Publication Ref: SIHHAT/2017/SUP/INT/01

CLARIFICATION No:1

To the

TENDER DOSSIER

Publication Ref: SIHHAT/2017/SUP/INT/01

Subject: Vaccine and Vaccine Transport Vehicles

Location –Europe (non EU/Turkey)

The following clarifiction is made to the tender dossier

INSTRUCTION TO TENDERERS

Question 1:

Article 21.1: Which documents will be submitted before the contract? (in accordance to Public tendering Agency, judicial registration document, social security, tax debt, bankruptcy) shall we obtain them after tender opening? Or like in public tendering agency the documents shall be provided on tender opening (18.08.2017)? We kindly ask it to be sure whether the documents dated one year before will be accepted?

Answer 1:Please follow ITT article 21.

Question 2:

Article 21.4 (c4b_itt_en) :

100% increase and decrease in vaccine supply are not applicable. It is not possible to respond to the 100% increase in vaccine production, which is a biologic product, since there is at least a 9 months process from the delivery of bulk to production, and unpredictable problems in the production process. So it would be appropriate to limit the material to 20% as in the PPA contracts.

Answer 2: Please follow ITT article 21.4

Question 3:

The technical and financial offers must be placed together in a sealed envelope. The envelope should then be placed in another single sealed envelope/package, please confirm.

Answer 3: Please follow ITT article 10.4

GENERAL CONDITIONS

Question 4:

Implementation of the tasks shall begin no later than 90 days following notification of award of contract is written. Does it mean it will start after notification of award? Contract signature is given as 07.11.17 and first delivery date is given as December. Please clarify.

Answer 4:Please follow Special Conditions Article 13

ANNEX II +III: TECHNICAL SPECIFICATIONS AND TECHNICAL OFFER

LOT 11

Question 5: Who will supply the barcode reading device?

Article 1.27

Artıcle 1.27- The broken and defected surfaces that shall be made suitable for the cold room door to be expanded in the specified area shallbe turned original form by plastering. A barcode reading room shall be built in front of the warehouse and electrical installation shall be done. The rooms shall be painted with the existing wall coloring to make the room suitable to original form.

Answer 5:Republic of Turkey, Ministry for Health will provide barcode reading device.

LOT 11

Article 1.28

Questıon 6: How many meters distance will be approximately between the generator and the electric panel? How many meters the electricity cable will be needed.

How far is the distance between the external cooling unit and the internal cooling unit?

Answer 6:Max 50 meters electricity cable will be needed. Max 25 meters distance between the external cooling unit and the internal cooling unit

LOT 10

Article 1.30

Artıcle 1.30- 20 kVA diesel generator with cabin shall be installed in accordance shall be connected to the cooling groups.

Questıon 7: Who will supply the diesel generator?

Answer 7: Contractor will provide diesel generator.

LOT 11

Article 1.33:

Question 8:Within the warranty coverage of the cold room to be installed and during the duration of maintenance contract, in case of a fault, the successful bidder shall reach the cold room with fault with technical personnel within 1 hour and must repair the fault within at most 5 hours.

Suggestion to 1.33- We request that the intervention period be changed to at least 12 hours and the repair period to 2 days. This is the scope of the statutory period. Also, since the devices are backed up, the hours suggested will be sufficient.

Answer 8. Please see the Changes to Tender Dossier

LOT 12

Question 9: for Article 1.36- Would an automation system be required for the two devices in the same enclosure?

Answer 9:Please follow Technical Specifications.

Question 10:Documents to support the technical specifications can be submitted as a copy in the tender dossier and can be presented originally if our company is awarded?

Answer 10: Notary certified copy of original copy “IDENTICAL COPY”is acceptable. Before contract signature original document shall be submitted to contracting Authority.

Question 11:

LOT 13

At number 1.22 of theTechnical Specifications it is mentioned that the vehicle should have minimum 5 seats.

In this context the height is mentioned with minimum 2381mm at number 1.7 which is the height of a vehicle with minimum 2 seats.

