guidelines on the international packaging and …...guidelines on the international packaging and...

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DIP 818 4 5 6 7 8

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Guidelines on 10

the international packaging 11

and shipping of vaccines 12 13

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The Department of Essential Medicines and Products 35 thanks the donors whose unspecified financial support 36 has made the production of this publication possible. 37

38 This publication was produced by the 39

Vaccines Assessment Team 40 of the Department of Essential Medicines and Products 41

42 43

Ordering code: WHOEMP- 44 Printed: 2019 45

46 This publication is available on the Internet at: 47

www.who.int/vaccines-documents/ 48 49

Copies may be requested from: 50 World Health Organization 51

Department of Immunization, Vaccines and Biologicals 52 CH-1211 Geneva 27, Switzerland 53

• Fax: + 41 22 791 4227 • Email: [email protected] • 54 55

56 57

© World Health Organization 2019 58 59 60 All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World 61 Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: 62 [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for 63 noncommercial distribution – should be addressed to Marketing and Dissemination, at the above address (fax: +41 22 791 4806; 64 email: [email protected]). 65 The designations employed and the presentation of the material in this publication do not imply the expression of any opinion 66 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its 67 authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines 68 for which there may not yet be full agreement. 69 The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended 70 by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions 71 excepted, the names of proprietary products are distinguished by initial capital letters. 72 All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the 73 published material is being distributed without warranty of any kind, either express or implied. The responsibility for the 74 interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages 75 arising from its use. 76 Printed by the WHO Document Production Services, Geneva, Switzerland 77 78

Revision history: This document, Guidelines on the international packaging and

shipping of vaccines, was first published in 1990. Since then it

has gone through four revisions: in 1995, 1998, 2001

(WHO/V&B/01.05), 2005 and 2017. This revision, produced in xxx 2019, replaces all previous

versions.

mailto:[email protected]

Contents 79

80

Abbreviations 81 82 Glossary 83 84 Preface 85 86 1. Insulated Packaging Standards 87

1.1 Introduction 88 1.2 Temperature Criteria 89 1.2.1 Class A packaging 90 1.2.2 Class B packaging 91 1.2.3 Class C packaging 92

1.3 General Packaging Criteria 93 1.3.1 Insulated Cartons 94 1.3.2 Pallet Shipper & other shipping units 95 96 2. Temperature monitoring devices 97 2.1 Introduction 98 2.2 Electronic Device specifications 99 2.3 Electronic Device instruction card 100 101 102 3. Labelling for International Shipments 103

3.1. Labelling for secondary packages 104 3.2. Labelling for tertiary packages (Insulated packages) 105 106

4. International Shipping Procedures 107 4.1. Temperature control during international transport 108 4.2 Route and arrival dates 109 4.3. Advance shipment arrival notification 110 4.3. Documents that accompany shipments 111 112

5. Vaccine Arrival Report 113 114

Annex 1: Guidelines to confirm that packaging complies with WHO recommendations 115 Annex 2: Shake test protocol 116 Annex 3: List of contact points for NRAs 117 Annex 4: Bulking factors for insulated packaging 118 Annex 5: UNICEF Vaccine Arrival Report 119 Annex 6: PAHO Form 183: Confirmation of Arrival of Shipments 120 Annex 7: Complete list of WHO prequalified vaccines, their recommended class of shipping boxes 121 and their recommended types of electronic temperature monitors to be used 122 Annex 8: List of changes to the current edition 123

Abbreviations 124

° C degree Celsius 125 ° F degree Fahrenheit 126 AWB airway bill 127 BCG Bacille Calmette–Guérin (tuberculosis vaccine) 128 CCM (vaccine) cold chain monitor 129 cm3

