The purpose of this information is to provide details about how ALK-Abelló A/S (ALK) processes personal data related to the reporting of side effects. In accordance with Article 13 of the General Data Protection Regulation (GDPR), ALK is required to provide you with certain information when processing your personal data in connection with the reporting of side effects.
ALK, as the data controller, is responsible for the processing of your personal data. Therefore, ALK solely determines the purposes and measures for processing your personal data collected in connection with the evaluation of any complaints or side effects potentially related to an ALK-Abelló medical product.
Our contact information:
ALK-Abelló A/S
Address: Bøge Allé 1
2970 Hørsholm
Denmark
Tel.: 45747576
Email:data.protection@alk.net
Data Protection Officer:
Bech-Bruun Advokatpartnerselskab
CVR nr.: 38538071
Gdanskgade 18
2150 Nordhavn
Denmark
Tel.: +45 72 27 30 02
Email: dpo.alk@bechbruun.com
Encrypted email via: https://dpo.bechbruun.com/alk
If you have any questions regarding the processing of your personal data, you can always reach out to ALK or our Data Protection Officer.
Processing personal data is necessary for compliance with legal obligations imposed on ALK, including the requirement to monitor the safety and efficacy of our medical products and to report side effects to regulatory authorities, in accordance with GDPR Article 6(1)(c) and GDPR Article 9(2)(j).
The personal data is obtained from the following sources:
Below, you can read about the data we collect from you.
i. ALK EMPLOYEES & EXTERNAL PROCESSORS
The recipients of your personal data will be employees of entities belonging to the ALK Group and external processors providing specific services and processing personal data on our behalf. They will receive your personal data only on a ‘need-to-know’ basis, subject to confidentiality obligations and after signing appropriate legal agreements.
ii. INDEPENDENT THIRD PARTIES
When needed, we may disclose your personal data to independent third parties, such as attorneys, public authorities, or third-party auditors. In other situations, such as when using external shipment or payment providers, you will be involved in the process and, where relevant, offered choices regarding the transaction or payment method.
iii. TRANSFERS OF DATA FROM EU/EEA TO THIRD COUNTRIES
If we share data from the EU/EEA with a company or ALK affiliate in a third country, we will apply contractual clauses that meet EU standards to ensure the receiving company handles personal data appropriately, unless the country where the company operates is already deemed by the EU to offer an adequate level of data protection. More information about such clauses is available here. If data transfers are required in other situations, we will inform you about the specific compliance measures in place to enforce EU law.
Data is kept for as long as it is relevant or necessary in the global safety database.
Under the General Data Protection Regulation (GDPR), you have certain data protection rights:
a) Right to access
You have the right to request access to your personal data held by ALK, as well as additional details.
b) Right to rectification
You have the right to request correction of inaccurate or incomplete personal data.
c) Right to erasure
You have the right to request the deletion of your personal data, except when retention is required by law.
d) Right to restrict processing
You have the right to request the restriction of your personal data.
e) Right to object
You have the right to object to the processing of your personal data.
f) Right to data portability
In specific situations, you are entitled to receive your personal data in a structured, widely used, and machine-readable format.
If you would like to exercise any of these rights, please contact us using the contact details provided in section 1.
You have the right to file a complaint with the Data Protection Authority if you are dissatisfied with the way we process your personal data. Contact information for the Data Protection Authority can be found on their website.
If you have any questions or concerns about this privacy notice or our processing of your personal data, please contact us using the contact details provided in section 1.