Withdrawal of medicinal products

General procedures for the recall of medicinal products and the possibility of providing information on defects in the quality of medicines and other measures.

Legislation

In the event of detection of a quality defect in a registered medicinal product, the Marketing authorization holder (MAH), following Article 33(3)(c) of Act No 378/2007 Coll. on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals), as amended, shall adopt measures to ensure the possibility for a patient to have the medicinal product exchanged by any pharmacy for a medicinal product without such a quality defect and, unless such medicinal product is available or unless such exchange can be ensured, it shall ensure complete recall of the medicinal product from the market.

All operators, including pharmacies and other health service providers, shall be obliged, following Article 23(1)(e) of the Medicinal Products Act, to take all measures necessary to recall a medicinal product from the market if the MA Holder takes measures to recall the defective medicinal product, the medicinal substance or an excipient to the extent and in the manner notified by the MAHolder. Therefore, when recalling a medicinal product, the operator shall always proceed under the measure of the MAHolder, which is communicated by the SIDC on its website and through the quality defects web interface. Level of recall and classification of quality defects.

A medicinal product may be recalled from three different levels: distributors level, pharmacy level (from distributors, pharmacies, clinics and other medicinal institutions), or patients level (from distributors, pharmacies, clinics, other medicinal institutions and patients).

The level of recall is determined primarily with regard to the level of risk and the severity of the potential impact of the quality defect on the patient’s health.

Class I – high-risk quality defects are defects that are potentially life-threatening or could cause serious risk to health. e.g. mix up of products  within a pack or microbial contamination of the sterile injectable or ophthalmic product.

Class II Moderate risk quality defects are defects that could cause illness or mistreatment with potentially non-serious medical consequences but are not classified as critical, e.g. Significant OOT stability test results.

Class III Low-risk quality defects are defects that are not likely to pose a significant hazard to health., e.g. Unclear labeling, minor labeling errors.

The classification of the classes of quality defects is always reported in the monthly summary information and also in the web interface (see more below).

Pharmacy recall procedure

There is no unified procedure for the recall of medicinal products. Information on measures taken by marketing authorization holders and recalls is published on the SÚKL website, in the Important notices – Quality measures or Medicinal products withdrawn for registration reasons, see links (only in czech language):

and in the web interface. The pharmacy must react to the recall information provided by MAH without delay. The pharmacy must block the dispensing of the recalled medicinal product in its stock. It shall further treat the withdrawn medicinal products following the instructions of the MAH. In the event of a recall at the pharmacy level, it means from clinics, hospitals, and other medicinal institutions the pharmacy shall return the medicinal products to the distributor who supplied them to the pharmacy. Medicinal products returned from healthcare facilities (e.g. hospital wards, outpatient clinics) to which the products were dispensed by the pharmacy based on requests are also handed over to distributors. The distributor then returns the withdrawn packs to the MAH.

In the case of recall in the patient level, patients are informed through a communication published on the Institute’s website in the public section, as well as through social networks or in other ways, e.g. by the attending physician. In this case, patients shall return the recalled packs to the pharmacy, preferably to the pharmacy where the product was dispensed unless otherwise instructed by the marketing authorization holder. Clinics and other medical institutes shall return the medicines to the pharmacy from which they were dispensed. The pharmacy shall subsequently return both the products from patients and clinics and the products in its stock to the distributor. If a package of a different safe batch is available, the pharmacy shall exchange it instead of the recalled package based on an exchange protocol. If it is not possible to arrange for the replacement of the recalled package with a non-hazardous package, the pharmacy shall provide the patient with financial compensation following the instructions of the MAH.

The pharmacy shall keep a written or electronic record of complaints due to quality defects and the recall of medicinal products from the market or the exchange of withdrawn medicinal products, as the case may be, enabling the identification of the medicinal product withdrawn or exchanged, indicating its SÚKL code and the batch number; the record shall also include a brief record of the reason for the recall, the date on which the medicinal product was returned to the distributor, the date on which the exchange was carried out, if any, or a record of the surrender of the withdrawn medicinal products under Article 89(3) of the  Act of pharmaceuticals.

The procedure for keeping a written record of the recall of medicinal products containing addictive substances listed in Annex 1 and 5 of the Government Regulation on the lists of addictive substances is presented on the website of SÚKL in the section for pharmacies:

The above records shall be kept in the pharmacy similarly to other operational documentation for 5 years from the date of the last record.

Provision of information on defects in the quality of medicines and other relevant measures

For informing operators, the SIDC also uses the web interface, which is used for automated communication between the information system of pharmacies, distributors and the SIDC. This system allows information on recalls and other measures to be uploaded directly into pharmacy and distributor systems, without the need to actively search for this information.

To set up this web interface, please contact your information system supplier’s representative who will provide you with details and options for making this system operational in your pharmacy. Another option is to access information via the Institute website: