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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NEW REGISTRATION OF MEDICINAL PRODUCTS IN COUNTRIES NOT BELONGING TO ICH REGIONS

The new registration of medicinal products in countries not belonging to ICH (International Conference on Harmonization) Regions is a challenging…

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THE LEGAL BASIS OF A MARKETING AUTHORIZATION APPLICATION AND THE PAEDIATRIC REGULATION

Even if for most of applications the definition of the legal basis appears to be quite obvious, the choice can…

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