Annex 2 to the Procedure for Surveillance over Adverse Reactions to Medicinal
Products Permitted for Medical Use
Reporting Procedure
Report on adverse reactions and/or lack of efficacy of medicinal products at medical use at health facilities
for 20 ____
Submission date
To be submitted by/to
1. All health facilities subordinated to MoH Ukraine as well as health facilities subordinated to
other authority – to the Ministry of Health of the Autonomous Republic of Crimea, Health
Departments (Central Departments) of the Oblast, Kyiv and Sebastopol City State
Administrations.
2. Ministry of Health of the Autonomous Republic of Crimea, Health Departments (Central
Departments) of the Oblast, Kyiv and Sebastopol City State Administrations – to Post-registration
Surveillance Board, PE “State Expert Center MoH Ukraine”, 40, Ushynskyi St., 03151 Kyiv,
Ukraine; tel./fax (044) 4984358, e-mail: vigilance@pharma-center.kiev.ua)
Form № 69
January 20
APPROVED
January 30
The MoH Ukraine Order
of 27.12.2006 № 898
(in wording of the MoH
Ukraine Order
of 29.12.2011 No 1005)
Annual
To be sent by mail
Name of organization
Location
EDRPOU
Territory (KOATUU)
Codes of organization
Economic activity
Form of ownership
(KVED)
(KFV)
Organizational and
legal form of
Ministry, other
central executive
management (KOPFG)
1
2
3
4
5
authority to which
the organization is
subordinated
(KODU)
6
Table 1000. Cases of adverse reaction and/or lack of efficacy of medicinal products at medical use
Sequence
number
Full
name
Gender
(M/F)
Age
Number of case history
or medical history
Suspected MP (trade
name, presentation,
manufacturer, country)
1
2
3
4
5
6
Description of
Main clinical and concurrent
manifestations of adverse diagnoses (indicating ICD reaction to suspected MP
10 code)
7
8
Table 1001
Number of health
facilities
Number of health
facilities, which
submitted case
reports on adverse
reactions and/or
lack of efficacy
Number of doctors (excl. those
not involved in medical care)
Ppopulation size (average
annual)
1
2
3
4
Including children (0 - Number of case reports
18 years)
on adverse reactions
and/or lack of efficacy
5
6
7
Head of facility
Date
Executor
_________
_________________________
(signature)
(full name)
Chief of the Oblast (City) Health Department
___ __________ ______
________________________
______________________________________
(in numbers)
(signature)
(full name)
______________
_______________________________________
(signature)
(full name)
Place of stamp
Place of stamp
REQUIREMENTS
to drawing up report on adverse reactions and/or lack of efficacy of medicinal
products at medical use at health facilities
I. Table 1000 shall be completed by the person in charge as follows: data on all revealed
cases of adverse reactions and/or lack of efficacy of medicinal products at medical use
in health facilities of the oblast (city) shall be entered to every column. Every next case
shall be entered to the new line of the table.
1. Sequence number.
2. Full name
Patient’s surname, name, patronymic name shall be indicated by initials, e.g.: Olena
Ivanivna Koval – O.I.K.
3. Gender:
Female or male.
If the report deals with the medicinal products taken by pregnant woman, and adverse
reaction and/or lack of efficacy developed in fetus, provide all data (except for adverse
reactions) about mother indicating the pregnancy trimester.
4. Age:
For patients aged 3 years and over indicate the number of years (e.g., 4 years); for
patients aged under 3 years indicate the number of months (e.g., 24 months); for
patients aged under one month indicate the number of days (e.g., 5 days).
5. Number of case history or medical history:
Indicate number of case history or medical history.
6. Suspected medicinal product (trade name, presentation, manufacturer, country)
Indicate trade name of a medicinal product suspected in causing adverse reaction and/or
lack of efficacy, its presentation, manufacturer (full name), country.
7. Description of manifestations of adverse reaction to suspected medicinal product.
Indicate manifestations of adverse reactions of medicinal product – negative clinical
manifestations/signs associated with prevalent or combined effect on digestive system,
skin, central nervous system, cardiovascular system, respiratory system, urogenital
system, immune and other systems because of the prescription of suspected medicinal
product or combination of medicinal products that result in certain body dysfunction. In
case of lack of efficacy at use of medicinal product indicate: lack of efficacy.
8. Main clinical and concurrent diagnoses (indicating ICD -10 code)
Indicate main clinical and concurrent diagnoses of the patient who developed adverse
reaction, indicating ICD 10-code.
II. Table 1001 shall be completed by the person in charge as follows:
Enter absolute figures for the region (city) concerned to the table columns:
1. Number of health facilities.
Indicate number of all functioning health facilities regardless of types of ownership
located at the territory of political unit (oblast, city).
2. Number of health facilities, which submitted case reports on adverse reactions and/or
lack of efficacy
Indicate number of all functioning health facilities regardless of types of ownership
located at the administrative territory (oblast, city), which during the reporting year
submitted case report forms about adverse reactions and/or lack of efficacy of medicinal
products at medical use.
3. Number of doctors (excl. those not involved in medical care)
Indicate total number of doctors, excluding those not involved inmedical care
(pathologists, laboratory doctors, doctor- statisticians, etc.).
4. Population size (average annual)
Indicate total average annual size of population in the administrative territory (oblast,
city) in the reporting year (according to the Department of Statistics).
5. Including children (0 - 18 years).
Indicate average annual number of children (0-18 years inclusive) in the total population
in the administrative territory indicated in column 4.
6. Number of case reports on adverse reactions and/or lack of efficacy.
Indicate total number of case reports about adverse reactions and/or lack of efficacy of
medicinal products at medical use sent from the administrative territory (oblast, city)
concerned.
(annex 2 in wording of the MoH Ukraine Order
of 29.12.2011 No 1005)