Adverse Event Reporting Form

Patient details
Medicine information
Adverse event(s)
Reporter details

Fields that you must complete are marked with an asterisk (*)

Patient details

Report *

Choose raport type

initial Follow-up

Patient initials

Country of occurrence of the adverse effect

Patient gender *

Choose patient gender

Female Male

Is the patient pregnant?

Yes > No > Unknown

Which trimester/week?

Date of birth of the patient

Age
?
Patient age at the time of the adverse event

Enter Patient age

Patient weight kg

Height cm

Suspected medicine

A adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a casual relationship with this treatment.

Enter at least one medicine

Name of the medicine *

Batch number/ Expiration date

Single dose

Dose frequency

Route of administration
?
e.g. oral, sublingual, intravenous

Country where medicine was obtained

What date did you start taking the medicine?

What date did you stop taking the medicine?

Reason for taking

Action taken with drug as a results of the reaction

WAS THE EVENT ABATED AFTER DISCONTINUED USE OF MEDICINE/REDUCED DOSE?

DID THE EVENT REOCCUR AFTER REUSE OF THE MEDICINE?

Do you think there is a connection between the adverse event and the medicine used?

Any other medicines being taken and additional details

Enter at least one medicine

Are any other medicines being taken (including herbal medicines), which you do not suspect of causing the adverse event(s)?

Yes No

Name of the medicine

Single dose

Dose frequency

Route of administration
?
e.g. oral, sublingual, intravenous

What date did you start taking the medicine?

What date did you stop taking the medicine?

Reason for taking

Additional relevant information
e.g. medical history, test results, allergies,. If pregnant, when was the last menstrual cycle?

Additional details

Adverse event(s)

Suspected event *

Enter name of adverse event

Start date

End date

Type of reaction *

Choose at least one position

Non-serious (does not meet the below criteria) Serious

Check the appropriate field/fields for serious reaction:

Choose at lease one position

Caused death

cause of death: Date of death:

hospitalization or prolonged hospitalization

concerns a stay in hospital for more than one day due to adverse event (s)

Incapacity or disability

Life threatening

Congenital anomaly/birth defect

Other medically important condition

Other information you think might be important,

Please enter description

Please select an outcome for suspected reaction:

Recovered

Recovered with abnormality

Recovering (during treatment)

Not recovered

Caused death

Unknown

Reporter details

First name and surname *

Please enter reporter name and surname

Telephone number

Please enter telephone number or email address

Profession/Specialization

Please enter profession/specialization

Mailing address

Please enter reporter address

Email address

Do you agree to further contact with us in order to supplement the information you have provided? *

Choose your answer

Yes No

Preferred way of contact:

Please enter telephone number or email address

Email address

Please complete if this information was not provided in the "Reporter details"

Telephone number

Please complete if this information was not provided in the "Reporter details"

PERSONAL DATA CONTROLLER - GENERAL INFORMATION

On the basis of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation, hereinafter referred to as: “GDPR”), we hereby inform that:

[Controller, data protection officer, contact details]

The Controller of your personal data is the Marketing Authorization Holder of the medicinal product which is the subject of the notification, i.e.:
1. Zakłady Farmaceutyczne Polpharma S.A. with its registered office in Starogard Gdański (83-200) at ul. Pelplińska 19
You can contact the Controller in writing to the above addresses. The Controller has appointed a Data Protection Officer, whom you may contact in all matters relating to the personal data protection, by writing to Zakłady Farmaceutyczne POLPHARMA S.A. (office in Warsaw) Bobrowiecka 6, 00-728 Warszawa, by sending an e-mail to: dpo@polpharma.com or by telephone on: 22 364 63 11.
Where an adverse event has occurred following the use of a medicinal product, the adverse event may be reported to Medical Department, adress: Zakłady Farmaceutyczne POLPHARMA S.A. (office in Warsaw), ul. Bobrowiecka 6, 00 -728 Warszawa, tel.: 22 364 61 00, email: phv@polpharma.com.

[Purpose and legal basis for personal data processing]

Your personal data will be processed:
1. for the purpose necessary for the Controller’s ensuring high standards of quality and safety of medicinal products and, in particular, monitoring the safety of medicinal products, including the keeping of records of individual adverse events to medicinal products and the reporting of individual adverse events to medicinal products to the competent authorities– on the basis of:
  - personal data, including the name and surname and address of the medical profession of the person reporting the adverse event of a medicinal product pursuant to Article 6(1)(c) of the GDPR, i.e. processing is necessary to fulfil the legal obligation imposed on the Controller pursuant to Article 36e(1) (2) and (3) of the Polish Pharmaceutical Law, also pursuant to Article 9 (2) (i) GDPR;
2. determination, investigation or defence of potential claims between you and the Controller - basis of Article 6(1)(f) of the GDPR, i.e. on the basis of the legitimate interest pursued by the Controller, which is the possibility to pursue claims.
You will not be subject to automated decision-making, including decisions based on profiling.
Provision of Your personal data is obligatory.

