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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
To ensure the ongoing safety and efficacy of medicinal products, after marketing authorisation has been granted, Colombian legislation provides a reporting procedure concerning adverse events and any other quality issues relating to the use of medicinal products. In this regard, the National Food and Drug Surveillance Institute (INVIMA) requires marketing authorisation holders or pharmaceutical product manufacturers to report adverse events and quality issues to acknowledge the medication profile in such a way that the preexisting factors are identified in time.
Resolution 2004009455 issued by the INVIMA on 28 May 2004 specifies the requirements and frequency with which pharmacological reports must be created under Article 146 of Decree 677. Under this regulation, the marketing authorisation holder and/or the pharmaceutical product manufacturer must adopt a pharmacovigilance programme to ensure the creation of periodic reports about the safety and efficacy of the medicinal product. The reports must be submitted according to the following considerations:
- Any serious and unexpected adverse event must be reported within 72 hours of its knowledge under the pharmacovigilance programme.
- Any non-serious or unexpected adverse event must be reported within the last five working days of each bimester.
An ‘adverse event’ is defined in the resolution as an unfortunate medical event that may occur during treatment with a medicinal product. The occurrence of such an event does not necessarily have a causal relationship with the medical treatment or product.
What data protection issues should be considered when conducting pharmacovigilance activities?
According to applicable sanitary law, Law 1581/2012 and Decree 1377/2013, in addition to standardised local business practice – and particularly considering that pharmacovigilance programmes may involve sensitive personal data – the personal data (ie, subject names, identification information or disease information) associated with any adverse event or quality issue need not be included when reporting to the relevant authority. These reports are usually made based on a codified number, which does not allow for the transfer of personal data.
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