sİrkÜler (g-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and...

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ORTA ANADOLU İHRACATÇI BİRLİKLERİ GENEL SEKRETERLİĞİ O rta Anadolu İhracatçı Birlikleri Genel Sekreterliği Ceyhun Atuf Kansu Cad. No: 120 06520 BALGAT ÇANKAYA ANKARA Tel : (312) 447 27 40 Faks : (312) 446 9605 - 447 0180 e-posta : [email protected] / www.oaib.org.tr Ayrıntılı bilgi için: KUBİLAY YAPICIOĞLU - İDARİ MEMUR Sayı: 70430465- TİM.OAİB.GSK.2018/20317-23330 Ankara, 02/10/2018 Konu: Sri Lanka Sağlık Hizmetleri Birimi Ilaç İhale Ilanı SİRKÜLER (G-2018) Sayın Üyemiz, Sri Lanka Sağlık Hizmetleri Biriminin tedarik etmek istediği tıbbi malzemelere dair açılacak İhale duyurusu daha önceki yazımızda iletilmişti. Bu defa, bahsekonu ihalenin T.C. Ticaret Bakanlığı İhracat Genel Müdürlüğü’nden alınan yazıda, Dışişleri Bakanlığı’ndan alınan ve bir örneği ekte yer alan ihale duyurusu çerçevesinde revize edildiği bildirilmektedir. Bilgilerine sunulur. S. Tansel KÜNBİ Genel Sekreter A. Şube Müdürü EK: İhale Duyurusu (46 Sayfa, e-posta ile gönderilmektedir.) 5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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Page 1: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

ORTA ANADOLU

İHRACATÇI BİRLİKLERİ

GENEL SEKRETERLİĞİ

O rta Anadolu İhracatçı Birlikleri Genel Sekreterliği Ceyhun Atuf Kansu Cad. No: 120

06520 BALGAT ÇANKAYA ANKARA Tel : (312) 447 27 40 Faks : (312) 446 9605 - 447 0180 e-posta : [email protected] / www.oaib.org.tr Ayrıntılı bilgi için: KUBİLAY YAPICIOĞLU - İDARİ

MEMUR

Sayı: 70430465-TİM.OAİB.GSK.2018/20317-23330 Ankara, 02/10/2018 Konu: Sri Lanka Sağlık Hizmetleri Birimi Ilaç İhale Ilanı

SİRKÜLER (G-2018)

Sayın Üyemiz,

Sri Lanka Sağlık Hizmetleri Biriminin tedarik etmek istediği tıbbi malzemelere dair açılacak İhale

duyurusu daha önceki yazımızda iletilmişti. Bu defa, bahsekonu ihalenin T.C. Ticaret Bakanlığı İhracat Genel Müdürlüğü’nden alınan yazıda,

Dışişleri Bakanlığı’ndan alınan ve bir örneği ekte yer alan ihale duyurusu çerçevesinde revize edildiği bildirilmektedir.

Bilgilerine sunulur.

S. Tansel KÜNBİ Genel Sekreter A.

Şube Müdürü

EK: İhale Duyurusu (46 Sayfa, e-posta ile gönderilmektedir.)

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 2: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

_______________ __________________________________

PROCUREMENT NOTICE - GLOBALSTATE PHARMACEUTICALS CORPORATION OF SRI LANKA

The Chairman Procurement Committee of the State Pharmaceuticals Corporation of Sri Lanka will receive sealed bids for supply of following items to the Department of Health Services for year 2019.

Item Description Non-refundable

Bid Fee

Date of issue of Bidding Documents

from21.08.2018

CiosingDate

&Time

Bid Number

Rs. 3,000/= + Taxes

300,000 Tabiets of Isoniazid Tabiet 100mg

02.10.2018 at 9.00 a.m.

DHS/P/WW/713/19

Bids should be prepared as per particulars given in Bidding ‘’ “ T fbidders on working days between 0930 hours to 1500 hours at the Head Office of the StatePharmaceuticals Co rporation of Sri Lanka, No.75, Sir Baron Jayatillake ^ q'S ®rndmicK-cuu^a k refundable Bid Fee per set as mentioned above. Offerscould be purchased on cash payment of a u ■received without enclosing original payment receipt are liable to be rejected.

non-

Wherever applicable potential bidder/bldders should get registered in terms of the Public Contract Art No.3 of 1987 before collecting the Bidding Documents and also should get the contract registered afterthe tender is awarded.

All Bids should be accompanied by a Bid Bond as specified in the Bidding Documents.

Sealed Bids may be sent by post under registered cover or may be personally deposited the box Lailable for this purpose at Internal Audit Department in the mezzanine floor of the State Pharmaceuticals Corporation at No. 75, Sir Baron Jayatillake Mawatha, Colombo 1, Sri Lanka.

Bids will be closed at the Head office of the State Pharmaceuticals Corporation on the dates and time mentioned above and will be opened inimediately thereafter. Bidders or their authorised representatives will be permitted to be present at the time of opening of Bids.

being sent to Sri Lanka missions abroad and foreign missions in Sri Lanka also.Bidding Documents are

CHAIRMAN DEPARTMENTAL PROCUREMENT COMMITTEE STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

00 94-11- 234408200 94-11- 2326227/[email protected]

FAXTELEPHONEE-MAIL

Chairman- Procurement Entity On behalf ofCHAIRMAN DEPARTMENTAL PROCUREMENT COMMITTEE STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 3: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

f

ANNEX-1TENDER NO. DATE OF ISSUE

: DHS/P/WW/713/19: 21®T a u g u s t 2018

CLOSING DATE & TIME : OCTOBER 2018 AT 09.00 HOURS SRI LANXA TTMF

ORDER LIST NO. 2019/SPC/N/R/P/QQ135

SR No. Item Description/ Specificat-inn Quantity Delivery00104201 Isoniazid Tablet 100mg

Isoniazid tablets BP / USP, lOOmg Each tablet to contain 100mg of Isoniazid BP Tablets also should conform to dissolution test for Isoniazid tablets as per USP

300,000Tablets

300,000 Tablets -April 2019

ORIsoniazid tablets USP, lOOmgEach tablet to contain 100mg of Isoniazid USP.

Mote:01 .The sheif life of the product shouid be minimum of 24

months.

Packing : 100 Tablets in a bottle

Page No. 5 Condition No. 5 (Bid Fee) -

DoTume^nte Rs.3,000.00 + taxes should be paid in cash to SPC for each set of Tender

Amendments to the Bidding Documents for Procurement of Pharmaceuticals for the Department of Health Services of the Government of Sri Lanka (Blue Book). (DPC)Terms and Conditions of Bid/Instructions to Bidder

Rage No. 8 Condition No. 11.1 (Fresh Stocks - to be amended to read as folinw.-.f n H I ’’® ? manufactured recently conforming to the stipulated specificationsqnnn f I ''f® remaining at the time of receipt of goods^at MedicalSupplies Division, Sri Lanka should be greater than 85% out of the total shelf life of the product.

Page No. 9 Terms & Condition No. 14.2 rPackina & Storanp/rnnrimnnc-i follows: --------------^Packing of all items shouid be suitable for storage and use under tropical conditions. Final Export packing should indicate the required storage temperature for goods which require Refriqeration/Cool storage/Coid storage/ Freezer Storage enabiing the cargo handiing staff at the Port of Destination to a r r jg e proper storage for such goods immediately on amival. Further refer condition chain maintaining cargo. Sri Lankan ambient storage conditions temperature and 75% +/-5% relative humidity.

Page No. 36, Conditions of Cnntrarf

3 to be amended as Free Replacement/Reimbursement due to quality issue.Condition No. 3.2 to be amended to read as,

thJ^NMOAL f authorized personnei atAuthohty.^^ by an expert committee appointed by the reievant

futSrT 'Pd'nffip i'f V'" * ® ^®'®uce wiil be destroyed byfo M ^ g d e s S o n ' by SPC

- to be amended to read

31.4 for cold are in the ranges of 30°C +/- 2°C

Condition No.

PS n r \A/ifhHrotA/r> ....f ...:a u __

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 4: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

N.B. clearly indicate in Annex il. If Local Agent Commission to be paid the percentage should be

2 Storage temperature of the offered item should be *"?'“ *“ *“Full description of the item offered and the standar in i Bidding Document)

1B in the coiumn

(Annex II B of

of the NMRA registration certificate certified by Attorney-at-Uw T s t^ e o? pU should be submitted along wHh the The

regarding storage temperature accepted by NMRA for information is not included in the registration

3. A Certified copy/Commissioner of Oaths or Bidder should provide details granting registration in the event such certificate.

ronditions ofSupplv_:1, The consignments supplied in respect of

sample submitted and the product mformat on in the bid document by^ p ^ t ^ ^ r c r m e T ^ m ^ e , and included in the Indent /

Purchase Order (PO), issued by SPC.

3. Maintaining the validity of the

" " "produce reievLt valid registration certiflcates/licenses, when requested by MSD/produot/manufaoturing licenses and registrations of j W f

license, product registration and GMP sctd™ ^^ byr s 2 p :,in ^< :d S » "° r i sha„ be submitted to MSD by thesupplier when deliveries are made.

the

waiver of registration from NMRA.

When the validity of the

15% of the quantity in the consignment.

