CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have been included in the relevant list of the Consolidated Text on drug substances
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new digital channels
Payback for medical devices: on June 28 Italian parliament approved the Law which, among other things, extends the deadline for the payment of the amount reduced by 52% from June 30th to July 31st.
Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, implementing Lgs. D. 137/2022, were published on 13 and 14 June.
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical devices entered into force following publication on EU's Official Journal
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization procedure and (iii) regulate the transitional period for evaluation activities
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published in the Official Gazette
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazette
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation (EU) 2017/745 (MDR) across the European Union.
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional provisions of Article 120(3) of the MDR.
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
Clinical Trials Regulation - European Commission updates the Questions and Answers Document
Clinical trials Regulation: AIFA endorsed a proposal for the temporary administration of trials pursuant to the CTR, pending the publication and full implementation of the ministerial decrees on the reorganization of ethics committees and single tariff
The Regulation amending Regulation (EU) 2017/746 as regards new transitional provisions for certain IVDs and the deferred application of conditions for in-house devices has now been published