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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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Regulatory News | 24 October 2016 | By Zachary Brennan
The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IAIN and Type IA variations, for 2016 by 30 November.
MAHs are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations in 2016 by 13 December 2016. The deadlines have been set so that EMA can acknowledge the validity of the submissions before the agency's closure between 23 December 2016 and 2 January 2017, and within the 30-day timeframe set by the regulations.
The agency warns that for submissions received on or after 14 December 2016, the acknowledgment procedure may not start until January 2017.
Type IAIN and IA variations have no impact on the quality, safety or efficacy of the medicine. Type IAINmust be sent to the national competent authority or EMA immediately following implementation, in order to ensure the continuoussupervision of the medicine, whereas Type IA variations do not require immediate notification and should be sent to the national competent authority or EMA within 12 months of implementation, or earlier in certain cases.
Type IB variations must be sent to the national competent authority or EMA before implementation, but do not require a formal approval. Upon acknowledgement of a valid notification, the MAH must wait 30 days to ensure that the notification is deemed acceptable by the national competent authority or EMA before implementing the change.
For procedural or regulatory inquiries on these procedures for human medicines, EMA says MAHs can email email@example.com or firstname.lastname@example.org.
Tags: Type I variations, EMA deadlines