Application for Marketing Authorisation and Variations
The new application forms for marketing authorization applications and variations are available at esubmission.ema.europa.eu/eaf/.
Variations not requiring assessment (VNRA)
Variations not requiring assessment have to be submitted and processed directly via the UPD. Currently, there are still technical problems and delays in uploading data. For more information, please visit www.ema.europa.eu/en/veterinary-regulatory/overview/veterinary-medicines-regulation/union-product-database, EMA support can be contacted via the following link: servicedesk.ema.europa.eu/jira/servicedesk/customer/portal/283/user/login. Please bear in mind that such changes can also be submitted up to 30 days retrospectively.
Recently the UPD was developed in order that marketing authorisation holders (MAH) are able to apply for several variations not requiring assessment (VNRA) for several marketing authorisation (MA) called as “technical grouping”. The CMDv has decided a stepwise approach so that only veterinary medicinal products (VMP) belonging to the same range (ex : IT/V/012/001-005) can be technically grouped.
The UPD was also developed to allow the changes related to QPPV and PSMF to be automated. Indeed, the automation of the updates as a result of an approval of VNRAs related to Pharmacovigilance (PhV) (C1, C5 and C6) was released to production. This functionality, that is available for both CAP and non-CAPs products, will allow MAHs to provide the values of the PhV attributes at the time of submission, and once the Responsible authority approves the VNRAs, the system will automatically update the PhV data in the products impacted.
The CMDv has discussed at the December plenary meeting the update of the UPD concerning the information related to QPPV and PSMF for already authorised VMPs. So the CMDv agreed that the technical grouping facilities would be extended to the changes concerning QPPV and PSMF considering that those VNRA are now automated in the UPD.
Moreover, it was also proposed that the technical grouping can only be accepted for VMP from the same MAH with the same Member State as decision making authority for products authorised via MRP/DCP or purely nationally. This means that for those specific changes MAH are allowed to apply for MRP/DCP/SRP AND NAP in a same VNRA provided that the RMS of MRP/DCP/SRP is the same and that the NAPs are authorised in this MS.
The other changes are currently not possible to be handled if VMPs are not from the same range of products.
CMDv would like to thank EMA and all NCAs for their collaboration in achieving this agreement which will contribute to a simplified mechanism for the update of the UPD and the handling of the VNRAs.
Variations requiring assessment (VRA)
Changes requiring assessment (VRA) have to be submitted as usual via CESP and the data are shared with all MS via CTS.
Change of ownership
Information on change of ownership acc. to § 25 AMG can be found here.