5
Apr
Regulation (EU) 2023/607 extending CE certificates for medical devices and in vitro devices came into force
Regulation (EU) 2023/607 extended the duration of CE certificates for legacy devices and the relevant period during which such devices can be placed on the market or put into service, previously scheduled to expire on May 26, 2024.
9
Apr 21
Parallel import of medicines: New simplified AIFA procedure for negotiating price and reimbursement
On March 25, 2020, the Italian Agency of Medicines (AIFA) published a resolution on the simplified procedure for negotiating the price and reimbursement of parallel imported medicines.
17
Feb 21
New AIFA guidelines for compiling dossiers for medicine reimbursement and pricing requests effective March 1, 2021
On December 23, 2020, the Italian Agency of Medicines (Agenzia Italiana del Farmaco – the “AIFA”) issued Guidelines for the compilation of the dossier to support the request for reimbursement and pricing of a medicine (“Guidelines”), pursuant to the Ministerial Decree of August 1, 2019 (“Decree”).
1
Dec 20
Court of Justice of the European Union on cannabidiol: CBD is not a narcotic drug and marketing prohibitions must be appropriate to and strictly necessary for protecting public health
On November 19, 2020, the Court of Justice of the European Union (“CJEU”) ruled on cannabidiol (“CBD”) in case C-663/18.
8
Apr 20
COVID-19 emergency: clinical trials and early access to drugs
To address the current emergency caused by COVID-19, several initiatives have been undertaken at the regulatory level to promote and facilitate clinical trials and early access to drugs.
6
Feb 20
Stability Law 2020: news about homeopathic medicines
Stability Law 2020 (Law No. 160 of December 27, 2019) extended the period for homeopathic medicines available on the Italian market on June 6, 1995 to remain on the market, subject to the regulation provided by Article 20 of the Pharmaceutical Code (Legislative Decree No. 219 of April 24, 2006) and Article 1 (590) of Law No. 190 of December 23, 2014.
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