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European Medicines Agency - News and Events - Regulatory update ...
www.ema.europa.eu
Marketing authorisation holders intending to submit type IB variations or groupings of type IBs and type IAs in December should liaise with the EMA prior to submission. An email should be sent to: .eu indicating in the subject line: “Type IB December Submission” and mentioning ...
Regulatory information - EMA encourages companies to submit quality...
www.ema.europa.eu
Marketing-authorisation holders intending to submit quality type-IB variations in December should liaise with the EMA prior to submission. Type-I variations are minor changes to the marketing authorisation of a medicine. Type-IAIN and -IA variations have no impact on the quality, safety or efficacy of the medicine.
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