Please note that the height of the vehicle with minimum 5 seats should be minimum 2022mm. So, this may be revised in the tender documents please.

Answer 11: Please see the Changes to Tender Dossier

LOT 13

Question 12:Please note that the vehicle with minimum 5 seats has also 1 back door. So, this may be revised in the tender documents please.

At number 1.21 of the Technical Specifications it is mentioned that the vehicle should have 2 doors on the right and 1 door on the left.

Answer 12:Please see the Changes to Tender Dossier

Question 13:

LOT 13

The vehicle introduction and training must be done for all 57 vehicles in Ankara, right?

Answer 13:It will be realized in Ankara in 3 days. Each day 19 people will be trained.

Lot 2: The “DTaP-IPV-HIB” Vaccine

Question 14:

4.DOCUMENTS REQUIRED DURING EXAMINATION AND PRODUCT PROPERTIES

4.4.1 Batch Release Certificate of the product, of the series imported from places specified in the annex of EEC directive 89/342 of the European Union, shall be delivered

However, if the vaccine is to be filled in our country, the document will be prepared by TITCK-National Control Laboratory based on the quality control test results to be carried out by the TITCK. The same is valid for the DaPT-IPV Vaccine, as it should be in Article 3.7.1, correctly expressed:

Lot 7:The “DaPT-IPV” Vaccine

3. PRODUCT PROPERTIES AND DOCUMENTS TO BE REQUESTED

3.7.1. If the product is manufactured in a country belonging to the European Union, it is produced outside the European Union from the places specified in the EEC directive 89/342 of the European Union, a Batch Release Certificate issued by the National Regulatory Authority (NRA) on the WHO list . This document shall be requested at the final stage of acceptance if product filling or production is done in Turkey and it shall be provided by Turkish Medicines and Medical Devices Agency Drug, Biological and Medical Products Laboratory Department.

Therefore we ask you to write the same statement in LOT 7 also for LOT 3.

Answer 14: Please see the Changes to Tender Dossier

LOT 12

Question 15:

Although the requirement of SIHHAT / 2017 / SUP / INT / 01 - LOT 12 article 1.1 “Internal volume of the Cooling Units is required to be 915 lt,”, the dimensions of the technical specifications of the same Lot are given as 1500x1200x1180 mm. For a device with these dimensions , 915 lt. volume is not possible.

- We would kindly ask you to be informed about the matter.

Answer 15:Please see the Changes to Tender Dossier

LOT 11

Question 16: Due to the lack of detailed information on the Delivery and Mounting Locations of the Vaccine Storage, where technical details of the LOT11 are given, we have difficulty in cost studies. We request further information.

Answer 16:The details will be ready after contract signature. The tenderer may go site visit at the contractor’s own expense.

LOT 13

Question 17: There is no information on production year (Model Year) of Vaccine Transport Vehicles on the 13th lot.

Answer 17:Please see the Changes to Tender Dossier

Question 18:

LOT 2

Despite the constantly increasing demand for DaPT-IPVvaccine every year in the global market, due to the problems encountered in production, the supply shortage is experienced globally and it is estimated that these shortages will continue for a few more years.

For this reason, the supply of Lot 2: DtaP-IPV-HIB, Lot 3: Oral polio (OPV), Lot 7: DaPT-IPV vaccines in question, which are subject to your considered purchase, will be possible only in the frame of the following calendar, quantity and remaining shelf life or last usage date at the delivery date . We offer to you your permission to make changes in the subject matter for our associate or to allow you to submit a conditional offer.

On the other hand, our research for Lot 6 is ongoing, and your Ministry will be notified of the possible procurement program as soon as possible).

