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Veterinary medicinal products (VMP)

Requirements for VMP applications





- REQUIREMENTS FOR NATIONAL AND MUTUAL RECOGNITIONS VMP APPLICATIONS

     
 

For all procedures if necessary - SPC, labels and leaflet:
Prior to the authorisation, proposed texts of the SPC, labels and leaflet in portuguese (and english if necessary) and proposed mock-ups in portuguese, should be sent in electronic format.
. The template for NP, MRP and DCP should be used.
 

Responses to questions:
Please send us the responses preferably by e-mail or by other electronic means (1 copy).
  

FEES:
  
. AMOUNT DUE FOR APPLICATIONS (please see Fees Document)

. More Frequent Fees for MRP and DCP when Portugal acts as CMS

. METHOD AND TIME OF PAYMENT (please see Payment Document)

. Proof of payment must quote the Decreto-Lei n.º148/2008, of july29, alterado pelo Decreto-Lei n.º314/2009, of october 28, the name of the veterinary medicinal product, the type of application (MA, Type I variation… etc.) and, in case of MRP/DCP, the MRP/DCP application number.

- PORTUGAL CONTACT POINTS


   PORTUGAL CONTACTS:


National procedures
(MA, Renewals and Variations)

For all National procedures is the same email:
national@dgav.pt



   MUTUAL RECOGNITION / DECENTRALIZED PROCEDURES

For general issues


Portugal as RMS:
MA, Renewals and Variations
:
rms@dgav.pt
PT CMS:
MA: aim.cms@dgav.pt
Renewals: ren.cms@dgav.pt
Variations: var.cms@dgav.pt

Advice on MRP/DCP procedures


Portugal as RMS:
MA, Renewals and Variations
:
rms@dgav.pt
PT CMS:
MA: aim.cms@dgav.pt
Renewals: ren.cms@dgav.pt
Variations: var.cms@dgav.pt


Submission of new applications (PT as RMS or CMS) or Submission of renewals or variations (PT as RMS)

rms@dgav.pt


Submission of renewals (PT as CMS)

ren.cms@dgav.pt


Submission of variations (PT as CMS)

var.cms@dgav.pt


Issues regarding the naming of the VMP

rms@dgav.pt

Submission of electronic response documents during MRP/DCP procedures


Portugal as RMS:
MA, Renewals and Variations:
rms@dgav.pt
PT CMS:
MA: aim.cms@dgav.pt
Renewals: ren.cms@dgav.pt
Variations: var.cms@dgav.pt

Submission of translations in MRP/DCP procedures


Portugal as RMS:
MA, Renewals and Variations:
rms@dgav.pt
PT CMS:
MA: aim.cms@dgav.pt
Renewals: ren.cms@dgav.pt
Variations: var.cms@dgav.pt

Labelling and mock-ups, multilingual packs


Portugal as RMS:
MA, Renewals and Variations:
rms@dgav.pt
PT CMS:
MA: aim.cms@dgav.pt
Renewals: ren.cms@dgav.pt
Variations: var.cms@dgav.pt

Address for advice on fees & terms of payment


Portugal as RMS:
MA, Renewals and Variations:
rms@dgav.pt
PT CMS:
MA: aim.cms@dgav.pt
Renewals: ren.cms@dgav.pt
Variations: var.cms@dgav.pt

Request for EU ASMF number


jpsilva@dgav.pt

Technical validation of e-Submissions


Portugal as RMS:
MA, Renewals and Variations:
rms@dgav.pt
PT CMS:
MA: aim.cms@dgav.pt
Renewals: ren.cms@dgav.pt Variations: var.cms@dgav.pt

EU borderline network contact points


ines.almeida@dgav.pt




General information:

Direção-Geral de Alimentação e Veterinária - DGAV
Divisão de Gestão e Autorização de Medicamentos Veterinários- DAGMV
Teleph. - +351 213 239 500
Telefax - +351 213 463 518




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Update on: 2018-12-14

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