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How to make a suggestion or file a complaint

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Complaint Procedure

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 info@cs-medica.com, 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

how to file a complaint

As a customer of Galaxa Pharma, 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 GP 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: info@galaxapharma.com
complaint levels
Level 1:
  • 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 
Level 2:
  • Urgent complaints which are classified as significant and/or critical complaints are regarded 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.

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

 

handling your complaint
responsibility

Complaints made to Galaxa Pharma are handled and investigated by the Marketing and/or Science Department depending on the nature of the complaint.

Level 1 complaints:
  • Receipt of recording:
  • When GP receive a complaint, you will be sent an email confirmation of complaint receival and recording within 5 business days.
  • Investigation
  • GP strive to investigate and resolve your complaint within 5 business days from the confirmation of your complaint if possible. If GP are not able to resolve the complaint within this time frame, GP will update you continuously in the process and until the resolution of your complaint.
  • Communication:
  • We will keep you informed as much as reasonably possible of the progress of you complaint and any actions we may have taken about your complaint.
Level 2 complaints:
  • If your complaint is classified as urgent, such as a safety issue classified as a significant and/or critical complaint, as per definitions above, GP will top-prioritise your complaint and attempt to resolve it as soon as possible in close collaboration with you, from the confirmation of recieval of your complaint. If we cannot answer within 2 business days, we will update you until the complaint is resolved.
resolution actions
  • When your complaint is resolved, we will confirm this with you within 2 business days.
  • 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 GP was not the party responsible for the fault/harm, the complaint might be resolved in favour of GP.
    – GP claims the right to resolve the complaint in an alternative manner not listed above, shall the particular case require so.

right of appeal

Shall the consumer not be satisfied with how the complaint has been resolved, they can appeal to/via:

  • In Denmark: Nævnenes Hus Toldboden 2 8800 Viborg naevneneshus.dk
  •  If in other EU country: The European Commission’s online complaint portal http://ec.europa.eu/odr

confidentiality and data protection

Shall the consumer not be satisfied with how the complaint has been resolved, they can appeal to/via:

  • GP complies 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 GP shall not be distributed without previous authorization of GP.
  • 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 via e-mail info@cs-medica.com