New routines in Sweden for handling recalls of medicinal products from the 15th of March, 2010
Wednesday, March 17, 2010
On the 15th of March, 2010, new routines for handling recalls will be introduced in Sweden for all products regulated by the legislation (Medicinal Products Act (SFS 1992:859) of the medicinal products: conventional medicinal products, herbal medicinal products, traditional herbal medicinal products, natural remedies, certain medicinal products for external use, homeopathic medicinal products and standardised extemporaneous preparations (stock manufacturing).
A procedure for dealing with complaints and recalls called ”Röda Pärmen” was introduced in 1980 and was developed within The Swedish Assocoation of the Pharmaceutical Industry (LIF) in co-operation with the Medical Products Agency, and Apoteket AB (the former National Corporation of Swedish Pharmacies). A working team, ARI-group, was established. In 2003 this procedure was uppgraded from a paper version to a web version, ”The Red Web”. Until now the procedure is based on different recall forms depending on the extent or distribution of the concerned product or batch and the degree of seriousness of the recall.
Today the regulation of the Swedish market for medicinal products is changed and the monopoly of the National Corporation of Swedish Pharmacies is changed to new clusters of pharmacies and private pharmacies. In addition some OTC-products will be available from the retail trade. Thus it seemed logical to leave the old procedure and to develop a new simple procedure, the same for the whole market.
Now it will be only one recall form for all recalls from both retail trade and pharmacies and the health care. The recall form will reach the destination by a cascade effect. The recall will be sent from the pharmaceutical company (the Manufacturing Authorization Holder (MAH) and/or its local representative) to the wholesalers/distributors and further to the pharmacies or retail traders and finally to the health care and in serious and urgent cases to the patients/customers depending on the distribution of the product to recall. The distribution of the recall will preferably be by e-mail. Every part in this chain is responsible to distribute the information to the next part.
Till now a colour system has been used but in this new procedure only classification of the state of seriousness according to the Rapid Alert System will be used. This Rapid Alert System is the same for the entire EU and will be found at the web site of EMA. www.ema.europa.eu/Inspections/GMPCompproc , Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects.
The classification is in three stages where Class I is the most serious one and Class III is the less serious one.
When a recall is to be initiated by the pharmaceutical company the following has to be done:
- Trace the distribution of the concerned batches/products to the wholesaler/distributor who received the product at the first level.
- Stop further distribution from this wholesaler/distributor.
- Immediately call the Medical Products Agency, Drug Inspectorate and make a proposal for a recall form.
From the 15th of March, 2010, no more recalls will be handled according to the old system but from this date only the new system will be used.