MEDICAL DEVICES – NEW CLASSIFICATION REQUIREMENTS ACCORDING TO EUROPEAN REGULATION 2017/745
The European regulation 2017/745, that will become effective in May 2020, introduces several new requirements with an impact on several…
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IMPLEMENTATION OF A NEW VERSION OF THE OsSC PLATFORM FOR THE SUBMISSION OF CTAs AND AMENDMENTS IN ITALY
Changes in the management of Clinical Trial Applications and amendments have recently been introduced in Italy. A new version of…
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BREXIT- ARE YOU FULFILLING YOUR TASKS?
Further to the Brexit, all Union laws cease to apply to the United Kingdom from 30th March 2019. The “transition…
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AIFA – ANNUAL FEE 2017: UPCOMING DEADLINE FOR PAYMENT (JULY 31ST, 2018)
We are getting close to the deadline relevant to the payment of the annual fee due to AIFA. Every year,…
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SERIALIZATION: COMMISSION DELEGATED REGULATION (EU) 2016/161
According to the Commission Delegated Regulation (EU) No 2016/161, new measures for the control of medicinal products in Europe have…
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PROMOTIONAL MATERIAL: NEW SUBMISISON PROCEDURE IN ITALY
In Italy, a new submission procedure for the promotional material addressed to healthcare professionals has come into force on June…
READElemental Impurities: risk-based control strategy
The guideline ICH Q3D – GUIDELINE FOR ELEMENTAL IMPURITIES, which is now fully into force (effective for new marketing authorization…
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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745: THE PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
The European regulation 2017/745 of medical devices will become effective in May 2020 and manufactures, authorized representatives, distributors and all…
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NEW LEGISLATION ABOUT COMPASSIONATE USE IN ITALY
The new legislation about “Discipline of the therapeutic use of an investigational medicinal product” (Ministerial Decree September 7, 2017) which…
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NEW EUDRAVIGILANCE VERSION: IMPACT ON THE ITALIAN PV SYSTEM
On November 22nd, 2017 EMA will launch a new and improved version of EudraVigilance. This will have impact also to…
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