UP-to-Date – EMA’s Union Product Database implementation guide

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 (UPD). With that in mind, implementation acts are required laying out electronic exchange mechanism and data format, database functionality and interface/API as well as detailed specifications of the data to be managed.

The EMA recommends building a system utilising existing functionalities as far as possible. This, for example, includes the current development of SPOR (Substance, Products, Organisation, Referentials) which is applicable to both human and veterinary products. However, because of the tight time frame, the initial development will focus on a minimum viable product fulfilling only legislative requirements.

Part of SPOR is the Product Management Service (PMS) that has been modelled based on ISO IDMP (Identification of Medicinal Products), managing medicinal products for humans and veterinary use. However, PMS is slightly smaller than the full ISO IDMP. The UPD now mandates fields and entities that largely fall within the scope of PMS. However, there are a few exceptions required in the UPD that are not covered under PMS such as volume of sales or variations not requiring assessment.

So, what is the suggested content of the UPD?

The UPD has been designed to simplify data sharing from Marketing Authorisation Holder (MAH) via regulators to patients. With that in mind, for veterinary medicinal products the following data fields are considered:

  1. name of the veterinary medicinal product;
  2. active substance(s) and strength;
  3. summary of product characteristics;
  4. package leaflet;
  5. the assessment report;
  6. manufacturing sites;
  7. the dates of the placing of the veterinary medicinal product on the market.

For homeopathic veterinary medicinal products, the data fields are as follows:

  1. name of the registered homeopathic veterinary medicinal product;
  2. package leaflet; and
  3. manufacturing sites.

Furthermore, veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6) are also managed in the UPD.

Last but certainly not least, the annual volume of sales and information on the availability for each veterinary medicinal product is also managed in the UPD. This point is one that needs urgent attention from MAHs as this data has to be collected in the relevant Regulatory Information Management (RIM) systems. Further details on the format of the data to be collected can be found in EMA/CVMP/586518/2019.

What about other UPD stakeholders?

The Federation of Veterinarians of Europe (FVE) for example describes the UPD as the most important tool to increase availability of veterinary medicines for practitioners, mainly because it allows searching for veterinary products EU wide in case no suitable treatment can be found nationally (FVE/20/doc/055, August 2020). The FVE also made some interesting suggestions including the point that all veterinary products should be entered into the UPD no later than January 2022 to avoid the current status of the EudraPharm Veterinary Database, which is still seen as incomplete.

One other interesting suggestion from the FVE is to state strongly that “The Union product database must avoid duplicate input of data in different Union systems.” Moving away from ‘The Union product database should be developed…” clearly demonstrates the desire to reduce data duplication. Now why should this remind me of the “Single Place of Truth”® for Regulatory Information Management?

In summary

The Union Product Database has been welcomed by many and will certainly improve the safety, availability and maintenance of veterinary medicinal products in the EU. Furthermore, with the implementation of the NVR, of which the UPD is a pivotal part, administrative burden on MAH and regulators will be reduced although some additional information such as sales data will be required. I am looking forward to seeing more detailed UPD implementation guide in due course.

Please feel free to contact us if you require further information.

EMA provides latest on Article 57

Action required before end of January 2021.

Since 1 February 2020, when the United Kingdom withdrew from the European Union (EU), the UK has become a ‘third country’ as far as the EU is concerned. A withdrawal agreement has provided direction for the transition period, ending 31 December 2020 (European Commission, Notice to Stakeholders, 13 March 2020). At the end of the transition period, the EU rules for medicinal products will no longer apply to the UK.

What about the impact on Marketing Authorisations?

The UK leaving the EU has, of course, an impact on Marketing Authorisation Holders (MAHs). One example being that according to Article 2 of Regulation (EC) No 726/2004, the MAH must be established in the EU. Not a major impact on multinational companies, but what about a Small to Medium Enterprise (SME)? At the end of the transition period, an MAH from the UK must have the marketing authorisation transferred to an MAH in the EU with an impact, for example, on labelling and packaging.

What about access to EU databases?

On 16 October 2020 the European Commission published Commission Decision C(2020)7126, granting the United Kingdom (in respect of Northern Ireland) access to databases established under EU law. Besides information about agriculture, energy or tax, the decision also outlines database access for the pharmaceutical sector.

So, what will change?

Under section “Medicinal Product”, the European Commission outlines access to Eudralink (full access), EudraNet (partial access) but also Extended EudraVigilance, Article 57 (XEVMPD) with read only access for medicinal products authorised in Northern Ireland.

Moreover, on 1 December 2020 the EMA posted an updated guidance document EMA/520875/2020 on the impact of Brexit, especially with regards to Article 57 and the steps required by MAHs. MAHs will be able to amend EVMPD data from 15 December 2020 with review and updates of records to be finalised by end of 2020. Even with the extended deadline of 31 January 2021, the time for MAHs to act will be very short.

So what action is required by MAHs?

Maintenance of records for medicinal products outside the EEA in Article 57 database is voluntary. MAHs with medicinal product records currently referencing ‘United Kingdom (GB)’ as the ‘Authorisation Country Code’ should review their product data in the Article 57 database and, for products that will continue to be authorised by the UK with respect to Northern Ireland after 31 December 2020, change the country of authorisation to ‘United Kingdom (Northern Ireland)’ with the assigned country code ‘XI’.

The authorised medicinal product (AMP) records should be updated by submitting an extended EudraVigilance Medicinal Product Report Message (XEVPRM) with operation type ‘Update’ for the relevant EV Codes. It is worth reminding MAHs that it is their responsibility to ensure that their records in the Article 57 database are accurate.