[Categories of personal data recipients]

Your personal data may be disclosed to the following entities: employees, IT service providers, providers of consulting and legal services.

[Personal data storage period]

After the expiry of the aforementioned period, personal data shall be stored for 10 years from the expiry date of the medicinal product series to which the application referred or until the claims expiry or until you have objected to the processing (if the processing is based on legitimate interest of the Controller) or have withdrawn your consent (if the processing is based on consent) – whichever occurs first.

[Rights]

You have the right to:
1. access to data concerning you, the right of rectification, erasure, restriction of processing, the right to object to the processing of data;
2. transfer personal data, i.e. to receive from the controller personal data in a structured, commonly used machine-readable format;
3. to the extent that the processing of your personal data is based on consent, the right to withdraw consent to the processing of your personal data at any time. The withdrawal of consent shall not affect the lawfulness of the processing carried out on the basis of consent prior to its withdrawal.
In order to exercise the above rights, you need to contact the Controller or the Data Protection Officer, using the aforementioned contact details (contact details provided above).
You also have the right to lodge a complaint with a personal data protection supervisory authority (President of the Personal Data Protection Office), if you believe that the data processing violates the GDPR.

Patient details
Medicine information
Adverse event(s)
Reporter details

If you require urgent medical assistance, please contact your doctor or the emergency room by calling 999 or 112.

We kindly inform you that you can also report an adverse event concerning POLPHARMA products using the 24-hour voice mailbox available on our helpline +48 22 364 61 01. Before calling, please prepare the following information:

the name of the Polpharma product to which the notification relates
description of the symptoms that occurred after its use,
patient identification data, such as initials
and contact information of the reporting person.

Please be informed that we are required to keep a record of all adverse events. Please read our Privacy Policy and information regarding the processing of personal data. The contact for the Data Protection Officer is 22 364 61 00. You will also find detailed information on their processing in the Privacy Policy tab.

You can download and print the form from the Adverse Event page in the "Download" section.

Fields that you must complete are marked with an asterisk (*)

Patient details

Report *

Choose raport type

initial Follow-up

Patient details

Who experienced the suspected adverse event(s)? *

Select who is affected by the adverse event

At whom?

Patient initials

Country of occurrence of the adverse effect

Patient gender *

Choose patient gender

Female Male

Is the patient pregnant?

Yes No Unknown

Which trimester/week?

Date of birth of the patient

Age
?
Patient age at the time of the adverse event

Enter Patient age

Patient weight kg

Height cm

Suspected medicine

A adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a casual relationship with this treatment.

Enter at least one medicine

Name of the medicine *

Batch number/ Expiration date

Dose frequency

Single dose

Route of administration
?
e.g. oral, sublingual, intravenous

Country where medicine was obtained

What date did you start taking the medicine?

What date did you stop taking the medicine?

Reason for taking

Action taken with drug as a results of the reaction

Any other medicines being taken and additional details

Enter at least one medicine

Are any other medicines being taken (including herbal medicines), which you do not suspect of causing the adverse event(s)?

Yes No

Name of the medicine

Single dose

Dose frequency

Route of administration
?
e.g. oral, sublingual, intravenous

What date did you start taking the medicine?

What date did you stop taking the medicine?

Reason for taking

Additional details

Other information you think might be important, including any other medical condition, any allergies, results of any test performed, if pregnant, when was the last menstrual cycle etc.

Adverse event(s)

Side effect experienced *

Enter side effect

Type of reaction *

Choose reaction type

Serious Non-serious (does not meet the below criteria)

Check the appropriate field/fields for serious reaction:

Choose at lease one position

Caused death

cause of death: Date of death:

hospitalization or prolonged hospitalization

concerns a stay in hospital for more than one day due to adverse event (s)

Incapacity or disability

Life threatening

Congenital anomaly/birth defect

Other medically important condition

Start date

End date

Please select an outcome for side effect

Recovered

Recovered with abnormality

Recovering (during treatment)

Not recovered

Caused death

Unknown

Other information you think might be important,
What side effect(s) did you observe? Please specify.

Please enter description

Was any treatment received for side effect?

Yes No

What medicines were uses?

WAS THE EVENT ABATED AFTER DISCONTINUED USE OF MEDICINE/REDUCED DOSE?

Yes No Unknown

DID THE EVENT REOCCUR AFTER REUSE OF THE MEDICINE?

