Legal centre · website notice

Safety reporting guidance

A suspected medicine safety issue should reach an appropriate healthcare professional and the responsible reporting route. The company contact is available for concerns involving Luang Pharma or a product represented as associated with it.

Updated

This notice applies to the Luang Pharma corporate website. It is published for information and is not legal or medical advice.

01

Medical emergencies come first

If symptoms are severe, rapidly worsening or potentially life-threatening, seek urgent medical help through local emergency services. Do not wait for a company response. This website and its contact form are not emergency or continuously monitored clinical services.

Do not start, stop or change prescribed treatment solely because you are preparing a report. A qualified healthcare professional should advise on immediate treatment and any necessary alternative medicine.

02

When to contact the company

Contact us about a suspected adverse reaction, medication error, unexpected lack of effect, exposure during pregnancy or breastfeeding, overdose, misuse, occupational exposure, or quality issue involving a product represented as linked to Luang Pharma. A concern can be raised even if information is incomplete or the cause is uncertain.

The public portfolio concerns a facility and products under development. Its presence does not confirm that a product offered to you originated from Luang Pharma. An unexpected commercial offer, pack or website using the company name should be treated as a matter requiring verification. For a clearly unrelated manufacturer’s product, the responsible manufacturer and the local reporting system will ordinarily be the relevant routes.

03

How to submit an initial report

Use the contact form, saying in the message that it concerns Safety report and include what is readily available:

  • The product name printed on the actual pack, active substance, strength and dosage form. Public trade names may be withheld on the portfolio, but the real pack wording is useful for a report.
  • Batch or lot number, expiry date and where the product was obtained, if known.
  • The country, approximate event date and a plain description of what happened and the outcome so far.
  • Your name or professional role and a contact route for necessary follow-up.
  • A limited patient description, such as age group, only where relevant; avoid directly identifying the patient in an initial general email.

Do not delay a concern because you lack a batch number or complete record. Photographs of the pack can help if they do not expose patient labels or other private information. Do not send used needles, opened medicines, biological samples or unsolicited physical products.

04

Follow-up and responsible routes

The company may need further details to understand the concern, establish any connection to Luang Pharma and identify the responsible party. Relevant information may need to reach a qualified safety professional, the actual manufacturer, a supply-chain party or a competent authority where legally appropriate. Sending a report is not an acknowledgement that a product is authentic, defective or causally responsible for an event.

Do not rely on company correspondence to fulfil a healthcare professional’s or organisation’s own reporting obligations. You can also report directly through the national medicines authority or official safety system in the country concerned. The FDA MedWatch link below is a United States reporting resource, not a worldwide substitute for local channels.

This notice does not certify an operational pharmacovigilance system or specify a company case-processing deadline. Any applicable regulatory duties remain governed by law and the responsible party’s actual role.

05

Protecting report information

Safety reports can contain sensitive health information. Share only what is necessary and what you are authorised or otherwise lawfully permitted to provide. Initial reporting should avoid full patient names, addresses, identity numbers and complete medical records. A suitable follow-up arrangement may be needed for further detail.

Confidentiality is important, but absolute secrecy cannot be promised where lawful assessment or reporting requires disclosure. The privacy policy explains the information-handling framework. Applicable safety-record duties may limit deletion of a report; such a limit should be explained for the actual record.

06

Quality, authenticity and recall concerns

For damaged packaging, suspected contamination, unusual appearance, labelling problems, storage concerns or suspected falsification, also read the product quality and recall guidance. Preserve the package and evidence where it is safe to do so. A concern that includes harm or suspected harm should be identified as both a quality issue and a safety report.

Follow an official recall notice or instructions from a competent authority and your healthcare professional. Do not use a product catalogue page to decide whether a batch is affected.

Sources and further reading