In summary

With the UK leaving the EU, many MAHs will be required to update their medicinal product information, whether via XEVPRM messages or Variations. With an impact on product licenses, labelling and packaging, stakeholders are advised to take all necessary steps to account for the UK being outside of the EU regulatory system for medicinal products at the end of the transition period.

If you require further information, please do not hesitate to get in touch.

uNcoVeR the EU’s New Veterinary Regulations

Uncovering the New Veterinary Regulations (NVR) EU 2019/6 for Regulatory Information Management (RIM) is not quite straight forward. The NVR will become applicable from 28th January 2022, bringing additional burden but also benefits to the veterinary industry. It contains new measures for increasing the availability and safety of veterinary medicines and is one of the biggest changes to European veterinary regulations for a very long time.

Let’s have a look at the main objectives of the NVR 

  • Simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines; this will be welcome news specifically for all regulatory departments;
  • Stimulate the development of innovative veterinary medicines; certainly welcome by everybody dealing with or concerned about animals;
  • Improve the functioning of the internal market for veterinary medicines;
  • Strengthen EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals.

What are the key benefits of the NVR?

  • Increased availability and access to safe and high-quality veterinary medicines; probably the most important benefit of the NVR for everybody concerned about animal welfare;
  • Reduced administrative burden and better incentives for pharmaceutical companies developing new and innovative veterinary medicines; although a benefit not immediately seen by the public, any reduction in administrative work will finally filter through the medicinal product life cycle;
  • New and enhanced rules to keep antimicrobials effective.

But what does it all mean to Marketing Authorisation Holders (MAH)?

There are clear wins for MAHs such as the removal of renewals as veterinary medicinal products will be valid for an unlimited period of time. The benefit will be that even if products are not marketed for a long time, marketing authorisations will not lapse. Please note that there are exceptions to this rule.

Other changes include that MAHs registering marketing applications for generic veterinary medicinal products are not required to submit documentation on safety and efficacy (as long as certain criteria are met). This will streamline the marketing authorisation process for Generics and benefit animals and animal owners alike.

What about variations though?

Variations are another area that has been simplified. From Type Ia/Ib and Type II to two simple types of variations: variations that require assessment and variations that do not. The EMA gave recommendations on the list of variations not requiring assessment (EMA/CVMP/263581/2019) based on the following criteria, listed in Article 60(2) of Regulation (EU) 2019/6:

  • the need for a scientific assessment of changes in order to determine the risk to public and animal health or to the environment;
  • whether changes have an impact on quality, safety or efficacy of the veterinary medicinal product;
  • whether changes imply no more than a minor alteration of the summary of product characteristics;
  • whether changes are of an administrative nature.

What does it mean for Regulatory Information Management though?

Changes even to variations that do not require assessment still have to be recorded in the Union Product Database (UPD), one of the major additions coming with the NVR. RIM solutions have to be adapted to cater for a change in handling variations, license validity and most of all the UPD itself. Furthermore, new data fields will be required to comply with latest regulations. The ability to collect annual volume of sales and information on product availability are only two examples. IDMP and SPOR are already advancing for management of the human medicinal product life cycle. The veterinary medicinal product life cycle would certainly benefit from using a similar, if not the same approach although it is already known that certain data fields are not covered by either.

So what next?

I consider the least favourite option to be doing nothing. The NVR will come, and it will come quickly. Adapting to new regulations is never straight forward and the NVR is no exception. Processes have to change to cater for a change in handling variations and additional data fields need to be implemented to be able to feed into the UPD. The time frame for NVR implementation is short and MAH are advised to act promptly.

Regulatory Information Management (RIM) for Veterinary

With the new veterinary regulations Regulation (EU) 2019/6 coming into effect in January 2022,isn’t it time to look at the benefits of streamlining veterinary product management?  Wouldn’t it be beneficial to get support for submission planning, drill deep down into data using Analytics, minimise manual more error prone tasks and at the same time increase efficiency and data quality?  Many pharmaceutical companies have implemented Regulatory Information Management (RIM) solutions, benefitting from improved business processes, data sharing (specifically across different business units) and shortening their timelines to submit marketing applications.  Why should companies manufacturing and managing veterinary products not be able to achieve the same?

For some time, VNeeS has been the preferred submission format in Europe with the latest guidance version 2.7 to be implemented in October 2020.  Already, with the implementation of Step 7, the VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, GL53) provided details of recommended electronic file formats.  In contrast to the eCTD (electronic Common Technical Document) for human drugs, PDF/A has been favoured.  PDF/A is an ISO standardised version of PDF (Portable Document Format), especially used for archiving electronic documents; however, PDF/A prohibits features such as external content references and encryption.

Regulatory Information Management can of course assist during the process of document creation, management and archiving, whether these documents are PDF/A or any other format. This already provides benefits of a single place of access across business functions, the ability to use and harmonise document structures, as well as data security. The real advantages though come from the ability to plan and manage the entire submission lifecycle via project templates, increase data consistency via the ‘single place of truth’ and synchronise business processes via the use of technology. Moreover, with management of multiple species per product and the addition of medical devices for animals, Regulatory Information Management suddenly becomes a viable option for companies that would like to increase their productivity. RIM can assist with secure data access, management of global product portfolios and task automation to bring life saving products to the market faster.

 Samarind RMS is one of these options.

Please feel free to contact us with any questions or if you require further information.