Pilot Voluntary Harmonisation Procedure project for the joint assessment of Clinical Trial Applications by AIFA and the Ethics Committees in Italy

The Voluntary Harmonisation Procedure (VHP) is a harmonised procedure for assessing multinational clinical trials (involving 2 or more member states)…

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THE LINGUISTIC REVIEW PROCESS OF PRODUCT INFORMATION FOR CENTRALLY AUTHORISED MEDICINAL PRODUCTS

To ensure high quality and consistent Product Information (PI) of centrally authorised medicinal products in the Member States of the…

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EMA’s PRIME scheme: early dialogue on PRIority MEdicines for the patients

On 1st June 2016 the European Medicines Agency (EMA) released the outcome of the assessment of the first group of…

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RECALL PROCEDURE IN ITALY

When a recall procedure is required due to quality product defects, the Company GMP Qualified Person must inform immediately AIFA…

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REGULATORY PHARMA NET EXHIBITS AT DIA EUROMEETING 6-8 APRIL 2016, HAMBURG, GERMANY

RPN will exhibit at DIA EuroMeeting which will be held in Hamburg. You are warmly welcome to visit our booth…

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UNIFARM DATABASE FOR THE FULFILLMENT OF THE BILINGUAL REQUIREMENT IN THE ITALIAN PROVINCE OF BOLZANO

According to the Italian Decree n. 219/2006 (implementing 2001/83/EC Directive and following amendments), at least the information reported in the…

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PROMOTIONAL MATERIAL OF MEDICINAL PRODUCTS

In Italy, the promotion of medicinal products to the public and to healthcare professionals is regulated by legislative decree 219/06….

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REGULATORY PHARMA NET AWARDED RENEWAL AND EXTENSION OF ISO 9001:2008 CERTIFICATION

Regulatory Pharma Net has just obtained the renewal of the UNI EN ISO 9001:2008 certification for the quality management system…

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PHARMACOVIGILANCE FLOW IN ITALY

The Italian pharmacovigilance system is based on the National Pharmacovigilance Network (RNF), which guarantees the collection, management and analysis of…

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VARIATIONS WITH IMPACT ON PIL/LABELLING TEXTS: SELLING OUT OF STOCKS OF MEDICINAL PRODUCTS

According to AIFA disposition n. 371 dated April 14th 2014, in the case of variations with impact on Package Information…

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