25% surcharge on the labeling cost, (total charge - [a]+Lajxu.^o; or whichever is the highest.Ail'po'ssible tender-deviations such as Packing ' * e l i n ^ ^ ^ ^.Ode a oonditions,^ . sha,|be ^ n r * .a t io : s , t? apply penalty (asby the supplier, clause No. 36).

specifications of the product offered in the bid, by the s u r lie r shall match with the tender speciflcations for the item and any form of alternate offers will not be entertained.6. The

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 5: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

Shelf life & Warrantees

remaining at thM im V i^dd ive iy of’go^^^ in S r^ a n S ^ S D store ^ "'®product, shaii be 85% of the shelf iife requested(specmedTorder/Went/Po! "'®

r^sr s":,7re;'2;sdis,s s nTbi°:nTrhrr <*®“‘ ®-®®""®months.

considered as, 36 months for'K^iS, itemfa:dl4“ r^® ^a^?ar^^^^^ Sms"'®

\ !.‘ssrr,tsr.ssss .-S5r,.r.trar.2s;~

Standards & Qualify

10. Withdrawal from use of ifems due to quality failure found as manufacturer's f(a) . In case of batch withdrawal,

from the supplier.(b) . In case of product withdrawal,

from the supplier.

ault:value of entire batch quantity supplied shall be recovered

value of entire product quantity supplied shall be recovered

'^"ssrs»;sa::iss„is'rr.ca~“ '-11. The storage conditions and the

conform to the

“ nV''n®r^r Tam'pra®Tp?sr?et ^ '®®"" ®— 'VS pS H rS arsM S H fiand entire expenses on such tests, like value of samples etc, will be recovered from the supplier.

consignment, transport, sampling & testing charges.

nrnH®'Tw Conditions indicated on product labels and/oroualiVaff accepted for product registration at NMRA), shall be considered aspos iTnoat™ ® "*® ®®®‘‘rance of such consignments shall be carried out bypost delivery testing at government / semi government laboratory in Sri Unka or at an accreditedbv (f°r8'9^ocal). All the expenses on such an event, including storage cost shall be borne

clause S r ® •«®'®<‘ 8S quality failed (as5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 6: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

Pack si?6, Labeling & Packaging

u . Ofre. . r pao. s.es a. a :oweMave,g™,,eritem desariPtoa'af not L ertertain^d unless otherwise offered with the original bidr n r r o e W lK o u r r r “ with the oonourrenoe of MSD.

blister/strip packs), “DHS” mark shall be ,15. In respect of bulk packs (not applicable for(a) embossed or printed in case of tablets(b) . printed in case of capsules purchase order is less than 100,000^ r s / c " (?ny SeZdons to'this oondition, is noffled in the relevant MSD order list

0^ rM=ure,Dale of Expiry and "STATE LOGO’ of G ^em ^ert^f Sr, Manufacture (in any form

as*Y l?& MontIV or "No Exp® V n the innermost pack and supplier's invoice.

17. Description of the SR ^o Date of

r e C ? r i n « d u I S o s t pack oentainin Ure minimum unit of -a s .e , «

Lte ^of InrctuMDotyDr ^and DOM & DOE shall consist of at least the year & month,

manner. This may be printed, stenciled or label properly affixed.

IfcodrsW L°'pJnXnme rab^at a“ tev:?d paX g ls ^ d ^ e t e w , co^ntelngloThe

Lximum barcode size shall be 5.0cm (length) x 2.5cm (width).

20. in case of receiving goods ibaPPtoP"®!® “ "b^Tofl'T^110*10 of thesorted out by MSD to select the item® ® ®° h an evLt (including demurrage charges, cold consignment, all expenses incurred to MSD charges incurred until goods are reac,rptanTharte^tyir/to^'MSD rth :“ pn®r, h®*or® a«®®=‘ing to checking theconsignment 100%, by MSD. ^ g jl 35 gpove. .

yx^enS incurS ioTsD shaTbe recovered from the supplier by SPC and refund to MSD.such extra

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 7: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

storage Conditions & Temperatnro

product s ta g e c o S o S .th a N ro n fo m to Sri u S l m b i e ^ ' l " ' accepted30 c +/- 2°c temperature and 75% +/-5% relative humiditv storage conditions in the ranges of clearly indicated at all levels of labels/packages W s ^ conditions shall be

22. Maintenance of Cold Chain;

included foUach^cSn^and'^he S id cha ^ recording devices) shall beinstructions during storage. transpoSSd deliveS manufacturer’s

b.Supplier shall useappropriate colours and S e s7 (^ easySeSSttS^^^^^^ marks of iriternational standard, with USB Devices for temperature dLta l o a a l S h ^ cold cargo. Supplier shall use standardized data logger readers &/ software freadina annc P^cl^Oes and shall provide free of charge, department of SPC in advance to enable ''''‘"^°ws-07/latest) to wharfbefore taking over the consignment by MSD. ^ ^ maintenance of cold chain in transit, and

c o ^ n m e m ^ s W ^ L '^ e ^ S ^ 1 n d ic L ta ^ ° ' 'Z ^ MSD, such

'drv1ce1and“ hfvSth®a,rhaw ^ ^

- sr.sr 'ss r&s '.rconsignments shall be recovered from the supplier ^ * clear/store/receive such

Delivery Requirements

24. ^1 items shall be supplied as per the latest/final delivery schedule

(L/C, DP, TT, etc). Any deviation from this delivery.

« a . ,s denvarsd a „ . toe due de,.e^?a£ o T r iX ^ iJ ^ v i r

. communicated to the supplier, ciginal schedule in the Indent/PO

agreed delivery s c h e d u ta M X ? e a te d '? s T X 'u lte d

S e " t o ® Z e X l X '» S t o e r ".o ^®™9 pcin, asf c h a l , he avolded nless ctoe:L^r:X ":rh :rg?a :.ed^7 r^^^^

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 8: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

,e. Defaulted oons,n.entsw i. respeot.o ^ ^ ^ ^ ^ ^

' S " e « v 1 r S ' ffter t U grace period shall be considered for acceptance subject to a penalty to the supplier as described below ,

delivery schedules.(b). When the delay exceeds 60days MSD^ese^e^the righrl^r^cove^r liquidatedsS ,S S ”3 S K ! r s s r ' - ■

SSSS/mttetotrfsuppleroHhVc^^^^^^^28. in respect of local manufacturers/ local ^ ^ ^ S e ^ " y e T r m ^ ^ t i o ^

K£'src»rjr«s;S'Sir..(regarding defaulted consignment) of the conditions of supply. , „ the same dav

29. The extension of L/C’s overstepping delivery ^hedules^^^^^ (regarding

^ e S e ro n tg rn u r r^ n ro ^ 'I r rZ r lS addLnal costs/llguldated damages, relating/consequent to extension of L/C

borne by the supplier.

Documents & Information

32. one of the tender samples of '? f "The'co'^n'men^ recifved unde®r the indentff>0.(applicable for all surgical items and

regular category of laboratory items when box/shipper carton, that

I^TsTer.^^ r.;rd'?atNng"=nrshararbe provided wibrin 14 days ofreleasing the indent by SPC.

RhioDino documents to (Including Bills of Lading / Draft Air Way Bills_...r.n.. Cl ih m it nil

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 9: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

supply on the hd ln t/po" sh^lTetfpdated manufacturing &

Common conditions

exclusions or addiWonsTo the^same ftated^in thTcover^''^V specific amendments,relevant conditions as per the tender document ilsuedTvTpc fr^ °specific; new conditions or amendments to General Order^rn^’n t aPPl'cable. The order/item list Itself and as a remark entry in the MSMIS^order L o rd s .^ ^

paoteg S p o r. supply or delayed deliver as per

Regulatory Authority/Sri Lanka SPC poration, MSD, Medical Supplies Division/Ministry of Health-Sri Lanka. '

Special Condit-inns fo r Bidriinq ■

: state Pharmaceuticals

2. Offered item should bear our SR number

compared as

tender document in " *“ S“ '»>'«sion ot Tenders" of the

separately S a e'fchItel^Tn'lddWon'to ?uoted°*&™prire'^T^e vdume each item should be given in cubic meters ( m ^ ^

' S^S3S3?" “ '''Syff iq e n t quantity Pf .SamplM shniliri he fo ivm rri.H fa - ^ . . i

receipt to be obtained

uation

10. Bid should be valid till 31.03.20io.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 10: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

. d submitted Should be duly signed and e n d o . e d b ^ ^ ^ ^

name and designation of the ^ letter^of authorization and power of attorney (ifoffers on behalf of their submit documentary proof on their registration

03(where applicable).

reQUir6ment will b6 claimed from the supplier.

. . ... bid is administered by the provisions raster'himself" -h °e . . . contact a. and produce such

valid original certificate of registration with the bid. ico ctoraoe

- s.=r»=r=ss K7»ssr3£ “‘‘ !Sri2SSrS”,,S:K!SS.1ir!.S.^^

LTolTn waiver cerdficate issued by Ceylon Shipping Corporabon

or their Authorized Agent in the Supplier's Country.

11. The

full set of copy document to SPC at least 3

14. This

of item on msSn^s " e tetel " d “ iterStc^dsjM iorB^^^ Snd stul2 ° b ^ X i t t " v a . i d up to 30.04.2019 together with the tender.

19. SPC reserves the right to reject offers which do not comply with above conditions.

Please refer Global Bid DocumentB: Global Tender - Bid Document for Pharmaceutical DPC

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 11: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

procurement NOTICEj^GLOB^STATE PHARMACEUTICALS CORPORATION OF SRI LANKA

of Sri Lanka will

Item Description Non-Date of issue of Bidding Documents

from21.08.2018”

CiosingDate

&Time

refundabie Bid Fee

Bid Number

Rs. 3,000/= + Taxes350,000 Capsules ofDHS/P/WW/711/19 02.10.2018 _ _

at 9.00 a.m. Rifampicin Capsules ______ 150mg___________

B,d. Should be prepared as^ r ; " c : u ^ i : f S p S “ u T , N°o75, Sir Baron :aya«,laKe Mawab^a,Colombo 1. ^^e ^

could be purchased on cash payment of a non-refundable Bid Fee per set as mentioned above. Offers

rece?v^' S r e ^ c i ^ M ^ e n t T e ^ are liable to be rejected.

the tender is awarded.All Bids should be accompanied by a Bid Bond as specified in the Bidding Documents.

SHSSfprtfedlob p ^ ^ ^Bidding Documents are being sent to Sri tanka missions abroad and foreign ■ .

CHAIRMAN DEPARTMENTAL PROCUREMENT C O m m E STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

No

missions in Sri Lanka also.

00 94-11- 234408200 94-11- 2326227/[email protected]

FAXTELEPHONEE-MAIL

Chairman- Procurement Entity

CHAmM^^ DEPARTMENTAL PROCUR^ENT^STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 12: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

: DHS/P/WW/711/19DATE OF ISSUE ; 21® AUGUST 2018SLpSlNg DATM n M f ; OCTOBER 20111 AT no nn hours SPT. ORDER LIST NO. 2019/SPr/|y|/R/P/nni^.;SR No.

W104401

ANNEX-1

Item Description/ Snerificatinn

Rifampicin Capsules 150mg --------------------

Rifampicin Capsules BP 150mg.Each capsule to contain 150mg of Rifampicin BP

ORRifampicin Capsuies USP 150mg.Each capsuie to contain 150mg of Rifampicin USP.

Mote:01 .The sheif iife of the product should be minimum of 24

months.

