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1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health, Welfare and Sport. The Ministry…
An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 119.   1. What are the regulatory authorities with jurisdiction…
An insight into regulatory, pricing and reimbursement overview in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices…
A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and…
Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.    1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices…
The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices…
An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical…
The legal framework for regulatory, pricing and reimbursement of drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical…
Key legal info on regulatory, pricing and reimbursement in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain.   The guide is available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs,…
An insight into regulatory, pricing and reimbursement overview in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices…