A healthcare professional is a doctor or other person who has received a medical degree in accordance with the procedure established by law, meets the qualification requirements established by the central executive authority in the field of healthcare, works in a healthcare institution or as an individual entrepreneur.
The reporting source is the original source of information from which the adverse reaction, safety issue or other information was reported.
Step 1 / 5.
Information about the source of the message- Initials of the source of the notification
- Name of the healthcare facility or organisation of the source of the notification
- Qualification of the source of the notification
- doctor
- pharmacist
- druggist
- other healthcare professional
- other
- Do you agree to be contacted by phone or email for additional information?
- Phone
- E-mail
- Country of form filling
- Afghanistan
- Aland Islands
- Albania
- Algeria
- American Samoa
- Andorra
- Angola
- Anguilla
- Antarctica
- Antigua and Barbuda
- Argentina
- Armenia
- Aruba
- Australia
- Austria
- Azerbaijan
- Bahamas
- Bahrain
- Bangladesh
- Barbados
- Belarus
- Belgium
- Belize
- Benin
- Bermuda
- Bhutan
- Bolivia (Plurinational State of)
- Bonaire, Sint Eustatius and Saba
- Bosnia and Herzegovina
- Botswana
- Bouvet Island
- Brazil
- British Indian Ocean Territory
- British Virgin Islands
- Brunei Darussalam
- Bulgaria
- Burkina Faso
- Burundi
- Cabo Verde
- Cambodia
- Cameroon
- Canada
- Cayman Islands
- Central African Republic
- Chad
- Chile
- China
- China, Hong Kong Special Administrative Region
- China, Macao Special Administrative Region
- Christmas Island
- Cocos (Keeling) Islands
- Colombia
- Comoros
- Congo
- Cook Islands
- Costa Rica
- Cote d'Ivoire
- Croatia
- Cuba
- Curaao
- Cyprus
- Czechia
- Democratic People's Republic of Korea
- Democratic Republic of the Congo
- Denmark
- Djibouti
- Dominica
- Dominican Republic
- Ecuador
- Egypt
- El Salvador
- Equatorial Guinea
- Eritrea
- Estonia
- Eswatini
- Ethiopia
- Falkland Islands (Malvinas)
- Faroe Islands
- Fiji
- Finland
- France
- French Guiana
- French Polynesia
- French Southern Territories
- Gabon
- Gambia
- Georgia
- Germany
- Ghana
- Gibraltar
- Greece
- Greenland
- Grenada
- Guadeloupe
- Guam
- Guatemala
- Guernsey
- Guinea
- Guinea-Bissau
- Guyana
- Haiti
- Heard Island and McDonald Islands
- Holly See
- Honduras
- Hungary
- Iceland
- India
- Indonesia
- Iran (Islamic Republic of)
- Iraq
- Ireland
- Isle of Man
- Israel
- Italy
- Jamaica
- Japan
- Jersey
- Jordan
- Kazakhstan
- Kenya
- Kiribati
- Kuwait
- Kyrgyzstan
- Lao People's Democratic Republic
- Latvia
- Lebanon
- Lesotho
- Liberia
- Libya
- Liechtenstein
- Lithuania
- Luxembourg
- Madagascar
- Malawi
- Malaysia
- Maldives
- Mali
- Malta
- Marshall Islands
- Martinique
- Mauritania
- Mauritius
- Mayotte
- Mexico
- Micronesia (Federated States of)
- Monaco
- Mongolia
- Montenegro
- Montserrat
- Morocco
- Mozambique
- Myanmar
- Namibia
- Nauru
- Nepal
- Netherlands
- New Caledonia
- New Zealand
- Nicaragua
- Niger
- Nigeria
- Niue
- Norfolk Island
- North Macedonia
- Northern Mariana Islands
- Norway
- Oman
- Pakistan
- Palau
- Panama
- Papua New Guinea
- Paraguay
- Peru
- Philippines
- Pitcairn
- Poland
- Portugal
- Puerto Rico
- Qatar
- Republic of Korea
- Republic of Moldova
- Reunion
- Romania
- Russian Federation
- Rwanda
- Saint Barthelemy
- Saint Helena
- Saint Kitts and Nevis
- Saint Lucia
- Saint Martin (French Part)
- Saint Pierre and Miquelon
- Saint Vincent and the Grenadines
- Samoa
- San Marino
- Sao Tome and Principe
- Sark
- Saudi Arabia
- Senegal
- Serbia
- Seychelles
- Sierra Leone
- Singapore
- Sint Maarten (Dutch Part)
- Slovakia
- Slovenia
- Solomon Islands
- Somalia
- South Africa
- South Georgia and the South Sandwich Islands
- South Sudan
- Spain
- Sri Lanka
- State of Palestine
- Sudan
- Suriname
- Svalbard and Jan Mayen Islands
- Sweden
- Switzerland
- Syrian Arab Republic
- Taiwan, Province of China
- Tajikistan
- Thailand
- Timor-Leste
- Togo
- Tokelau
- Tonga
- Trinidad and Tobago
- Tunisia
- Turkey
- Turkmenistan
- Turks and Caicos Islands
- Tuvalu
- Uganda
- Ukraine
- United Arab Emirates
- United Kingdom of Great Britain and Northern Ireland
- United Republic of Tanzania
- United States Minor Outlying Islands
- United States of America
- United States Virgin Islands
- Uruguay
- Uzbekistan
- Vanuatu
- Venezuela (Bolivarian Republic of)
- Viet Nam
- Wallis and Futuna Islands
- Western Sahara
- Yemen
- Zambia
- Zimbabwe
- Country of occurrence of the case
- Afghanistan
- Aland Islands
- Albania
- Algeria
- American Samoa
- Andorra
- Angola
- Anguilla
- Antarctica
- Antigua and Barbuda
- Argentina
- Armenia
- Aruba
- Australia
- Austria
- Azerbaijan
- Bahamas
- Bahrain
- Bangladesh
- Barbados
- Belarus
- Belgium
- Belize
- Benin
- Bermuda
- Bhutan
- Bolivia (Plurinational State of)
- Bonaire, Sint Eustatius and Saba
- Bosnia and Herzegovina
- Botswana
- Bouvet Island
- Brazil
- British Indian Ocean Territory
- British Virgin Islands
- Brunei Darussalam
- Bulgaria
- Burkina Faso
- Burundi
- Cabo Verde
- Cambodia
- Cameroon
- Canada
- Cayman Islands
- Central African Republic
- Chad
- Chile
- China
- China, Hong Kong Special Administrative Region
- China, Macao Special Administrative Region
- Christmas Island
- Cocos (Keeling) Islands
- Colombia
- Comoros
- Congo
- Cook Islands
- Costa Rica
- Cote d'Ivoire
- Croatia
- Cuba
- Curaao
- Cyprus
- Czechia
- Democratic People's Republic of Korea
- Democratic Republic of the Congo
- Denmark
- Djibouti
- Dominica
- Dominican Republic
- Ecuador
- Egypt
- El Salvador
- Equatorial Guinea
- Eritrea
- Estonia
- Eswatini
- Ethiopia
- Falkland Islands (Malvinas)
- Faroe Islands
- Fiji
- Finland
- France
- French Guiana
- French Polynesia
- French Southern Territories
- Gabon
- Gambia
- Georgia
- Germany
- Ghana
- Gibraltar
- Greece
- Greenland
- Grenada
- Guadeloupe
- Guam
- Guatemala
- Guernsey
