One of the chosen jurisdictions was Colombia. At OlarteMoure we drafted this guide, in which we explain in depth the regulation of the Pharma and Medical Device industry in this country. We touch on topics like its regulatory framework, clinical practice, marketing authorization, amending authorizations, recall, promotion, enforcement of advertising rules, pricing and reimbursement, off-label use and unlicensed products, sale and supply, and recent trends that have been noticed.
In this guide, you will learn more about plenty of topics, like the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices in Colombia, the sanctions that authorities can impose on entities or their directors and officers for breach of the requirements concerning controlled activities, and the requirements that apply to recording and publishing details of transfers of value to healthcare professionals and organizations by companies marketing medicinal products or medical devices in the country.
This detailed and enriching document was carefully crafted by Carlos R. Olarte, our Partner, Gina Arias, our Regulatory Affairs Manager, Catalina Jiménez, our Partner and Compliance Director, and Liliana Galindo, our Patent Litigation Coordinator. This team of experts provided their lengthy knowledge of this industry to provide clear and in-depth information for each of the categories requested.
We hope this type of resource is useful for understanding the regulation of this important industry, that is present in our day to day live, and is constantly evolving and innovating.