HPRA Inspection Readiness Assessment
CASE STUDY
As part of the HPRA’s proactive monitoring of advertising in Ireland, the HPRA Advertising Compliance group aim to carry out between three and five regulatory compliance inspections per year to understand how companies are understanding, meeting, and monitoring adherence to the regulatory standards as per SI 541/2007. Marketing Authorisation Holder (MAH) companies with commercial responsibilities in Ireland are in scope for these inspections; MAHs are selected using the HPRA’s own Advertising Compliance risk assessment tool, or are selected based on a recently identified compliance-related issue for that MAH company. Our client had not been subject to a HPRA advertising compliance inspection, however, was keen to ensure that should they be notified, they would be well prepared.
The client wanted to be exposed to an independent assessment that would align with what a full advertising inspection would entail. They wanted to be informed of any potential non-compliances so they could take remedial action, and gain insight into good practices across the industry.
HPRA Inspection Readiness Assessment
CASE STUDY
Pharma Integrity conducted a review of advertisements and non-promotional material associated with a number of the MAH’s products against S.I. 541/2007. It also included a review of the company’s Quality-related activities and their regulatory commitments. The process included a remote review of quality documents, onsite interviews with cross-functional staff, and subsequent follow-up. A report of non-compliances was produced and presented at a company meeting along with recommendations and examples of good practice that the company could look to integrate.
