Temporary suspension of placing on the market of nine medicinal products due to non-compliance with the good clinical practice
Based on recommendations of the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices (HALMED) temporarily suspended the placing on the market of nine medicinal products in Croatia due to non-compliance with the good clinical practice. The clinical trials based on which the concerned medicinal products are authorised were carried out by GVK Biosciences at the investigational site in Hyderabad in India. Based on the fact that an inspection at the site discovered non-compliances with the good clinical practice rules, this temporary decision will be in effect until marketing authorisation holders have submitted new data, or carried out new trials on other sites.
In addition to the temporary suspension of placing on the market of these medicines, those medicines already on the market are being recalled to the pharmacy level.
This temporary suspension of placing on the market and recalls are being carried out as a precaution measures and are not initiated by safety reasons.
All medicines that are being recalled from the Croatian market may be replaced by authorised respective other medicines and therefore there will be no disruption in the supply chain.
The list of medicines affected by the temporary suspension in Croatia is accessible here.
The referral procedure that resulted in this recommendation of the EMA's Committee for Medicinal Products for Human Use on the temporary suspension of placing on the market of medicines was initiated by an inspection of the French Medicines Agency (ANSM) on GVK Biosciences, where non-compliances with the good clinical practice rules were discovered. Several hundreds of medicines for which trials were carried out by GVK Biosciences are encompassed by this procedure.