- Guinea
- Guinea-Bissau
- Guyana
- Haiti
- Heard Island and McDonald Islands
- Holly See
- Honduras
- Hungary
- Iceland
- India
- Indonesia
- Iran (Islamic Republic of)
- Iraq
- Ireland
- Isle of Man
- Israel
- Italy
- Jamaica
- Japan
- Jersey
- Jordan
- Kazakhstan
- Kenya
- Kiribati
- Kuwait
- Kyrgyzstan
- Lao People's Democratic Republic
- Latvia
- Lebanon
- Lesotho
- Liberia
- Libya
- Liechtenstein
- Lithuania
- Luxembourg
- Madagascar
- Malawi
- Malaysia
- Maldives
- Mali
- Malta
- Marshall Islands
- Martinique
- Mauritania
- Mauritius
- Mayotte
- Mexico
- Micronesia (Federated States of)
- Monaco
- Mongolia
- Montenegro
- Montserrat
- Morocco
- Mozambique
- Myanmar
- Namibia
- Nauru
- Nepal
- Netherlands
- New Caledonia
- New Zealand
- Nicaragua
- Niger
- Nigeria
- Niue
- Norfolk Island
- North Macedonia
- Northern Mariana Islands
- Norway
- Oman
- Pakistan
- Palau
- Panama
- Papua New Guinea
- Paraguay
- Peru
- Philippines
- Pitcairn
- Poland
- Portugal
- Puerto Rico
- Qatar
- Republic of Korea
- Republic of Moldova
- Reunion
- Romania
- Russian Federation
- Rwanda
- Saint Barthelemy
- Saint Helena
- Saint Kitts and Nevis
- Saint Lucia
- Saint Martin (French Part)
- Saint Pierre and Miquelon
- Saint Vincent and the Grenadines
- Samoa
- San Marino
- Sao Tome and Principe
- Sark
- Saudi Arabia
- Senegal
- Serbia
- Seychelles
- Sierra Leone
- Singapore
- Sint Maarten (Dutch Part)
- Slovakia
- Slovenia
- Solomon Islands
- Somalia
- South Africa
- South Georgia and the South Sandwich Islands
- South Sudan
- Spain
- Sri Lanka
- State of Palestine
- Sudan
- Suriname
- Svalbard and Jan Mayen Islands
- Sweden
- Switzerland
- Syrian Arab Republic
- Taiwan, Province of China
- Tajikistan
- Thailand
- Timor-Leste
- Togo
- Tokelau
- Tonga
- Trinidad and Tobago
- Tunisia
- Turkey
- Turkmenistan
- Turks and Caicos Islands
- Tuvalu
- Uganda
- Ukraine
- United Arab Emirates
- United Kingdom of Great Britain and Northern Ireland
- United Republic of Tanzania
- United States Minor Outlying Islands
- United States of America
- United States Virgin Islands
- Uruguay
- Uzbekistan
- Vanuatu
- Venezuela (Bolivarian Republic of)
- Viet Nam
- Wallis and Futuna Islands
- Western Sahara
- Yemen
- Zambia
- Zimbabwe
Step 2 / 5.
Information about the patient- Patient initials
- Gender (at birth)
- male
- female
- Weight (kg)
- Height (cm)
- Age (at the time of the reaction)
- Age unit
- Year
- Months
- Days
- Treatment
- outpatient
- inpatient
- selftreatment
- unknown
- Age group
- Newborns (0-1 month)
- infants (2-12 months)
- children (1- 12 years old)
- teenagers (13-18 years old)
- adults (19-64 years old)
- older (65 ≤...)
- General medical information (allergies, including drug allergies, renal, hepatic, cardiac dysfunction, surgeries, pregnancy, with indication of the term, etc.)
- Detailing the anamnesis
Information in case of patient's death
- Date of death
- Cause of death
- Was an autopsy performed?
- yes
- no
- unknow
- Comment
Step 3 / 5.
