The requirements of the European Pharmacopoeia are mandatory for manufacturers, importers, distributors and other economic operators placing medicines on the market in the Republic of Moldova. These relate to medicines, the active substances and excipients used in their manufacture, as well as the specifications and analytical methods applied in authorisation and quality control.
For medicinal products manufactured and authorised in the US or Japan, the standards of the United States Pharmacopeia (USP) or the Japanese Pharmacopoeia (JP) may be applied, as appropriate, in accordance with the requirements of the International Council for the Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The Medicines and Medical Devices Agency (AMDM) will ensure the application, compliance with and monitoring of the requirements of the European Pharmacopoeia in the process of authorisation, official quality control and post-market surveillance of medicines.
“This measure represents a decisive step towards guaranteeing the safety, efficacy and quality of medicines supplied to patients in the Republic of Moldova, whilst also facilitating the integration of the national pharmaceutical market into the single European market,” the agency states.
This story was translated with the assistance of artificial intelligence.The translation was also reviewed by the Logos Press editorial team.
Follow our updates
Have information for the newsroom? Share it with Logos-Press
Comments
0No comments yet. You can start the conversation.
Comments are open to readers with a Logos Press account.
Sign in to comment