Additional DATA requested (1)

RO

Statement of compliance with GMP

X¹³

Statement for the MA transfer to local subsidiary

-

A certified copy of the marketing authorisation  granted by the RMS

X¹³

Contract between marketing authorisation holder ant responsible of batch release/manufacturer/importer

X¹³

Application form signed by the MAH of the first authorisation

-

Legalised statement of acceptance to manufacture, control, … on behalf of MAH signed by QP (authentification of signature and of powers to act as the QP)

-

Method of manufacture

-

Drug substance specification

-

Finished product specification

-

GMP certificate (requested only if the GMP statement is not included in the A.R.)

X¹⁴

The person responsible for placing the medicinal product on the market in France (so called “exploitant” in french) should be specified, knowing that this “exploitant” should be a pharmaceutical site

-

Certificate of analysis (active/non active substance, etc.)

X

EDQM TSE certificate of suitability in case of company renewal application

X

TSE-tables

X¹³

Pharmacovigilance Responsible in National Territory

X¹³

The person responsible for placing the medicinal product on the market in Portugal, so called  “Director  Technico/Qualified Person” should be specified and his pharmaceutical site

-