Information about the case- Date of receipt of case information
- Country of form filling
- Afghanistan
- Aland Islands
- Albania
- Algeria
- American Samoa
- Andorra
- Angola
- Anguilla
- Antarctica
- Antigua and Barbuda
- Argentina
- Armenia
- Aruba
- Australia
- Austria
- Azerbaijan
- Bahamas
- Bahrain
- Bangladesh
- Barbados
- Belarus
- Belgium
- Belize
- Benin
- Bermuda
- Bhutan
- Bolivia (Plurinational State of)
- Bonaire, Sint Eustatius and Saba
- Bosnia and Herzegovina
- Botswana
- Bouvet Island
- Brazil
- British Indian Ocean Territory
- British Virgin Islands
- Brunei Darussalam
- Bulgaria
- Burkina Faso
- Burundi
- Cabo Verde
- Cambodia
- Cameroon
- Canada
- Cayman Islands
- Central African Republic
- Chad
- Chile
- China
- China, Hong Kong Special Administrative Region
- China, Macao Special Administrative Region
- Christmas Island
- Cocos (Keeling) Islands
- Colombia
- Comoros
- Congo
- Cook Islands
- Costa Rica
- Cote d'Ivoire
- Croatia
- Cuba
- Curaao
- Cyprus
- Czechia
- Democratic People's Republic of Korea
- Democratic Republic of the Congo
- Denmark
- Djibouti
- Dominica
- Dominican Republic
- Ecuador
- Egypt
- El Salvador
- Equatorial Guinea
- Eritrea
- Estonia
- Eswatini
- Ethiopia
- Falkland Islands (Malvinas)
- Faroe Islands
- Fiji
- Finland
- France
- French Guiana
- French Polynesia
- French Southern Territories
- Gabon
- Gambia
- Georgia
- Germany
- Ghana
- Gibraltar
- Greece
- Greenland
- Grenada
- Guadeloupe
- Guam
- Guatemala
- Guernsey
- Guinea
- Guinea-Bissau
- Guyana
- Haiti
- Heard Island and McDonald Islands
- Holly See
- Honduras
- Hungary
- Iceland
- India
- Indonesia
- Iran (Islamic Republic of)
- Iraq
- Ireland
- Isle of Man
- Israel
- Italy
- Jamaica
- Japan
- Jersey
- Jordan
- Kazakhstan
- Kenya
- Kiribati
- Kuwait
- Kyrgyzstan
- Lao People's Democratic Republic
- Latvia
- Lebanon
- Lesotho
- Liberia
- Libya
- Liechtenstein
- Lithuania
- Luxembourg
- Madagascar
- Malawi
- Malaysia
- Maldives
- Mali
- Malta
- Marshall Islands
- Martinique
- Mauritania
- Mauritius
- Mayotte
- Mexico
- Micronesia (Federated States of)
- Monaco
- Mongolia
- Montenegro
- Montserrat
- Morocco
- Mozambique
- Myanmar
- Namibia
- Nauru
- Nepal
- Netherlands
- New Caledonia
- New Zealand
- Nicaragua
- Niger
- Nigeria
- Niue
- Norfolk Island
- North Macedonia
- Northern Mariana Islands
- Norway
- Oman
- Pakistan
- Palau
- Panama
- Papua New Guinea
- Paraguay
- Peru
- Philippines
- Pitcairn
- Poland
- Portugal
- Puerto Rico
- Qatar
- Republic of Korea
- Republic of Moldova
- Reunion
- Romania
- Russian Federation
- Rwanda
- Saint Barthelemy
- Saint Helena
- Saint Kitts and Nevis
- Saint Lucia
- Saint Martin (French Part)
- Saint Pierre and Miquelon
- Saint Vincent and the Grenadines
- Samoa
- San Marino
- Sao Tome and Principe
- Sark
- Saudi Arabia
- Senegal
- Serbia
- Seychelles
- Sierra Leone
- Singapore
- Sint Maarten (Dutch Part)
- Slovakia
- Slovenia
- Solomon Islands
- Somalia
- South Africa
- South Georgia and the South Sandwich Islands
- South Sudan
- Spain
- Sri Lanka
- State of Palestine
- Sudan
- Suriname
- Svalbard and Jan Mayen Islands
