EUDAMED – REGISTRATION OF LEGACY DEVICES
“Legacy devices” are medical devices, covered by a valid Medical Device Directive certificate (Declaration of Conformity for class I medical…
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DIGITAL APPLICATION DATASET INTEGRATION (DADI) NETWORK PROJECT
The Digital Application Dataset Integration (DADI) is a Network Project led by the EMA to transform and optimise regulatory procedure…
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PUBLICATION OF THE UPDATED AGREEMENT TEMPLATE BY THE NATIONAL COORDINATION CENTER OF ETHICS COMMITTEES FOR CLINICAL TRIALS ON MEDICINES FOR HUMAN USE AND ON MEDICAL DEVICES
The National Coordination Center of Ethics Committees for clinical trials on medicines for human use and on medical devices has…
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SUNSET CLAUSE IN ITALY: CURRENT REGULATION AND EXEMPTION REQUEST
According to the Legislative Decree 219/2006 (art.38), any Marketing Authorisation of National/MRP/DCP medicinal products ceases to be valid: In case…
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PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE FOR MEDICAL DEVICES
The presence of at least a Person Responsible for Regulatory Compliance (PRRC) is one of the new regulatory obligations introduced…
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RARE DISEASES AND ORPHAN DRUGS IN ITALY
On 27th November 2021, a new piece of legislation on rare diseases was published in the Italian Official Journal (Law…
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ADVERTISING OF OTC/SOP MEDICINAL PRODUCTS FOR GENERAL PUBLIC ON SOCIAL MEDIA
The responsible Authority for the evaluation of the advertising concerning OTC/SOP medicinal products on social medial in Italy is the…
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MDCG 2022 – 5 GUIDANCE ON BORDERLINE BETWEEN MEDICAL DEVICES AND MEDICINAL PRODUCTS UNDER REGULATION (EU) 2017/745 ON MEDICAL DEVICES
The Medical Device Coordination Group (MDCG) recently published the Guidance on borderline between medical devices and medicinal products under Regulation…
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RULES AND PROCEDURES TO ACCESS THE AIFA NATIONAL FUND FOR ORPHAN DRUGS
Law 326/2003 provided for the establishment of a national fund at AIFA for the use of “orphan drugs and for…
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PHARMACOECONOMIC AND BUDGET IMPACT ANALYSES SUBMITTED TO AIFA – REPORT 2021
In accordance with the new AIFA Guidelines entered into force on 30 December 2020, the Applicant has to submit pharmacoeconomic…
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