Delivery
Date / Amount / Shelf-Life
LOT 2 / 12/2018 / 600.000 / Min 15 m*
05/2019 / 300.000 / Min 15 m
LOT 7 / 12/2017 / 150.000 / 30/09/2018**
03/2018 / 0 / Min 15 m
05/2019 / 75 / Min 15 m
LOT 3 / 12/2017 / 160 / 31/08/2018**
06/2018 / 160 / Min 12 m
05/2019 / 160 / Min 12 m
(*) : Months
(**): Exp date

Answer 18. Please see the Changes to Tender Dossier

LOT 2

Question:19

It has been stated that in article 3.4 of section 3 of Annex II + III of the Lot 2 (DtaP-IPV-HIB Vaccines) the vaccines should be delivered to the Ministry's repositories within 48 hours following the withdrawal of the vaccine from customs.

However, if the vaccine components are filled and packaged in our country, it is not possible to deliver the products within 48 hours. The bulk of the vaccine is imported 4-5 months before delivery and the local operation is finalized in our country.

However, starting from bulk importation, the records of the conditions in which the product is filled and packed, the conditions in which it is stored, the temperature at which it enters the store, and the temperatures during which all the shipments are exposed can be presented during delivery.

For our company, Lot 2 and Lot 7, if the tenderer awarded, local operation will be decided according to the developing procurement conditions. However, we will provide you with the possibility to arrange the technical specification (Article 3.4) considering the local operation in our country.

Answer 19. Please follow technical specifications.

Question 20:

LOT 3

Lot 3 In order to be able to offer oral polio vaccination, we offer you the following technical specifications (Annex II + III) to allow packaging materials to be changed or to submit conditional technical proposals as follows

3.3.2 "The product shall be packaged in packages of up to ten vials or tubes for single, 10 or 20 doses. If the products are packed in ten packs, there will be a separator such as foam or cardboard which prevents the vials or tubes from breaking in contact with the packages.

If the product is packaged separately, the packages will then be connected in tenfold. The vaccine droppers will also be in 10 sterile blisters or packets. The firm will provide as much as 0.2% of the vial or tube quantity of the purchased vaccine. "

3.3.2 "The product shall be packaged in packages of up to ten vials or tubes for single, 10 or 20 doses. If the product is packed in a single package, the packages will then be connected in tenfolds. The vaccine droppers will also be packed in 10 pieces. The Company will provide as much as 0.2% of the vial or tube quantity of the purchased vaccine. "

Answer 20: Please see the Changes to Tender Dossier

LOT 3

Question 21:

3.3.3. "On the inner package and on the package of the product, the name of the manufacturer and the product name, lot, batch number, expiry date, amount of content (in TClDso- or PFU), application type (oral), storage temperature in one dose will be written and will not be erased.

On the package of the product, " Sağlık Bakanlığı Malıdır, SATILAMAZ" will take place. While "Vaccine Vial Monitor will be found" indicating the exposure of each vial or tube to heat;

3.3.3. "The name of the manufacturer and the product name, lot, batch number, expiry date, amount of content (in ml), application type (oral), storage temperature, etc. will be written on the inner package of the product and on the packages. On the package of the product, " Sağlık Bakanlığı Malıdır, SATILAMAZ" " will take place. We ask you to re write as "Vaccine Vial Monitor will be found" indicating the exposure of each vial or tube to heat

Answer 21: Please see the Changes to Tender Dossier

LOT 3

Question 22

3.3.5 "The packages will be put into the boxes later. On these boxes, the name and address of the product manufacturer and representative, the name of the product, the lot number, the storage grade, the expiry date and the dose amount in the box shall be written.

If the products are packed single, ten boxes will be placed in each box. If the products are packed ten packs, five packages will be placed in each box

3.3.5 "The packages will be put into the boxes later. On these boxes, the product manufacturer and representative company names and addresses, product name, lot number, storage grade, expiry date, dose amount in the box shall be written

We ask you to re write if the products are packed single, ten boxes will be placed in each box "

Answer 22:Please follow technical specifications.

