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November 5, 2021 Agency Alerts

EMA to Marketing Authorization Holders (MAHs): Submit Type I Variations for 2021 by end of Month


On Friday, October 29, 2021, the EMA published a statement providing marketing authorization holders (MAHs) recommended submission dates for 2021 variations in order to meet the regulatory deadlines.

What are Type I Variations?

Type I variations “are minor changes to the marketing authorization of a medicine.” Type IAIN and IA variations have no impact on the quality, safety, or efficacy of the product. For type IA variations, MAHs are not required to notify the EMA or national competent authority immediately. In the case of most type IA variations, MAHs need to notify the national competent authority or EMA within 12 months of implementation. However, type IAIN variations do require notification immediately following implementation. These variations require immediate notification so that the national competent authorities and/or EMA can ensure the product is continuously supervised.

For type IB variations, the marketing authorization holder must notify the national competent authority or EMA prior to the variation’s implementation. However, type IB variations do not require formal approval. In its statement, EMA notes that, “upon acknowledgement of receipt of a valid notification, the marketing authorization holder must wait for a period of 30 days to ensure that the notification is deemed acceptable by the national competent authority or EMA before implementing the change.”

EMA Advise Regarding the Submission of Type IA Variations for 2021

In its statement, EMA advises marketing authorization holders to submit type IA and type IAIN variations for 2021 by Tuesday, November 30, 2021. This recommendation comes as EMA prepares for its upcoming closure from December 23rd, 2021, through January 3rd, 2022. Receiving all 2021 variations by the end of November “will enable EMA to acknowledge the validity of the submissions” within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

EMA’s Recommendations for When to Submit Type IB Variations for 2021

With regard to any type IB variations or groupings of type IBs and type IAs, the Agency is recommending MAHs to file all submissions no later than December 3rd in order for EMA to start the procedure in 2021. Furthermore, EMA notes that any submission received on or after December 6th, the Agency cannot guarantee the procedure will begin prior to January 2022.

What about Variations for Veterinary Medicines?

In last week’s statement, EMA advised MAHs of veterinary medicines “to submit type IB and type IA variations for assessment under Commission Regulation (EC) No 1234/2008 no later than 20 January 2022, to ensure that the validation is completed on or before 27 January 2022.” Furthermore, the Agency points out that any type IB variation that has not been validated before January 27, 2022 may require as a variation requiring assessment under Regulation (EU) 2019/6. For additional guidance and information regarding which variations require assessment and which do not, view EMA’s recent guidance document.

ProPharma Group: EMA Regulatory Submission Experts

Do you need to submit your 2021 variation to EMA in the coming weeks? Are you still in the process of putting the submission together? Maybe you haven’t started yet and need to hit the ground running to meet the impending deadlines. Regardless of where you are in the process of developing your variations, time is of the essence. However, compromising the quality of your submission because you’re rushing could be disastrous for your product at this point. We can help you avoid making mistakes and ensure your variation meets with all regulatory requirements and is submitted to EMA on time.

Interested in learning more? Contact us today to find out how we can help not only your EMA submissions, but all of your global regulatory needs.


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