1. Introductory provisions
1.1 In accordance with Act 362/2011 Coll. on Medicinal Products and Medical Devices, as amended, Commission Implementing Regulation (EU) 2021/1248 on measures relating to good distribution practice for veterinary medicinal products, Decree of the Ministry of Health of the Slovak Republic 128/2012 Coll. on requirements for good manufacturing practice and good wholesale distribution practice for medicinal products for human use, and in accordance with Act 513/1991 Coll., the Commercial Code, as amended, PHARMACOPOLA, s. r. o., with its registered office at Svätokrížske nám. 11, 965 01 Žiar nad Hronom, ID No.: 31570895, VAT No.: 2020479230, VAT No.: SK2020479230, which is registered in the Commercial Register of the District Court of Banská Bystrica, Section: Sro, File No.: 685/S, issues this Complaints Procedure, which is an integral part of the General Terms and Conditions, which the Buyer is obliged to get acquainted with before concluding the purchase contract.
1.2 Acceptance of the Complaints Procedure is confirmed by the Buyer by signing the invoice, the purchase contract or by taking delivery of the goods and confirming receipt of the goods with his signature.
2. Subject of the complaint procedure
2.1 The Buyer is entitled to complain about the following defects of goods purchased from PHARMACOPOLA s.r.o.:
2.1.1 Obvious defects of the goods detected upon receipt of the goods:
(a) damage to the outer and inner packaging of the goods (torn, deformed, broken, dented, etc.)
b) incompleteness of the consignment (missing transport units – cartons, bags, crates, etc.)
(c) non-compliance with transport conditions (temperature regime, safety regime, etc.)
2.1.2 Shortcomings in quantity and quality: missing goods, delivery of other goods, goods delivered in excess, so-called hidden or manufacturing defects (delivery of incomplete or empty packaging, non-functioning goods, change in appearance/colour/smell of the product) or delivery of goods with a different expiry date/shelf life than on the document or as agreed, etc.
2.1.3 Other defects – e.g. incorrect price of the goods, incorrect labelling of the product, illegible batch/expiry date, etc.
2.2 The Buyer shall not be entitled to return to the Seller medicines and other goods which it has received back from its patients and customers and the reason for the return is for a reason other than the defects and deficiencies referred to in clauses 2.1, 2.4 and 2.5.
2.3 The Buyer may return the Goods to the Seller for reasons other than those set out in clause 2.1 (e.g. if the Buyer has misjudged the Goods, failed to consider their price, features, if the Buyer has incorrectly ordered the Goods when placing an order on B2B and has not modified their order, if the Buyer has ordered the Goods or placed an entire order duplicatively – see clause 3.8) only if the Products:
– they are in unopened and undamaged packaging and are in good condition
– they are not expired
– in the case of medicines stored and transported in a refrigerator, they have been stored and handled in accordance with the manufacturer’s requirements, which the Buyer confirms by an affidavit, which the Buyer indicates when submitting the online form
– in the case of medicinal products for human use for which safety features are verified, the condition under point 5.4 must additionally be complied with.
2.4 A product which is withdrawn from the market at the initiative of the Institute for State Control of Veterinary Biopreparations and Medicinal Products (ÚŠKVBL), the State Institute for the Control of Medicinal Products (ŠÚKL), the Central Inspection and Examination Institute for Agriculture (ÚKSÚP) or the manufacturer shall be considered as the subject of a complaint.
2.5 A product which has been used or handled and is subject to an adverse reaction report within the meaning of Act No 362/2011 on Medicinal Products and Medical Devices, or a product suspected of being ineffective or ineffective, shall be deemed to be the subject of a complaint.
2.6 The content and precise description of a submission is decisive for assessing whether it is a complaint (in whole or in part), a request, a complaint or an adverse reaction report.
3. Obligations and rights of the Buyer
3.1 The Buyer is obliged to inspect the delivered goods in accordance with §427 of the Commercial Code. In the case of obvious defects of the goods found (referred to in clause 2.1.1. ), the Buyer shall file a complaint immediately after the inspection, at the latest within 3 working days from the delivery/acceptance of the goods. If the customer does not inspect the goods, he can only claim for defects detectable on inspection if he proves that the goods already had such defects at the time of receipt of the goods.
3.2 Defects in the goods which are not immediately apparent upon inspection of the delivery of the goods (referred to in clauses 2.1.2 and 2.1.3) shall be claimed by the Buyer as soon as they are detected.
3.3 The Buyer shall have the right not to accept the delivery or part thereof in the event of a defect in the goods which is already apparent upon delivery. In this case, the Seller’s employee delivering the goods shall mark the non-acceptance of the goods in the delivery note and the Buyer shall confirm his consent by signing. The Buyer will then be contacted by the employee responsible for claims, who will further resolve the case with the Buyer.
3.4 The Buyer shall have the right to enquire about the expiry date/shelf life of the goods when ordering and shall have the right to reject goods with an expiry date that is not satisfactory to the Buyer when ordering. At the same time, however, if he does not reject the goods and if the expiry date has not yet expired, these goods cannot be the subject of a complaint due to the expiry date, unless otherwise contractually agreed with the Buyer.
3.5 The Buyer is obliged to return the claimed goods to the Seller in the original packaging and in the original condition (without labels, price tags, descriptions, which mark the goods for their needs). The Buyer must return the claimed goods that have already been used to the Seller unsoiled.
