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National and Mutual Recognition Procedures: “additional data” requested

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	-

………………….

………………..

¹³ In separate folder

¹⁴ For all sites involved in the process, requested only if the GMP statement is not included in the Assessment Report. All documents not enclosed in the dossier at the time of submission must be supplied in original or legalized copy

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