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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.

CONTACT POINTS:

1. IMMUNOLOGICALS

MRP and DCP

Marketing Authorisations
Dr. João Pedro Duarte da Silva
joao.silva@dgav.pt

Variations
Dra. Filipa Faria
filipafaria@dgav.pt


Renewals
Dr. Henrique Costa
henrique.costa@dgav.pt

National Procedures
Dr.ª Inês Dias
idias@dgav.pt

2. PHARMACOLOGICALS

MRP and DCP

Marketing Authorisations
Dr. João Pedro Duarte da Silva
joao.silva@dgav.pt

Variations
Dra. Filipa Faria
filipafaria@dgav.pt

Renewals
Dr. Henrique Costa
henrique.costa@dgav.pt


National Procedures
Dr.ª Inês Dias
idias@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: 2017-05-25

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