Variations not requiring assessment

This list shows the variations, the conditions and the documents to be submitted side by side. The legal basis for a VNRA is set out in Article 61 of the Veterinary Medicinal Products Regulation.

Classification of variations not requiring assessment

The following categories of variations not requiring assessment have been described:  

A. Administrative changes;
B. Changes to the quality section of the dossier;
C. Changes in the section of the dossier discussing safety, efficacy and pharmacovigilance;
D. Changes in the section of the dossier discussing the vaccine antigen master file. 

Category B is by far the largest of these categories. 

Variations not described in Implementing Regulation (EU) 2021/17

If the variation you would like to submit is not described in Implementing Regulation (EU) 2021/17, you must always apply for a variation requiring assessment.

However, if the variation should be classed as a VRNA in your opinion, please submit a request to this end to the CMDv. 

The CMDv Best Practice Guides for variations stipulate the following under Not already listed variations: 

• A description of the procedure for requesting advice; 
• A request form for a recommendation on the classification of a not already listed variation. 

• The variation you would like to submit is not described in Implementing Regulation (EU) 2021/17.

The CMDv and the EMA may subsequently decide that a variation not included in the list can be classified as a VRNA. You must wait until the Implementation Regulation has been updated before you can submit this VRNA to the UPD.

Submission of an application

To submit an VNRA, you must enter the variation in the Union Product Database (UPD) yourself. You must do so here, no later than 30 days after the variation has been applied. The change procedure begins on the day you enter the variation in the UPD. You will need to upload the full submission pack. 

The competent authority is not able to ask you for any clarification or additional information or documents. The clock cannot be stopped either. It is also not possible to withdraw the variation. A VRNA can only be approved or rejected. You will receive a notification about this within 30 days. 

Required documents

The Best Practice Guide for variations not requiring assessment tells you what information you need to enter in the UPD. If the SPC, labelling or package leaflet has changed, you must include them with the variation (in all the required languages). The SPC, labelling or package leaflet must be drawn up in accordance with the established format. Further information on the SPC, labelling or package leaflet can be found in the CMDv guidance documents for the SPC, labelling and package leaflet.

Application procedures

You can use the following application procedures to submit a VNRA:

• National procedure; 
• Mutual recognition or decentralised procedure (MRP/DCP); 
• Centralised procedure.

National procedure

If a veterinary medicinal procedure was granted marketing authorisation in the Netherlands via the national procedure, the variation will be approved or rejected by the Veterinary Medicinal Products Unit. This unit will also enter the information in the UPD. In this case, the Veterinary Medicinal Products Unit is the competent authority. 

MRP/DCP

If a veterinary medicinal procedure was granted marketing authorisation via an MRP or a DCP, the variation will be approved or rejected by the Reference Member State (RMS). The RMS will also enter the information in the UPD. In this case, the RMS is the competent authority. 

A CMS must include the definitively approved translations of the SPC, labelling and the package leaflet in the national marketing authorisation within 3 months. 

Centralised procedure

If a veterinary medicinal procedure was granted marketing authorisation via the centralised procedure, the variation will be approved or rejected by the European Commission. The Commission will also enter the information in the UPD. In this case, the Commission is the competent authority. 

For more information about variations, see Variations on the EMA website. 

Approval of variations

When the variation is approved, the competent authority will determine the definitely improved SPC, labelling and package leaflet.

Rejection of variations

The competent authority will inform you that the variation has been rejected. In the case of a rejection, you must undo any changes you have already implemented. You have the option to submit the variation again at a later time, with revised documentation. To do this, submit a new application in the UPD. In some instances you will need to submit the variation as a VRA. 

More information

Further information can be found in the Best Practice Guide for variations requiring assessment. If you have any further questions about VNRA, please contact the Veterinary Medicinal Products Unit.

Important note: The VRNA procedure based on the Veterinary Medicinal Products Regulation is new. Expectations are that the procedures will be clarified further in the period ahead and that Best Practice Guides will be supplemented or amended. The above text will be updated as soon as any developments take place.