Quantity~350,000Capsules

Delivery350,000 Capsules

-April 2019

Packim : 100 Capsules In a pack__________Page No. 5 Condition No. 5 (Bid Fee) -

in cash to SPC for each set of Tender

Terms and Conditions of Bid/Instructions to Bidder

s .„» . . . u .. .Eaqe No. 9 Terms & Condihnn Mo 14.2 fPaddnn R >nditions1 - be amended to read egfollows:

pacts stuldtroSr tj;frsfoS7Serare f?arrange proper storage for auch X s i Z t ? a t e ^ ^ ‘®chain maintaining cargo. Sri Lankan ambient «?tnrano r. .'. condition No. 31.4 for coidtemperature and 75% +/-5% reiative humidity. ^ conditions are in the ranges of 30°C +/- 2°C

Page No. 36, Conditions of Cnntrart

Condition No. 3 to be amended as Free Replacement/Reimbursement due to quality i Condition No. 3.2 to be amended to read as,

issue.

Samples from the available batches will be retained by SPCauthorized officers in the j----- ' ■ ^following destruction.

the total value concerned as an A d m in i s S c S ^5% °f

presence of Local Agent and a ceS ^^f^ ru rn tfe rb rsp '^^^

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 13: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

N.B.Annex III Agent Commission to be paid the percentage should be clearly indicate in1. IfLoca

B in the columnshould be prominently indicated” in Bid Form (Annex II B of Bidding»sSr<,rorthe n s and the standard

Document)

item

temperature accepted by NWIRA for is not included in the registration

granting registration in the event such informationcertificate. ts -jj-

4. in the event any discrepancy ' " r c u T e S S e m S r a ^ n S ' ; : !

n S r o ^ n S c e s o f Ihe Government of Sri Unka. The former shall supersede.

rnnriitions of Supply:

1. The consignments supplied where applicable,sample submitted and the product mfo mation descnpbons^^^^^^ yr.rr=.rc: ~ i—Purchase Order (PO), issued by SPC.

" s i Orto(PO&TrsPC^^^waiver of registration from NMRA.

3. Maintaining the validity of the lice"ns1ng^arNM^. is a"^re-requisite

period Of supp. « “ V r i e l u S f t c ' S ^ tS ^When the validity of the license, product registration during the year or during the the supplier. A certified copies of afore m supplier when deliveries are made.

15% of the quantity in the consignment.

5. If MSD decides to accept a part or g ® t o , eitherwith regard to labeling/packaging eta) B nr recovering the total cost [a] of rectifyingrectifying the defect within 05 ^ nrovid’ing such services), from the supplier with a.ha dafec by MSD or 2 ^ o, fhe invoiced value,25% surcharge on

; r r o S ^ » : L o n s such as Pacing,mode & be considered as tender violations, to apply penalty (asby the supplier, clause No. 36).

soecifioations of the product offered in the bid, by the supplier shall match with the tender s p e X a to s fo r the item Ind any form of alternate offers will not be entertained.6. The

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 14: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

Shelf life & Warrantees

product, shall ba 86% of the shelf life request^speclfiedh

t “ ns ulab: fa ^ ^ lth f/o n s ^ S S eTupto r""^ 'Jh®Wh "''1 *°.3PP““ «°n of a penalty (as clause No 36 )

c o n s W e re V a s 's e lrs f o r S o a l iiU s"and1“ T o rX ^ ^ ^ ^ Sms."'®Standards & Quality

^ ^ n la C e r a l la L 1 r ,3 a i 'rS m d ® Tn opedfloations,s^S o T rrndar?fptoSr,h°etm

10. W jf^aw ayrom use of items due to quality failure found as manufactum,r's fault

fromTe suw Sr. ™ '‘'® I-®(b). In case of product withdrawal,

from the supplier.

circumstances. ( r S S u s e No 2 ^ ■'"S'otrat.cn granted by NMRA in exceptional

rb id ° " rd e S S roertfy'7e NM^ ac®i‘7d -PpHer must provide withpack details/ccntents/sizes and standard batch quan% feeS ?h “ rcduS

S S ‘7S®'‘7dt7^m7Tampfe® f p Z r 7 PPP-P-.elygovernment/semi-government/accredfed libo rLo^ 'ftf7hp® ^T consignment at aitems, depending availabiKS ^S'sS ® S ° d X I a S T V ^ r slm'pL?^"®'

etc, will be recovered from the supplier. ^ sampling & testing charges

recovered

value of entire product quantity supplied shall be recovered

& Lab is found to be

~m B == ! ~ = ~ S ~raH .-~-H SSS.-~

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 15: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

Pack size. Labeling & Packaging

14. Offers for pack sizes at ® hfghSlevel (larger

, “DHS” mark shall be ;15 In respect of bulk packs (not applicable for blister/strip packs)(a), embossed or printed in case of tablets

NO “ n ^ C a C u l r ( ,? o t|r^ J p ^ — ^M ^aSure,

17. Desoriptipp of the No Date ofr e " r i n ^ S l u I S o s t pack o o n « e minimum unit of nreas «, i «

"p S 'o f in offer shai, be approved by MSD

d DOM & DOE shall consist of at least the year & month.

n ^r rBairNo!"tr ^ ^ ^manner. This may be printed, stenciled or label properly affixed.

-■llrsrb:y^^^nT^Maximum barcode size shall be 5.0cm (length) x 2.5cm (width).

20. In case of receiving goods j|]®PPg P"®j® ^g®otd^o"de?"bTToO^^^^ of thesorted out by MSD to select ‘tern g (including demurrage charges, coldconsignment, all expenses incurred to MSD incurred until goods are ready for

i S a t e f h ^ v e to be'pird t o ^ D by tea local supplier, before attending to checking the

consignment 100% by MSD. ^ as above, such extra™ e ? — : & s » t r l ’c J J e ^ r e S e supplier by SPC and refund to MSD

less than 100,000

16. Each;

an

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 16: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

Storage Conditions & Temperature

clearly indicated at all levels of labels/pa^ckages/boxes.^ conditions shail be

22. Maintenance of Cold Chain-

instructions during storage, transport and deliveiy. according to the manufacturer’s

appropriate colours a"SdSLs7(5?easJ^dem international standard, with

“S £ H : S S ~ = ‘» -« =recovered from the supplier ^ arranging the cold storage shall be

ss“.s;r.!»SE~S“r ““any additional expenses incurred to MS “ and SPC , r C u s t o m lconsignments shall be recovered from the supplier. clear/store/receive such

S)«tf30®c‘2'ao‘' 'L T ° ‘‘’’° ’T '? " ® temperature storage (Eg < 25»c 2-25»c 15

stored items and at 25°c +/- 2°c & 60% +/- 5% rh fnr r « i i ♦ L ■? ^ ° ^the latest report submitted to NMRA or a report issued »thin lastM Je'rJi. ( 4 1 ^ t s e No.TlT

, and

Delivery Requirements

24. All Items sha l be supplied as per the latest/final deiivery scheduie as an amended Indent/PO delivery schedule (if not amended will apply) mutually agreed between MSD& SPC(L/C, DP, TT, etc). Any deviation from this delivery.

3, communicated to the supplier, onginal schedule In the Indent/PO

agreed delivery scheduirsS b rt?elted as aTefa

®^hedule is vioiated by the

thereof, that is delivered afteM h^duf d e S ^ d a te Co '^dr ki consignment in full or part be applied. Condition No. 26 on delayed deliveries, shall

supplier for no fault of

^^ ’ dirPr^Pd ^r® ''^® ^ at Medical Supplies Divisidirected. However sending consignmentsJanuary shall be avoided,deliveries.

or an alternate receiving point asion10thsuch

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 17: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

iff Kssr 5£S r s r4s -to a penalty to the supplier as described below .

-Kstssr s-s ?;,'r=.p:sdefaulted performance. In s^ch a situat - ^ ^ released prior to such c=arasX‘=risis-»»““--»-on

27. (i). If any local purchases were fc S ^ i ' c A h enoncompliance of Indent/PO/its ’. extra expenditure incurred on such localgrace period for delivery from du ^ gl gH j^g recovered from the supplier.

" d X “ d « ■■rpror° lsD Item.

i - o ? " o corresponainp SPC nrain order.

28. In respect of local 't"® receiving

(regarding defaulted consignment) of the c»ndd.ons of pp y.

:uUof“ airaS'':p-eX"^^^^^extension of L/C's overstepping

d e f e u L r L ' S l ' X a n T l y other direct or indirect additional costs/liguidated damages,

relating/consequent to extension of L/C

29. The

30. When adeguate storage space IS not a v a i , a . e ^ ^ ^

(deviating from the delivery “ ^nging temporary external storage and other

r x ^ e " " a : ~ d : ~ ^ ^ storage,^handling cum transport, etc.) shall he

borne by the supplier.

nnriim ents & InformationQR Nn Batch No Date of Manufacture, Date of Expiry and

• p r ^ r a T e r d i t ” “ e.fnraid®in all Supply Invoices and detailed Packing Lists.

32. One of the tender samples ‘ tr®sample (can make it; a part of the jndent/PO (applicable for all surgical items and

I ^ r s T e ^ v : r t ird '^ n g -Z d lln rs h a ll also he provided within 14 days of releasing the indent by SPC.

to (including Bills of Lading / Draft Air Way Bills5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 18: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

supply on the Went/PO?sM b e lp d a tS S ^ k iy throuah ’ ^''^f^cturing &

period (for supplyl, ™ rtS t,h e r s T le ^ " 0Common conditiong

exclusions or addiHonsto the^^saml, Sated' in t h r c o J S a m e n d m e n t s ,p."!rs;sr;-i%:?rr£S'? ““list Itself and as a remark entry in the MSMIS order records included in the order

- .ender conditionpacfo^g a short supply or delayed delivery as per the cabin's,

Special Conditions for Biririin#| ■1. Offers should be accompanied with the valid

National Medicines Authority.

2. Offered item should bear our SR number.

.'tr.srs.rsKsrKdelivery date. ^ surcharge 0.5% of total bid amount per day from the due

offerlare recdvl^'an Impoit&'supJ^tas™fro7lra°iu"'r "®‘ ®«eptable. IfAll local supplie^/^nufactu^rs should quote In LKR for 7 msd ifotS!-

r made on Imports & Supply basis will be compared asComparison of foreign offer and local offe follows.

SSiSSa?f basis both FOB and

eparately against each item in addition to quoted C & Feach Item should be given in cubic meters (m ).

from Administration Department of SPC acknowledgement receipt to be obtainedSuffidient quantity gf Samnlw shoulrl ho for-yaixted for

'• - - e d to the offer.

