCAs):

  • Create product via UI (for centralised and national procedures)
  • Search product via UI
  • View product via UI
  • Manage notifications via UI (for centralised and national procedures)

This should allow NCAs to test their interaction with the UPD using the UI.

The API has been enhanced too with the following:

  • Get a specific Product version
  • Get everything of Product version
  • Get all Product versions
  • Update Product
  • Validate Product
  • Create document
  • Retrieve document (by ID)
  • Search document (by ID)
  • Update document (by ID)

There are further updates on existing APIs such as changes to the “create Product key” and “update Product” in line with the changes in the UI. Some examples will help defining and understanding the FHIR (Fast Healthcare Interoperability Resources) messages. However, there is also a long list of issues with the UI and API.

In summary

Release 01.02 of the UPD brings some additional functionality, allowing NCAs to test their data exchange method with the UPD. However, as this release is based on the guidance document from 2020, the data structure as well as API and UI might still change which will make life difficult for MAHs and solution providers alike. With the implementation timeline for the NVR in January 2022 looming, not much time is left for stakeholders to comply. A stable data structure and API will be a must to move forward successfully.

EMA’s Union Product Database user research

Union Product Database: EMA’s Veterinary Medicines Division released user research.

In January 2021, the EMA released some interesting findings about how stakeholders might want to make use of the Union Product Database (UPD).

What is the UPD?

According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database. In an earlier blog we provided other details about the UPD itself [link] as well as the latest updates [link].

To get access to data maintained in the UPD, the future public portal should provide access for everybody with an interest in veterinary medicines including veterinary professionals, agencies (full access), marketing authorisation holders (access to their own Marketing Application data) and the public (limited read access) to

  • search and view information on all authorised veterinary medicines in the EU;
  • check on availability of veterinary medicine in specific member states;
  • ability to consider alternative treatments.

The public will be able to search the UPD for product information nationally and in the wider EU. Data fields of interest include but are not limited to the product name, active substance, country of authorisation, target species, and Marketing Authorisation Holder (MAH).

EMA’s UPD user research

In 2020 the EMA conducted user research with regards to the public portal of the UPD, providing some interesting insights from nearly 400 responses. (ref. EMA/33780/2021, Union Product Database user research). In this blog we will focus only on a few areas that will be of interest.

  1. How often do you look up information on veterinary medicines?
Source: EMA

From the data analysed, it seems users are looking for information regularly on a weekly or daily basis.

2. What drives you to look up information on veterinary medicines?

Source: EMA

The main reason for stakeholders to access data seems based around product and safety information for the veterinary medicinal product.

3. How would you typically search for information on veterinary medicines?

The ability to search the UPD was one of the most important factors for all user groups. In particular, users were interested in searching the following:

  • Active substance name;
  • Medicine name;
  • Species;
  • Indication;
  • Medicine’s availability in member states
Source: EMA

4. Other areas of the user research

EMA’s user research included some further details on

Safety data
– Finding comprehensive safety data on veterinary medicines, including possible side effects.
Tracking changes
– The ability to monitor changes on a specific medicine.
Downloading data
– The ability to download data for offline use.
– Which language users mostly use for searching.

In summary

From the user research undertaken by the EMA it is clear that users would prefer a single database where they can find data about the veterinary medicine as well as further information about availability and safety. One of the main functionalities desired is the ability to search and filter the data to each individual need. To make the UPD successful, the EMA will need to ensure that the end user’s needs are met.