The Directives of Pharmacovigilance
Issued by the high commission of Drug and Pharmacy according to article 5/A of the
Law of Drug and Pharmacy and its amendments approved by virtue of the decision
of The Board of directors of Jordan Food and Drug Administration on 29/6/2006 .
Article (1):
These directives are called The Directives of Pharmacovigilance and are effective
from the date they are approved and published in the official gazette.
Article (2):
For the purpose of applying these directives, the definitions stipulated in the law of
Drug and Pharmacy no (80) and the law of Clinical Studies no. (67) for the year
2001 will be applied, in addition to the following:-
Pharmacovigilance System – PhS:A system that is concerned in collecting, analyzing and evaluating the adverse drug
reactions and the problems related in using post marketed drugs with an aim to
reduce or eliminate such reactions.
The Company:
The drug manufacturing company or the Marketing Authorization Holder.
Adverse Drug Reaction – ADR:The unwanted, undesired or unintended response of the patient to the drug
including the abnormal laboratory results which occur upon taking approved doses
of the drug by the patient.
Serious Adverse Drug Reaction – SADR:The adverse reaction that leads to one of the following consequences:
- Death
- Puts life in danger
- Permanent disability
- Admission into a hospital
- Prolonged stay in a hospital
- Physiological or Physical deformities.
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Company Core Data Sheet-CCDS:All the information related to the drug which is available with the company such as
safety information, indications, doses, adverse reactions etc.
Company Core Safety Information- CCSI:The drug safety information available within the drug data of the company.
Reference Safety Information:The drug safety information which is based on CCSI depended by the company in
the PSUR.
Summary of Product Characteristics – SPC:The information related to the registered drug and approved by the Administration
made available by the company to the workers in the health sector.
Reporter:One of the health care professionals entitled to report on the suspected drug adverse
reactions, or the problems related to its usage. It includes the doctor or the
pharmacist or the nurse.
Spontaneous Adverse Drug Reaction Report:The report that is sent by the reporter to the Company, its Representative or the
Administration reporting the suspected drug adverse reactions, or the problems
related to its use. (Appendix 1).
Adverse Drug Reaction Report:The report that is sent by the company to the Administration which includes
reporting the drug adverse reactions spotted from the spontaneous reports or from
post-marketing studies or from scientific publications.
Pharmacovigilance Qualified Person – PHQP:The qualified doctor or pharmacist to follow up and update the drug safety
information, in addition to submit the required safety reports to the Administration
and to fulfill the company obligations towards the Administration or towards the
local or international community.
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Unexpected Adverse Drug reaction- UADR:The reported adverse reaction in the spontaneous reports and is not included in the
SPC whether in its type or severity or effects in comparison with the information
available in the SPC.
Listed Adverse Drug reaction- LADR:The adverse reaction, which, type, severity, or effects are in accordance with the
information included in the drug safety information of the company CCSI.
International Birth Date- IBD:The date on which, the drug was registered and allowed to be sold for the first time
in any country in the world.
Jordan Birth Date-JBD:The date on which, the drug was registered and allowed to be sold for the first time
in Jordan.
Data Lock Point – DLP/ Cut-off date:The date on which adding data to the Periodical Safety Update Report is being
stopped. It can be specified according to the JBD of the drug or according to the
IBD.
Pharmacoepidemiological Studies:These are Statistical studies related to the effect of drugs and their adverse reactions
on large population.
Post registration Studies- PRS:This is any clinical or statistical study that is conducted in accordance to the
indications included in the approved SPC by the Administration under normal
usage conditions. It includes the safety studies conducted after registering the drug
which aim to quantify and qualify the risks linked to using the registered drug.
Compassionate Use of drug:Using a non-registered drug in Jordan, for specific medical cases and patients
identified by their names.
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Article (3):
The Administration has the right to seek advice from specialists whenever needed.
Article (4):
The company must name a PHQP to follow up on the drug safety information. This
professional is responsible for the vigilance of the adverse reactions of the drugs of
his company and for the problems related to its use; his responsibility will be
supplying the Administration with the following; ADR reports (Appendix 2)
 PSURs reports (Appendix 3)
 Drug safety reports for the studies financed by the company and conducted on
the drug after its registration
 Constant evaluation safety information reports of the drug after its registration
and marketing (Appendix 4)
 Any additional necessary information requested by the Administration to
evaluate the benefits and risks of using the drug, including information related
to the sales volumes of the drug or the number of patients who had used it.
Article (5):
The company or the PHQP must inform the Administration of serious adverse
reactions through the ADR reports within no later than 15 days from the date of
receiving the minimum information that requires to be reported (Appendix 2) and
includes the following reactions:-
A- The suspected unexpected serious reactions that is included in:1- The spontaneous reports of drugs adverse reactions reported to the company
whether from Jordan or from countries where the drug is being marketed.
