What is a quality defect?
Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorisation. Quality defects of a medicine can result in harm to patients or incorrect treatment. If a quality defect is detected, it may be important to stop further sales and, if necessary, initiate a recall of the affected product on the market. There may also be a need to assess the necessity of the medicine against the risk of using a product with a quality defect and in some cases accept that medicines remain in the supply chain despite the quality defect. It is important to report any quality defects to the Icelandic Medicines Agency (IMA) in the interest of protecting public health.
Examples of a quality defect are defects in the medicine itself, incorrect labelling, damage to the packaging or dosing equipment, unusual appearance of medicine, deviations from the approved marketing authorization (MA) such as deviations from the specifications, GMP failure of the drug substance manufacturer or drug manufacturer that can affect the use of the medicine.
What are falsified medicines?
Falsified medicines are fake or counterfeit medicines that pose as real, authorized medicines. Falsified medicines can cause serious harm to patients, and it is important to report falsified or suspected falsified medicines to IMA if detected.
Examples of falsified medicines are medicines that have been illegally repackaged, stolen medicines that are subsequently sold illegally in the legal chain, medicine that may contain ingredients of low quality or in the wrong doses, the wrong ingredients, or low levels of the active ingredients.
Marketing authorisation holders, manufacturers, wholesalers, pharmaciesand/ persons authorised or entitled to supply medicinal products to the public are required to notify IMA of falsified or suspected falsified medicines immediately upon discovery.
How to report a quality defect or suspicion of falsified medicine?
Quality defects or suspected falsified medicine can be reported to IMA via contact us on our website.
What information is required when reporting?
Healthcare professionals or consumers:
In case of a notification of a quality defect from healthcare professional or a consumer the following information should be provided at a minimum, if possible:
- All relevant information about the medicinal product:
- Name
- strength
- batch(es)
- expiry date
- material number
- Clear description of the quality defect
- Pictures or a sample of the medicinal product if possible
Manufacturers, market authorisation holders or wholesale distributers:
In case of a notification of a quality defect from a company within the supply chain e.g. manufacturers, market authorisation holders, wholesale distributers etc. Please provide the following information:
- All relevant information on the medicinal product, (name, strength, batch(es), expiry date, etc.).
- Clear description of the quality defect and an account of preventive measures.
- Information about the manufacturer, market authorisation holder and distributor in Iceland and if applicable, legal representative in Iceland.
- The status of the stock levels in Iceland and distribution within Iceland.
- Information on parallel importation in Iceland.
- Frequency of the quality defect.
- Risk assessment of the quality defect, if available.
- Proposed market actions and type of market actions (e.g. how far down the chain of distribution the recall should take place (wholesaler, pharmacy, patient).
What does The Icelandic Medicines agency do upon receiving reports of quality defects of suspicion of falsified medicines?
IMA is the national authority in Iceland that is responsible for receiving reports on quality defects or suspicion of falsified medicine.
The agency reviews the provided information and if necessary, a recall may be initiated in collaboration with companies involved, usually the market authorisation holder.
Product defect notification can come from several sources:
- Pharmaceutical company (manufacturer, market authorisation holder, wholesale distributor)
- Authorities from other countries (via the Rapid Alert System)
- Pharmacies
- Healthcare professionals
- Consumers
Up on receiving notifications on quality defect suspicion of falsified medicine IMA assesses the notification in connection with patient safety. Possible shortages or supply difficulties that might affect patients is a part of the assessment.
The product defect is assessed according to patient risk based on the following classification:
- Class 1: The defect is potentially life-threatening and/or could cause a serious risk to health.
- Class 2: The defect may cause disease or mistreatment of the patient, but is not Class I
- Class 3: Other, the defect may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Notifications from healthcare professionals or consumers are forwarded to the market authorisation holder for investigation.
What is the process in case of a recall?
If an error is discovered involving a medicinal product that is on the market in Iceland or is exported from Iceland a recall may be initiated on the affected batches.
A recall of a medicinal product means that one or more batches of the product will be withdrawn from the market.
In case of a proposed recall the pharmaceutical company (e.g. market authorisation holder, manufacturer or wholesale distributor) should notify IMA as is required in EU GDP and EU GMP guidelines (and national laws and regulations).
Assessment is performed by IMA on the provided information and proposed market actions. Possible shortages and potential effect on supply is a part of the assessment.
Assessment is also performed on whether other national competent authorities need to be informed and the notification is communicated via a shared network.
Once a recall has been decided the pharmaceutical company sends a recall letter to IMA before the letter is sent formally and thus initiating the formal recall process.
Once a recall has been concluded a recall report shall be available for review by IMA, if requested.