- Sweden
- Switzerland
- Syrian Arab Republic
- Taiwan, Province of China
- Tajikistan
- Thailand
- Timor-Leste
- Togo
- Tokelau
- Tonga
- Trinidad and Tobago
- Tunisia
- Turkey
- Turkmenistan
- Turks and Caicos Islands
- Tuvalu
- Uganda
- Ukraine
- United Arab Emirates
- United Kingdom of Great Britain and Northern Ireland
- United Republic of Tanzania
- United States Minor Outlying Islands
- United States of America
- United States Virgin Islands
- Uruguay
- Uzbekistan
- Vanuatu
- Venezuela (Bolivarian Republic of)
- Viet Nam
- Wallis and Futuna Islands
- Western Sahara
- Yemen
- Zambia
- Zimbabwe
- Country of occurrence of the case
- Afghanistan
- Aland Islands
- Albania
- Algeria
- American Samoa
- Andorra
- Angola
- Anguilla
- Antarctica
- Antigua and Barbuda
- Argentina
- Armenia
- Aruba
- Australia
- Austria
- Azerbaijan
- Bahamas
- Bahrain
- Bangladesh
- Barbados
- Belarus
- Belgium
- Belize
- Benin
- Bermuda
- Bhutan
- Bolivia (Plurinational State of)
- Bonaire, Sint Eustatius and Saba
- Bosnia and Herzegovina
- Botswana
- Bouvet Island
- Brazil
- British Indian Ocean Territory
- British Virgin Islands
- Brunei Darussalam
- Bulgaria
- Burkina Faso
- Burundi
- Cabo Verde
- Cambodia
- Cameroon
- Canada
- Cayman Islands
- Central African Republic
- Chad
- Chile
- China
- China, Hong Kong Special Administrative Region
- China, Macao Special Administrative Region
- Christmas Island
- Cocos (Keeling) Islands
- Colombia
- Comoros
- Congo
- Cook Islands
- Costa Rica
- Cote d'Ivoire
- Croatia
- Cuba
- Curaao
- Cyprus
- Czechia
- Democratic People's Republic of Korea
- Democratic Republic of the Congo
- Denmark
- Djibouti
- Dominica
- Dominican Republic
- Ecuador
- Egypt
- El Salvador
- Equatorial Guinea
- Eritrea
- Estonia
- Eswatini
- Ethiopia
- Falkland Islands (Malvinas)
- Faroe Islands
- Fiji
- Finland
- France
- French Guiana
- French Polynesia
- French Southern Territories
- Gabon
- Gambia
- Georgia
- Germany
- Ghana
- Gibraltar
- Greece
- Greenland
- Grenada
- Guadeloupe
- Guam
- Guatemala
- Guernsey
- Guinea
- Guinea-Bissau
- Guyana
- Haiti
- Heard Island and McDonald Islands
- Holly See
- Honduras
- Hungary
- Iceland
- India
- Indonesia
- Iran (Islamic Republic of)
- Iraq
- Ireland
- Isle of Man
- Israel
- Italy
- Jamaica
- Japan
- Jersey
- Jordan
- Kazakhstan
- Kenya
- Kiribati
- Kuwait
- Kyrgyzstan
- Lao People's Democratic Republic
- Latvia
- Lebanon
- Lesotho
- Liberia
- Libya
- Liechtenstein
- Lithuania
- Luxembourg
- Madagascar
- Malawi
- Malaysia
- Maldives
- Mali
- Malta
- Marshall Islands
- Martinique
- Mauritania
- Mauritius
- Mayotte
- Mexico
- Micronesia (Federated States of)
- Monaco
- Mongolia
- Montenegro
- Montserrat
- Morocco
- Mozambique
- Myanmar
- Namibia
- Nauru
- Nepal
- Netherlands
- New Caledonia
- New Zealand
- Nicaragua
- Niger
- Nigeria
- Niue
- Norfolk Island
- North Macedonia
- Northern Mariana Islands
- Norway
- Oman
- Pakistan
- Palau
- Panama
- Papua New Guinea
- Paraguay
- Peru
- Philippines
- Pitcairn
- Poland
- Portugal
- Puerto Rico
- Qatar
- Republic of Korea
- Republic of Moldova
- Reunion
- Romania
- Russian Federation
