Pharmaceutical companies will be required to follow up side effects of drugs
they sell and report them immediately to the Health Ministry, which sent
proposed regulations to the Knesset Labor, Social Welfare and Health Committee
for approval on Wednesday.
The ministry prepared the regulations in the
wake of the Eltroxin scandal of last year, in which a drug company – without
informing the ministry – changed the formulation of the medication for
hypothyroidism, an alteration that caused serious side effects in many
Even after the drug is registered, the manufacturers and
importers will be required to tell the ministry about any undue side effects and
describe the risks from its use, as well as what is needed to ensure
The regulations will take effect a year after their publication
in Reshumotm, the state’s official record of laws.
Committee chairman MK
Haim Katz welcomed the regulations and said he hoped the committee would not
again be faced by “disorder in the health system that may threaten
The committee decided that every prohibition or limitation listed
by the manufacturer or a recognized health authority abroad must be reported to
the ministry within three days.
Any concern by a manufacturer or importer
here about a serious and unusual side effect has to be reported to the ministry
within 15 days.
If the manufacturer or importer fails to do so, its
license for the marketing of the product may be canceled.
A physician or
pharmacist with a least two years of experience must head the
He must also coordinate risk management, collect reports from
doctors and patients and send the reports to the ministry’s director-general,
who will supervise the results, carry out periodic supervision and distribute
the data to the relevant authorities.
The director-general has the power
to cancel the marketing of any pharmaceutical if he is convinced that it poses
In addition, the regulations require the health funds and
hospitals to report unusual side effects they have observed.
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