Pharmaceutical product. Inesem business school course in drug registration and regulatory affairs (university degree with 5 ects credits) more information two of the main systems used in the field of traceability to ensure the tracking of all products are the printed or die-cut batch and expiration date. On the one hand, a batch is the amount of a drug that is produced in a manufacturing cycle. Since the essential characteristic of the manufacturing batch is its homogeneity, if an error is detected in a unit, the batch to which it belongs can be quickly found in order to take the corresponding action.
For example, remove the lot. For this reason, pharmacovigilance is also a fundamental part of quality assurance and the rational use of medicines. It facilitates fax number list the possibility of detecting adverse reactions and other drug-related problems, activating the appropriate mechanisms to ensure the safety of drug use. How is traceability regulated? The traceability of medicines is regulated in article 90 of the main medicine law in spain, royal legislative decree 1/2015 , of july 24,
which approves the revised text of the law on guarantees and rational use of medicines and health products. In said article, six essential points are developed in the field of traceability guarantee. Likewise, there is also a european regulation. This is in charge of unifying criteria and guaranteeing the quality of the medicine within the entire territory of europe. Specifically, the new regulation (eu) 2017/745 of the european parliament and of the council, of april 5, 2017, on medical devices. With it, the european union