Privacy and Data Protection

The data controller is the HPRA unless otherwise specified.

The data protection officer can be contacted at dataprotectionofficer@hpra.ie.

Personal data are processed by the HPRA in the performance of our regulatory functions to protect and enhance public and animal health through assessing the safety, quality and effectiveness of healthcare products. Personal data are processed by HPRA employees, who shall ensure the confidentiality of the data.

The legal bases for the of processing is that it is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the HPRA and that it necessary for reasons of public interest in the area of public health. Some processing may be carried out as it is necessary for compliance with a legal obligation to which the HRA is subject. A list of relevant legislation outlining our responsibilities can be found here.

Any personal information which you provide is made available to other regulatory bodies in Europe and third countries when required to fulfil our regulatory functions. Personal information may be also be shared with a third party when you are making an online payment to the HPRA.

In relation to the reporting of safety and quality concerns, specific information on who data is shared with and transferred to can be found under the privacy notices for each type of report.

All personal data relating our regulatory functions are kept indefinitely.

The HPRA fully respects your right to privacy and treats all personal information with the appropriate standards of security and confidentiality, strictly in accordance with the General Data Protection Regulation 2016/679.  

Personal data is only processed for secondary purposes under the following conditions:

  • The secondary use is related to the original reason the data was collected and/or is part of the HPRA’s regulatory functions.
  • The data are not sensitive personal data.
  • The processing of the personal data is unlikely to cause damage or distress to the data subject.
  • There are no consequences for the data subjects following further processing.
  • There are safeguards in place to ensure the confidentiality and integrity of the data.

                                                     

Your data protection rights

The GDPR provides you with the following rights regarding the processing of your personal data

  • the right to request access to your data
  • the right to request your data be rectified or erased
  • the right to object to processing or request processing of your data be restricted.
  • the right to data portability
  • the right to lodge a complaint to the Data Protection Commissioner.

 

The HPRA uses profiling for recruitment purposes.

To make a request regarding your personal data under the GDPR, please submit your request in writing or via email:

Data Protection Officer
Health Products Regulatory Authority 
Kevin O’Malley House, 
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: +353 (1) 6764971
Fax: +353 (1) 6767836

Email: dataprotectionofficer@hpra.ie.

Please ensure that you describe the records you seek in the greatest detail possible to enable us to identify the relevant records. The HPRA must confirm within one month if data is held and if so, the description of the data and the purposes for which they are kept.  The Irish supervisory authority for data protection is the Data Protection Commission. They may be contacted here. Details of your entitlement to complain to the Data Protection Commissioner will be included in the decision letter or email.

Further details on data protection can be found here.

Details on the collection of information online and regarding cookies on the HPRA website can be found here.