The Chief Pharmaceutical Inspector (GIF) issued two decisions regarding a drug for patients with irritable bowel syndrome. The reason is a quality defect of the medicine
This is a drug called Mebelin intended for the treatment of symptoms of irritable bowel syndrome. These capsules are available only by prescription. Now two announcements have been issued: suspending the drug from circulation and banning its introduction to marketing. Both decisions are immediately enforceable.
Mebelin – details of the GIF decision
The announcement provided details about the preparation (both in the decision to suspend marketing and to prohibit placing on the market):
Mebelin (Mebeverini hydrochloridum),
modified-release capsules, hard, 200 mg
package of 30 capsules GTIN no. 05909991425289,
package of 60 capsules GTIN no. 05909991425296,
responsible entity: Aristo Pharma sp. z o. o., based in Warsaw;
Why was Mebelin withdrawn?
In Mebelin, during tests at the National Medicines Institute, it was found that the product “does not meet the quality requirements due to the negative test result in terms of the mebeverine hydrochloride release parameter.” Already in June this year, GIF issued a decision to suspend trading in Mebelin in Poland. Current decisions are further consequences of that case.
After it turned out that the drug had a quality defect, the MAH had a chance to prove that it did not affect all batches of the drug. That didn’t happen. As we read in the announcement, “the party did not comment on the negative result of testing the quality parameters of the medicinal product, and in particular did not comment on the cause of the identified irregularities or on the possible limitation of their occurrence within the analyzed medicinal product. Therefore, the party did not indicate any circumstances that could indicate that batches of the medicinal product other than the tested one are free from the identified quality defect.