This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. It will be updated regularly to reflect new developments, to include guidance on further postauthorisation procedures and to reflect the implementation of the new European legislation.
Revised topics will be marked by “New” or “Rev” upon publication. The Agency emphasises the importance of pre-submission meetings between MAHs and the EMA/(Co-) Rapporteur. The product team is available to address any questions MAHs may have regarding a particular upcoming post-authorisation applications. Where appropriate, a pre-submission meeting could be organised at the Agency in order to obtain further procedural and regulatory/legal advice.
This guidance information and fruitful pre-submission dialogue between MAHs and the Agency should enable MAHs to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated and processed promptly.
In addition, MAHs are strongly recommended to inform the Agency and (Co-) Rapporteur of all upcoming post-authorisation submissions for the following 6-12 months, in order to allow optimal planning, identification of procedural issues and handling of overlapping applications.
Note:
It should be highlighted that this document has been produced for guidance only and should be read in conjunction with "The Rules governing Medicinal Products in the European Union, Volume 2, Notice to Applicants".
MAHs must in all cases comply with the requirements of EU Legislation. Provisions, which extend to Iceland, Liechtenstein and Norway by virtue of the EEA agreement, are outlined in the relevant sections of the text.
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