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Pharmacovigilance Requirements in Bosnia-Herzegovina

#1 · November 29, 2020, 7:20 AM

Quote from VigiServe Admin on November 29, 2020, 7:20 AM
Deadlines for reporting adverse drug reactions:

the marketing authorisation holder shall be required to provide complete information about every serious adverse drug reaction or suspicion which are received from medical staff on the territory of Bosnia and Herzegovina, and to report to the Agency using the report form for adverse drug reaction, within 15 days after being informed of an adverse reaction or a suspicion;

the marketing authorisation holder shall be required to provide complete information about every unexpected serious adverse drug reaction or suspicion which is received from medical staff on the territory of Bosnia and Herzegovina, and to report to the Agency using the report form for adverse drug reaction, within 15 days after being informed of an adverse reaction or a suspicion;

the marketing authorisation holder shall be required to provide complete written information about every serious adverse and unexpected drug reaction, which is received from outside of the territory of Bosnia and Herzegovina, within 15 days after receipt of the report, using the form in which the information is originally received;

the marketing authorisation holder shall be required to inform the Agency in writing about any other adverse drug reaction or events that are connected with consumption of or suspicion on medicinal product, regardless of its geographic origin or source of data in form of periodic reports of medicinal product safety.

The deadlines for reporting of the adverse reactions related to medical devices are:

for serious threat to public health: IMMEDIATELY, no later than two days after the manufacturer has become aware of the threat

for patient’s death or unexpected serious deterioration of patient’s health condition: IMMEDIATELY, no later than ten days after the manufacturer of the medical device has detected connection between medical device and adverse event;

for other adverse reactions: IMMEDIATELY, no later than thirty days after manufacturer of the medical device has established connection between medical device and adverse event

Deadlines for reporting adverse drug reactions:

the marketing authorisation holder shall be required to provide complete information about every serious adverse drug reaction or suspicion which are received from medical staff on the territory of Bosnia and Herzegovina, and to report to the Agency using the report form for adverse drug reaction, within 15 days after being informed of an adverse reaction or a suspicion;

the marketing authorisation holder shall be required to provide complete information about every unexpected serious adverse drug reaction or suspicion which is received from medical staff on the territory of Bosnia and Herzegovina, and to report to the Agency using the report form for adverse drug reaction, within 15 days after being informed of an adverse reaction or a suspicion;

the marketing authorisation holder shall be required to provide complete written information about every serious adverse and unexpected drug reaction, which is received from outside of the territory of Bosnia and Herzegovina, within 15 days after receipt of the report, using the form in which the information is originally received;

the marketing authorisation holder shall be required to inform the Agency in writing about any other adverse drug reaction or events that are connected with consumption of or suspicion on medicinal product, regardless of its geographic origin or source of data in form of periodic reports of medicinal product safety.

The deadlines for reporting of the adverse reactions related to medical devices are:

for serious threat to public health: IMMEDIATELY, no later than two days after the manufacturer has become aware of the threat
for patient’s death or unexpected serious deterioration of patient’s health condition: IMMEDIATELY, no later than ten days after the manufacturer of the medical device has detected connection between medical device and adverse event;
for other adverse reactions: IMMEDIATELY, no later than thirty days after manufacturer of the medical device has established connection between medical device and adverse event