The EMA Common Repository has been mandatory for veterinary submissions through the centralised procedure since June 2018 - what does this mean and what difference has it made?
What is the Common Repository?
The European Medicines Agency (EMA) Common Repository has been available for Centrally Authorised Products on the human side since February 2014, and use of it has been mandatory since July 2015. The principle of this system is that the Applicant or Marketing Authorisation Holder (MAH) makes an electronic submission once only, through the EMA’s online ‘Gateway’ portal, and the National Competent Authorities / CHMP / CVMP Members and Alternates then access the data from this single point.
Mandatory use with submissions for Veterinary Medicines
The use of the Common Repository by National Competent Authorities to access submissions for veterinary medicinal products (VMPs) relating to Centralised procedsures is now mandatory (since 1st June 2018). For VMPs authorised Nationally, via MRP or DCP, submission of all dossier types must still be made using CESP, or on CD-ROM according to the Member State Authorities’ preferences. This also remains the case for VMPs authorised via these routes where worksharing procedures handled by EMA involve both NP-DCP-MRP licences and centrally authorised veterinary products (CAPs). However, for CAP-only submissions, the process is now streamlined. For example, whereas previously for initial MAA dossiers the data had to be uploaded to the EMA via the Gateway, to each of the Competent Authorities via CESP or CD-ROM (where the CVMP Members were affiliated with the agency in that territory), and then again separately to the CVMP Members who are affiliated with academic institutions or independent experts, now only a single online upload is required. The common repository is to be used for all types of dossiers relating to CAPs including MAA, variations, MRL applications, PSURs…
Cyton welcomes this initiative for veterinary submissions, as the introduction of the Common Repository has not only reduced the time required for receiving and validating applications by the EMA, but has also considerably reduced time relating to submissions by Applicants.