Quality defects and recall of medicinal products
QUALITY DEFECTS AND RECALL OF MEDICINAL PRODUCTS
In accordance with the provision of Article 23 of Medicines Act (ZZdr-2, Official Gazette of RS, no. 17/14) all person liable authorized with marketing authorization must inform JAZMP about the inadequate quality of the product or suspected counterfeit medicines on the market.
Quality defect of the product is any difference in the appearance, physical-chemical, microbiological and pharmaceutical-technological properties of the actual situation of medicinal product and information from marketing authorization. This includes artwork non-compliances as well (patient leaflet, primary and secondary packaging material).
Counterfeit medicinal product is any medicinal product for following information are falsely represented:
- The identity, including packaging and labelling, or the name or structure of any of the ingredients including excipients and their intensity,
- Source, including the manufacturer, country of manufacture, country of origin or the marketing authorization holder or
- History, including the records and documents relating to distribution channels.
In case of quality defects of a medicinal product, suspicion or discovery of a counterfeit or illegal medicinal product, please submit a Form provided to share any suspicions or concerns regarding the unsuitable quality of a medicinal product (Slovenian version only) to:
- e-mail: firstname.lastname@example.org
or in case of emergency contact 24-hours available mobile phone number: + 386 41 790 133
Next section of the document provides guidance with examples on reporting of certain specific defect types or suspected counterfeit medicines on the market to JAZMP. The list of categories of defects is not exhaustive and should be used as a guide only.
1. Product mix up
Reporting of a potential product mix-up is considered mandatory, as the administration of an incorrect product or an incorrect strength of a product to a patient could lead to serious situations such as overdose, underdose, allergic reaction or interaction with another contraindicated medicine.
- correct medicinal product, wrong strength (10mg blisters, containing 10mg tablets, inside a carton labelled as 20mg).
- mix up of medicinal product inside secondary packaging (two different blisters inside secondary packaging or two different tablets inside blister).
- wrong medicinal product (ampoules containing product A, labelled and cartoned as product B)
2. Product contamination
Microbacterial, chemical or physical should be reported without delay to JAZMP.
3. Non-compliance with specification and non-compliant medicine composition
Non-compliance of finished dosage product with product specification
- OOS (out of specification result)
- non-compliant organoleptic properties of medicinal product (for example appearance, odour).
4. Falsified medicines
When reporting a suspicion or discovery regarding a counterfeit or illegal medicinal product, please be sure to include the name of the product, batch number, and other relevant information: pharmaceutical form, dosage strength, name of manufacturer or marketing authorization holder for medicinal product, and date and time of the suspicion or discovery of a counterfeit or illegal medicinal product.
5. Packaging, container damages/issues and sterility assurance
Damages to primary or secondary packaging material, that could have negative effect on the quality of the product (for example sterility) and can represent a contamination risk of the healthcare professional or user or risk for public health or animals if administered.
- cracks in vials, non-evident leaks in infusion bags, damages of childproof caps, difficulties during application using injector/inhalers
6. Stability issues
All confirmed OOS results and significant OOT results, obtained during execution of stability studies in accordance with Chapter 6 of EU GMP guidelines.
7. Artwork and CMC/MA non-compliance
All cases of non-compliant artwork (carton, label, leaflet) with valid marketing authorization, that affect quality, safety and efficacy of the medicinal product.
In the event that the medicinal product with non-compliant artwork is not yet released to the market and marketing authorization holder assesses that the non-compliance does not affect quality, safety and efficacy of the medicinal product, it is not necessary to report quality defect. In accordance with Articles 22 of ZZdr-2, marketing authorization holder can
apply for approval of individual deviate. Marketing authorization holder must provide information on the proposed scope of the measure granting of individual deviate and provide evidence that the deviation does not affect quality, safety and efficacy of the product and propose preventive and corrective measures to be taken to establish the supply of medicinal products within the terms of the marketing authorization.
This is valid only in cased of one non-compliant batch of the medicinal product. In case of several non-compliant batches of medicinal product, non-compliance needs to be reported in accordance to procedure for reporting of quality defects to JAZMP, as described above under section Notification procedure. Following is true also in case medicinal product with non-compliant artwork is already released to the market.
8. Packaging and/or labelling defects
All defects, related to packaging or labelling of medicinal products need to be reported to JAZMP, despite the fact that they may not affect the product quality directly, but have an impact on the manner in which the product is prepared, administered or used. Such cases need to be reported in accordance to the procedure as described above under section Notification procedure.
9. Unauthorised product on the market or distribution of medicinal products performed by person liable not authorized to wholesale or retail medicinal products
10. Non-compliance of manufacturing process with MA
Non-compliance of production of medicinal product with valid marketing authorization, for example non-registered manufacturing process, analytical methods, non-approved starting materials, vendors, must be reported to JAZMP.
Exception are minor, one-time, non-planned departures from approved manufacturing process or analytical procedures, that do not affect quality, safety and efficacy of the medicinal product. Such cases should be handled in accordance to Annex 16 of EU GMP guidelines (Chapter 3: Handling of unexpected deviations). In case, deviations are reoccurring they must be reported to JAZMP.
In case, inadequate quality of the active pharmaceutical ingredient is confirmed, for material used of the production of finished dosage product, already released to the market, this needs to be reported to JAZMP (Reference II. part of EU GMP guidelines).
Notifications issued by JAZMP related to quality defects can be found on the following link:
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