Adverse Event Reporting
Guidelines for Adverse Event Reporting
You can use this website to report any adverse events you have experienced while taking products from Samil Pharmaceutical Co., Ltd. This page is used solely for reporting adverse events to regulatory authorities based on the information you provide. If you are not a healthcare professional, you should first seek advice about the adverse event from a doctor, pharmacist, or other medical expert. This adverse event reporting process is not related to compensation.
An adverse event refers to the occurrence of an undesirable medical condition or the worsening of a pre-existing condition after or during the administration of a medication, regardless of its causal relationship with the drug. Undesirable medical conditions can include ① symptoms (e.g., headache, vomiting, dizziness), ② signs (e.g., jaundice, arrhythmia, anemia), and ③ abnormal test results (e.g., abnormal findings on tests or ECGs). Additionally, information such as drug exposure during pregnancy and lactation, off-label use, drug overdose, drug interactions, and drug misuse are also collected
An adverse event refers to the occurrence of an undesirable medical condition or the worsening of a pre-existing condition after or during the administration of a medication, regardless of its causal relationship with the drug. Undesirable medical conditions can include ① symptoms (e.g., headache, vomiting, dizziness), ② signs (e.g., jaundice, arrhythmia, anemia), and ③ abnormal test results (e.g., abnormal findings on tests or ECGs). Additionally, information such as drug exposure during pregnancy and lactation, off-label use, drug overdose, drug interactions, and drug misuse are also collected
Information
| Reporting Subject | Adverse events suspected to be caused by "Samil Pharmaceutical’s products", including diseases, disabilities, deaths, and other safety and efficacy information of pharmaceuticals. |
|---|---|
| Reporting Method |
|
| Reporting Form | [Below] Adverse Event Reporting Form |
| Required Reporting Items |
|
| Terms Agreement |
|
| Other Reporting Items |
Any specific information possible for adverse event evaluation (Severity, Seriousness, Outcome of the Adverse Event, etc.) |
Terms Agreement * The form can be downloaded after agreeing to the terms.
Guidance on the Collection and Use of Personal Information
Samil Pharmaceutical Co., Ltd. collects the following personal information prior to reporting adverse events for the purpose of collecting and reporting adverse events.
Only the personal information necessary for Samil Pharmaceutical to comply with current regulations is entered into Samil Pharmaceutical's safety database and stored permanently or for the period required by current laws. Samil Pharmaceutical processes the collected personal information in an encrypted form that cannot identify specific individuals.
Only the personal information necessary for Samil Pharmaceutical to comply with current regulations is entered into Samil Pharmaceutical's safety database and stored permanently or for the period required by current laws. Samil Pharmaceutical processes the collected personal information in an encrypted form that cannot identify specific individuals.
1. Purpose of Collection and Use: Collection and reporting of adverse events for post-marketing safety management in accordance with relevant laws such as the 『Pharmaceutical Affairs Act』 and 『Regulations on Safety of Pharmaceuticals』.
2. Collected Items
-
Patient's Personal Information
- name, gender, date of birth (age or age group), contact information, pregnancy status and duration, smoking status, past medical history or previously administered medications, detailed information about experienced adverse events, symptom onset and end dates, final observation results, current illnesses, product name or concomitant medications, purpose of administration (indication), single dose, frequency of administration, duration of administration, etc.
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Reporter’s Personal Information
- Name (initials), qualifications of the medical professional, country.
3. Retention and Use Period of Personal Information
Up to 5 years after the termination of the product license.
4. Disadvantages of Refusing Consent
Customers may refuse to consent to the collection, but service usage for reporting adverse events will be restricted.
Notice on Consent for Third-Party Provision
Samil Pharmaceutical Co., Ltd. may provide personal information to third parties as follows to comply with its obligation to report adverse events.
1. Recipients
National regulatory authorities (Ministry of Food and Drug Safety, Korea Institute of Drug Safety & Risk Management) and domestic and international partner companies (companies with which Samil Pharmaceutical has product license agreements).
2. Purpose of Provision
Collection and reporting of adverse drug events for post-marketing safety management in accordance with relevant laws such as the 『Pharmaceutical Affairs Act』 and 『Regulations on Safety of Pharmaceuticals』.
3. Information Provided
-
Patient's Personal Information
- name, gender, date of birth (age or age group), contact information, pregnancy status and duration, smoking status, past medical history or previously administered medications, detailed information about experienced adverse events, symptom onset and end dates, final observation results, current illnesses, product name or concomitant medications, purpose of administration (indication), single dose, frequency of administration, duration of administration, etc.
-
Reporter’s Personal Information
- Name (initials), qualifications of the medical professional, country.
4. Retention and Use Period
Up to 5 years after the termination of the product license.
5. Disadvantages of Refusing Consent
Customers may refuse to consent to the collection, but service usage for reporting adverse events will be restricted.
Notice on Consent for Follow-Up Investigation
If the adverse event report you submit is unclear or contains missing information, we may contact you to conduct a follow-up investigation. Do you agree to be contacted by Samil Pharmaceutical Co., Ltd. for further questions or follow-up investigations regarding your report?
