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Marketing authorisation

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The medicinal products are subject to changes throughout their regulatory lifetime in order to be kept always up-to-date. Those changes must be authorised by INFARMED, I.P. and follow standard procedures designated by variations to the terms of marketing authorisation.

The Commission Regulation (EC) No. 1234/2008 of 24 November 2008, concerning the examination of variations to the terms of marketing authorisations, amended by the Commission Regulation (EU) No. 712/2012 of 3 August 2012, intended to establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public health protection.This regulation is applicable to variation applications submitted by centralised procedure and mutual recognition/decentralised procedure since January, 1st 2010.

It is not applicable to the transfers of a marketing authorisation.

The Commission Regulation (EC) No. 1234/2008, amended by the Commission Regulation (EU) No. 712/2012, is also applicable to the national procedure from August, 4th 2013. Until August, 3rd 2013, variations applications by national procedure should be submitted in accordance with the Decree Law No. 176/2006, from August 30th, republished by the Decree Law No. 20/2013, from February 14th.

 


The purpose of this document is to clarify aspects related to the submission to Infarmed of variation to the terms of Marketing Authorisations (MAs) by national procedure and by Mutual Recognition and Decentralised procedure after 4th August 2013, and it should be used as a supplement to the European Commission Guidelines. 

 

 

Frequently Asked Questions -  Variations to the terms of marketing authorisations (MA) for medicinal products when Portugal acts as reference Member State (PT - RMS) or as concerned Member State (PT - CMS)

 

Variations submitted before August, 5th 2013 (except type I variations by national procedure) will continue to be managed outside the scope of the eletronic portal, therefore submission of supplementary information (namely responses to RSI) should be made in accordance with the requirements detailed in CMDh Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for Variations and Renewals within MRP or National procedures

From August, 5th 2013 all types of national and MR/DC variation applications (Type IA, IAIN, IB, II, grouped applications and worksharing procedures) should be submitted only via Infarmed's electronic portal for management of medicinal products for human use (SMUH) in particular, SMUH-ALTER for submission of variations to existing marketing authorisations. 

Additionaly, applications for renewals, MAH transfers and update of labelling and/or PIL not related with the SPC must be submitted exclusively and mandatorily through the same eletronic plataforma (SMUH-ALTER) from February 1st 2017.

The payment of fees applicable to these applications will be integrated into the new SMUH-ALTER portal. MAHs are advised to carefully read the instructions on this topic which will be made available by Infarmed at the appropriate time.

Electronic submission

Electronic submission of renewals, transfer of MAH and changes to the labelling or the package leaflet not connected with the SmPC - Instructions to applicants for submitting variations, renewals and transfer of MAH.

Applications for update of manufacturing flowchart in Infarmed's Database

On June, 24th 2013 a new version of the portal for submission of applications for update of manufacturing flowchart as registered in Infarmed's database will be available. 

This new version allows the update of information on the manufacturing flowchart formedicinal products authorised by national, mutual recognition and decentralised procedures.

Marketing authorisation holders should access to the new portal and check the information on the manufacturing flowchart in accordance with Infarmed's database, and if applicable submit the application to update the information. The relevant supporting documents, namely proof of the correct manufacturing flowchart as authorised by Infarmed, should be submitted with the application. 

Marketing authorisation holders should be aware that the existence of information not up-to-date in Infarmed database regarding the manufacturing flowchart of medicinal products may result in limitations in the submission of online variation applications affecting the manufacturing flowchart.

Applications for update of manufacturing flowchart in Infarmed's Database

Online Registration of Users of the Electronic System for the Management of Medicinal Products of Human Use (SMUH)

Request for Transfer of marketing Authorisation Holder

The current Marketing Authorization Holder should present the following documentation at the transfer request:

  • Cover letter addressed to the President of The Executive Board of Infarmed, I.P., signed by the current Marketing Authorization Holder (or its legal representative).
  • If applicable, letter of authorization for communication on behalf of the current Marketing Authorization Holder (Power of Attorney).
  • Document referring the name of the medicinal product concerned by the transfer, the national authorization numbers and the date on which the Marketing Authorization was granted.
  • Document referring the identification (name and address) of the current holder of the Marketing Authorization and the identification (name and address) of the proposed person/holder to whom the transfer is to be granted, signed by both holders.
  • Document certifying that the complete and up-to-date file concerning the medicinal product has been made available to the person/holder to whom the transfer is to be granted, signed by both holders.
  • Document stating the proposed date (dd-mm-yyyy or immediately after approval) on which the person/holder to whom the transfer is to be granted can actually take over all responsibilities as Holder of the Marketing Authorization for the medicinal product concerned, signed by both holders.
  • Document identifying the Qualified Person for Pharmacovigilance (QPPV) and the local contact (in Portugal) of the proposed Marketing Authorization Holder, together with a curriculum vitae and the address, telephone and fax number, signed by both holders.
  • Document describing the scientific service in charge of information about the medicinal product of the proposed Marketing Authorization Holder, together with a curriculum vitae and the address, telephone and fax number, signed by both holders.
  • Revised product information (SmPC, PIL, Labelling in QRD format - CTD Modules 1.3.1, 1.3.2 and 1.3.3).
  • Document stating that no changes were made in product information (SmPC, PIL, Labelling) besides those concerning to the transfer of the Marketing Authorization Holder, signed by both holders.

 

The calendar for decision is 60 days after receipt of the full documentation and the applicable fee.

Electronic submission

From February 1st 2017, the applications for Transfer of Marketing Authorization Holder (MR, DC and National procedures) must be submitted exclusively and mandatorily through the electronic platform Medicinal Product for Human Use Management System (SMUH-ALTER)  available at Infarmed's website.

For further information regarding Transfer of Marketing Authorization Holder, please contact:

Paula Neto

Tel.: +351 21 798 72 06

E-mail: paula.neto@infarmed.pt or submissao.alteracoes@infarmed.pt

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