Monthly update on implementation of the New Veterinary Regulation — March 2021
Update of note by the EMA
All four projects under the EMA’s veterinary regulation IT development scheme have now been initiated. The development is proceeding in an ‘agile’ manner. A further release of the Union Product Database (UPD) has been issued on 16 March, and this will be tested by national competent authority users in the coming period.
The HPRA understands that the EMA has developed a new pre-submission (eligibility) request form for marketing authorisation applications for the centralised procedure in respect of new products which are intended to be submitted from 28 January 2022 under Regulation (EU) 2019/6.
The revised QRD template was released for a 7-week public consultation on 29 March. The QRD template, which will come into effect in January 2022, contains a new structure for the summary of product characteristics and the package leaflet. The EMA has also published its fourth Newsletter on the implementation of the NVR.
Update of note by the CMDv
Discussions are ongoing with the EU Commission in respect of the transition of authorisations which fall due for renewal after the date of application of the Regulation on 28 January 2022. A number of guidelines and best practice guides (BPGs) are under development by the CMDv:
Variations classification guideline;
Variations not requiring assessment;
Variations requiring assessment;
Unforeseen variation; and
Allocation of procedure number.
Update of note by the European Commission
The European Commission has stated that although it is currently busy working to complete the 20 or so delegated and implemented acts that must be elaborated before 28 January 2022, there are a further 11 legal acts needed post 2022. These include the rules on the identification code; labelling abbreviations and pictograms; rules for functioning of work-sharing; GMP for veterinary medicinal products and active substances; rules for medicines administered orally via the drinking water or top dressing; list of antimicrobials not to be used off-label; and lists of essential substances for equine and aquatic species.
Update of note by the HPRA
In order to facilitate the interface between the HPRA’s IT platform for processing applications and managing SPCs, the HPRA’s current platform, known as EOLAS, will need to be adapted. Detailed planning for this work is ongoing, and the necessary development will commence shortly. The HPRA expects to commence the uploading of product data to the UPD during the summer.
The HPRA held a webinar for marketing authorisation holders and veterinary manufacturers in respect of changes which are likely to affect them, especially regarding interfaces with the HPRA on regulatory procedures. A recording of this webinar, together with a response to questions raised during the webinar will be uploaded to the HPRA website by 15 April.