ALERT – LIFE SCIENCES
Clinical Trials – Research product dispensing unit
NTS No. 219-MINSA/DIGEMID-2024, Technical Health Standard regulating the dispensing unit for clinical trials (RM 883-2024/MINSA) was approved.
Some considerations:
- Applies: To public and private health facilities. Specifically to the dispensing units for clinical trials (UDEC) dependent on the UPSS-Pharmacies of the research institutions where clinical trials are conducted.
- Validity: Effective from August 20, 2025, that is, eight months after its publication.
- Topics: The purpose of the technical health standard is to establish technical criteria to maintain the quality of the product under investigation, complying with the Good Storage and Dispensing Practices regulated in the Manual of Good Pharmaceutical Office Practices, through the UDEC. The NTS regulates the activities of reception, conservation and/or storage, repackaging and/or preparation, return, control and inventory and archiving of records related to the product under investigation.
- Annexes: The NTS includes nine annexes that must be used by the UDEC in its activities, such as: reception form, delivery form, research product control form, daily temperature and humidity monitoring, research product return form, among others.
The regulation states that, in case of using forms provided by the sponsor or by the Contract Research Organization, these must contain the information requested in the annexes approved in the NTS.
Read the Ministerial Resolution here
For further information, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and Solange Noriega (snoriega@estudiorodrigo.com).