cubic centimetres 130 DT Diphtheria–Tetanus vaccine 131 DTP Diphtheria–Tetanus –pertussis vaccine 132 DTP-HepB-Hib Diphtheria–Tetanus –Pertussis, Hepatitis B, Haemophilus influenzae type B 133 ETA Estimated Time of Arrival 134 135 HepB Hepatitis B (vaccine) 136 Hib Haemophilus influenzae type B (vaccine) 137 HPV Human Papillomavirus Vaccine 138 IPV Inactivated Polio Vaccine 139 IATA International Air Transportation Association 140 IVB (Department of) Immunization, Vaccines and Biologicals (WHO) 141 JE Japanese Encephalitis (vaccine) 142 kg kilogram 143 LCD liquid crystal display 144 LRC lot release certificate 145 LSP Logistics Service Provider 146 MMR Mumps–Measles–Rubella (vaccine) 147 MR Measles–Rubella (vaccine) 148 NRA national regulatory authority 149 OCV Oral Cholera Vaccine 150 OPV Oral Polio Vaccine 151 PAHO Pan American Health Organization 152 PCV Pneumococcal Conjugate Vaccine 153 PQS performance, quality and safety 154 PQT Pre-Qualification Team (WHO) 155 RV Rotavirus Vaccine 156 SD Supply Division (UNICEF) 157 SLP summary lot protocols 158 Td Tetanus Toxoid and Diphtheria (reduced component) vaccine 159 TT Tetanus Toxoid (vaccine) 160 UN United Nations 161 UNICEF United Nations Children’s Fund 162 VAR Vaccine Arrival Report 163 VVM Vaccine Vial Monitor 164 WHO World Health Organization 165 YF Yellow Fever (vaccine) 166 167 168

Glossary 169

Definition

Primary packaging The first level of container for the vaccine: the vaccine primary container – vial, ampoule, pouch or other.

Secondary packaging The second level of packaging comprises the intermediate packaging that contains the primary packages: the vaccine carton box with the vials/ampoules/leaflet.

Grouping case The grouping case is a box in which there are multiple units of secondary packaging.

Tertiary packaging

The third level of packaging is the shipping unit. The shipping unit is the outer insulated box (protected by a cardboard or plastic external layer) that contains the secondary packages or grouping cases. Tertiary packaging shall be the outer shipping unit.

Electronic Temperature Monitoring Device

Electronic device pre-qualified by WHO as a shipping indicator for use in international shipments of vaccines

Logistics Service Provider The logistics provider responsible for the planning and coordination of the international shipment of vaccines

170

Preface 171

172

173

174

1. Insulated Packaging Standards 175 176

This chapter describes requirements by manufacturers to ensure vaccine packaging is of sufficient quality and performance to:

- maintain the integrity of the packaging during international transportation - prevent vaccine loss or damage due to exposure to heat or freezing or physical damage

during international transportation

1.1 Introduction 177

To protect the vaccines from exposure to both extreme temperatures and physical damage during 178 international transportation, WHO requires manufacturers to pack and dispatch vaccines in an 179 insulated box (shipping unit). The vaccine is kept cool during transport with the use of coolant 180 packs and packed inside the shipping unit 181 182 In addition to the insulation, the design of the shipping unit must be able to withstand the physical 183 conditions encountered during international transportation by air. 184

1.2 Temperature Criteria 185

On the basis of their thermo-stability and presentation, vaccines are classified into three 186 categories (see Table 1) for packaging for international shipments. WHO specifies the minimum 187 and maximum acceptable temperatures to which vaccines in each category can be exposed during 188 international transport. 189 190 As part of the WHO prequalification scheme, vaccine manufacturers are required to ensure that 191 their packaging complies with the appropriate temperature criteria specified below. Qualification 192 data should be produced in three consecutive successful runs. If any changes are introduced in 193 the packaging after qualification, the solution must be re-qualified. 194 195 The temperature criteria listed in Table 1 have been defined to represent temperature exposure 196 situations unlikely to occur outside a temperature-controlled supply chain. These situations may 197 include exposure to ambient temperature extremes during airport tarmac transfer, logistics 198 delays, cold chain equipment breakdown or handling errors, which can be outside the limits 199 described by the manufacturer or as labelled on the outer packaging, but within the limits the 200 temperature excursion allowances as defined by thermo-stability data of the vaccine. 201 202 All vaccine manufacturers are encouraged to validate their Class A and B packaging with frozen 203 icepacks in order to phase out the use of dry ice. 204 205 The validation test protocol is provided in Annex 1. 206

1.2.1 Class A packaging - Highly heat sensitive and not freeze sensitive 207

Prior to and at the time of packing, the vaccines must be kept within the storage temperature 208 limits recommended by the manufacturer. 209

