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Romania - specific requirements

Regulatory Affairs - Romania

Written by Administrator

Thursday, 19 April 2007

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Romania - specific requirements
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National Medicines Agency of Romania has published country specific requirements for MRP and DCP

Useful information abut specific requirements related to Romania are available.

LANGUAGES TO BE USED FOR DOSSIER, RESPONSES, VARIATIONS AND RENEWALS

National and Mutual Recognition applications

Dossier	CTD	RO
	Module 1.1	RO/EN
Part IA - Format	Module 1.2	RO/EN
Part IB - SPC	Module 1.3.1	RO/EN¹⁵
Part IB – Leaflets & Labels	Module 1.3.2 – 1.3.4	RO/EN¹⁶
	Module 1.4	RO/EN
	Module 1.5	RO/EN
	Module 1 - Annex	RO/EN
Part IC – Expert Reports	Module 2	RO/EN
Part II	Module 3	RO/EN¹⁷
Part III	Module 4	RO/EN
Part IV	Module 5	RO/EN
Written responses		RO/EN
Variations
Application form
Type I Documentation		RO/EN
Type II Documentation		RO/EN
Written responses		RO/EN
Renewal		RO/EN

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¹⁵ EN for MRP/DCP and RO for national procedures. An electronic version (EMEA template) is also required

¹⁶RO for Module 1.3.2 and Module 1.3.3 and EN for Module 1.3.4

¹⁷ An electronic copy, preferably in word format is also required

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