Privacy Notice – Reporting of adverse events related to the use of veterinary medicinal products

What information do we process?

The HPRA operates the national system for recording and reporting details of suspected adverse events occurring in Ireland that are notified in association with the use of veterinary medicinal products. These reports are submitted to the HPRA directly by veterinary professionals, those working in the agriculture industry, and animal owners. 

Some of the information in adverse event reports will comprise personal data such as name, contact details, age and gender. The contact details included on adverse event report forms are used solely for the purposes of interaction regarding the report submitted. 

We may also seek further information from any veterinary professional(s) nominated by you for additional information, following provision of their contact details and an indication of your agreement for us to do so.

Legal basis for processing

As part of its statutory role in the regulation of veterinary medicinal products, the HPRA is legally obliged to collect adverse event reports to veterinary medicines. The legal basis for such collection is Article 76 of Regulation (EU) 2019/6. 

The HPRA is also legally obliged to transmit details of adverse event reports received (excluding personal identifiers and contact details) to the Union Pharmacovigilance Database. This database is owned and administered by the European Medicines Agency (EMA), which is an agency of the European Union and is also subject to the laws of the European Union. A joint controller arrangement is in place between the EMA and all Member States, including Ireland, regarding the processing of personal data in the database. Further information on the Union Pharmacovigilance database, the EMA and the joint controller arrangement can be accessed on the EMA’s website.  

The legal basis for processing of personal data in adverse event reports is firstly, Article 6(1)(c) of the General Data Protection Regulation (GDPR), which states:
Processing is necessary for compliance with a legal obligation to which the controller is subject.’

Secondly, in terms of special categories of personal data, the HPRA relies on Article 9(2)(i) of GDPR, which states:
Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy;’.

How is your information shared?

Following transmission of reports to the Union Pharmacovigilance database by the HPRA, partially anonymised details of reports are shared with other bodies also involved in safety monitoring of veterinary medicinal products, in accordance with the legislative provisions. These bodies include the EMA and as appropriate, the company(ies) that hold the licence(s) for the medicine(s) concerned (i.e. marketing authorisation holders or ‘MAHs’) – further details are provided below. Sharing of the information you are submitting ensures that the information is available to all parties responsible for the ongoing safety monitoring of veterinary medicinal products.

Through these systems, adverse event reports are pooled with data from other countries to provide information on the global safety experience with veterinary medicinal products. Information from these sources, together with additional safety data (e.g. from the scientific literature, cumulative safety data analysis, etc.) are assessed on an on-going basis in a process known as ‘signal management’. This is done in conjunction with our EU counterparts to continually appraise the known safety profile of the medicine in question and any need for regulatory changes to support safe and appropriate use. Such changes could include recommendations to restrict use, or the addition of warnings to the product information for veterinary healthcare professionals, those who work in agriculture and animal owners.

The HPRA does not transmit names or contact details of individuals when transmitting adverse event reports to the Union Pharmacovigilance database. The information provided includes a unique identifier number, but no names or specific locations (e.g. veterinary practice name) are included. However, given the nature of adverse event reports, some information may include data that in conjunction with other information contained in the report or elsewhere, may identify individuals.

Personal pharmacovigilance data collected by the HPRA is not transmitted to third countries by the HPRA. The data is retained 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 data protection legislation.  

What are your rights under data protection law?

Data protection law provides you with the following rights regarding the processing of your personal data:
o The right to request access to your data.
o The right to request your data be rectified or erased if it is inaccurate.
o The right to request processing of your data be restricted.
o The right to lodge a complaint to the Data Protection Commission.

How to contact us

The data controller for this activity is the HPRA and the data protection officer can be contacted at the details provided below. 

For more information or to make a request regarding your personal data under data protection law, please submit your request in writing or via email to:

Data Protection Officer
Health Products Regulatory Authority
Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2
Tel: +353 (1) 676 4971
Fax: +353 (1) 676 7836

Please provide sufficient information in your request to enable us to deal with your query. 

Further information regarding data protection at the HPRA can be found in our main privacy notice.