COMPLAINTS PROCEDURE

All attempts should be made to settle a dispute through direct communication between the companies involved, at the General Manager (GM) or Chief Executive Officer (CEO) level. The procedures for filing formal complaints via PReMA are as follows:

6.1

Complaint Submission - All complaints must be submitted in writing directly to the PReMA CEO. Complaints can be made by either member companies or from non-member sources, e.g. Thai FDA, healthcare professionals or professional organizations, patients or patient groups.

6.2 Complaint Validation - Any complaints submitted to PReMA shall be validated by the PReMA CEO to ensure that:

6.2.1

It appears to be a genuine matter, submitted in good faith.

6.2.2

There is sufficient evidence to enable the complaint to be processed.

6.2.3

It is not a duplication of a case, which has already been resolved under the Code.

6.2.4

The minimum information required is;


Source of the complaint

o If the complaint is from a company or organization, it must be printed on the company’s or organization’s letter head and signed off by the GM or CEO. For complaint from an individual, real name, address and contact telephone number must be provided.


Alleged Company

o For each case in the complaint, the identity of company which is alleged to be in breach of the Code and the name of any product(s) /marketing activities must be specified.


Reference material

o For each case, a specific reference to the source of the advertisement/activity or printed material which is the subject of the complaint as well as any other evidence must be provided.


Date

o The date of the alleged breach of the Code.


Summary

o If possible for each case, a brief description of the complaint with a specific reference to the part of the Code under which the complaint is being made (section & paragraph)

6.3 Complaint Processing - When the PReMA CEO receives a signed complaint validated in accordance with section 6.2, and it appears that the alleged company may have contravened the Code, the case will be accepted for adjudication. The PReMA CEO may request for additional information or evidence from the complainant or the alleged company. The case with all evidence will then be forwarded to the CCC. The names of the complainant company, the alleged company in breach and any healthcare professionals involved, will remain confidential, EXCEPT when it is not possible to adjudicate the case without the name of the product, activity or venue involved being disclosed.

6.4 Complaint Adjudication - The CCC shall review the case. If there is a need for additional information or evidence, a request will be made to the complainant and alleged company via the PReMA CEO. The CCC will then adjudicate whether a breach of the Code has occurred based on the compiled evidence.

6.5 Complaint Disposal - The decision of the CCC will be reported directly to the PReMA CEO, who will inform both the alleged company and the complainant of the decision. Sanction against the company found in contravention of the Code will be applied by the PReMA CEO, subject to Section 7 of the Code.

6.6 Complaint Resubmission - Where the alleged company or complainant disagrees with the decision of the CCC they may request a second instance ruling. The resubmission must be made in writing with any new evidence within 10 days after receiving the notification from the PReMA CEO. If new evidence or arguments are put forward, the other party shall be invited to provide comments within 30 days. The decision of CCC at this stage will be regarded as final and executory.

6.7 The PReMA CEO shall report all valid complaints received, the CCC adjudications and the actions taken to the members. The name of the complainants will remain confidential but the names of the breaching companies will be disclosed.

 

 
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