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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SPONSOR OF CONGRESSES AND MEETINGS: AIFA REQUIREMENTS

The Marketing Authorization Holder or the pharmaceutical company responsible for the commercialization of medicinal products in Italy, in order to…

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MEDICAL DEVICES: REGULATORY OBLIGATIONS IN ITALY

Medical devices are classified into four classes depending on their characteristics and safety profile (e.g. invasiveness , dependence on a…

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REGULATORY PHARMA NET MANAGING DIRECTOR, ANITA FALEZZA, INTERVIEWED @ TOPRA ANNUAL SYMPOSIUM 2015 – BERLIN

TOPRA’s Annual Symposia – covering pharmaceuticals, veterinary medicines and medical devices – are together the largest forum for European regulatory…

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READABILITY USER TESTING: THE DEADLINE FOR SUBMISSION FOR NATIONALLY AUTHORIZED PRODUCTS IS GETTING CLOSER

For all medicinal products registered in Italy via national procedure, the Marketing Authorization Holder is requested to submit within December…

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