Yes No Unknown

REPORTER DETAILS

First name and surname *

Please enter reporter name and surname

Telephone number

Please enter telephone number or email address

Mailing address

Please enter reporter address

Email address

Do you agree to further contact with us in order to supplement the information you have provided? *

Choose your answer

Yes No

Preferred way of contact:

Please enter telephone number or email address

Email address

Please complete if this information was not provided in the "Reporter details"

Telephone number

Please complete if this information was not provided in the "Reporter details"

PERSONAL DATA CONTROLLER - GENERAL INFORMATION

[Controller, data protection officer, contact details]

The Controller of your personal data is the Marketing Authorization Holder of the medicinal product which:
1. Zakłady Farmaceutyczne POLPHARMA S.A. with its registered office in Starogard Gdański (83-200) at ul. Pelplińska 19
(hereinafter referred to as the “Controller”).
You can contact the Controller in writing to the above addresses. The Controller has appointed a Data Protection Officer, whom you may contact in all matters relating to the personal data protection, by writing to: Zakłady Farmaceutyczne POLPHARMA S.A. (office in Warsaw) Bobrowiecka 6, 00-728 Warszawa, by sending an e-mail to: dpo@polpharma.com or by telephone on: 22 364 63 11.
Where an adverse event has occurred following the use of a medicinal product, the adverse event may be reported to the Medical Department, address: Zakłady Farmaceutyczne POLPHARMA S.A. (office in Warsaw) ul. Bobrowiecka 6, 00 -728 Warszawa, tel.: 22 364 61 00, email: phv@polpharma.com.

[Purpose and legal basis for personal data processing]

Your personal data will be processed:
1. for the purpose necessary for ensuring high standards of quality and safety of medicinal products by Controller and, in particular, monitoring the safety of medicinal products, including the keeping of records of individual adverse events to medicinal products and the reporting of individual adverse events to medicinal products to the competent authorities– on the basis of:
  - data concerning health will be processed pursuant to Article 9(2)(i) of the GDPR, i.e. processing is necessary for reasons related to the public interest in the field of public health in the form of ensuring high standards of quality and safety of medicinal products pursuant to the provisions of law, i.e. pursuant to Article 36e(1) of the Polish Pharmaceutical Law Act;
  - other personal data will be processed pursuant to Article 6(1)(c) of the GDPR, i.e. processing is necessary to fulfil the legal obligation imposed on the Controller pursuant to Article 36e(1) of the Pharmaceutical Law Act;
2. contacting the attending physician and obtaining additional information from the attending physician in connection with adverse events to the medicinal product - pursuant to Article 6(1)(c) of the GDPR, i.e. processing is necessary to fulfil the legal obligation imposed on the Controller pursuant to Article 36e(1) of the Pharmaceutical Law Act;
3. determination, investigation or defence of possible claims between you and the Administrator with regard to health data pursuant to Article 9(2)(b) of the GDPR, i.e. processing is necessary for the determination, investigation or defence of claims; in the case of other personal pursuant to Article 6(1)(f) of the GDPR, i.e. on the basis of the legitimate interest pursued by the Administrator, which is the possibility to pursue claims. You will not be subject to automated decision-making, including decisions based on profiling.
You will not be subject to automated decision-making, including decisions based on profiling.
Provision of Your personal data is voluntary.

[Categories of personal data recipients]

Your personal data may be disclosed to the following entities: attending physician (if consent is granted to contact with the attending physician), employees, IT service providers, providers of consulting and legal services.
Your personal data may be made available to entities and bodies authorized to process such data under the law, in particular to the President of the Office of Medicinal Products, Medical Devices and Biocidal Products, the European Medicines Agency and other competent authorities of the Member States of the European Union, in which the Controller has obtained a marketing authorisation for a medicinal product.
The Controller does not intend to transfer your personal data outside the European Economic Area or to an international organisation.

[Personal data storage period]

Your personal data shall be processed for the period necessary to achieve the purposes for which the data are processed or until an objection is raised (if the processing is based on the legitimate interest of the Controller) or until the withdrawal of consent (if the processing is based on the given consent) - depending on which of the events occurs earlier.
After the expiry of the aforementioned period, personal data shall be stored for 10 years from the expiry date of the medicinal product series to which the application referred or until the claims expiry or until you have objected to the processing (if the processing is based on legitimate interest of the Controller) or have withdrawn your consent (if the processing is based on consent) – whichever occurs first.

[Rights]

. You have the right to:
1. access to data concerning you, the right of rectification, erasure, restriction of processing, the right to object to the processing of data;
2. transfer personal data, i.e. to receive from the controller personal data in a structured, commonly used machine-readable format;
3. to the extent that the processing of your personal data is based on consent, the right to withdraw consent to Pharmacovigilance and Medical Information Department Zakłady Farmaceutyczne POLPHARMA S.A. 6 Bobrowiecka Street, 00-728 Warsaw, Poland, email: phv@polpharma.com, fax: +48 22 364 61 66 p. 5 the processing of your personal data at any time. The withdrawal of consent shall not affect the lawfulness of the processing carried out on the basis of consent prior to its withdrawal.
In order to exercise the above rights, you need to contact the Controller or the Data Protection Officer, using the aforementioned contact details (contact details provided above).
You also have the right to lodge a complaint with a personal data protection supervisory authority (President of the Personal Data Protection Office), if you believe that the data processing violates the GDPR.

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