Notification of Adverse Events

基立福是一家1909 年成立于巴塞罗那的全球医疗集团，致力于改善世界各地人民的健康和福祉。集团下设生物制药、诊断和生物用品三大业务部门，在全球 100多个国家/地区开发、生产和销售创新解决方案和服务。

基立福尊重将个人数据委托给基立福的所有数据主体的隐私权，并承诺遵守各国家/地区适用的数据保护法规。

本隐私声明根据《欧洲通用数据保护条例》（简称“GDPR”）与适用的隐私和数据保护法律编制；有关具体规定，请参阅第 7节。It outlines Grifols' data collection practices and the data subjects’ rights in the context of Grifols collection, use and sharing of their personal data.

This privacy notice applies to the processing of personal data of the (a) individuals reporting an adverse event related to Grifols' products, (b) the individuals suffering the adverse event, and (c) healthcare professionals involved in the adverse event. For the purpose of this privacy notice, "data subject" refers to three types of individuals.

1，个人数据控制方/所有方的身份识别

The data controllers/owners are:

the Grifols' group company that holds a marketing authorization of the pharmaceutical product in any given territory or the Grifols' group company with pharmacovigilance functions at a national level, or
the Grifols' group companies acting as sponsor of clinical trials jointly with Grifols Worldwide Operations Ltd.

The identity and contact details of the Grifols' companies that are marketing authorization holders, that hold pharmacovigilance functions at national level and/or that are clinical trial sponsors in a specific country are available here. These Grifols’ companies will be collectively referred to as "Grifols".

2，明确数据保护专员

The data protection officer acts as an interlocutor between Grifols and you in order to ensure Grifols’ compliance with the data protection legislation and best protect your rights under such legislation. You may contact the data protection officer at dpo@grifols.com, unless the data controller is Grifols Deutschland GmbH, in which case you may contact the data protection officer at dsb@grifols.com

The data subjects may ask, if they wish so, the data protection officer for more information on the essential aspects of the joint controllership agreement resulting from what is set out in Section 1.

3. Purposes, lawful basis for processing, categories and recipients of personal data

目的

To comply with all pharmacovigilance related obligations as a pharmaceutical company, including without limitation:
- Continuous monitoring of the pharmacovigilance data submitted, including its scientific evaluation of risks;
- Ensuring the quality, integrity and completeness of the information submitted on the risks of medicinal products, and
- Effective communication with the data subjects and competent authorities.

个人数据的类别和接收方

个人数据类别：

For reporters of an adverse event and healthcare professionals involved in the adverse event:

Identification data¹.
联系方式²
职业数据³。

For individuals exposed to the adverse event:

Demographic data⁴.
Data related to the product.
Special categories of personal data⁵.

接收者：

Grifols' group of companies (pharmacovigilance teams and any other competent teams).
产品和服务供应商
公共或私营组织。

合法依据: 法律义务
Vital interest
Public interest
合法利益

To carry out maintenance tasks in websites, landing pages and apps to offer a secure environment to users.

个人数据的类别和接收方

个人数据类别：

浏览历史数据⁶。

接收者：

基立福集团公司。
产品和服务供应商

合法依据: 合法利益

管理公司重组活动。

个人数据的类别和接收方

个人数据类别：

Identification data¹.
联系方式²
职业数据³。
Demographic data⁴.
Special categories of personal data⁵.
浏览历史数据⁶。

接收者：

基立福集团公司。
产品和服务供应商

合法依据: 合法利益

¹ For example, name, last name and relationship with the patient.
² For example, phone number, e-mail address and location.
³ For example, phone number, e-mail address, job position and place of work.
⁴ For example, gender, age in years and country.
⁵ For example, race/ethnic origin, health data and factual description of the adverse event.
⁶ For example, IP address, device or user ID, browser type and version, visited sections, country from which the connexion is made.

¹ For example, name, last name and relationship with the patient.
² For example, phone number, e-mail address and location.
³ For example, phone number, e-mail address, job position and place of work.
⁴ For example, gender, age in years and country.
⁵ For example, race/ethnic origin, health data and factual description of the adverse event.
⁶ For example, IP address, device or user ID, browser type and version, visited sections, country from which the connexion is made.
目的	个人数据的类别和接收方	合法依据
To comply with all pharmacovigilance related obligations as a pharmaceutical company, including without limitation: Continuous monitoring of the pharmacovigilance data submitted, including its scientific evaluation of risks; Ensuring the quality, integrity and completeness of the information submitted on the risks of medicinal products, and Effective communication with the data subjects and competent authorities.	个人数据类别： For reporters of an adverse event and healthcare professionals involved in the adverse event: Identification data¹. 联系方式² 职业数据³。 For individuals exposed to the adverse event: Demographic data⁴. Data related to the product. Special categories of personal data⁵. 接收者： Grifols' group of companies (pharmacovigilance teams and any other competent teams). 产品和服务供应商公共或私营组织。	法律义务 Vital interest Public interest 合法利益
To carry out maintenance tasks in websites, landing pages and apps to offer a secure environment to users.	个人数据类别：浏览历史数据⁶。接收者：基立福集团公司。产品和服务供应商	合法利益
管理公司重组活动。	个人数据类别： Identification data¹. 联系方式² 职业数据³。 Demographic data⁴. Special categories of personal data⁵. 浏览历史数据⁶。接收者：基立福集团公司。产品和服务供应商	合法利益

Without prejudice of the categories of personal data shown in the table above, please be informed that the categories of personal data that are processed for compliance with legal obligations may differ depending on the jurisdiction of the relevant data controller.