2- The published scientific papers.
3- Studies that are conducted after registering the drug inside or outside Jordan
and are financed by the company.
B- The suspected unexpected and expected serious reactions
included in the special cases below:1- Reports informing of abnormal results upon using the drug by pregnant
women.
2- Reports informing lack of effectiveness of the drug in life threatening
diseases, or when lack of effectiveness has dangerous effects on health.
3- Reports informing of serious adverse reactions of a non registered drug
which is being used in Jordan.
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C- Suspecting the increase incidence of expected serious adverse
reaction and explaining the basis behind suspecting the average
increase.
Article (6):
The researcher responsible for the clinical study conducted in Jordan, in addition
to what is stipulated in the Clinical Studies Law must inform the Administration of
the following:1- The unexpected serious adverse reactions which led to the death or had
threatened the life of the volunteer or the patient while conducting the
studies and within seven days of his knowledge of the adverse reaction on a
form specially prepared for this purpose.
2- The balance of the unexpected serious adverse reactions which occurred
during the studies and within fifteen days.
Article (7):
The reporter must inform the Administration and/or the company of any serious
drug adverse reaction through the spontaneous reports forms within maximum
fifteen days (Appendix 1)
Article (8):
Responsibilities of Jordan Pharmacovigilance Center:-
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Monitoring, analyzing and evaluating drug safety information including the
adverse reactions of circulated drugs in Jordan and the problems related to
its use and preparing aggregate reports of it.
Supplying the Uppsala Monitoring Center with all drug safety information
that was monitored inside Jordan and the organizational procedures taken
by the Administration for reasons related to drug safety.
Publishing the information related to drug safety and making it available to
the presenters and receivers of medical services.
Training and educating the presenters and receivers of medical services on
the concept of vigilance and its mechanism.
Article (9):
The company and/or the Administration must take any, some or all of the
following procedures:-
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Banning importation, holding distribution, holding selling, holding
circulating or canceling the registration, retrieving the drug, changing the
method of prescribing or amending the package insert or taking other safety
procedures.
To respond to the new available drug safety information which affects the
risk/benefit ratio of using the drug and within 90 days of the date of knowing
such information by the company or the Administration and to inform the
presenters and receivers of the medical services with all procedures taken
and the changes that occurred on the drug information.
Appendix (1)
The Form for reporting the spontaneous drug adverse reactions and the problems
related to pharmaceutical preparations.
Appendix (2)
The minimum information that must be reported in the drug adverse reactions
report:- Identified patient: by the indicating the initials of his name, age, weight and
gender
- The full name of the reporter, his address and specialization.
- Name of the suspected drug: to name at least one pharmaceutical
preparation or one active ingredient suspected to cause the adverse reaction.
- A suspected adverse reaction/s: at least one adverse reaction must be
mentioned.
o It is a necessary that the original words used by the reporter in
describing the adverse reaction be mentioned and translated into
Arabic or English if it was in another language or use the terminology
available in WHO- art to describe the adverse reactions.
o The company may comment on the existence or No causal relationship
between its drug and the reported adverse reaction and it must
therefore, present the basis of its conclusion.
Appendix (3)
Periodical Safety Update Reports (PSUR):It is the report which is submitted periodically by the company to the
Administration that includes safety experiences or updated safety information for
one of its drugs gathered from all countries where the drug is being marketed. This
report also includes comparative updated safety information to the Reference
Safety Information approved by the company, in addition to procedure undertaken
or already taken by the company based on the updated safety information and the
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results of the comparison carried out in order to increase the safety of the drug and
improve its benefits/risk ratio. This report is presented periodically and as follows:1- Upon submitting drug registration application for drugs that have an
international birth date (IBD) preceding the Jordanian birth date (JBD) for
a new or a generic product.
2- Every year for the first five years after registering new drugs (NME) in
Jordan.
3- Every five years upon renewing the drug registration for both New or
Generic drugs.
The periodical safety updates report must be presented in a manner that covers the
specified period from the date of the last PSUR and within 60 days from the date of
Data lock point (DLP). To coordinate and facilitate the update of PSURs on the
international level, the company may use the (IBD) to specify the (DLP) instead of
the (JBD)
Appendix (4)
Reports for Continuous Safety Evaluation related to the drug and
after it is registered and marketed:Those are the reports that are prepared by the company in the periods between the
consecutive PSURs. The objectives of those reports is, to evaluate emergency or
updated drug safety information that could have a tangible effect on the risk/
benefit ratio of the drug. As a result of these reports, safety procedures may be
taken to improve the benefits of the drug and reduce or stop its risks
Minister of Health
Eng. Said Sameeh Darwazeh
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