17
Feb 21
<!--:it-->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”).
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
Telemedicine: Italian State-Regions Conference issues "National indications for the provision of telemedicine services" to implement telemedicine services in Italy
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3
Dec 20
Generic and biosimilar medicines: Italian Medicines Agency adopted a new simplified pricing and reimbursement procedure
On October 15, 2020, the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) published a new simplified pricing and reimbursement procedure for generics and biosimilars.
2
Dec 20
E-commerce of medicinal products: According to the Court of Justice, a foreign pharmacy may be subject to the restrictions in force in Member States where it sells medicines online
With e-commerce becoming more and more widespread, including in the pharmaceutical sector, we are taking a close look at the small but growing number of decisions in both national and European courts that are already providing early indication and some interpretation of the many gray areas left by applicable legislation in this field.
1
Dec 20
Botanical health claims: Clarification from the Court of Justice of the European Union
On September 10, 2020, the Court of Justice of the European Union (“CJEU”) ruled on health claims referencing the effects of plant or herbal substances, commonly known as botanical substances (“Botanicals”), in case C-363/19.
