Anna Kowalczuk, Damian Świeczkowski, Urszula Religioni, Anna Gawrońska-Błaszczyk, Agata Błażewicz, Magdalena Popławska, Nuno Pinto De Castro, Urszula Włodarczak, Piotr Merks

Rola laboratorium kontroli produktów leczniczych (OMCL) w procesie implementowania założenia unijnej Dyrektywy ds. leków sfałszowanych – rekomendacje kierunku działań polskich organizacji regulacyjnych
2017-01-05

The role of the Official Medicine Control Laboratory (OMCL) in the process of implementing the Falsified Medicine Directive – recommendations for regulatory agencies

The implementation of the regulations provided by the Falsified Medicines Directive (FMD) will be directly associated with the close and effective collaboration between the medicines authentication service (NMVS) and drug quality control laboratories under the supervision on the National Medicine Verification Organization (NMVO). Currently, we observe a lack of specific regulations and limited discussion in this scope in Poland. However, based on international scientific deliberation, the role of Good Authentication Practice (GAP) should be stressed out. We believe that the role of drug control laboratory remains one of the most important factors contributed to effective implementation of FMD in Poland in relation to strict cooperation with the NMVO. Potential falsified medicinal products should be examined by the high‑quality standards core to ensure patients’ safety and to marginalize the financial effect of incorrect authentication as well as support the creation of national procedures. Of note, creating the new regulations and procedures is the further steps of introducing FMD in Poland, should be understood as the common effort of stakeholders, regulatory organization and academic bodies. This process should be considered as the tremendous challenge in the long way of introducing amendments in the community and hospital pharmacy subsets, and, therefore, should be understood as the part of scientific and practice deliberation.

Keywords: Official Medicine Control Laboratory, Falsified Medicines Directive, National Medicine Verification Organization, Good Authentication Practice.

© Farm Pol, 2016, 72(10): 665–668