10. Bid should be valid till 31.03.20iq .

Freight charges should be quoted price. The volume of the total quantity of

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 19: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

11. The bid submitted shouid be duiy by fe^'rra'Stetives submittingname and designation of the . ^ ig^g,. of authorization and power of attorney (ifoffers on behaif of their = submit documentary proof on their registration

. . . = = = « r s r r » - 7 : : : :"■ zsv s"«",~ rir 2-Ss F-SSSssk

S S cettfflLte issued by Ceylon Shipping Corporation

or their Authorized Agent in the Suppiiers Country.uncondidonai Bid Bond -ca^^^e-^dem and to ^

19. SPC resenres the right to reject offers which do not comply with above condrtions.

Please refer Global Bid DocumentB: Global Tender - Bid Document for Pharmaceutical DPC

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 20: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

procurement NOTICEj^GLOB^STATE PHARMACEUTICALS CORPORATION OF SRI LANKA

Non-refundable

Bid Fee

Date of issue of Bidding Documents

from

Item DescriptionCiosing Date

&Time

DHS7P^/710/19| 02.10.2018 ^000’° ° °at 9.00 a.m. Lefiunomide Tablet 10mg

Bid Number

Rs. 3,000/= + Taxes

21.08.2018

Bids should be prepared to ^1500 ^hours'^at the* Statebidders on working days between 0930 hours to ° ^ Mawatha, Colombo 1. These

received without enclosing original payment receipt are liable to be rejecte .

the tender is awarded.accompanied by a Bid Bond as specified in the Bidding Documents.

Bidding Documents are being sent to Sri Lanka missions abroad and foreign missions in Sri Lanka aiso.

CHAIRMAN DEPARTMENTAL P' O UREMENT COMM^E^STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

All Bids should be

00 94-11- 234408200 94-11- 2326227/94-11-2335374pharma.manaaercaispc.lk

FAXTELEPHONEE-MAIL

Chairman- Procurement Entity

C H A m S DEPARTMENTAL PROCUR^ENT^STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 21: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

SR No,01400901

ANNEX-1

________Ite m Pescrip tion/^perifjcatinnQLeflunomide Tablet lOmgLeflunomide 10 mgEach coated tablet to contain lOmg of Leflunomide

Mote:01.The shelf life of the product should be minimum

months

Quantity

T,000,000Tabiets

Delivery500,000 Tabiets

- March 2019

500,000 Tablets - June 2019

of 24

Packim : 1000 Tablets in a bottle______________Page No. 5 Condition No. 5 (Bid Fee) -

^ in cash to SPC for each set of Tender

Terms and Conditions of Bid/Instructions to Bidder

Soppnes O.s,on, Sd U n .a should o f ^ ^

No. 9 Terms & Condition No 14.2 (Packing R gt-nr., roiiows: --------- le/conditions) - to be amended to mad ac

packing shouid indicate°the reputed stor^gelemp^^^^^ conditions. Finai Export

Page No. 36, Conditions of Cnnfrart-

Condition No. 3 to be amended as Free Replacement/Reimb

Condition No. 3.2 to be amended to read as.ursement due to quality issue.

Authority.

authorized officers tn tlie^ preSnS^oTLcal'^Aa^^^^^ baiance will be destroyed byfollowing destruction. ^ ^ certificate of destruction issued by SPC

va“ e1fTh“ q u " ^ ^ ^ ^ -™ ^nrse SPC the totalthe total value concerned as an A d m ln te ta fiv T S withdrawn product with an additional 25% of

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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N.B. Annex 11nt Commission to be paid the percentage shouid be cieariy indicate in

1. If Local AgeB in the column

(Annex II B of

3. rcertffleT copy of the Tpea^ rhouw'‘2lt4m°£^^^^

gmlg'^gttrSirn't rtereS^inform ltion is not inciuded in the registration

certificate.

4. in the event any discrepancy ^ ^ - r c u T e ^ ^ u r e l r tS :^J?m ;m "c?ra " t s S^IKe Government of Sri Lanka. The former shali supersede.

Conditions ofSupplv_:

1. The consignments supplied in respect where applicable,sample submitted and the product information descnp^ns s ^ yrisr-iars rs“ rj-txai,Purchase Order (PO), issued by SPC.

waiver of registration from NMRA.

stated in the

3. Maintaining the validity o, the — t^^^

, i _ pmdu. . . rr s ^ u p ; t ? T id » s T a t S Shall be submiUed to MSP by thesupplier when deliveries are made.

15% of the quantity in the consignment.

5. If MSD decides to accept a part or full consignment, with deviations^^

with regard to labeling/packaging eta) due ^ jpg ^^e total cost [a] of rectifyingrectifying the defect within 05 party pm S n g such s e flL s ). from the supplier with athe defect by MSD (via a duly contracted third pa ^ rgi+ralxO 25) or 2% of the invoiced value, 25% surcharge on the labeling cost, (total charge - [aJ+Lajxu.^o/ or

When the validity of the

such as packing l ^ e i l n ^mods & a o n d i « o . shal^^^^^^^ penalh, (asby the supplier, clause No. 36).

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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Shelf life & Warrantees

remaining fn s'ri‘’S /M fD '-''®

residual sheif life and requeued shdf Itfe haH S m ^r^rh ln^M "'®

« ! t u s ulabt is7er‘r h ™ m S f lT u p ^ r™ ^ 7and will subject to application of a penalty (as clause' No. 36 ) .* ®®"®

c o n s L e V a ^ /m o lr^ f^ ^ S N e m ^ a ^ liS S ^ r ^ S m ^ / r a S ^ Sms."^Standards & Quality

8.

Sri Lan.a are also aocep.ble when no b l d r r e t S S r r d ^ a r ^ r c S ^ ^ ^

" airLrm7nt '7.7L d“ ap7oS; ^ ^ ^10. Withdrawal from use of items due to quality failure found as manufacturer

(a) . In case of batch withdrawal, from the supplier.

(b) . In case of product withdrawal,from the supplier.

ilflJn® above, supplier shall beIWSD, of the quality failed supplies with 25%

information^given by the manufarture^^nd^acceS^h ^ product shall conform to theconform to the information submitted P''°duct registration or shallcircumstances, (refer clause No 23) registration granted by NMRA in exceptional

i rbiddermrn r^'To x :ss zt: ?r r •pack details/contents/sizes and standart batch quantity/size of fhe^mduct

specification.

's fault:value of entire batch quantity supplied shall be recovered

value of entire product quantity supplied shail be recovered

surcharged the total cost involved for administrative surcharge of the same.

“ s-rr.: “ ■« ■»?“ »and entire expenses on such tests like valup nf Q^mn^o I " batches/ lote in the consignment, etc, will be recovered from the supplier. ^ sampling & testing charges.

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o.nU Labeling & Packaging

14. Offers for pack sizes at a loweritem description/specification and ^SD order t otherwise offered with the original bid

S'SS.’SS.’S S S —rST.15 In respect of bulk packs (not applicable for blister/strip packs)

(a) , embossed or printed in case of tablets(b) . printed in case of capsules auantitv in the purchase order is less than 100,000

S s / S p s l ° s , (?ny S J ^ io n s to'this condition, is notiflod in the relevant MSD order hs.

Date of Expiry and STATE LOGO jg* gf gxpiry & date of Manufacture (in any form

17. Description of srLankTGovernmenUhL'n'b^^^^^^^“c ^ S om rindtduIk^nnerm os. pack containing the minimum unit of — , .nciudmg

Dat o r M a « potrDTof°Exp1^ m .he offer shaii be approved by MSDand DOM & DOE shall consist of at least the year & month.

manner. This may be printed, stenciled or label properly affixed.

'• ssi:rh5» ,2-" a'j sssMaximum barcode size shall be 5.0cm (length) x 2.5cm (width).

20. In case of receiving goods ’?(J5^d l5rcler°"b^^ che^cking/handling of thesorted out by MSD to select the items n demurrage charges, cold

5 S i o 4 ' baTd%o*MSD ^ th ^ s ^ p ^ L rb e to a adanrg loT hX ' the

“DHS” mark shall be ;

Barcoded (in Code 128 or 2D formats) and, conforming to the

it as above, such extra

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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storage Conditions & Temperatnro

storage coSoiS ,thal"ra^^^^ NMRA accepted30 c +/- 2“c temperature and 75% +/-5% relative humiditv The* ’° ? 8 f “ iii'tions in the ranges of clearly indicated at all levels of labels/package^oxe™ conditions shall be

22. Maintenance of Cold Chain-

included for M c h S n ^ a iT th e S id chain s*hallte^^^ rerarding devices) shall beinstructions during storage, transport and delivery ^ according to the manufacturer’s

' alSro^rLfo S l “ f s L ' s 7 o T S ^ ^ ^ »■«’USB Devices for temperature data f o o a ^ ^ cold cargo. Supplier shall use standardized data logger readers &/ e X a r f f re a d ^ n c charge,department of SPC in advance to enableLa^rSninafhP^.!I^•^'^‘‘ ' Windows-07/latest) to wharf before taking over the consignment by MSD. ^ maintenance of cold chain in transit

^onsi^g°rIL''?trsharL'^ejecteTln^^^^^^ the consignments by MSD. suchdelivery documents, in suS an even the SPrshJ^I - J n "consignment untii ‘observed coid chain break’ is inve^inptPH?^H- storage for theof consignment and the expenses born by MSD / SPcIn ^recovered from the supplier. ^ arranging the cold storage shall be

devices and the v X e X l l havrNMRA apprw^^^ temperature monitoring

consignments shall be recovered from the supplier. ’ clear/store/receive

^ ^ ■ 2 o S T 2 ° 8 o r e t / ! ‘’ ‘‘ ‘''’‘ f temperature storage (Eg < 26»c 2-25“c 15

invm^^^f'the%?n'^g>nS'^;t' K d u rs S ^ ^ ^ ^ ^ ^stored items and at 25»c +/- 2»c & 60% 1^5% rh f t r 'n w T ° the latest report submitted to NMRA or a report issued within la ro s yla,?). rS J^fous I N c T i?

, and

such

Delivery Requirempntg

s' ara^fn^ fo Z K 7 e C tc S " ( r ; n o1'renl "**'' ' T T "* “ ' ‘' *°Will apply) mutually agreed between MSD & SPC a? thp 2m ’ f edule in the Indent/POs£? "■ »>-*■-. i~ iSi“ 5:,iis!ri2.=i.sContravening the above directions MSD/SPC/MOH and in thereof, be applied.

the event Ms2d dPHH.^ schedule is violated by the supplier for no fault ofasis?.; s "K rarjiraHirprJ delivered at Medical Supplies Divisiondirected. However sending consignmentsJanuary shall be avoided, unless deliveries. otherwisc^?';'’pp®l‘(®:i‘’ btrgramed b y ^ s / f r " " "such

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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C o : s l " S * e r e d Ster .ha? grace pehod shall be considered for acceptance sub,act

to a penalty to the supplier as described below;

26. De

delivery schedules.

■"ss:^fe=~ill be considered as automatically cancelled, the right to recover liquidated

released prior to such a

l S a n t S , “S S Amended

- r L t S r o f ^ r ^ e v » r n o r k sba l be recovered from .e supplierdelivery defaulted (vtolattng detivery schedule In the

an urgen. local P-="d?o^tpry"he°tosafpu-hase order at ^the cost difference will be

(11). If aagent, who participate in Quoting the same product or any similar product Lded^ cost of the defaulted SPC main order. In of theset off from the payments to the supplier of the corresponding SPC mam o

same,

28. In respect of local manufacturers/ local the receiving

(regarding defaulted consignment) of the conditions of supply.

su \jT c tfsT S alt cra^ge^^^rof E by^e supplier.

29. The extension of UC's 26 (regarding

L r u ? a r L " t s r - n ^ ^ ^ ^ dlrac' or mdlreci additional costsdiguldated damages, relating/consequent to extension of L/C

r ,“ '=snr-— »»««> «■borne by the supplier.

nocuments & Information

32. one Of me tender samples Of the selectedsample (can make it, a part of '^s g ^/pQ (applicable for all surgical items and

3iT. rri K™"=r*.r zreleasing the indent by SPC.

Hncludinq Bills of Lading / Draft Air Way Bills.1___ - I I -UirvrvSnn H r ir i im f in t s tO

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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supply on the h d e n V P O ^S be updated ° t manufacturing &SHSEs?sif:::rz.:rCommon conditinns

exclusions or addlonsTo the same ^tated'^in specific amendments,relevant conditions as per the tender te ^ m a r t is s u e X s P C ^re 1 * ’" I " ' 'specific; new conditions or amendments to Generai n r Z r ^ The order/itemlist itself and as a remark e n t^ J ^ re

'® “ rrc re S e tfe t’t5Tuppi: r pondltlonpacld^g a short supply or delayed deliver as per tKe c a L ^ t t ' ^ c l s I o m T e f N o "

order

Special Conditions fo r Bidding !

State Pharmaceuticals

' SC“-s^i'ts'r.“szrs'=roS.“rK;2. Offered item should bear our SR number.

f ‘P to the delivery schedule due towould r^ u lt in the supplier being surcharge 0.5% of total delivery date.

no fault of the SPC/Ministry bid amount per day from the due

offers are rereit!Sd m Im p o it^ & \u p ^ "ta s 'ls ft^ °S l^ s u M n e re "h* "At. toca, suppne,s/manufac.„.m sSSu'ld

S l l 3 " “ " “ “ P '^ '' " ’P"® ®" ' " " ’•■TS1 Supply basi s Will be compared as

" S iS S a?

from Administraflon Depaitm U o^SPC acknowledgement receipt to be obtainedSuffic ien t quantity o f Sap ip lw should be thrwarH..^ fa ,

are not acceptable. Submission of Tenders" of the

'■ tP « ® Offer.

9. Procurement Committee has the authority to decide whether ore-shinm^nf/ samples to be tested. In such cases the supplier will have to bear the cost^ ^

10. Bid should be valid t i l l 31.03.20 iq .

pre delivery/post delivery of testing samples.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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(where applicable).

”'E c S = := = r -=•-.»«-.«requirement will be claimed from the supplier.

”' 5 S :S " H =rSS1rH “E"SSi“s;valid original certificate of registration with the bid.

16. 5,e"Si? li™2dt's'sho^* d T L lS le " . fTSc"'

17. All shipments should be made Sse7?f°the Ceylonchartered by CSC. Shipments on chinmpnt or if thev are not available for time by shipment ofL T i n waiver carflflcate issued by Ceylon Shipping Corporabon

or their Authorized Agent in the Supplier's Country.

be submitted with valid up to 30.04.2019 together with the tender.

19. SPC reserves the right to reject offers which do not comply with above conditions.

full set of copy document to SPC at least 3

your

Loading

Please refer Global Bid DocumentB; Global Tender - Bid Document for Pharmaceutical DPC

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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- GLOBALprocurement notice' STATE PHARMACEUTICALS CORPORATION OF SRI LANKA

Pharmaceuticals Corporation of Sri Lankf will t of Health Services for year 2019.

Non-refundable

Bid Fee

Date of issue of Bidding Documents

from21.08.2018“

Item DescriptionClosing Date

&Time

DHS/P/WW/712/I9I 02.10.2018 I 120,000 Tablets ofat 9.00 a.m. Pyrazinamide Tablet __________ 500mg___________

Bids Should he prepared - iculars give^bidders on working days between 0930 hours “ javatiliake Mawatha, Colombo 1. These

S e " s ^ d ° r i l ^ t m e n ^ o f a noh refu Bid Fee per set as mentioned above. Offers

received without enclosing originai payment receipt are liabie to be rejected.

Bid Number

Rs. 3,000/= + Taxes

the tender is awarded.

All Bids should be accompanied by a Bid Bond as specified in the Bidding Documents.

or may be personaliy deposited in the box the mezzanine floor of the StateS r S S 135122*™, ™s. L.-.

on the

missions in Sri Lanka also.Bidding Documents are being sent to Sri Lanka missions abroad and foreign

CHAIRMAN DEPARTMENTAL PROCUREMENT COMMITTEE STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON 3AYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

00 94-11- 234408200 94-11- 2326227/[email protected]

FAXTELEPHONEE-MAIL

Chairman- Procurement Entity

S aIRMAN DEPARTMENTAL PROCUREME ^ ^ST/ TE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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tender no.DATE OF ISSUE CLOSING HATF

ANNEX-1: DHS/P/W W /712/19: 21®T a u g u s t 2018

OCTOBER 2018 AT no I ORDER LIST Nn ■>nt9 /S P C /N /R /p /o n n i;

Itgm DescripHon/Specifirqtion Pyrazinamide Tablet SOOmg ------------

Pyrazinamide Tablets BP SOOmg Each tablet to contain SOOmg of Pyrazinamide BP.Tablet also should conform to dissolution test for Pyrazinamide tablets as per USP

ORPyrazinamide Tablets USP SOOmg Each tablet to contain SOOmg of Pyrazinamide USP.

Note;01 .The shelf life of the product should be minimum of

24 months.

--------------[Packing ; IQQ Tablets in a boltle______________

Page No. 5 Condition No. 5 (Bid Fee) -

^ ^ in cash to SPC for each set of Tender

Terms and Conditions of Bid/Instructions to Bidder

uppl.es be from fresh ^ooks manufactured recently conforming to the stipulated specifications

Supplies Oivision, Sd Lanka shcuid b e X " t Z a s % =

^ ^ ’ ^P^cklna «,

packing should indicate°the requM^stor^ge^tempetalure for conditions. Final Export

temperature and 75% +1-5% reiative humidity.

Page No. 36, Conditions of Cnntrari-

Condition No. 3 to be amended as Free Replacement/Reimbursement due to quality issue.Condition No. 3.2 to be amended to read as,

S ? " “ e7“b“ “

a®Z;rzei™;<^m“ restcro f^ niance wii, be destroyed byfollowing destruction ^ certificate of destruction issued by SPC

'.'1,''.®®® withdrawals due to quality faiiure the sunniipr «hn, ,ih

SR.No,

1)0104301 Quantity120,000Tabiets

DeliveryT20,000 Tablets

-April 2019

and shelf life in Annex 1.

- to be amended to read as

31.4 for cold conditions are in the ranges of 30°C +/- 2°C

s authorized personnei at an expert committee appointed by the relevant

r^ lrv » K i C *r^ /^ J.I__ j.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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Local Agenl Commission to be paid the percentage should be clearly indicate In Annex II

B in the columnItem Should be P— «y» e s X C r t h e t e r n 's and the standard’’ in

Document)

3. A certified »PV 2Hfo rstee 74 te rs"hou7dS m T ^'S w rr^^^ /Commissioner of Oaths or Justice ot Keace snouiu accepted by NMRA for

S / ^ g S o n t Se'rS"ruc'h""inform Sion is not included in the registration

4. in

rnnditions ofSuPPlV_i

Purchase Order (PO), issued by SPC.

waiver of registration from NMRA.

supplier when deliveries are made.

15% of the quantity in the consignment.

5. if MSD decides to accept a part or full ccnsignmenL w „ ^

25% surcharge on the labeling cost, (total charge - [aj ■ )

clause No. 36).

6 The SDecifioations of the product offered in the bid, by the supplier shall match with the tender ■ specfflcations for the item and any form of alternate offers will not be entertained.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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Shelf life & Warrantees

7.

TrlTeofome t e i n ord^rds"nt/?SI Pf w® '■equested shelf life equal or more than 24 months

residual shelf life and requested shelf life, shall not be more than 04 any deficit between themonths.

sSlS£ESirzS"~rnr^stiKs, : e - - -Standards & Quality

be

10. Withdrawal from use of items due to quaiity failure found as manufacturer's fault'

^ from the suM er^^^^ 'IPPPatV suPPitod(b). In case of product withdrawal,

from the supplier.

M S D ^ r S a n a m jiv l a’’ sproharged the total cost involved for. e quality failed supplies with 25% administrative surcharge of the same.

shall be recovered

value of entire product quantity supplied shall be recovered

olroumTtanoes (m rc tT e “ "or shall

by NMRA in exceptional

' " S ' t i ' e " m n d o m ® L f h“ ®°- " ' f subjected to testing appropriately

govemment/semi-government/ac^SdNed l ib o S 'to ^ ! ( to 'b e ^ S L ly ^ p p L d T o T 'lu r S i ' u b^ound to be

and entire expenses on such tests, like value of samples, transport etc, will be recovered from the supplier. ^

consignment, , sampling & testing charges.

13. Consrgnments supplied to MSD violating the storage conditions indicated on pmduct labels and/or

duJ^ rafflcted r NMRA), shall be considered asMS d e t e r t l ^ n n ,™ assurance of such consignments shall be carried out byp t delivery testing at government / semi government laboratory in Sri Lanka or at an accreditedbv lh T ° '^ (^fagn/local). All the expenses on such an event, including storage cost shall be borneclause consignment will be treated as quality failed (as

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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Park size. Labeling & Packaging

14. Offers for pack sizes at ^description/specification and order Us otherwise offered with the original biditem

“DHS” mark shall be ;15. In respect of bulk packs (not applicable for blister/strip packs)

(a) embossed or printed in case of tablets

as "Year & Month" or "No Exp.’ ), in the innermost pack and supplier s invoice.

