Medication exposure reporting form during pregnancy : Farmak Poland

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Medication exposure reporting form during pregnancy

Information on the mother

Initials

Masa Ciała (kg)

Height (cm)

Other relevant information (e.g. existing diseases, pregnancy, breastfeeding)

Is the pregnancy still ongoing?

Pregnancy age in weeks

Expected date of childbirth

Date of childbirth

Diagnosis of pregnancy

Information about the notifying person

Qualifications of the applicant

Date of application

Medical and gynaecological-obstetric history

Did any medical events occur during the pregnancy?

Information on termination of pregnancy

Was the abortion recommended by a doctor?

Information concerning the child

Body weight (g)

Length (cm)

Date of birth of the child

Gender of the child

Apgar score:

at 1 minutes of life

at 5 minutes of life

at 10 minutes of life

If an event (maternal, foetal, neonatal) has occurred, is there a reasonable possibility that it may have been caused by the medicine(s) used during pregnancy?

Medicines used during pregnancy

Personal data processing

The administrator of the personal data included in the form is Farmak International spółka z ograniczoną odpowiedzialnością, 22 Jana Pawła II Avenue, 00-133 Warsaw. Your personal data is processed on the basis of Article 6(1)(c) and Article 9(2)(i) of the General Data Protection Regulation (RODO, EU 2016/679 of 27 April 2016). The personal data provided are processed solely for the purpose of fulfilling the obligations of monitoring the safety of use of medicinal products in accordance with Regulation (EU) No 520/2012 of 19 June 2012. The provision of the data of the notifier is necessary for the acceptance of the notification. The recipients of your personal data will only be entities authorised to obtain personal data under the law. You have the right to access and correct your data. Your personal data will be stored for the entire period of marketing authorisation of the medicine and for 10 years after the expiry of the authorisation. You have the right to lodge a complaint with the President of the Office for Personal Data Protection if you consider that the processing of personal data concerning you violates the provisions of the RODO.