Executive Board of the Health Ministers Council For G.C.C. States 2211Principles of Tender Awarding Pharmaceutical Products (Drugs, Vaccines & Serums Chemicals Pesticides Radioactive Isotopes - Renal Dialysis Solutions)While studying the pharmaceutical products tender (Drugs, Vaccines & Serums Chemicals Pesticides Radioactive Isotopes - Renal Dialysis Solutions) the Tender Awarding Committee should stick to the following texts:

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First Definitions:1- The registered items, which are legible for entering the Group Purchasing should be registered and marketed in two of the GCC Member Countries with reference labortatories (Saudi Arabia, Kuwait, UAE & Oman), or the items which are centrally registered at the Executive Board Office. Companies which shall be invited to participate in the SGH Tenders must be duly registered in two GCC Member Countries with reference laboratories, or centerally registered. 2- Technical Specifications and Features: include the following:

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(a) Central registration or registration . in three referential-lab countries. .

(b) Validity and expiry period. (c) Sample shape. (d) quality and packing

.. .. .. 3- : : . . Narrow Therapeutic Index

Company's adherence to the defined delivery dates.

3- Sensitive Items: include the following: (a) Drugs with narrow therapeutic index which are taken orally (P.O) (b)

Drugs involving biological . technology for which no bioequivalence can be made . available, but rather need clinical or dynamic studies. Generic drugs for which no bioequivalence can be found, and are taken through mouthinhalation or some nasal atomizers.

(c)

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: : 1- Tenders are to be awarded to the 2- conformant proposal which offers the lowest price and is centrally . registered or registered in two countries with referential labs. 2- A bid registered in one country with 1- : referential lab may be considered for awarding in one of the following cases: (a) No conformant bid which is . centrally registered or registered in . two countries with referential labs is available among the bidders. b. The SGH Tender Committee shall () have the right to award the item

which is duly registered in one GCC . Member Country if its price is cheaper than the price of the item registered at two GCC Member Countries or centrally registered. 3- Technically-related items shall be 3- awarded as one set, and the total costs . shall be calculated for the whole set, then the tender shall be awarded to the lowest price. 4- Due to the global shortage in the blood derivatives, the tender committee may award biological medicines derived of blood to more than one company, with reasonable prices, in case the bidding companies are eligible to supply the whole required quantity.

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5- Loose tablets and capsules are to be 5- . awarded according to their small registered pack. 6- The award may be given to the 6- researching company, for its ) Generics( innovated product, if its quoted price . is cheaper than the generic company's price, before adding the percentage of subsidy to Gulf industries. 7. Cardiac and dibities medicines are to 7- be selected from two bidders; one ) Brand( bidder is researhing company (Brand) ) Generic( and the other company (Generic). The GCC Member Countries shall have the right to choose their preference. 8- In case prices are identical in more 8- than one bid, the tender shall be

awarded as follows:

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(a) If the manufacturers of a "Brand" . and a "Generic" product offered ( ) an equal price for the same item, ( ) or the difference between the two (12%) offered bids is up to 10% (before ( ) adding the subsidy percentage . given to GCC manufacturers), the "Brand" product would be awarded, on condition that it is the company's originally patented product. (b) In case the two identical prices are offered by two generic companies, the tenders shall be awarded after considering the offered technical specifications and features. In case no significant difference could be highlighted, the tender shall be awarded according to the technical justification.

. ) Generics( .

9- Non-registered concentration shall be 9- accepted in case the item is registered . in different concentration in the same pharmaceutical form. 10- A non-registered item may be 12- accepted in case no other proposal is available, its bid is conformant and . the offered sample is appropriately accepted, and it is duly registered and marketed at the country of origin. 11- Conformant bids with the lowest 22- prices shall be disregarded in any of the following cases: : (a) In case of sensitive drugs as it is . a condition that they are centrally registered, tested in the Gulf Countries, participant countries and no technical observations .

were made on them by the participant countries or agencies. (b) If the Executive Board office . received adverse reports pertaining to the quality of the . company product, either from international accredited entity or the GCC Member Countries. (c) The company fails to abide by the defined delivery dates according to reports received by the Executive Board from GCC Countries & other participating health sectors. (d) In case of repeated failure of a preparation in laboratory analysis in one of the member countries in at most 10% of the total number of batches supplied for one item. (e) Having some conditions set by the company which are not accepted by the Committee. 12- All GCC states shall participate in issuing the tender award decision. In case of voting, the votes of the countries which have the biggest share in the concerned item shall win. 13- If the company changes the country of origin after awardation, and in case the new company not registered in executive board office the award should go to the next offer and purchased on behave of the awarded company. 14- Insecticides tender: the insecticide law procedure will be imposed as stated in the executive articles of the GCC states. 15- The Support Resolution issued by the Health Ministers' Council for GCC States shall apply to this

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tender, offering the following support to the Gulf factories: (a) A priority of 5% shall be given . the national product over other foreign products. %5 A national product: involves any : product manufactured in one of the GCC States and is considered ( a national product under the laws . ) of such state (as made condition for bidders). (b) A priority of 3% shall be given . to a GCC State originated . %3 product over other similar : foreign products. A GCC State originated product: is any product in which the added value resulting from its manufacturing in one of the GCC member states is not less than 40% of the total value of the complete product. The ownership percentage of the GCC proprietor should not be less than 51% according to the Certificate of Origin.

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