Tagged with Legal

Pharma Legal Handbook Upcoming regulatory reforms affecting Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1.     Are there proposals for reform or significant change to the healthcare system? E-pharmacy…

Pharma Legal Handbook Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   CANNABINOID DRUGS Global Comment:…

Pharma Legal Handbook Want to know more about orphan drugs & rare diseases in India? Read on! Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What is the…

Pharma Legal Handbook The key facts about the localization in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. Are there any rules or regulations requiring and/or…

Pharma Legal Handbook An insight into biosimilars & biologics in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic…

Pharma Legal Handbook An insight into digital health in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119. 151. Is the term ‘digital health’ defined in your jurisdiction? If…

Brazil Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on HTA Dossiers and Data requirements in the Brazilian pharma market today. Buy The Pharma Legal Handbook: Market Access & HTA – Brazil here for £359.   HTA DOSSIERS Have local authorities published…

Morocco Camilia Benani, recently promoted to partner at DLA Piper’s Casablanca office, explains why the Moroccan healthcare sector has become a lightning rod for M&A activity in recent years. Drawing on her experience advising many of the organisations involved in these deals, Benani touches on the evolution of deal structuring in…

Pharma Legal Handbook 1.  Please make a general introduction to the public health sector in your country and its organization The National Health System (“NHS”) is based on the principles of universal coverage and solidarity. Art. 43 of the Spanish Constitution establishes the right to healthcare as one of the basic principles that…

Pharma Legal Handbook 1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The main administrations in charge of public health and reimbursement of medicinal products in Spain are: the Spanish Agency of Medicines and Medical Devices (“AEMPS”), the Ministry of…

Pharma Legal Handbook 1. What are the pricing models, processes and principles for originator drugs? Originator medicinal products must go through price and reimbursement proceedings (P&R Procedure) where it is decided if they are to be reimbursed or not. If reimbursed, the PVL is also fixed. To determine whether a medicinal product is…

Pharma Legal Handbook 1. Price Control 1. How does price control at ex-factory prices work in your country? This question may be broken down in two parts: (i) situations in which a medicinal product may be in connection with its reimbursement status/price; and (ii) criteria to determine PVL.   Situations in which a…