Update of product information for veterinary medicinal products in line with version 9 of the QRD template
According to Article 152 of Regulation (EU) 2019/6, product information for all veterinary medicinal products granted marketing authorization under Directive 2001/82/EC must comply with version 9 of the QRD template. Marketing authorisation holders are kindly reminded of their obligation to ensure that their veterinary medicinal products comply with Article 152 of Regulation 2019/6 by January 30, 2027.
A variation requiring assessment under the classification G.I.18 should be submitted to harmonise the product information text with version 9 of the QRD template.
To facilitate the timely assessment of variations aiming to update the product information to QRD template version 9, marketing authorisation holders are kindly requested to:
- Include only changes to the product information texts that are strictly related to the update to version 9 of the QRD template. Other changes to the texts will not be accepted under the G.I.18 variation.
- Only include editorial changes to the product information texts where necessary (e.g. to reduce the risk of confusion and/or medication errors).
- Provide working documents of the product information texts with all proposed changes in tracked changes.