Question 23:

LOT 3

3.3.6 "The vaccines will be frozen. Packaging boxes will be placed in strafora. The four faces of the strap (bottom and sides) will be suitable for the whole and parcel size and the top cover will be the feature to pass to the other part. The straforas will then be placed in the parcel

At least the upper surface of the strap will be covered the amount of ice or gel etc. The lid will be placed at the desired place in the strafora. Ice battery or gel etc placed in strafora shall be tranferred with dried or frozen ice

The width of the parcel will be 40 centimeters, lenght 60 centimeters, height 40 centimeters. These sizes can be up to ± 2 centimeters tolerence.

The name and address of the manufacturer, the name of the product, the lot number, the storage grade, the expiry date, the amount of the dose in the parcel, the parcel measures and the weight shall be written on these branches ";

At least the upper surface of the strap will cover the amount of ice or gel etc. The lid will be placed in the desired location in the strap

We ask you to re write Frozen or dry ice placed on strafor shall be transferred with ice or gel etc.. The name and address of the product manufacturer and representative of the product, the name of the product, the lot number, the storage temperature, the expiry date, the amount of the dose in the parcel, the parcel measures and the weight shall be written

Answer 23: Please follow technical specifications.

LOT 3

Question :24

3.3.7 The parcel will then be placed in the palette. Pallets euro pallet

(120 cm ± 2 cm × 80 cm ± 2 cm × 10-15 cm). Each pallet will have 16 parcels

The height will not exceed 2 (two) meters with the pallet after the arms are placed in the pallets. The arms can protrude up to 5 cm from the palette.

We ask you to rewrite 3.3.7 "The arms will then be placed in the palette. Pallets euro pallet

(120 cm ± 2 cm × 80 cm ± 20 cm × 10 cm). The height will not exceed 2 (two) meters with the pallet after the arms are placed in the pallets

Answer24: Please follow technical specifications.

LOT 3

Question 25:

Our research is ongoing in terms of procurement. We can not catch the delivery schedule and shelf life in some products. We will ask for an addendum. Will it be evaluated?

Answer 25:Change to tender dossier will be prepared if needed.

LOT 10

Question 26:

1.Is it allowed to blow cold air (minus O C) directly towards the shelf area where the vaccine and other medicine are stored?

Opinion: Vaccine and delicate medicine must be kept at a specific temperature range. Air blowing temperature plays a critical role if cooling air from the vents is directly blown to the shelf area where thevaccine is stored. in such case, cooling air temperature below O C at the vents may cause vaccine to get frozen. The colder the air b/owing temperature the higher the risk of freezing. Freezing risk is relatively much higher for vaccine stored closer to the vents. Besides, such risk is increased at higher operating (ambient) temperature due to the fact that compressor runs for longer. Such longer operation wil1 cause vaccine to be exposed to cold air blowing at longer periods, thus increasing the risk of freezing even though cooling air temperature is slightly below O.

Proposal: There must be no vents at all at shelf area(s) where vaccine is stored. ıf there exists any vent that islocated at a shelf where vaccine is stored, air outlet temperature at vent mııst be above O C at all ambient conditions.

Answer26: Please see the Changes to Tender Dossier

LOT 10

Question 27:

Is it allowed to have glass shelf/shelves?

Answer 27:Please follow technical specifications

LOT 10

Question 28:

How does it measured and assessed the noise and vibration level of the storage unit?

Opinion: A vaccine storage appliance must operate silently and should be constructed to reduce the transmission of vibration to the compartment, whether/rom the refrigerator compressor or/rom any external source. A measurable and verifiable method must be defined for this purpose. Sound power /eve/ in units of dBA that is defined and declared on the energy labelling of household refrigerating appliance is a well established method and considered an appropriate parameter for verification purposes.

Proposal: As a minimum technical requirement, Sound Power Level (SPL) in units of dBA should be included in the technical specifications. Minimum proposed SPL value is 42 dBA. All measurements must be done inaccordance with the IEC 60704-1 and IEC 60704-2. Verification should be performed according to the verification procedure described in the EU energy labelling regulation for refrigerating appliances 2010/1060/EU