Pharma and medical device regulation—Colombia—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Pharma and medical device regulation—Colombia—Q&A guide
  • 1. Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.
  • 2. Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?
  • 3. Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.
  • 4. What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?
  • 5. What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?
  • 6. Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?
  • 7. How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?
  • 8. What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?
  • 9. To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?
  • More...

Pharma and medical device regulation—Colombia—Q&A guide

This Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device regulation in Colombia published as part of the Lexology Getting the Deal Through series by Law Business Research (published: August 2020).

Authors: OlarteMoure—Gina A. Arias; Catalina Jimenez; Liliana Galindo

1. Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.

The provision of health services is headed by public and private entities, such as:

  1. the Administrator of Resources of the General System of Social Security in Health (ADRES), whose specific objective is the adequate management of financial resources for the System and to implement the respective controls;

  2. health maintenance organisations (HMOs), which are health-promoting entities that are responsible, by delegation of ADRES, for the affiliation and the registration of affiliates and the collection of their contributions – their basic function is to organise and guarantee the provision of the health benefits plan to affiliates, and they can operate within the contributive or the subsidised regime; and

  3. healthcare provider institutions (IPS): for example, hospitals, clinics and doctors that provide healthcare services to the affiliates and beneficiaries within the parameters and principles indicated in the law.

Additionally, the following entities are responsible for the inspection, monitoring and control of the entities involved in the health system:

  1. the Ministry of Health and

Popular documents