3.1，关于处理个人数据的合法依据的其他信息

上表按用途显示了处理个人数据的适用法律依据。在本节中，您可以找到有关处理合法性的其他详细信息：

法律义务： 基立福需要处理所要求的个人数据以遵守法律义务。未能提供所要求的个人数据可能导致基立福无法遵守此类法律义务。第7节包括了适用于基立福的需要处理个人数据的具体规定的细节。
Vital interest: Grifols needs to process patients' personal data suffering an adverse event to protect his/her vital interest, even where the patient has not been notified due to its health condition.
Public interest in the area of public health: the processing of special categories of personal data (e.g. race/ethnic origin or health data, including the factual description of the adverse event) is based on reasons of public interest in the area of public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices on the basis of applicable law on pharmacovigilance.
Legitimate interest of Grifols and/or third parties: Grifols is interested in contributing to the advancement of medicinal products in a secure environment with the aim of guaranteeing people's health. 因此，基立福追求高于数据主体基本权利和自由的以下合法权益时，该处理应符合数据主体基于其与基立福关系的合理预期：
- 跨国集团公司的日常管理和内部管理，这意味着与 Grifols 集团公司共享信息，以及
- 建立一个安全的信息系统基础设施，以防止可能损害个人数据的非法或恶意活动。

在任何情况下，数据主体均可通过向privacy@grifols.com提出请求，要求提供有关合法权益的进一步消息，或行使其反对基于合法权益处理其个人数据的权利。

3.2，个人数据接收方

上表显示了基立福可能按目的与之分享个人数据的接收方类别。本节包括有关这些接收者的其他信息（如适用）：

The following Grifols' group of companies:

Company name

Grifols, S.A.

国家/地区: 西班牙

Contact Details: Avenida de la Generalitat, 152, 08174, Sant Cugat del Valles (Barcelona)

Instituto Grifols, S.A.

国家/地区: 西班牙

Contact Details: Polígono Levante, Calle Can Guasch, s/n, 08150, Parets del Vallès (Barcelona)

Grifols Therapeutics LLC

国家/地区: 美国

Contact Details: 8368 US Hwy 70 West
Clayton, North Carolina
27520

Grifols Deutschland, GmbH.

国家/地区: Deutschland

Contact Details: Colmarer Str. 22 60528 Frankfurt am Main

Grifols Biologicals, LLC.

国家/地区: 美国

Contact Details: Lillyvale Avenue Los Angeles, California 90032

Grifols Australia Pty, Ltd

国家/地区: 澳大利亚

Contact Details: 5/80 Fairbank Rd. Clayton South, Victoria 3169

Company name	国家/地区	Contact Details
Grifols, S.A.	西班牙	Avenida de la Generalitat, 152, 08174, Sant Cugat del Valles (Barcelona)
Instituto Grifols, S.A.	西班牙	Polígono Levante, Calle Can Guasch, s/n, 08150, Parets del Vallès (Barcelona)
Grifols Therapeutics LLC	美国	8368 US Hwy 70 West Clayton, North Carolina 27520
Grifols Deutschland, GmbH.	Deutschland	Colmarer Str. 22 60528 Frankfurt am Main
Grifols Biologicals, LLC.	美国	Lillyvale Avenue Los Angeles, California 90032
Grifols Australia Pty, Ltd	澳大利亚	5/80 Fairbank Rd. Clayton South, Victoria 3169

公共或私人组织，for example, national or international competent health authorities, healthcare professionals or companies with whom Grifols has signed commercial and/or license agreements or who are responsible of assessing the pharmaceutical products, with the sole purpose of complying with the pharmacovigilance obligations.
产品和服务的提供者：for example, IT service providers, call center service providers, insurance providers, regulatory affairs agencies and clinical research organizations.
潜在投资者或购买者

Grifols will endeavor that the personal data is only transferred to countries that offer an adequate level of data protection. If the personal data is processed in countries that do not offer said level of protection, Grifols and/or the providers (as the case may be) will adopt, if necessary, the appropriate safeguards (e.g., the standard contractual clauses included in the Commission Implementing Decision (EU) 2021/914 of 4 June 2021, if GDPR is applicable) to carry out such international data transfers in accordance with the applicable data protection legislation. 有关适用于各项国际数据传输的适当保障措施的具体信息，可通过基立福网站 privacy@grifols.com获取。

基立福仅在获得数据主体授权或适用法律要求下才会与其他第三方分享个人数据。

4，保留期限

基立福将在为实现个人数据收集目的而绝对必要的时间内保留个人数据，或者在适用的情况下保留至可能产生的任何责任的法定时效结束，以及在遵守任何适用法律义务所需的期限内保留这些数据。

5，个人数据来源

If you do not directly provide Grifols with your personal data, Grifols may obtain your personal data from the reporter or patient's healthcare professional. The personal data of the healthcare professional could be obtained from the reporter or from any other third person.

