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.