- Rwanda
- Saint Barthelemy
- Saint Helena
- Saint Kitts and Nevis
- Saint Lucia
- Saint Martin (French Part)
- Saint Pierre and Miquelon
- Saint Vincent and the Grenadines
- Samoa
- San Marino
- Sao Tome and Principe
- Sark
- Saudi Arabia
- Senegal
- Serbia
- Seychelles
- Sierra Leone
- Singapore
- Sint Maarten (Dutch Part)
- Slovakia
- Slovenia
- Solomon Islands
- Somalia
- South Africa
- South Georgia and the South Sandwich Islands
- South Sudan
- Spain
- Sri Lanka
- State of Palestine
- Sudan
- Suriname
- Svalbard and Jan Mayen Islands
- Sweden
- Switzerland
- Syrian Arab Republic
- Taiwan, Province of China
- Tajikistan
- Thailand
- Timor-Leste
- Togo
- Tokelau
- Tonga
- Trinidad and Tobago
- Tunisia
- Turkey
- Turkmenistan
- Turks and Caicos Islands
- Tuvalu
- Uganda
- Ukraine
- United Arab Emirates
- United Kingdom of Great Britain and Northern Ireland
- United Republic of Tanzania
- United States Minor Outlying Islands
- United States of America
- United States Virgin Islands
- Uruguay
- Uzbekistan
- Vanuatu
- Venezuela (Bolivarian Republic of)
- Viet Nam
- Wallis and Futuna Islands
- Western Sahara
- Yemen
- Zambia
- Zimbabwe
- Consequence of the adverse reaction or lack of efficacy (select from the following)
- Other
Step 4 / 5.
Information about the suspected medicinal product- Trade name
- Form of issue
- Ointment
- Effervescent tablets
- Gel
- Cream
- Lozenges
- Granules
- Oral drops, solution
- Solvent for preparing an injection solution
- Infusion solution concentrate
- The tablet is indivisible
- Tablet with chamfer for division
- Capsule
- Infusion solution
- Powder for injection
- Injectable solution
- Solution
- Injectable solution
- Flow
- Spray
- Drops
- Powder
- Shampoo
- Suppository
- Patch
- Hot drink
- Syrup
- Series
- Expiry date
- Indications for use
- Method of administration
- Dose
- Multiplicity
Step 5 / 5.
Information on suspected adverse reactions or lack of efficacy- Description of the case of adverse reaction or indication of lack of efficacy.
- Date and time of onset of adverse reaction or lack of efficacy in the format DD.MM.YYYY, where DD is the day of the month, MM is the month, YYYY is the year
- At the time of filling out the form, has the manifestation of PR/Lack of Effectiveness ended?
- Date and time of the end of the adverse reaction or lack of efficacy in the format DD.MM.YYYY, where DD is the day of the month, MM is the month, YYYY is the year
- Consequence of PR/Lack of effectiveness
- Was the adverse reaction or lack of efficacy corrected?
- Indicate the medications used for correction, the time dependence, and the result of the correction
- Time interval from the start of medication to the onset of PR
- Time
- minutes
- hours
- Were there concomitant medicines not related to the manifestation and correction of the adverse reaction or lack of efficacy (e.g. treatment of chronic diseases, etc.)?
- Indicate the drug, drug product, dose, time dependence, route of administration and indications
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A specialized edition intended for medical institutions and doctors.