New AIFA Regulation: where are we?
Almost one year after the publication of the relevant law, the long-awaited reorganisation of the Italian Medicines Agency (AIFA) seems…
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PERIODIC SAFETY UPDATE REPORTS (PSURs) ACCORDING TO REGULATION (EU) 2017/745 (MDR)
The MDR requires manufacturers of class IIa, class IIb, and class III devices to prepare and submit a Periodic Safety…
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ADVERTISING ON SOCIAL MEDIA: UPDATED GUIDELINE IN ITALY
On July 21st this year the Italian Ministry of Health (MoH) released a new guideline about the use of social…
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The Revolutionary Role of Artificial Intelligence in Medical Devices
Artificial Intelligence (AI) has been a true revolution in many sectors, but perhaps one of the most promising is that…
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MDR: EXTENSION OF TRANSITIONAL PERIOD FOR LEGACY MEDICAL DEVICES
With the publication in the Official Journal of the European Union, the amendment to Regulations (EU) 2017/745 and (EU) 2017/746…
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ENVIRONMENTAL LABELLING OF PACKAGING: REQUIREMENTS FOR COSMETIC PRODUCTS
In September 2020, Legislative Decree No. 116 of 3 September 2020 was published in the Italian Official Journal (IOJ), in…
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ALTERNATIVE APPROACH FOR CARCINOGENICITY TESTING OF PHARMACEUTICALS IMPLEMENTED AS ICH S1B(R1) ADDENDUM
The ICH S1B(R1) Guideline provides international regulatory guidance on approaches for evaluating the carcinogenic potential of small molecule pharmaceuticals. An…
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ELECTRONIC PRODUCT INFORMATION (ePI)
The European Medicines Agency (EMA) and its European medicines regulatory network partners are working to enable the use of electronic…
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BILINGUALISM REQUIREMENT FOR MEDICINES IN THE PROVINCE OF BOLZANO AND POSSIBLE EXEMPTIONS
The Italian Decree n. 219/2006 (implementing 2001/83/EC Directive and following amendments) establishes that at least the information reported in the…
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CRITERIA FOR MARKETING AUTHORIZATION (MA) NUMBER(S) ASSIGNMENT BY AIFA IN THE CONTEXT OF NEW MA/EXTENSION OR VARIATION APPLICATIONS
The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has provided Marketing Authorization Holders (MAH) with the criteria used to…
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