17.Desonp«onoftheltem SRNo D ^ o fM ^

r in ^S — S p * c e n t a l minimum unit o, ^

"of "orJanuireTootroTd DOM & DOE shall consist of at least the year & month.an

'• « £ r3 S 2 S H iS ~ " - =industry standards in Barcode printing and pasting

= ^ C o o S I ^ ^ e 1 ^ 1 m ^ ; :n f ) x 2 tm ,width).Maximum

20. In case of receiving goods { " ^ P P ^ ' in ' fo d ^ o r d ^ ’ " b T ° O o f ch^^^ of ‘he

r f n T h a J lt ^ p r^ M S P ?vVe‘t a » " “f ^ e attend ‘o checking the

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

Page 34: SİRKÜLER (G-2018)oaib.org.tr/tr/sirkuler-2018-23330.pdf · produot/manufaoturing licenses and registrations of j W f ^ license, product registration and GMP sctd™^^ by r s2p:,in^

Storage Conditions & Temperature

product S°ri S a n specification. NMRA accepted30 c +/- 2°c temperature and 75% +1-5% reiative humiriih storage conditions in the ranges of cleariy indicated at all levels of labels/patkaSste^^^^^ " “ Editions shall be

22. Maintenance of Cold Chain-

instructions during storage, transport and delivl^ry according to the manufacturer’s

“SS3HSSsE=v-“ “s."issH“T-“ •■1“ ^before taking over the consignment by MSD ^ maintenance of cold chain in transit, and

7Z«rr",tr,”r.t"LV£5:s'"ii^r,^^recovered from the supplier ^ arranging the cold storage shall be

during weekends, during which MSD stores is ciosed In r demurrage & storage chargesany additional expenses incurred to MSD Lnd^SPC to Custom T a r i f f “ 7 '’ '®“ '’ ' ’ '*'°"'consignments shall be recovered from the supplier clear/store/reoeive such

^ ^ '2 X » c * 2 ° a o 7 ® ,T ‘'‘'° ‘f ’T ' ! ' " ® dontrolled temperature storage (Eg. < 25»c 2-25”c 15

KsrssK 2r„r .. It shall be a true copy ofreport issued within last 05 years), (refer clause No.11)

Delivery Requirements

arame“ d1nZ ro?e iK hS 7rn "ren t^^^

MSD/STOMOH^n^In f t ? elrert’ MSD 2 d d i ® '''°'®*®d by the supplier for no fault of

™ a t IS d e .e re "d ^ L r d7?? “ S o n « o ^ ^ S ^ v I l ^ s ^ S

direde"d®Z:?efsrdftf S n l T , ^ I -®™ 3 P«' asfe s h a l i be avoided, uniessotherwise ^ tp re U r^b ^ rg rte ^^T r/D f7r such

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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to a penalty to the supplier as described below ;

delivery schedules.

dan?ages or to revoke the cancellation (eg. if payments have been released prior to such a cancellation), and accept the consignment subject to a 25/o admin surcharge.

on

27 (i) If any local purchases were to be made by MSD/SPC to ensure continuity of supply (due to ' noncompliance Sf Indent/PO/its’ amended; delivery schedule): in the ensuing period g?ace period for delivery from due delivery date, extra expenditure -ncurred on such ^ purchases, over the landed cost of relevant SPC main order, shall be recovered from the supplier.

(ii) If a delivery defaulted (violating delivery schedule in the Itim'agent, who participate in an urgent local purchase tender of SPC or MSDquoting the same product or any similar product, is bound to suppiy the locallanded cost of the defaulted SPC main order. In violations of the same, the cost difference will beset off from the payments to the supplier of the corresponding SPC main order.

28 In respect of local manufacturers/ local suppliers, all deliveries shaH beexcluding public holidays, also allowing adequate time to enable the completion ^® ^®®® ^ orocess at MSD stores before 3.30 p.m. In the event of failure to meet this deadline due to Lpplier’s fault (eg. In delivery: time, product, document, etc.) goods shall be accepted on the folSwing working day, such date shall be counted for working out penalties as per No. 26 (regarding defaulted consignment) of the conditions of supply.As an alternative, supplier can request MSD to take over the consignment on the same day, subject to settling ali adl. expenses (i.e. staff OT, forklift charge, etc.) of MSD. by the supplier.

shall not29. The extension of L/C’s overstepping delivery schedules in thein any way affect the recovery of late delivery charges, as per Conditon No. 26 (regarding defaulted consignments) and any other direct or indirect additional costs/liquidated damages, relating/consequent to extension of L/C

30 When adequate storage space is not available at MSD, to accept a delivery defaulted consignment (deviating from the delivery schedule in the Indent/PO/its' amendments) under the condition No 26, any additional expenses caused to MSD or SPC in arranging temporary external storage and o her expenses (eg. demurrage, detention, container storage, re-handling cum transport, etc.) shall be

borne by the supplier.

Documents & Information

31. MSD order No, Item Description, SR No, Batch No., Date of " " "shall be indicated in all Supply Invoices and detailed Packing Lists.product Storage Condition

32 One of the tender samples of the selected bid shall be forwarded to MSD, for using as a reference sample (can make it; a part of the last consignment or a returnable to supplier) for checking the conformity of the consignments received under the indent/PO.(appiicable for all surgical items and regular category of laboratory items, when specified in respective order lists).The images of the; specimen labels, minimum pack and outer most bo)^shipper jarton that satisfies the above mentioned labeling conditions, shall also be provided within 14 days of releasing the indent by SPC.

33. The supplier shall submit all shipping documents to (Including Bills of 'WebsiteRPC Imoorts department and MSD by e-mail (follow instructions m website

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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the supplier.( follow instructions in the website www.msd.gov.lk) ^ ^Complied Of the information so provided are found to be incomplete/false the orace

period (for supply delays) mentioned in the clause 26 will not be applicable. ’ ^

Common conditions

i x o to n s or ° [ f S'’-'' 8™ " item/order-list specific amendments,exclusions or additions to the same, stated in the covering letter of the order list and any other

P®*" tender document issued by SPC, are also applicable. The order/itemnS amendments to General Order Conditions, will be included in the orderlist itself and as a remark entry in the MSMIS order records.

25/o(on the value of goods), will be applied for tender conditiono a ^ k m l short standards & specifications, short0^0^? 9 ^ decision, (eg. As in conditions No.

Abbreviations ; National Medicines Regulatory Authority/Sri Lanka, SPC ; State PharmaceuticalsCorporation, MSD; Medical Supplies Division/Ministry of Health-Sri Lanka.

Special Conditions for Bidding :

1. Offers should be accompanied with the valid registration certificate (Notary Certified) issued by theS h o lity Regulatory Authority in Sri Lanka formerly Cosmetic Devices and Drugs

2. Offered item should bear our SR number.

3. I f awarded supplier is unable to adhere to the delivery schedule due to no fault of the SPC/MinistrydeTJery^dlte surcharge 0.5% of total bid amount per day from the due

4. Foreign offers should be on C & F (CPT/CFR) Colombo basis. FOB offers are not acceptable. IfA n !o L T L S !Z ! / ^ Supply basis from local suppliers, those offers should be in LKR.All local suppliers/manufacturers should quote in LKR for the total delivery price to MSD stores.

folEws"*°" Imports & Supply basis will be compared as

Local offers which are for Import & Supply basis will be divided by a hypothetical value for comparison of offers against C & F value based on the HS Code of the item as determined by

“'I!®?''' Pharmaceuticals Corporation are not acceptable.fonH T ® ®'‘® '■®'!"®!‘®‘* ‘•'■aw their attention to the clause "Submission of Tenders" of thetender document in this regard.

6. I f the shipment is being effected-4 . u Freight charges should be quotedseparately against each item in addition to quoted C & F price. The volume of the total quantity of each Item should be given in cubic meters (m^).

on

7. Representative samples in respect of items offered should be submitted to reach SPC on or beforeofVpc** acknowledgement receipt to be obtained

Sufficient quantity of Samples should be forwarded for evaluation

8. The original payment receipt for purchasing the bidding document has to be annexed to the offer Offers without same will be rejected.

authority to decide whether pre-shipment/ pre deiivery/post delivery sampies to be tested. In such cases the suppiier will have to bear the cost of testing samples.

10. Bid should be valid till 31.03.2019.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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name

- Sri Lanka(where applicable).

S n tr KsrthTCS «-

■is:=3s~i?ss?s"' Si'=K'Sr£SS ruSS2?S XS'””

lS : S S r S £ S v “5 S™ ^iSsisss:r.“s z 3 £ S K » £ '" “u" '^^°'^^'t'onal Bid Bond encashable on demand to the value of 2%i ss-sssr s s r s s = 5 .r - ss

19. SPC reserves the right to reject offers which do not comply with above conditions.

comply with this

at transit also and storage

Please refer Global Bid DocumentB: Global Tender - Bid Document for Pharmaceutical DPC

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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SAGLIK BAKANLIGINA TARIM VE ORMAN BAKANLIGINA TiCARET BAKANLIGINA ULA§TIRMA VE ALTYAPI BAKANLIGINASAMSUN VALlLlGl YATIRIMIZLEME VE KOORDiNASYON BA§KANLIGINA SAMSUN TARIM VE ORMAN iL mudurluguneSAMSUN BUYUK§EHiR BELEDIYEBA§KANLIGINAMAHALLi iDARELERSamsun(Tekkekoy Belediye Ba§kanligi)

"Bu beige, guvenli elektronik imza lie imzalanmistir."________________Mustafa Kemal Mahallesi Dumlupmar Bulvan Eskijehir Yolu 2151.Cadde No:154 06510 qiankaya/ANKARA S 03122015913H [email protected]

EiiCTicmp www.sanavi.eov.tr

Bilgi i?in Irtibat: Bulent AYAN-Muhendis

S 312 201 58 23 a www.sanayi.gov.tr

adresindeki e-hizmetler bOlumtlnden,evrak tarihi ile"ivozglF75348" DYS No ve

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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PROCUREMENT NOTICE - GLOBALL S P C j

STATE PHARMACEUTICALS CORPORATION OF SRI LANKA

The Chairman, Procurement Committee of the State Pharmaceufirals Corporation of Sri Lanka will receive sealed bids for supply of following item to the Department of Health Services.

Item Description Non-refundable Bid

Date of issuing ofClosing

Date&Time

Bid NumberFeeBidLKRDocuments

20,000/- + taxes21.08.2018Surgical Non Consumables03.10.2018 At 9.00 am

DHS/SUS/WW/176/19

Mawatha Colombo 1 These could be purchased on cash payment of a non-refundable Bidding document Fee per set as mentioned above. Offers received without enclosing original payment receipt are liable to berejected.