6，数据保护权利

以下数据保护权利在GDPR规定下适用。基立福承诺尊重依照各国家/地区适用的数据保护法规可能适用的其他数据保护权利。

权利

访问

内容: 您可以要求确认是否正在处理您的个人数据，如果确实如此，您可以获取访问基立福文件中包含的个人数据的权限。

纠正

内容: 如果您的个人数据不准确，您可以要求纠正。

删除

内容: 您可以要求删除个人数据。

反对

内容: 您可以要求在特定情况下不处理您的个人数据。

可移植性

内容: 您可以要求以电子文件的形式接收您向基立福提供的个人数据，并有权将这些数据传输给其他当事方。

限制处理

内容

在以下情况下，您可以要求对如何处理您的个人数据进行限制：

在您对个人数据的准确性提出异议后，核实这些数据的准确性。
您的个人数据受到非法处理，并且您反对删除这些数据。
Grifols no longer needs the personal data for the purposes of processing it, but you need it in order to prepare, exercise or defend a legal claim.
您已反对为执行出于公共利益或合法权益目的所必需的任务而处理个人数据，同时正在核实基立福的合法理由是否高于您的理由。

权利	内容
访问	您可以要求确认是否正在处理您的个人数据，如果确实如此，您可以获取访问基立福文件中包含的个人数据的权限。
纠正	如果您的个人数据不准确，您可以要求纠正。
删除	您可以要求删除个人数据。
反对	您可以要求在特定情况下不处理您的个人数据。
可移植性	您可以要求以电子文件的形式接收您向基立福提供的个人数据，并有权将这些数据传输给其他当事方。
限制处理	在以下情况下，您可以要求对如何处理您的个人数据进行限制：在您对个人数据的准确性提出异议后，核实这些数据的准确性。您的个人数据受到非法处理，并且您反对删除这些数据。 Grifols no longer needs the personal data for the purposes of processing it, but you need it in order to prepare, exercise or defend a legal claim. 您已反对为执行出于公共利益或合法权益目的所必需的任务而处理个人数据，同时正在核实基立福的合法理由是否高于您的理由。

You may exercise, when appropriate, your data protection rights by, for example, sending a written communication to Grifols at privacy@grifols.com with the subject line "Pharmacovigilance – Adverse Events Notification". To that end, Grifols may request further information or documents if necessary and appropriate to identify you.

此外，您可以向数据保护机构提出投诉，包括您的住所、工作地点或涉嫌侵权行为发生地的数据保护机构。

7，特定规定

欧盟

The lawful basis to process personal data identified in Section 3 are regulated in the following provisions of the GDPR:

Vital Interest: (article 6.1(d) of GDPR)
合法利益（基立福和/或任何第三方的合法利益）：article 6.1(f) of GDPR
法律义务：article 6.1(c) of GDPR.

The processing of special categories of personal data (e.g. race/ethnic origin or health data, including the factual description of the adverse event) is covered by public interest in the area of public health (article 9.2(i) of GDPR)

The legal obligation referred to in Section 3 regarding the performance of pharmacovigilance activities is regulated by:

Commission Implementing Regulation (EU) No. 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004, and
Directive 2001/83/EC of the European Parliament and of the Council

and any applicable legislation supplementing or replacing these, including national laws.

中华人民共和国

中国大陆：当您的个人数据由位于中华人民共和国大陆的任何基立福集团公司处理时，此处提供的附录对您适用。该附录是本隐私声明的补充，并构成本隐私声明不可分割的一部分。

法国

When Grifols France S.A.R.L. is the data controller, the applicable lawful bases for processing personal data in the context of pharmacovigilance are exclusively the fulfilment of legal obligations (article 6 of GDPR) and the public interest in the area of public health (article 9 of GDPR). Also, the data subjects have the right to provide guidance on the management of their data after death.

葡萄牙

如果 Grifols Portugal – Produtos Farmacêuticos e Hospitalares,Lda. 为数据控制者，数据主体有权就其身故后的数据管理提供指导。可由其继承人行使第6节中定义的数据保护权利。数据主体还可决定在其身故后不能行使这些权利。

如果存在保密的法律义务，将不能行使数据主体的权利。

英国

本文档中对 GDPR 的所有引用在适用情况下亦指构成英格兰和威尔士、苏格兰和北爱尔兰法律一部分的 GDPR。

Last update: August 2024

提供其他语言版本的隐私声明

DE – Datenschutzhinweis - Meldung unerwünschter Ereignisse

ES – Aviso de protección de datos – Notificación de reacciones adversas

FR – Notice d'information – Notification d'evenements sanitaires indesirables

IT - Informativa Privacy – Notificazione di reazioni avverse