The vaccine must be packed to ensure that the warmest temperature inside the insulated package 210 does not rise above +8°C in continuous outside ambient temperatures of +43°C for a period of at 211 least 48 hours. 212

1.2.2 Class B packaging –Heat sensitive and not freeze sensitive 213

Prior to - and at the time of packing, - the vaccines must be kept within the storage temperature 214 limits recommended by the manufacturer. 215 216 The vaccine must be packed to ensure that the warmest temperature inside the insulated package 217 does not rise above +30°C in continuous outside ambient temperatures of +43°C for a period of at 218 least 48 hours. 219 220 Diluents for lyophilized vaccines must always be included with the vaccine shipment in a quantity 221 that matches the quantity of vaccine; diluents however, do not require temperature-controlled 222 packaging unless specifically requested by the manufacturer. Refer Chapter 4 for diluent labelling 223 requirements. 224 225 For lyophilized vaccines bundled in the same packaging as diluents, freezing can only be allowed if 226 supportive data is available to demonstrate that freezing has no impact on the diluent’s safety, 227 quality, potency and presents no risk for the diluent ampoule/vial glass damage. 228

1.2.3 Class C packaging –Heat sensitive and freeze sensitive 229

Prior to and at the time of packing, the vaccines must be kept within the storage temperature 230 limits recommended by the manufacturer. 231 232 The vaccines must be packed to ensure that: 233 234

▪ the warmest temperature inside the insulated package does not rise above +30°C in 235 continuous outside ambient temperatures of +43°C for a period of 48 and 236

▪ The coolest storage temperature of the vaccine does not fall below +2°C in continuous 237 external temperatures of -5°C for a period of 48 hours. 238

239 Table 1. WHO classification and temperature criteria for international shipment of vaccines (For a complete 240

classification of vaccines according to their Class of shipping box, please go to Annex XX 241

Class Type of vaccine (see annex 7 for complete

list)

Ambient temperature

Minimum temperature

allowed

Maximum temperature

allowed

Time Criteria

A OPV +43oC no limit +8oC 48 hours

B

BCG Hib (freeze-dried)

Measles MR

+43oC no limit +30oC 48 hours

MMR Meningococcal A&C

Yellow Fever

C

DT DTP

DTP–HepB DTP–Hib (liquid) DTP-HepB-Hib

IPV JE

HepB Hib (liquid)

HPV Td TT

OCV PCV RV

+43oC not applicable +30oC 48 hours

-5oC +2oC not applicable 48 hours

242

1.3 General Packaging Criteria 243

244 Shipping units are defined as an outer insulated box designed to package and transport vaccines 245 during international shipment by air. This can either be an individual insulated shipping carton or a 246 pallet shipper. 247 248 Shipping units must be of sufficient durability to protect vaccines against mechanical manipulation, 249 repeated manual handling and environmental conditions whilst keeping the physical integrity and 250 properties intact, and ensuring carton quality is maintained throughout shipment. 251 252 Ice packs packed inside shipping units must be of satisfactory durability to ensure they do not leak 253 or crack during repetitive or poor handling. 254 255 1.3.1 Insulated shipping cartons 256 257 WHO recommends that each international insulated carton should weigh less than 50kg to ensure 258 ease of handling during transport as they are frequently loaded and offloaded manually at airports 259 and intermediate vaccine stores. 260 261 262 1.3.2 Insulated Pallet Shippers 263 264 Pallet shippers are defined as an outer shipping unit containing secondary packaging or grouping 265 cases designed to package and transport vaccines during export and the international shipment by 266 air. 267 268

Pallet shippers have a built in wooden or plastic pallet platform to enable handling and transport 269 by forklift or pallet handling equipment. Pallet shippers will generally accommodate higher 270 volumes of vaccines per unit, and normally with a reduction ratio of coolants to vials. 271 272 It is recommended that external dimensions of pallet shippers for vaccines procured through 273 UNICEF or other UN agencies should not exceed standard ISO pallet sizes: 274

