PROCUREMENT REVIEW PANEL

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1 P.SH 59/11 PROCUREMENT REVIEW PANEL, appointed by the President Pursuant to the Article 102 point 1 of the Law on Public Procurement in Kosovo composed of Mr. Ekrem Salihu- President, deciding according to the article of the Law on Public Procurement, concerning the complaint of the EO Medical Group from Prishtina, of the , regarding the tender Supply of medicines and expendable material from the essential list of MSH re-tender LOT-12, with procurement no , initiated by the Procurement Department/Ministry of Health, on the has issued the following: D E C I S I O N I.REFUSED as ungrounded the complaint of the EO Medical Group from Prishtina, of the , regarding the tender Supply of medicines and expendable material from the essential list of MSH re-tender LOT-12, with procurement no II. AUTHORIZED contracting authority to proceed further procurement procedure regarding the tender Supply of medicines and expendable material from the essential list of MSH re-tender LOT-12, with procurement no III.ORDERED contracting authority within a 15 day deadline, must notify the review panel in written form of all actions undertaken with regard to this procurement activity. IV. EO Medical Group from Prishtina conform article 118 point 3, it is returned the deposit in the amount of Euro (five hundred Euros).

2 R E A S O N I N G Contracting authority- Ministry of Health on the has published the notification for contract regarding the tender Supply of medicines and expendable material from the essential list of MSH re-tender LOT-12, with procurement no As a criterion for evaluation has chosen the accountable tender lowest price. For this procurement activity /LOT-12 have applied two economic operators: - Medical Group from Prishtina with price of ,00 Euro; - Agani from Prishtina with price of ,50 Euro. EO Medical Group from Prishtina within the legal deadline has lodged a complaint to PRB. Points of complaint: Provisions violated by the CA according to EO are dealt with: The evidence provided in the tender CCP wasn t for import in a European state as it was required, but CCP was for import in Egypt. Complaining party emphasizes that the product offered by the company Agani doesn t have a distribution authorization for Kosova and with the actual Law it can t be registered until it has evidence for the hearsay product import for at least 3 states of European Union. Complainant as well emphasizes that with such CCP contracting authority was obliged to announce the bid of the company Agani as not accountable for Lot 12. Review Panel on the , conform article of LPP has assigned the review expert Mr. Abdyl Limani with purpose to review the complaining claims of the complaining EO. Review expert on the hands over the report in written to the review panel with proposal that the complaint of the complaining EO to be refused as ungrounded. Expert review after analyzing of the procurement process has ascertained: Based on the examination of the tender dossier and review of the course of the tender procedure, ascertains as follows:

3 Ascertainment 1 After analyzing the procurement procedure entirely it is obvious that it is an opened procedure, with high value divided in Lots. Ascertainment 2 For this procurement activity have applied two economic operators, whereas both of them have completed the requirements according to the tender dossier. Ascertainment 3 Review expert ascertains that contracting authority complaining EO considered it as accountable, but the same has a higher price than economic operator recommended for contract award. Whereas regarding the claim of the complainant that company Agani should have been announced as not accountable, review expert ascertains that contracting authority in the case possesses a written request through electronic means made directly to the manufacturer Achyno on the regarding the product Goserelin-10.8 (filled syringes), while the response from the same manufacturer was that the hearsay product it is made and sold in Switzerland, and based on the Administrative Manual no.04/2008 it is required that the product to be exported in one of the states of the European Union or in Schengen area, where part of it is Switzerland. The complaint is ungrounded. During the hearing session representative of the complaining EO Mr. Skender Kutllovci among other stated quote: we have complaint because we believe that Ministry of Health in his requests required CCP from a EU state. CCP is a document that is issued for the countries importing. In this case CCP was from an African state respectively from Egypt. CCP is a document as a birth certificate of the medicament. At the Agency for the medical products I was personally and contacted with Mr. Jeton Shala- Executive Director and the same told me that there is no chance that the hearsay medicament or the product offered by the company Agani can be registered to our Agency with such CCP. Whereas in his last word the complainant stated: I remain by my complaint of the as well the memo of the Representative of the contracting authority Mr. Zenel Kuqi during the hearing session among other stated quote: CCP for the hearsay product it is for export of this medicament in Egypt. In the same CCP it is written that this product is made in Switzerland and it is sold also in Switzerland. The evaluation commission requested from company Agani explanation regarding this CCP, and they as a response have translated the part where you can see that this medicament is made in Switzerland and sold in Switzerland. We have contacted also with the manufacturer ACHYNOM in Switzerland and the same have confirmed that the hearsay product it is made and also sold in Switzerland. Then we requested from them if they have