Wherever r^ul^ r rtt reg'S md rS;of 1987 before tender is awarded.

All Bids should be accompanied by a Bid Bond as specified in the Bidding Documents.

Corporation at No. 75, Sir Baron Jayatillake Mawatha, Colombo 1, Sri Lanka,

representatives will be permitted to be present at the time of opening of Bids.

Bidding Documents are being sent to Sri Lanka missions abroad and foreign missions in Sri Lanka.

CHAIRMAN- DEPARTMENTAL PROCUREMENT COMMITTEE STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

00 94-11- 2335008 : [email protected]

TEL/FAXE-MAIL

Chairman- Procurement EntityOnbehaifof __ _CHAIRMAN- DEPARTMENTAL PROCUREMENT COMMITTEE STATE PHARMACEUTICALS CORPORATION OF SRI LANKA 75, SIR BARON JAYATILLAKE MAWATHA COLOMBO 1 SRI LANKA.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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-ANNEX'- lABID NO.

DATE OF ISSUE: DHS/SUS/WW /176/19: a u g u s t 2018

C L O S I N G D A T E & T I M E : 0 3 * ^ O C T O B E R 2 0 1 8 A T 09.00 HOURS SRI LANKA TTMFSpecial Conditions for tendering :1. Offers should be accompanied with the vaiid registration certificate

Reguiatory Authority in Sri Lanka issued by the IMationai Medicine

2. Offered item should bear both our SR number and the Item number. However at the bid ooenino onlv the Item numbers wiil be read out. Therefore price quoted should be shown against each item number ^

c™ ^The volume of the total quantity of each item should be given in cubic meters (m )

5. Foreign offers should be on C & F (CPT/CFR) Colombo basis. FOB offers are not acceptable. I f Aiftn* received on Import & Supply basis from local suppliers, those offers should be in LKR All local suppliers/manufacturers should quote in LKR for the total delivery price to MSD stores.

6. Fax/E-mail offers directly sent to State Pharmaceuticals Corporation are not acceptablein *“ of Bids" of Uio bid

4.

The original payment receipt has to be annexed to the offer. Offers without same will be rejected.

9. We reserve the right to reject offers which do not comply above.

10. The offer should be valid up to 01.04.2019

(Annexure - I I I )

GENERAL CONDITIONS OF SUPPt.Y FOR SPC ORnKRS -AoplicaHo fnr Consumables ----------------- ^

would result

8.

General fProduct & Consignments)

PurZe OrflffO), '

2. All items shall be supplied, sourcing from the manufacturer and country of manufacturer, stated in the

registration during the period of supply(delivery schedule),f o r ^ f u Z r n f ' "'^''^f^^'ture licensing at NMRA, is a pre-requisiten rL ? surgical, pharmaceutical and relevant laboratory items. Hence all suppliers shallproduce relevant valid registration certificates/licenses, when requested by MSD/SPC.

When the validity of the product/mannfaeturing licenses and registrations of NMRA (eg-r “® . f “ <1 OMP certificates), of local mannfactnrers / loeS

su^hers lapses during the year or during the period of supply (delivery schedule), it shall be extended

MSD by « S t h “n de“ rm ^e'“'°"5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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5 If ViSD decides to accept a part or full consignment, with deviations from certain tender conditions (eg; ■

25% surcharge on the labeling cost, (total charge - [a]+[a]x0.25) or 2% of the mvoieed value,whichever is the highest.

All possible tender deviations such as Packing, labeling, delivery schedule, storage status, payment mode & conditions, etc., shall be communicated and agreed upon before aceeptmg the tender award by the supplier. Noncompliance of same shall be considered as tender violations, to apply penalty(asclause No. 37).

6. The specifications of the produet offered in the bid, by the supplier shall mateh whh the tender specifieations for the item and any form of alternate offers will not be entertained.

Shelf life & Warrantees

providing technical support, repairs & spares, when necessary.

residual shelf life and requested shelf, shall not he more than 04 months. (Not applicable for Surgical Non Consumables)In the violation of the above tender condition. SPC/MSD rcserv^ the right to accept a reduced q^ntity that is usable (as per the consumption rate) up to three months before the expiry of same and will

m r'iheTeinife ^ norsplciM to ftetad^^ spec; the requested shelfconsidered as, 36 months for surgical items and 24 months for pharma. / laboratory items. (Not . applicable for Surgical Non Consumables)

8

In r

Standards & Quality

9. Standards: In addition to Pharmacopoeial Standards that are indicated m the item specifications other Pharmacopoeial Standards that are registered at National Mediemes Regulator Authority in Sn Lanka are also acceptable when no bidders have quoted for the standard specified in the item specification.

10. Any product deficient of its sub eomponents/ aecessories, not at the specified quality standards or all its components not unitized appropriately in paekaging (as a set), shall be rejected.

11. Withdrawal from use of items due to quality failure found as m^ufaeturer’ s fault:(a) . In case of batch withdrawal, value of entire batch quantity supplied shall be recovered from the

(b) .S ^ c ^ ro f product withdrawal, value of entire product quantity supplied shall be recovered fromthe supplier.

1 i 1

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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iz . me storage conaitions ana me paeiang requirements or me proauct snail coniorm to me mrormation

I f the offered product, deviate from NMRA registered product features, supplier must provide with the bid, a declaration to certify the NMRA accepted product details details/contents/sizes and standard batch quantity/size of the product.

such as; storage conditions, pack

13. Immediately after delivery at MSD, the consignments shall be subjected to testing appropriately drawn one random batch sample (Post-delivery sample) of the consignment at a gov'lmment/semft

14. Consignments supplied to MSD violating the storage conditions indicated on product labels and/or product information leaflet (as accepted for product registration at NMRA), shall be considered as quality affected consignments and quality assurance of such consignments shall be carried out by post- delivery testing at government / semi government laboratory in Sri Lanka or at an accredited laboratory (foreign/local). All the expenses on such an event, including storage cost shall be borne by the supplier.If found to be quality affected the consignment will be treated as quality failed (as clause No.l 1).

Pack size. Labeling & Packaging

15. Offers for pack sizes at a lower level(smaller quantity per pack) than the pack size specified in the item descnptio^specification and MSD order List, are also acceptable, but higher level (larger quantity per

16. In respect of bulk packs (not applicable for blister/strip packs), “DHS” mark shall be •(a) , embossed or printed in case of tablets(b) . printed in case of capsules

' ' ' purchase order is less than 100,000

pre-filled syringe or bottle, shall bear the item Description, SRD . . D .

18. Description of the Item, SR No, Date of Manufacture, Date of Expiry, Batch No, Name and address of^ v e ^ n f^ f th d- Government shall be clearly marked on the outercovenng of the mdividual/mnermost pack containing the minimum unit of measure, including blister &S nf ? carton^ox. Any deviations of the Date of Manufacture (DOM)/at le a su S y X & ^onth approved by MSD and DOM & DOE shall consist of

M packages) shall bear the MSD Purchase Order No, SPC Indent No SRNo, Batch No and Date of Expiry in size 1.5cm letters / figures in prominently visible manner. Thfr may be printed, stenciled or label properly affixed.

separately Barcoded (in Code 128 or 2D formats) and Barcode hall be pnnted on the labels at all levels of packing as described below, conforming to the industry

standards m Barcode pnntmg and pasting. ^5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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i i in case oi receiving goons unner inappropnate pacKaging connitionstnot m goon oraer), was to oe sorted out by MSD to select the items in good order by 100% checkin^andling of the consignment a expenses incmred to MSD in such an event (including demurrage charges, Mid stores charge^ l a t e charges etc. or any other charges incuired until goods are ready for acceptance) have to be paid to MSDbv the local supplier, before attending to checking the consignment 100/o, by MSD.In respect of SPC imported supplies, if the local agent does not follow suit as *ove, such extra expenses incurred to MSD shall be recovered from the supplier by SPC and refund to MSD.

stnrapp Conditions & Temperature

22. If the storage temperature & conditions are not specified in the item specifieation NMRA aecepted product storage conditions, shall conform to Sri Lankan ambient storage conditions m the ranges of 30 c +/- 2°c temperature and 75% +/-5% relative humidity. The product storage conditions shall be clearlyindicated at all levels of labels/packages/boxes.

for each carton

b'^'^SuppISlhairuS^^^^^^ prominently visible identification marks of international standard with appropriate colours and sizes for easy identification of cold cargo. SuPPjjer shall use standardized USB Devices for temperature data logging inside the packages and shall P^°^ ® of charge, data logger readers &/ software (reading apps compatible with Wmdows-07/latest) to wharf department of SPC in advance, to enable examining the maintenance of cold chain m transit,and before taking over the consignment by MSD.

c If the cold chain break is observed at the time of taking over the consignments by MSD such consignments shall be rejected, indicating the reason on the relevant WDN or copy of docuLnts. In such an event, the SPC shall arrange necessary cold storage for fte c o m i^ e n t until ‘observed cold chain break’ is investigated leading to acceptance / totd rejection of consignment and the expenses bom by MSD / SPC in arranging the cold storage shall be recovered

d *"Th* v S e s “ transporting cold cargo to MSD shall be equipped with temperature monitoringdevices and the vehicle shall have NMRA approval tor transport of pharmaceuticals.

e The suppliers shall dispatch consignments of the items, which require cold chain maintenance, to arrive to Sri Lanka during Monday to Thursday to avoid additional demuirage & storage charges during weekends, during which MSD stores is closed. In case of non-compliance of tois condihon any additional expenses incurred to MSD and SPC, to Custom elear/store/receive such

signments shall be recovered from the supplier.

24. In respect of the products requiring controlled temperature storage (Eg < 25°c, ^-25^’ 2- 8°c etc) supplier shall provide MSD with latest product stability study reports with the invoice of the e o n » W Shan include studies; at 300e +/- 20e & 75o/o ./- 5% ^ for AC stored i ems ^ d a 250c +/- 20c & 60% +/- 5% RH for Cold stored items. It shall be a true copy of the latest report submitted to NMRA or a report issued within last 05 years), (refer clause No.l2)

con

Delivery Requirements

25 All items shall be supplied as per the latest/final delivery schedule, communicated to the supplier amended Indent/PO delivery schedule (if not amended, original schedule in the I^den mutually agreed between MSD& SPC, at the time of establishing the payment terms (L/C, DP, 11, etc). Any deviation from this agreed delivery schedule shall be treated as a defaulted delivery.Contravening the above directions, if the delivery schedule is violated by the supplier for no fruit of MSD/SPC/MOH and in the event MSD decides to accept any such consignment m foil or part thereof, that is delivered after the due delivery date. Condition No. 27 on delayed delivenes, shall be applied.