⋅ US Pallet 1200mm x 1000mm, or 275 ⋅ Euro Pallet 1200mm x 800mm 276

277 Pallet shipper height should not exceed 1600mm. 278

279 It is recommended that pallet shippers are NOT qualified using dry ice as coolant. 280 281 NB: Where manufacturers wish to introduce use of pallet shippers for packaging vaccines for 282 international shipments, the UN procuring agencies must be consulted and the agency will agree 283 to a transition plan upon with respective countries prior to introduction. 284 285 Due to infrastructure and logistics constraints in some receiving countries, manufacturers must 286 ensure smaller pallet shippers or individual insulated cartons can still be supplied as and when 287 required. 288 289 Active packaging systems with a mechanical refrigeration are not to be used for the international 290 shipment of vaccines unless specifically requested by the UN agency. 291 292

293

294 295 296 297 298 299 300 301

2. Temperature Monitoring Devices 302

303 304

This chapter describes the requirements for temperature monitoring devices and required manufacturer practices for using these devices in international shipments to ensure the internal and ambient temperatures of the vaccine packaging are monitored from the manufacturer site until vaccine arrival in the recipient country.

2.1 Introduction 305

International shipments of vaccines must be in accordance with the recommendations established 306 by vaccine manufacturer and agreed to by the Logistics Service provider in order to keep the 307 product temperature within the defined range as described by the manufacturer or on the outer 308 packaging. The acceptance of shipments with temperature excursion outside the defined storage 309 temperature limits are addressed by the temperature alarm settings recommended by WHO in 310 this chapter. 311

Temperature monitoring devices should be included in all vaccine shipments to document 312 whether temperature allowance limits have been exceeded. These devices should: 313

1) serve as a quick reference to help recipient countries determine whether the shipment – or 314 parts of the shipment – have been exposed to temperatures at which vaccines could have 315 been damaged; and 316

2) help the procurement agency determine when, where, and to what extent temperature 317 allowance limits have been exceeded. 318

Electronic temperature monitoring devices provide the most reliable and accurate record of the 319 above information. 320

In addition to the temperature monitoring devices placed inside each shipping box mentioned 321 above, WHO now recommends one external data logger to be placed on the “index shipping box”. 322 This data logger ensures that unusual shipping conditions e.g. exposure to ambient conditions on 323 airport tarmac can be easily identified during the investigation of shipment complaint. This data 324 logger must be robustly fixed to the index box in such a way as to prevent any detachment during 325 the shipment. 326

Before accepting a shipment, the recipient should make sure that alarms have not been triggered 327 on the monitoring devices. If there is an alarm in one or more of the temperature monitoring 328 devices, the recipient should contact the procurement agency for action and ensure affected 329 vaccines are stored under the appropriate conditions and segregated under quarantine until 330 further assessment of the impact on the vaccine. 331

The point in time when a temperature excursion has occurred is important for the purchasing 332 agency and the manufacturer so they can identify the cause of the excursion, take corrective 333 measures, avoid similar situations in future shipments, and for insurance purposes. 334

2.2 Electronic Device - General information 335

WHO recommends that at least one electronic temperature monitoring device is included in each 336 and every insulated vaccine shipping unit. For shipping units exceeding 800mm in height, it is 337 recommended that two devices should be used and positioned according to the cold and hot spots 338 identified by thermal mapping. 339

Devices must NOT be started more than 72 hours prior to the shipping boxes being sealed 340 dispatch from manufacturer. 341

Diluents that are packaged separately are not required to have a temperature monitoring device 342 except in the case where diluent is freeze sensitive, then each diluent shipping carton requires use 343 of a device that can indicate exposure to freeze conditions. 344

WHO no longer recommends the use of the vaccine cold chain monitor (CCM). ) card. However 345 when batteries for electronic devices do not perform under extremely cold temperatures such as 346 when vaccines are being transported with dry ice, CCM cards may be used. 347

Shipments Use of lithium battery should be avoided (2017 Lithium Battery Guidance Document 348 IATA) as this would require shipments to be labelled as Dangerous Goods.).). 349

350 Table 2. Specifications of the electronic devices for international shipmentsa 351

Storage temperature Range: -25oC to +70oC Operating temperature Range: -25oC to +55oC Display visibility range Range: -10oC to +55oC Temperature measuring accuracy +/- 0.5oC or better Time measuring accuracy +/- 10 seconds per day, or better Logging Interval 10 minutes or less Initial delay (see point 2 below) 1 hour Recording period 40 days Storage before START minimum of 18 months Data retention after STOP minimum of 6 months Battery specification & Labelling Compliant with IATA regulations a For specific devices with these features, refer to the WHO website: http://www.who.int/vaccines-access/pqs.htm

