Registry Details for 'Health Products Regulatory Authority (HPRA)'
| Company Name: | Health Products Regulatory Authority (HPRA) |
| Ref Number: | 5221/A |
| Reg Type: | DC |
| Company Address: | Kevin O''Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 |
| Contact: | LorraineLeahy |
| Purpose: | The HPRA is the regulatory authority for human and veterinary medicines and manufacturing sites, human wholesalers, clinical trials, blood, tissue and cell establishments, cosmetics, organs for transplant, animal protection and medical devices |
| Continuation Due Date: | 09/12/2017 |
| Description: | (a) Adverse reaction/event reports - Original reports received generally include at least one personal identifier (e.g. name/initials/age/sex). A unique ID number is assigned to all cases on receipt and is used in all subsequent case correspondence and for database/system entry of records. These reports may include limited information, but typically the elements of information that may be received and when available are included in the computerised monitoring systems in place include the case identifier (i.e. unique ID number) , age, sex, details of the relevant medicinal products (e.g. product/substance name, dose, duration of use etc.) Tissue & Cell, or organ type, information on the nature of the suspected reaction (s)/event (s), outcome, relevant risk factors or underlying conditions, investigation findings, dates of case correspondence, reporter details and in the case of medicinal products, dates of notification to the relevant marketing authorisation holder and the European Medicines Agency (EMA). Paper based reports and associated correspondence are held on file, filed by a coded system, with electronic versions of reports/documents stored in a secure database (see below).b) Adverse incident manufacturer reports - the original report may include patient identifiers and medical information. A unique ID number is assigned to all cases on receipt and is used for all subsequent correspondence regarding the case and for computer data entry. The details held on computer include the case identifier, the manufacturer/authorised representative/supplier details, details of the incident (including third party details), the assessment of the issue and the investigation outcome. A paper copy of this information may be held on the file and an electronic copy is stored on the network, which is secured (see below). c) Field Safety Corrective Action reports - where a manufacturer conducts a field safety corrective action the manufacturer/authorised representative/customer/supplier/end user details may be provided as part of the field safety notice circulation listing and reconciliation report. A paper copy of this information may be held on the file and an electronic copy is stored on the network, which is secured (see below). (d) General public health issues relating to any area that we regulate, may result in patient information being given to the Board and such data will be saved in either or both paper and electronic means. (e)Accounts - Name, address, phone number, fax number, e-mail address of suppliers. Purchase order records, details of tendering procedure, records and details of travel and subsistence, payroll and pension records (f) Personnel - Name, home address, home phone number, home e-mail address, grade, annual leave, flexi time records, details of sick leave, and details of training needs. (g) Contacts - A directory containing contact details of persons with whom this organisation is in regular correspondence is maintained. This directory contains the name, address, phone number, fax number, e-mail address, and position within organisation. (h) Office Administration - Contact details of companies providing janitorial, maintenance and security services to this office, namely name, address, phone number, fax number, e-mail addresses, company name, position within the company. (i) E-mail system (j) Individual e-mail accounts, keeping the e-mail addresses of correspondents, along with such material as may be included in the bodies of e-mails. General e-mail accounts containing e-mails received and sent, along with the e-mail addresses of correspondents. (k) Door access control system - card holders name, date and times of entry and exit through controlled doors (l) Phone monitoring system - staff members name, extension number, date, time, duration, cost and phone number of all calls received and made. (m) CCTV camera in operation for security purposes. |
| Disclosees: | Adverse reaction/event reports- patient and reporter identities are regarded as confidential, with original information only released to the person to whom the report relates. Where interaction with third parties requires the release of a report, or information pertaining to a report (in line with a statutory obligation), the consent of the person to whom the report relates and/or the person submitting the report is obtained in the context of report completion and submission. Anonymised summary information or aggregated summary data based on reports is released, as appropriate. Medical Device Incident Reports and Field Safety Corrective Action Reports - information contained in a report may be released to a third party with the consent of the data owner. Personal data may be requested or received and may be utilised to contact the data owner in order to obtain additional information in relation to the medical device incident / field safety corrective action within the context of HPRA''s legislative role. |
| Transfers Abroad: | Yes |
| (A) Anonymised adverse reaction reports for medicinal products are shared with the relevant marketing authorisation holders, the EMA and the WHO in accordance with applicable legislative provisions and reporting standards in place (B) Aggregated information on serious adverse reaction and event reports (SAR/E) reports for haemovigilance and Tissue and Cell vigilance is shared with the EU Commission and report information may also be shared with other EU member state competent authorities, in accordance with applicable legislative provisions and reporting guidance (C) Reports of serious adverse reactions and events are shared with the HSE/ODTI in its joint role as national competent authority with HPRA for implementation of the legislation on human organs for transplantation (D) National Competent Authority Reports and Vigilance Enquiry Forms relating to medical devices are shared with other Competent Authorities and the European Commission in accordance with applicable legislative provisions. In the context of HPRA''s role as secretariat of the IMDRF NCAR exchange programme, reports may be shared with International participants in the programme (E) HPRA may engage in correspondence with manufacturer/authorised representatives/suppliers based outside of Ireland to obtain further information in relation to the medical devices incident / field safety corrective action (F) Anonymised cosmetic case specific data may be communicated to other EU member states using the PEMSAC enquiry form (market surveillance authority enquiry form ).Please note that adverse reaction/event information may be shared with third parties outside the EU, if appropriate, e.g. where follow up is needed in circumstances where the product originated outside of the EU. |
