Tagged with legal

Pharma Legal Handbook 1. Please describe the main cost containment policies in place in your country and their fundamental principles: a. Pricing and impact of generic/biosimilar approval The entry of generics/biosimilars into the market affects the price of original drugs by three main mechanisms: (i) homogeneous groups (“HG”), (ii) reference groups (“RG”), (iii)…

Pharma Legal Handbook 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. Three types of lists have been published by the AEMPS: “Essential medicinal products”: according to the WHO definition, these are the necessary medicinal products for a basic health system. “Critical medicinal…

Pharma Legal Handbook 1. What is the definition of an orphan drug in your country? In Spain there is no particularity in relation to the definition of “orphan drug” derived from the Regulation (EC) No 141/2000. Under Regulation (EC) No 141/2000 a medicinal product shall be designated as an orphan medicinal product if…

Pharma Legal Handbook 1. What is the definition of a vaccine in your country? The AEMPS defines a vaccine as an antigen-containing preparation capable of inducing specific and active immunity in humans against an infecting agent or the toxin or antigen elaborated by it. Immune responses include the induction of innate and adaptive…

Pharma Legal Handbook A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What are the regulatory authorities with…

Pharma Legal Handbook Preclinical and Clinical Trial Requirements in Chile – a legal guide. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. Are clinical trials required to be conducted locally as a…

Pharma Legal Handbook The key facts about marketing, manufacturing, packaging & labeling, and advertising in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What is the authorization process for the marketing…

Pharma Legal Handbook An intro to the legal situation for traditional products and OTC medicines in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional,…

Pharma Legal Handbook All about product liability in Chile pharma. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? In our jurisdiction, the liability…

Pharma Legal Handbook An insight into upcoming regulatory reforms affecting Chile pharma. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system?…

Pharma Legal Handbook The legal framework for cannabinoid drugs, medical cannabis and opioids in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   Cannabinoid Drugs   1. Are Cannabinoid Drugs authorized in your…

Pharma Legal Handbook Want to know more about orphan drugs and rare diseases in Chile? Read on! Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in…