3.6 In the case of a claim for medicines containing narcotic and psychotropic substances, medicines requiring refrigerated storage and transport conditions or flammables, corrosives and other specific types of goods, the Buyer shall be obliged to pack and mark the goods accordingly, taking into account the observance of safety measures, appropriate storage and transport conditions.
3.7 The prepared claimed goods with the claim record shall be taken over from the Buyer by the Seller’s driver/sales representative. The Buyer is obliged to notify the Seller’s employee when handing over the claimed goods what kind of goods they are (goods requiring special transport conditions).
3.8 When ordering via B2B, the Buyer shall be responsible for the type, quantity and expiry date/expiry date of the ordered goods, which the Buyer shall have the possibility to adjust and change in the order prior to its dispatch to the Seller. The Seller does not accept responsibility for the Buyer’s errors and is not obliged to accept such a claim and request for return of goods.
3.9.The Buyer shall immediately notify the Seller of any important permanent or temporary changes that are essential for the correct delivery of the shipment (change of address, change of contact details, change of opening hours, change of the time window in which the shipment can be delivered). In the event that the Seller incurs additional costs for the delivery of the consignment due to the Buyer’s failure to notify the Seller of such changes in time, the Seller shall proceed in accordance with clause 8.1.
4. Method and form of filing a complaint
4.1 The Buyer may submit a complaint in writing non-stop, on the basis of a legibly, completely and truthfully filled out online complaint form or by e-mail to reklamacie@pharmacopola.sk.
4.2 The online complaint form is also available in the B2B customer area of https://b2b.pharmacopola.sk.
4.3 The Buyer shall supplement the complaint submission with photographic documentation, especially in those cases where, in agreement with the Seller
it is not necessary to return the claimed goods. The Seller has the right to ask the Buyer for photo documentation,
if it is necessary and if the nature of the claim so requires.
4.4 For reporting the occurrence of adverse reactions to veterinary medicinal products to the national competent authority, it is necessary to use the electronic forms available on the website of the ÚŠKVBL – VETERINARY MEDICINES – Reporting of suspected adverse events (NU) | (uskvbl.sk)
4.5 The Buyer may also submit a complaint by telephone on weekdays between 7:30 a.m. and 3:30 p.m. by calling 045 6781 490.
4.6.When reporting a complaint by telephone or e-mail, the Buyer is obliged to state, in addition to his nationality, the type and number of the goods complained of, the reason for the complaint, the number and date of the document to which the complaint relates.
4.7 The Buyer is obliged to submit a claim or a request for return of goods in the case of medicines stored and transported in a refrigerator only via the online form (direct access in clause 4.2).
5. Time limits for filing a claim
5.1 The Buyer is obliged to claim defects detected after receipt of the goods immediately, but no later than within 3 working days after receipt of the goods.
5.2 Hidden defects (manufacturing defects) shall be claimed by the Buyer as soon as they are detected.
5.3. Goods withdrawn from the market at the initiative of the Institute of State Control of Veterinary Biopreparations and Medicines (ÚŠKVBL), the State Institute for Drug Control (ŠÚKL) or the manufacturer, the Buyer must return to the Seller immediately after notification, if no deadline has been set for the return of the goods until which the goods can be returned. After the specified date, the goods cannot be returned without the prior consent of the Seller, which is subject to the consent of the supplier/manufacturer.
5.4 Human Medicinal Products subject to safety features verification and which the Buyer intends to return to the Seller for the reasons set out in clause 2.3 above must be returned promptly as, according to the “SOOL Guidance on Safety Features Verification of Medicinal Products after 9 February 2021”, Article III, clause 9(b), the product may be reinstated to an active state within 10 days of deactivation (which the Seller shall carry out 1 day prior to the delivery of the Goods to the Buyer). If there is a risk that the medicine will be returned to the Seller’s warehouse by the date when it will no longer be possible to reactivate it, the medicine cannot be taken over from the Buyer.
6. Complaint handling
6.1 Part of the settlement of a complaint is to make or arrange for a remedy, provided that the remedy is possible and legally supportable.
6.2 The Seller is obliged to process a properly submitted complaint within 30 days of its receipt.
6.3 Accepted complaints shall be resolved by the Seller in accordance with the Commercial Code by replacing the goods, repairing the goods, providing a discount, refunding the money (credit note) or delivering the missing goods.
6.4 Complaints that are in the nature of a manufacturing defect or have been caused by the Seller’s supplier shall be sent to the manufacturer/supplier for professional assessment. After professional assessment by the manufacturer/supplier, the Buyer will be informed about the manner of handling the claim.
6.5 The Seller shall return the Product for which the claim has not been accepted back to the Buyer, unless otherwise agreed between the Seller and the Buyer.
7. Expiry of the right to claim
7.1 The right to make a claim shall be extinguished if:
(a) the goods have been damaged by unprofessional and rough handling on the part of the Buyer or its customer;
b) the storage conditions prescribed by the manufacturer have not been observed by the Buyer;
c) it is in breach of these Claims Regulations.
8. Final provisions
8.1 The Buyer may be charged a handling fee of EUR 5, excluding VAT, in relevant cases of return of goods for reasons other than a complaint (pursuant to clause 2.3.), as well as in cases of redelivery (due to non-acceptance by the Buyer upon first delivery).
8.2 The Complaints Procedure is valid from 1.3.2024.