|Rapid Alert Notifications about detected quality defects of medicinal products|
Rapid Alert Notifications about detected quality defects of medicinal products is an urgent warning of an agency of medicinal products to the agencies of other countries. The agency which first detected defect of medicinal product initiates a recall of affected batch (-es) of medicinal products. In such case a notification in an established form is issued and transmitted using the rapid Alert System.
Medicines agency of the country after receipt of the Rapid Alert Notification about detected quality defect of medicinal product investigates whether indicated medicinal product and its batch (-es) are present in the market of the country. The Agency depending on the risk class of the quality defect of indicated medicinal product and possible hazard to public health takes appropriate actions.
Agencies using this system also distribute information about cases of counterfeited medicinal products, as well as the information about suspension of the validity of the manufacturer of medicinal products, revocation of validity of such licence, seizures of medicinal products, cases of banned distribution, etc.
Batch recall is an action of termination of distribution of a medicinal product and withdrawal from a distribution chain. Batch recall may be whole or partial when batch is being recalled from specific distributors and consumers. A batch from the market is recalled on the basis of the Order of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (hereinafter- SMCA) (published in the Official Gazette), however batch recall may be conducted by the manufacturer of the medicinal product.
A manufacturer of medicinal product according to the requirements of Good Manufacturing Practice (GMP) is obliged to inform SMCA in writing about foreseen recall of a batch as well as the reasons for such recall.
Law on Pharmacy of the Republic of Lithuania (Law), Article 67, (Parliament of the Republic of Lithuania/X-709/2006-06-22/Came into force since 18 July 2006/Official Gazette, 2006, No78-3056)
Regarding confirmation of provisions of Good Manufacturing Practice of medicinal and investigational medicinal products (Order)(Ministry of Health of the Republic of Lithuania/268/2004-04-23/Came into force since 30 April 2004/Official Gazette, 2004, No 67-2358)
Regarding amendment of the Order No V-268 of the Minister of Health of the Republic of Lithuania of 23 April 2004 „Regarding confirmation of provisions of Good Manufacturing Practice of medicinal and investigational medicinal products (Order)(Ministry of Health of the Republic of Lithuania/V-523/2004-04-23/Came into force since 27 July 2005/Official Gazette, 2005, No. 90-3381)
Compilation of Community Procedures on Inspections and Exchange of Information Published in Agreement with the European Commission by the European Medicines Agency (see Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects).
|Last Update: 2011-09-16 15:18:18|