Direcção-Geral de Veterinária

Veterinary Medicinal Products (VMP)

Variations

1. Applicable legislation and community texts

. Decreto-Lei n.º 148/2008, de 29 julho, alterado pelo Decreto-Lei n.º 314/2009, de 29 out.

. Commission Regulation (EC) n.º 1234/2008, of 24 nov.

. Normas referentes às alterações aos termos das autorizações de introdução no mercado por procedimento nacional.

. Formulários para pedidos de alteração aos termos da AIM (see template)

. Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) n.º 1234/2008 of 24 november, concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.

- http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/betterreg/pharmacos/procedural_guideline_adopted.pdf

. Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

- http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/betterreg/pharmacos/classification_guideline_adopted.pdf

. Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure

. Please see - templates http://esubmission.ema.europa.eu/eaf/

2. Language

For all procedures, Portuguese is mandatory for the letter of access, for the variations format and for the SPC and literature, if necessary.

For MRP and DCP, literature in Portuguese should only be sent at the end of the procedures, by e-mail.

3. Copies

Type IA national and MRP variations when Portugal is CMS

1 CD-Rom - with the complete information including the “Variations format“ (Formulário para pedidos de alteração aos termos da AIM ) in portuguese.

or, the following paper copies:
Complete application (original) x 1 + Variation form, in portuguese x 1

Part IB, if necessary, in portuguese x 1

All other variations (Type IB national and MRP variations when Portugal is RMS and Type II)

2 CD-Rom - with the complete information including the “Variations format “in portuguese.

or, the following paper copies:
Complete application (original) x 2 + Variation form, in portuguese x 2

Part IB, if necessary, in portuguese x 2

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