4 distribution-authorization in Switzerland. This authorization they have sent it in German language. After all these communications and explanations we have defined to reward with contract the economic operator Agani from Prishtina. Whereas in his last word the representative of the contracting authority stated: I remain by the decision of the evaluation commission and at the same time request from the review panel refusal of the complaint of the complaining economic operator. Review expert Mr. Abdyl Limani during the hearing session among other stated quote: Contracting authority both applying companies has treated as accountable economic operators. Contracting authority has respected the criterion for contract award- the lowest price. I have justified the contracting authority and memos/ correspondence/ of the CA and the company ACHYNO i have considered as valid memos. Based also in the tender dossier where it is mentioned that every medicament which must be brought to Kosova it is obliged to be registered to AKPM. As well based on that the contracting authority has requested to ensure the execution of the contract in a sum of 10% of the contract value. Whereas in his last word stated: I remain by the expertise s report of the and ascertainments done in the expertise. Review panel ascertained that contracting authority on the requests of the technical abilities among other requested: -Authorization for participation from manufacturer; -Medicaments must have authorization for distribution in Kosova. -If the medicaments don t have AM/ for Kosova,then are valid the criterions as follows: -Medicaments must have valid certificates of AM from: a)ema ; b)fda ; c) States of the European Union/ Schengen states/ based on AM 04.04/2008. d) CCP ; e)gmp. From overview of the memos especially the correspondence between the contracting authority and the manufacturer it is ascertained that the manufacturer has confirmed that the hearsay medicament it is manufactured in Switzerland and the same is sold in Switzerland as well the same manufacturer has authorization-distribution in Switzerland, whereas concerning the disputed CCP, CCP is in the memos of the case, but in the tender dossier it is not specified if it is required the CCP for a country exporting or importing.

5 Review panel ascertained the claim of the complainant that the product which has offered the company Agani doesn t have distribution-authorization in Kosova and with the actual Law it can t be registered until it has evidence for the import the medicament concerned for at least 3 states of the European Union is ungrounded because the manufacturer of the medicament is company ACHYNOM from Switzerland which is a part of Schengen state and that the same company has presented to the contracting authority distribution-authorization in German language conform AM no. 04/2008 On the authorization of distribution for placing the medical products in the Republic of Kosova. Whereas regarding the evidence for the product import for at least 3 states of EU, review panel referring to the Law for medical products and medical equipment no. 2003/26 as well the Administrative Manual no. 04/2008 On the Authorization for Placing the medical products in the Republic of Kosova ascertained that such a thing is not provided in any article of the abovementioned legal acts. Review panel concluded that the issue of distribution-authorization is regulated with article 9 of the Law for the medical products and medical equipment no.2003/26 as well articles 3, 4, 6 and 7 of the Administrative Manual no.04/2008 On the Authorization of distribution for placing the medical products in the Republic of Kosova. Also based on the above mentioned Law and Administrative Manual, competent authority for issuing of distribution-authorization and licensing the medical products imported in Kosova is Agency of Kosova for the medical products. If the hearsay medicament doesn t fulfill the requirements according to the tender dossier and conform the Law for the medical products and medical equipment no.2003/26 and Administrative Manual no. 04/2008 On the Authorization for Placing the medical products in the Republic of Kosova, then AKPM will not do the licensing of the import of the hearsay product, whereas contracting authority will confiscate the insurance of the execution of the contract of 10% of the contract value. Therefore review panel evaluates that the complaint of the complaining EO is ungrounded and there is no reason for re-evaluation re-tender of the hearsay case. Review panel after demonstrating the proof one by one and connected to each other gave confidence to the review expert s report and the same approved it as grounded. From the abovementioned, review panel decided as in the provision of this decision. Legal advice: Aggrieved party can not appeal against this decision, but it can file charges for damage Compensation in front of the Supreme Court of Kosovo, within 30 days after the receipt of this decision. Chairman of the Review Panel Ekrem Salihu

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