Module 18 2021

07/02/2021

EMA consultation procedures

• The EMA is the CA for substances derived from human blood or human plasma or that fall under the scope of the Centralised procedure. • NBs may consult the EMA for other substances • e.g. if the Agency has already evaluated a medicine containing the same drug substance. • For a new MD, the NB acts as the applicant on behalf on device manufacturer in an initial consultation procedure with EMA. • It should provide an 'intention to submit' letter, preferably at least six months before it expects to submit the application.

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EMA consultation procedures

• When changes are made to an ancillary substance for which EMA has already given an opinion, in particular to its manufacturing process, the NB should consult the Agency to confirm that quality and safety are maintained. • This is called a post-consultation procedure with EMA.

The Organisation for Professionals in Regulatory Affairs

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