Legal
Complaints procedure
Channels
| Matter | Contact |
|---|---|
| Product safety incident or suspected defect | safety@dohrna.com · +63 927 499 4459 |
| Complaint about an order, a document or the service given | complaints@dohrna.com |
| Regulatory or technical enquiry | [[REGULATORY_CONTACT_NAME]] · support@dohrna.com |
| Data protection | dpo@dohrna.com |
The telephone number above is answered by a person during 09:00–17:00 CET, Monday to Friday, excluding Malta public holidays. Correspondence is acknowledged within two business days.
Safety incidents take priority
Where a complaint concerns a possible hazard to a person or to the environment, it is handled as a safety incident and not as a service complaint. It is logged immediately, escalated the same working day, and assessed against the notification duties in Arts. 20 and 35 of Regulation (EU) 2023/988.
Where notification is required, the Supplier notifies the competent authorities through the Safety Business Gateway and, where the matter concerns a Product already supplied, contacts every recipient of the affected lot.
Anyone reporting a safety incident is asked to supply, so far as it is known: the catalogue number, the lot number printed on the vial label, the date of receipt, the storage condition applied since receipt, and a description of what occurred.
How a complaint is handled
- Logged. Every complaint is entered in the complaints register with a reference, the date received, the channel, the catalogue and lot numbers where relevant, and the category.
- Acknowledged. Within two business days, with the reference.
- Investigated. By an operator independent of the matter complained of. Retained samples, batch records and the Certificate of Analysis for the lot are examined where the complaint concerns a Product.
- Answered. In writing, with the findings, the conclusion and any corrective action. The target is 10 working days; where more time is needed, an interim answer is sent with an expected date.
- Closed. With the outcome recorded in the register.
- Examined in aggregate. The register is examined quarterly for recurring themes, and a theme affecting product quality is referred into the corrective-action procedure.
Escalation
A complainant who is not satisfied with the answer may ask for the matter to be reconsidered by a senior operator, stating the reference and the grounds. Beyond that, the alternative dispute resolution information published on this site applies.
Nothing in this procedure limits the right to complain to a competent authority. Complaints about the handling of personal data may be made to the Office of the Information and Data Protection Commissioner (IDPC), Malta at any time.
Register and retention
The complaints register records every complaint, its category, the lot affected, the investigation, the outcome and any corrective action, together with any notification made to an authority.
The register is retained for 10 years, in line with the traceability records required by Arts. 9 to 12 of Regulation (EU) 2023/988, and is available for inspection by a competent authority.
Adverse events
Products are not supplied for administration to humans or animals, so no clinical adverse-event reporting obligation arises. The Supplier nevertheless operates a documented procedure for recording and escalating any report it receives of harm connected with a Product, because such a report bears on product safety and may bear on whether the supply restrictions are holding.
Reports of this kind are recorded in the register, escalated the same working day, assessed for notification, and retained for 10 years.