VETERINARY MEDICINAL PRODUCTS (VMPs)
PHARMACOVIGILANCE AND RECALL
Does the law obligate any person who reasonably believes that an animal has experienced an adverse reaction from receiving a VMP, or that a person has experienced an adverse reaction from handling a VMP, to report this to an appropriate authority (e.g. competent authority, pharmacist, veterinarian, distributor of VMP)?
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5.1 Reporters of Suspected ADRs
All health care workers, including doctors, dentists, pharmacists, nurses, other health professionals and the patients are requested to report all suspected adverse reactions to medicines (including vaccines, X-ray contrast media, complementary medicines), especially when the reaction is unusual, potentially serious or clinically significant. It is vital to report an adverse drug reaction to the Medicines Control Authority of Zimbabwe pharmacovigilance programme even when all the facts are not available or there is uncertainty that the medicine definitely caused the reaction.
5.6 Who Should Report
Reporters may be in the public or private health sector. They include physicians, pharmacists,
and nurses. Other reporters include public health professionals, staff in medical laboratories
and pathology departments, and pharmaceutical companies. Pharmaceutical companies
should refer to chapter 10 of this policy handbook. Health and community workers (who are
literate) should be encouraged to report, preferably to the clinician who prescribed the
treatment, or directly to the MCAZ. Consumers, patients or patient representatives may also
report using the e-ADR form or the standard ADR reporting form.
Does the law require any actor in the VMP value chain who reasonably suspects a VMP is likely to cause harm to animal or human health to initiate recall of all concerned products, and notify the competent authority?
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7.1 Product Defect Reporting and Recall Procedures
The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, including “Section 75 ” medicines, and do not place the patient at risk because of inadequate safety, quality or efficacy.
When products are suspected of being potentially harmful to users due to their defective quality, safety or efficacy, they may be subjected to a recall and all related information must be reported to the Pharmacovigilance and Clinical Trial Division at MCAZ. (...)
For the approved recall procedure, please refer to the MCAZ Guidelines for the Notification of a Medicinal Product Problem/Defect and Recall Procedure found on the MCAZ website (...)
Does the law empower the competent authority to recall a VMP that is likely to cause harm to human or animal health?
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Which kind of sanctions are imposed in case of offences (criminal, administrative) related to pharmacovigilance and recall of VMPs?
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