News updates from EMA in August and September

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)