During August and September, the EMA has published updates relating to the following topics:
eSubmissions
- Updated: VNeeS Q & A (Link) and FAQ relating to PDF/A (Link)
- VNeeS checker (v2.5b) entering into force January 2018 – updated information on website of France (Link) and Belgium (Link)
Updated Q & A pages
- GMP: How can a GMP non-compliance statement be lifted? (Link)
- MA transfers: Can I change the name of a medicinal product as part of a transfer application? (Link)
Guidance documents
- Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action – published together with overview of comments (Link)
Other news
- Zinc oxide Article 35 referral - updated documents and Q & A (Link)
- New leaflet published - “Better veterinary medicines for healthier animals and people” (Link)
- Updated organisation chart for the Veterinary Medicines Division (Link)
