1. Language Parts II, III, IV and answers to any list of questions, should be submitted in Portuguese or English for national procedures (NP) and only in english for MRP and DCP.
For all procedures, portuguese is mandatory for the letter of access and for parts IA (Formulário do pedido de AIM para MV) and IB (Modelos de RCMV, rotulagem e folheto informativo para pedidos por PN, PRM e PD).
For MRP and DCP, Part IB in portuguese should only be sent at the end of the procedures, by e-mail.
1 x 1 CD-rom - with a full complete application (for MR/DCP when Portugal is CMS)
3 x 1 CD-rom - with a full complete application (for national procedures and MR/DCP when Portugal is RMS)
.In case it is not possible to send the application in electronic format, the following paper copies should be sent:
1 x full paper copies (for MR/DCP when Portugal is CMS) 3 x full paper copies (for national procedures and MR/DCP when Portugal is RMS)
. In order to facilitate the distribution of the copies please send the copies divided as follows: 1 box -A - with:
1 complete application (including all parts)
+
part IA + IB in portuguese (for NP) or part I A in Portuguese (for MRP and DCP)
1 box - B - with:
1 complete application (including all parts)
+
part IA + IB in portuguese (for NP) or part I A in Portuguese (for MRP and DCP)
1 box - C - with:
1 complete application (including all parts)
+
part IA + IB in portuguese (for NP) or part I A in Portuguese (for MRP and DCP)
. In case the files do not fit in just one box, they must be divided by other boxes with the following on each box:
. Correspondent letter (A, B, C, D or E)
. Sequential numbering
. Parts included
Example (referring to A):
. Box A n.º 1 – Parts I and Parte IA, in Portuguese x 1
. Box A n.º 2 – Parts II and III IV
. Box A n.º 3 – Part IV
3. 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
4. Responses to questions: Please send us the responses preferably by e-mail or by other electronic means (1 copy).
