11/10/2018
Important legal info for regulatory, pricing and reimbursement in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Mexico? The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health. 2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices? The primary legislation for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is the General Health Law (Ley General de Salud) (HL) and its Regulations. These law and regulations are supplemented by Guidelines and Official…
29/06/2019
Cannabinoid drugs, medicinal cannabis and opioid drugs in Mexico – a comprehensive legal overview. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country?…
25/10/2016
Upcoming regulatory reforms in Mexican pharma. Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? INITIATIVE BIOTECHNOLOGY…
Need to know the legal situation for patents and trademarks in Mexican pharma? Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. 1. What are the basic…
All you need to know about product liability in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? A.…
The key points to know from a legal standpoint about traditional medicines and OTC products in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. 1. What are the regulatory…
Key legal info on marketing, manufacturing, packaging & labeling, advertising in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. 1. What is the authorization process for the marketing of…
Conducting preclinical or clinical trials in Mexico? Get the legal lowdown here. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as…
23/01/2019
20/01/2020
14/03/2020
08/11/2018
