Privacy notice for pharmacovigilance, medical information and product complaints
Our pharmacovigilance obligations require us to process certain information, which allow to directly or indirectly
identify a person, (“Personal Data”) of a patient and/or the reporter of an adverse event that we receive in order to
comply with strict obligations to perform assessments of our products continuously and report suspected adverse
reactions or events to relevant regulatory authorities.
This Privacy Notice provides important information to you about how we process Personal Data for
pharmacovigilance purposes, in line with our obligations under applicable data privacy laws and in particular the EU
General Data Protection Regulation ((EU) 2016/679) (“GDPR”).
- Date Controller (also “we”, us, etc.): Berlin-Chemie/A. Menarini Distribution Romania SRL. The data protection officer (“DPO”) can be reached at the following address: Calea Floreasca 169A, building A, etaj 7, sector 1, București, 014459, email: dpo.romania@berlin-chemie.com.
- Categories of personal data processed: The type of information that we collect from you will depend on
the data subject and the type of processing activity:
Pharmacovigilance: We may collect the name, contact details, and affiliations/profession of the reporting
individual. We may collect some additional personal data related to health and medical history of the
individual experiencing an adverse event if required for processing of adverse event for pharmacovigilance
purposes.
Medical Inquiries: We may collect the name, contact details and affiliation/profession of the individual
making the inquiry.
Product Complaints: We may collect the name, contact details and affiliation/profession of the individual
reporting the complaint. We may collect some additional personal data related to health and medical
history of the individual affected by the product complaint if such information is relevant to evaluate,
classify and assess the product complaint.
- Recipients of your personal data: We may share the data you provided to us among Menarini Group
companies and affiliates (the list of Menarini Group Companies is available on the website
www.menarini.com, or on request), business partners and service providers, which support the Companies
with pharmacovigilance-related obligations and procedures where required to fulfill obligation of
pharmacovigilance legislation and/or legislation regarding drug safety. The full list of recipients is available
on request.
We are also obliged to report certain pharmacovigilance and product relevant information to Health
Authorities worldwide, including those with different level of data protection compared to EU. The reports
contain details about the incident but will only contain limited personal data:
Patients: Information as provided, including age or date/year of birth and gender.
Reporting Individuals: Information as provided to allow the regulatory authority to follow up with the
reporting individual, including name, profession, initials, address, email, phone number.
It is possible that in the exchange of data within the Menarini Group, business partners and service
providers, your personal data may be transferred to countries that do not provide the same level of
protection as your own. We will take all necessary steps to ensure that the data you provide is adequately
protected in accordance with the requirements data protection laws of European Union. Where necessary,
we use EU standard contractual clauses to ensure a legally adequate level of data protection.
- Purposes and legal basis for processing:
Pharmacovigilance: We collect and process your data for these purposes in order to comply with our legal
obligations (Articles 6(1)(c) and 9(2)(i) GDPR). We may also be required to report the data to regulatory
authorities. We may share the data you provided to European Medicines Agency, National Agency for
Medicines and Medical Devices and Romanian Ministry of Public Health, according to legal obligations and
within the Menarini Group Companies. Your data will not be used for any other purposes.
Medical Inquiries: Any personal data provided to us related to a medical inquiry may be used to answer the
inquiry, follow up on such requests and maintain the information in a medical information database for
reference. Where required by law (such as for pharmacovigilance and drug safety), we may also be required
to report the data to regulatory authorities. Your data will not be used for any other purposes. We collect
and process your data to respond to your inquiries based on legitimate interests (Article 6 (1)(f)) GDPR and,
if you are a patient, your (explicit) consent (Articles 6(1)(a) and 9(2)(a) GDPR).
Product Complaints: Any personal data provided to us related to a product complaint will be used solely for
these purposes. This information is very important for public health and will be used for the evaluation,
classification and assessment of the product complaint, to follow up on such requests and to maintain the
information in a product complaints database for reference. We collect and process your data for these
purposes in order to comply with our legal obligations (Articles 6(1)(c) and 9(2)(i) GDPR). We may also be
required to report the data to regulatory authorities.
- Storage period: As information related to pharmacovigilance (reports about adverse events) are
important for public health reasons, reports are kept for minimum of 10 years after the withdrawal of
the product in the last country where the product is marketed.
Personal data retained as part of a medical information inquiry are kept for minimum of 10 and maximum
of 15 years after receipt.
As information related to product complaints and drug safety are important for public health reasons,
complaint records, including personal data contained, are kept for minimum of 15 years.
- Your rights: You may at any time request to be provided with information on your Personal Data stored
by us and demand that we correct, delete or block any incorrect data under the legal requirements.
Erasure or restriction of processing is only possible if and to the extent the processing of personal data is
based on consent or legitimate interest. Please note that due to our legal obligations for on
pharmacovigilance legislation, we may not be able to erase or restrict processing of your data if processed
for pharmacovigilance. In addition, you have the right to receive your data in a structured, common and
machine-readable format or to forward it to a third party under the legal requirements.
Right to object: You have the right to object at any time to the processing of your data on the basis of
Article 6 (1) f GDPR (data processing on the basis of a weighing of interests) or Article 6 (1) e GDPR (data
processing in the public interest) if there are reasons for doing so which result from your particular
situation. If you file an objection, we will no longer process your personal data unless we can prove
compelling reasons for the processing worthy of protection which outweigh your interests, rights and
freedoms, or the processing serves the assertion, exercise or defence of legal claims.
Right of revocation: The granting of your consent is voluntary and may be revoked at any time without any
detrimental effect on you. The lawfulness of the processing of your personal data until the revocation
remains unaffected by a revocation. Statutory notification and reporting obligations remain unaffected by
any revocation.
You can assert your rights free of form. Your message should be addressed as far as possible to the above
mentioned contact data.
If you have any questions in connection with the processing of your data, you can contact our DPO at any
time: dpo.romania@berlin-chemie.com. In addition, you have the right to file a complaint with the
responsible supervisory authority, the The National Supervisory Authority for the Processing of Personal
Data (ANSPDCP) in Bucharest.