Guidance to applicants - Submission of Marketing Authorisation Applications
approved by Executive Board of INFARMED, I.P. Deliberation nr 186/CD/2013 (dated 24/10/2013)
Eletronic pre-submission of MAA
A new version of INFARMED¿s electronic portal for management of medicinal products for human use for pre-submission of MAA (SMUH-AIM) will be made available on October, 21st 2013.
The new version of the electronic portal will allow pre-submission of marketing authorisation applications to INFARMED, I.P. by national and mutual recognition/decentralised procedures, including pre-submission of MR or Repeated Use procedures wherePortugal acts as Reference Member State (for which preparation of assessment report is required previously to the European procedure).
All MAA by national and mutual recognition/decentralised procedures must be pre-submitted in the new portal. However, for MR/DC procedures a transitional period will be considered and submission in the portal is only mandatory afterNovember, 4th 2013.
The payment of fees applicable to MAA will be integrated into the new SMUH-AIM portal and should be made via ATM reference issued in the portal by the applicant. MAHs are advised to carefully read further instructions on this topic which will be made available by Infarmed at the appropriate time.
The documentation supporting the application should be submitted in accordance with the currently applicable requirements, only after pre-submission and confirmation of valid payment of the fee in the online portal.
Applicants who do not have a user/password for access to the current online portal will have to submit a request for user/password in the Online Registration of Users of the Electronic System for the Management of Medicinal Products of Human Use (SMUH).
External User Manual (EN)
The current portal for pre-submission of MAA by national procedure will be unavailable during its replacement with the corresponding updated version (between October 15th, 5 p.m.and October, 21st)
Pre-submission of Marketing Authorisation applications SMUH-AIM (Login)
Submission of MAA
The documentation supporting the MAA should be submitted to Marketing Authorisation Unit of the Medicines Evaluation Department of INFARMED, I.P., only after eletronic pre-submission of the MAA and confirmation of valid payment of fee in the portal.
Requirements on submissions (number and formats) for New Applications within MRP, DCP or National procedures