, as an

26. All consignments shall be delivered at Medical Supplies Division or an alternate receiving point as— i-oaph Si*i T.nnka from 15*** December to 10th JanuaryJ.*

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./.^e iam tea consig^ents wim respect to aeiivery seneame snaii omy oe eonstagrea tor aeeeptanee, subject to a penalty imposed for the delay due to suppliers fault, allowing a grace period up to two

pr:;:ytoX prrat™^ ^ ^tn consignment value, calculated commencing from the 15th day upI c h e Z e f indent/PO or its’ latest amended delivery

purchase order will be considered as automatically cancelled on r e t v ^ " situation, MSD reserve the right to recover liquidated damages o’r torevoke the cancellation (eg. if payments have been released prior to such a cancellation), and accept the consignment subject to a 25% admin surcharge.

(a).

over the landed cost of relevant SPC main order, shall be recovered from the supplier. ^

(ii). If a delivery defaulted (violating delivery schedule in the indent/PO) SPC supplier/his local agent who participate m an urgent local purchase tender of SPC or MSD for the same item, quoting the same product or any similar product, is bound to supply the local purchase order at the landed cost of the defaulted SPC mam order. In violations of the same, the cost difference will be set off from the payments to the supplier of the corresponding SPC main order.

' i s p H i i lS iconsignment) of the conditions of supply. °

As an alternative, supplier can request MSD to take over the consignment on the same day, subject to settling all adl. expenses (i.e. staff OT, forklift charge, etc.) of MSD, by the supplier.

30. The extension of L/C’s overstepping delivery schedules in the Indent/PO/its’ amendments, shall not in any way affect the recovery of late delivery charges, as per Condition No. 27 (regarding defaultedto eSSSon of UC^""^ "" additional costs/liquidated damages, relating/consequent

31. When adequate storage space is not available at MSD, to accept a delivery defaulted consignment (deviating from the delivery schedule in the Indent/PO/its’ amendments) under the condition No 27 any additional expenses caused to MSD or SPC in arranging temporary external storage and otherexpenses (eg. demurrage, detention, container storage, re-handling cum transport, etc.) shall be borne by the supplier.

Documents & Information

33. One of the tender samples of the selected bid shall be forwarded to MSD, for using as a reference sample (can m ^ e it; a part of the last consignment or a returnable to supplier) for checking the conformity of the consignments received under the indent/PO.(applicable for all surgical items and regular category of laboratory items, when specified in respective order lists).The images of the; specimen labels, minimum pack and outer most box/shipper carton, that satisfies the a W e mentioned labeling conditions, shall also be provided within 14 days of releasing the indent by

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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f omit ail snipping aocuments to (mcmaing tmis or leaning / urart Air way wins etc) SPG Imports department and MSD by e-mail(foi.ow instructions in website ww.msd..ov.ik ), at least 03 daysbefore the Expected Time of Arrival (ETA) of sea freighted consignments & 02 days before the ETA of Air freighted consignments.

35. After releasing the Indent/PO or. X . , establishing L/C, the latest logistical position of manufacturing &supply on the Indent/PO, shall be updated biweekly through e-mails to SPG with a copy to MSD^ by the supplier. ( follow instructions in the website www.msd.gov.lk)If It IS not complied or the information so provided are found to be incomplete/false, the grace period (tor supply delays) mentioned in the clause 27 will not be applieable.

Common conditions36. In addition to the general conditions of supply given herein, item/order-list specific amendments,

exelusions or additions to the same, stated in the eovering letter of the order list and any other relevant conditions as per the tender document issued by SPG, are also applieable. The order/item specific- new eonditions or amendments to General Order Conditions, will be ineluded in the order list itself and as a remark entry in the MSMIS order records.

37. Administrative surcharge of 25%(on the value of goods), will be applied for tender condition violations that cause deficiencies in supply with respect to; quality, standards & specifications, short packing & short supply or delayed delivery as per the cabinet deeision.

Abbreviations :NMRA ; National Medicines Regulatory Authority/Sri Lanka, SPG ; Pharmaceuticals Corporation, MSD; Medical Supplies Division/Ministry ofHealth-Sri Lanka.

Special conditions for Surgical Non Consumable Itema. No. -17, under general condition for Non Consumable item shelf-life is not applicable.b. No. -17, under general condition for Non Consumable- Freshly manufactured product should

be supplied.Warranty document should be address to SPC with a copy to D/MSD and Warranty period is consider from the date of acceptance the consignment by MSD. Each individual items should be included a Warranty card with contact details of authorized local agent. Warranty details/period should be included in label and invoice.

(eg. As in conditions No. 08,05,10,13)

C. -

d.e. Art works and diagrams with dimensions for relevant products with catalog numbers should

be provided, if requested by MSD.f. Usage instruction pamphlet/user manuals in print/pdf/video format should be provided.

(Such instructions should carry details on maintenance, compatibility and storage)g. Provide copy of quotation with catalogue numbers for all article/components including

special instrument sets at the stage of offered item acceptance.h. Further to the condition 33, Tender sample of the selected bid shall be forwarded to MSD to

use as reference sample to check the consignment supplied on the indent/PO.

Abbreviations :NMRA ; National Medicines Regulatory Authority/Sri Lanka, SPG ; State Pharmaceuticals Corporation, MSD; Medical Supplies Division/Ministry o f Health-Sri Lanka.

All tenderers should furnish an unconditional Bid Bond encashable on demand to the value of 2% of Item on instances where the total Tendered Price of item exceeds LKR 1 million. Bid Bond should be submitted with valid up to 01.05.2019 together with the tender

Sufficient quantity of samples should be forwarded for evaluation.

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Soecial Conditions

• Suppliers should submit all shipping documents including the Bili of lading or Air Way Bili to SPC at ieast 2-3 days prior to arrival of the consignments to prevent any delay in clearance.

. In the event of an award made to you on this tender, SPC reserve the right to cancel/suspend the procuring of said order in any stage, if you would be placed the defaulted supplier's list due to quality failure found in your previous supplies made to SPC or non compliance of contractual agreement.

• This bid is administered by the provisions of the "Public Contract Act No. 3 of 1987" and therefore, in the event bidder is to retain an agent, representative, nominee for and on behalf of Bid or shall register himself and such public contact act in accordance with the section 10 of the Public Contract Act and produce such valid original certificate of registration with the bid.

• Where a purchase for a particular item is being made for the first time from a supplier, or where there are previous quality failures on goods supplied by a Particular supplier payments wiil only be made upon testing the quaiity and standards of the goods and comparing the bulk supply with the samples provided along with the offer.

. Destination Terminai Handiing charges (THC) should be borne by the supplier at the Port of Loading. Hence when the C&F prices are quoted this should be inclusive of THC.

• The bid submitted should be duly signed and endorsed by the Bidder/ Tenderer him self (with the name And designation of the signatory) or by the representative. Representatives submit offers on behalf of their principals should submit a ietter of authorization and power of attorney (if signing on behaif of the principals) and also should submit documentary proof on their registration as per the Act. No. 03 of 1987 with the Department of the Registrar of Companies - Sri Lanka.

• In the event of deiivery of consignments deviating from given delivery scheduie by MSD due to default of supplier and same is rejected due lack of storage space available at MSD warehouses, any resulting demurrage charges incurred shail be borne by the suppliers concerned.

• All Shipment should be made exclusively on vessels belonging to the Ceylon Shipping Corporation or those chartered by CSC. Shipments on other vessels will be permitted in instances where vessels of the Ceylon Shipping Corporation do not call at the Port of Shipment or if they are not available for timely shipment of cargo. In which event the supplier should attach a waiver certificate issued by Ceylon Shipping Corporation on their Authorized Agent in the supplier's country.

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.

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#<t

BID NO: D H S /S U S /W W /1 7 6 /1 9 CLOSING ON ; 03 .10 .2018 a t 9.00 a.m.

ORDER LIST NUMBER: 2019/SPC/N/C/S/00358

ITEM SR NO ITEM QTY DELIVERYNO Nos.

1 21200143 Broken screw removal set for 3.5 /4/4.5mm screws in sterilizing tray.

Reduction Forcep set, with all instruments,stainless steel, in aluminium case.

25 -Jan/2019

2 21200212 20 -Jan/2019

3 21208508 Air regulator only,for use with pneumatic hose (compatible with pneumatic hose SR No: 21208509.)

Pneumatic hose only, for use with air regulator (compatible with air regulator SR No; 21208508.)

DCP 1.5mm Instrument Set for Mini Fragments, for 1.5mm dyanamic compression plates (DCP), stainless steel, in sterilizing tray, with 20 implants sets.

22 -Jan/2019

4 21208509 22 -Jan/2019

5 21208602 8 -Jan/2019

6 21208601 DCP 3.5mm Instrument Set for Small Fragments, for 3.5MM dyanamic compression plates (DCP), stainless steel, in sterilizing tray, with 20 implants sets.

8 -Jan/2019

7 21208603 DCP 4.5mm Instrument Set for Large Fragments, for 4.5MM dyanamic compression plates (DCP),stainless steel, in sterilizing tray, with 20 implants sets.

8 -Jan/2019

1

Packing: 1 Nos.

1. Page 9 Condition No. 19.b

Registrar of public contracts

This clause should be amended as awards over Sri Lanka rupees Five Million instead of (LKR) Ten Miiiion.

1. Page 10 Condition No. 20. a

Representative samples in respect of items offered shouid be submitted to reach SPC on or before the ciosing time on the ciosing date of tender and acknowiedgement receipt to be obtained from Administration Department of SPC.

Contract:The successful supplier should agree to enter into a contract/Agreement is applicable normally for awards which are over LKR 500,000.00 instead of 10.0 Million.

Bidding Document Fee- As per the guideline 6.1.1 (a) of the Government Procurement Guidelines 2006.A non refundable fee of Rs.20,000.00 + taxes should be paid in cash to SPC for each set of

Tender Documents

Please refer Global Bid DocumentD; Global Tender - Bid Document for Surgical Items DPC

5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: cd1c3d29-40a8-4cd0-afe6-ae2c6a940288-31688612. Bu kod ile https://evrak.tim.org.tr/evrakdogrulama adresinden doğrulayabilirsiniz.5070 sayılı kanun gereğince güvenli elektronik imza ile imzalanmıştır.ID: 17efa2ad-892c-4831-a038-387f2fc20fe5-32926643. Bu kod ile http://evraktakip.oaib.org.tr adresinden doğrulayabilirsiniz.