How to make a suggestion or file a complaint
I. Purpose of the complaint procedure
CS MEDICA (Galaxa Pharma & CANNORDIC) seeks to provide high quality and efficient service to our customers. This procedure is intended to provide customers with a framework on how complaint procedure with Galaxa Phama and CANNORDIC shall be dealt with and it is established to ensure all complaints are handled as fast and effectively as possible. This procedure covers customer complaints (‘the consumer’) on all products that are manufactured and distributed by or on behalf of CANNORDIC and Galaxa Pharma respectively, which includes:
- CANNASEN®
II. Our responsibilities
- To provide an effective and fair system for handling complaints.
- To keep the customer reasonably informed about the progress of their complaint and the expected time for decision and resolution.
- To review the received complaints on a quarterly bases, in order to learn and improve the quality of our products and services.
III. How to make a suggestion
Customers who have used our products and would like to suggest an improvement rather than complaining formally are welcomed to send their feedback to: kundeservice@cannasen.dk.
We will be happy to hear from you. You will receive a confirmation that we have received your suggestion and, if grated your permission we will contact you in case we would like to follow up on it. When making a suggestion, please state:
- Which product your suggestion refers to
- Timespan of usage
- Your suggested improvements
- Whether we can contact you to follow up on your suggestion
IV. Complaint
As a customer of Galaxa Pharma and CANNORDIC, you are welcomed to make a complaint to us if any of our products or services did not meet your expectations. If you have a complaint regarding our products that is related to defects, quality, safety or performance of the product or possible damage during transport, we encourage you to make a written complaint. The policy and procedures for how a written customer complaint should be performed and how Galaxa Pharma and CANNORDIC will handle it can be found below:
- You should complain as soon as you can after the date on which the issue occurred or came to your notice. If you complain after a delay, we might not be able to process your complaint effectively.
- A 2-year right of complaint is granted. Our right of complaint applies to defects in material and / or manufacturing but does not apply if complaint is related to incorrect usage/application of the products. For the guidelines on correct product application, please consult the leaflet included in the packaging. For additional information, please contact physician or pharmacist. If in doubt, you are also welcomed to contact us on: help@cs-medica.com
Consider complaints of non-critical character, when products do not meet the expectations of the consumer, but do not constitute potential risk to the health or life of the consumer
Complaints which are classified as significant and/or critical complaints are regarded as urgent level 2 complaints, which can be defined as follows:
- Significant product defects comprise, but are not limited to: Product defects that constitute a potential risk to patients.
- Critical Complaints: Considered to possibly pose a threat against life, health or rights of patients.
- Includes complaints on devices reported as serious adverse events or incidents if considered related to the device fault.
V. Complaint procedure
Contact method: To ensure your case is reviewed and the matter investigated, please contact us via email at help@cs-medica.com in case of urgent complaints (as defined above) you are also welcomed to contact us by phone at +45 70 70 73 37
Necessary information: To handle your complaint effectively and quickly you will provide us with the following information:
- Your name and contact details
- Purchase information
- Receipt / purchase confirmation
- Order number
- A detailed description of the reason for the complaint including how the fault occurred if known and applicable.
- The nature of the complaint, e.g.:
- Impaired product related to safety or quality
- Impaired performance of the product
- Product defects e.g., impairment of content, container, labelling maybe due to transportation
- Other
- Copies of any documentation which supports your complaint.
- Pictures of the defect/impairment
- Detailed description of safety/quality/performance impairment with pictures if possible
- Purchase or order confirmation with visible date of purchase/order placement
- Any other relevant information
- Additionally, in case of urgent complaint of level 2:
- The consumer might be asked to return the residual product, for the purpose of more informed investigation
- Detailed information about the side effects (how the consumer reacted to the product) need to be included
VI. Handling of your complaint
Responsibility: Complaints made to Galaxa Pharma and CanNordic are handled and investigated by the Marketing and/or Science Department depending on the nature of the complaint.
Receipt of recording:
When Galaxa Pharma and CanNordic receive a complaint, you will be sent an email confirmation of complaint receival and recording within 2business days.
Investigation:
Response to the customer including description of root cause of the defect and appertaining corrective actions either completed or planned. This must be performed within 25 calendar days
Customer Response:
A customer response letter is drafted as soon as possible.
- The response must include a description of the root cause for the defect as well as the corrective and preventive actions both in concern of short term and long-term solutions.
- When a replacement is relevant, this must be approved according to guidelines.
- In case of doubt about required replacement this must be addressed to the customer, e.g. phrasing:” Please advise if any replacement is requested” in the customer response.
- The customer response letter can be sent by email after review and approval by the QA Manager or by a delegated QA team member.
- The QA Case handler sends the customer response letter via email as soon as possible and within 25 days from the assigned or 23 days after receipt of samples.
- In case this timeline cannot be met, the QA Case handler provides the customer with a complaint status letter explaining the progress and the status of the complaint handling.
If your complaint is classified as urgent, such as a safety issue classified as a significant and/or critical complaint, as per definitions above, Galaxa Pharma and CanNordic will top-prioritise your complaint and attempt to resolve it as soon as possible in close collaboration with you, from the confirmation of receival of your complaint. If we cannot answer within 2 business days, we will update you until the complaint is resolved.
VII. Resolution actions
- Depending on the result of the investigation, the following actions might be taken:
- A refund of the purchase amount
- A new product delivery
- The consumer might be asked to send back the product related to the complaint matter
- Shall the investigation proof the complaint to be invalid, in cases when Galaxa Pharma and CanNordic were not the party responsible for the fault/harm, the complaint might be resolved in favour of Galaxa Pharma and CanNordic.
- Galaxa Pharma and CanNordic claim the right to resolve the complaint in an alternative manner not listed above, shall the particular case require so.
VIII. right of appeal
Shall the consumer not be satisfied with how the complaint has been resolved, they can appeal to/via:
- If in Denmark:
- Nævnenes Hus
Toldboden 2
8800 Viborg
dk
- Nævnenes Hus
- If in other EU country:
- The European Commission’s online complaint portal http://ec.europa.eu/odr
IX. confidentiality and data protection
- Galaxa Pharma and CanNordic complie with GDPR and only stores and handles the information you have agreed to sharing upon purchasing our products and filing a complaint.
- We will record your complaint in the complaint handling system, so that we can learn and improve the way we work.
- We store your information securely for as long it as necessary according to our obligations as a private company and current legislation in force.
- We are obliged to monitor and report urgent complaints (as per definition above) to the Danish Medicines Agency.
- Any communication between the consumer and the representatives of Galaxa Pharma and CanNordic shall not be distributed without previous authorization of Galaxa Pharma and CanNordic..
- According to the Personal Data Act, the consumer has the right to insight into what information is registered about them. These can be acquired by sending an inquiry to Galaxa Pharma and CanNordic via e-mail info@cs-medica.com
Issue survey
- Updated according to Internal Audit Report for customer requirement 2021.
- The logos and mail addresses are updated
- CanNordic is a manufacturing and galaxa Pharma is distributor
- Updating and review according to annually updating