352 2.3 Electronic Device Specifications 353

The electronic devices should, at a minimum, meet the specifications outlined in Table 2 (above) 354 and have the functions outlined below. 355

1) A "start" function to activate the device at the time the carton is being loaded with vaccine1. . 356

2) A “stop” function to allow the recipient to stop the recording when the vaccine arrives at its 357 destination. 358

3) A one hour "initial delay" function so the device can acclimatize to the temperature inside the 359 shipping carton before it starts recording. 360

http://www.who.int/vaccines

4) A "history" function to provide details of violations of the temperature limits in terms of time, 361 range and duration displayed on the LCD screen. This function is primarily to provide 362 information for the use of the procurement agency. 363

5) A USB interface to download a time-temperature graph in PDF format obtained by plug-in and 364 without the need for user to download special software. 365

6) A liquid crystal display (LCD) screen to provide a visual display of the information and also to 366 show the symbol that indicates whether the device is functional or not. This symbol, and also 367 the alarm indicator, should be static (i.e. should not flash or blink) so as to be visible when the 368 screen is scanned or photocopied for documentation purposes. 369

7) An alarm set according to WHO recommended settings (see Tables 3, 4, 5 and 6 below). For a 370 complete classification of vaccines according to type of shipping indicator used, please kindly 371 go to Annex 7. 372

Table 3 (Type 1) WHO-recommended alarm settings for international shipments of DTP, DT, DTP-HepB-Hib, IPV, HPV, JE, 373 TT, Td, OCV, PCV, HepB, RV (Rotarix), liquid Hib and combination vaccines 374

Temperature Alarm type Period for triggering the alarm

High threshold >= 45°C single event 1 hour

Medium threshold >= 30°C cumulative exposure

10 hours

Low threshold <= -0.5°C single event 1 hour

375 Table 4. (Type 2) WHO-recommended alarm settings for international shipments of BCG, measles, MR, MMR, 376 meningococcal meningitis, lyophilized Hib, yellow fever and OPV 377




10 hours

Low threshold >= 10°C cumulative exposure

20 hours

378 Table 5. (Type Rotateq) WHO-recommended alarm settings for international shipments of Rotateq 379


High threshold >= 27°C single event 1 minute


2 hours

Low threshold <= -25°C 1 single event

1 minute

380 Table 6. (Type Prevnar) WHO-recommended alarm settings for international shipments of Prevnar 381

382




10 hours

Low threshold <= -0.5°C single event 1 hour

383 2.3 Electronic Device Instruction Card 384 385 Each electronic device should be attached to a backing card that includes the information outlined 386 below, in the appropriate language. 387

1. The type of device: (see annex 7 for a complete list of vaccines) 388

Type 1: for DTP, DT, DTP-HepB-Hib, IPV, HPV, JE, PCV, Rotarix, TT, Td, HepB, liquid 389 Hib and combination vaccines 390

Type 2: for OPV and freeze-dried BCG, measles, MR, MMR, lyophilized Hib, yellow 391 fever and meningococcal vaccines 392

Type Rotateq: for Rotateq vaccine 393

Type Prevnar: For Prevnar vaccine 394

2. For the person packing/sending the shipment: 395

a. instructions on how to activate the device; 396

b. a reminder that one device must be placed in each shipping carton; 397

c. devices should be numbered to clearly identify corresponding shipping carton for 398 use by recipient 399

d. space for the following information to be entered: 400

▪ the supplier’s name; 401 ▪ place, date and time of the packing; 402 ▪ vaccine purchase order number; 403 ▪ Number of boxes 404 ▪ vaccine type; 405

3. For the person receiving the shipment: 406

a. instructions on how to stop the device; 407

b. illustrations to show information on the LCD screen – how it will indicate 408 problems/no problems and the alarm-status display; 409

c. Tables 5 and 6 (below) showing what to do. 410

Table 57. Information to be displayed on the backing card of electronic device – Type 1 (for DTP, DT, DTP-HepB-Hib, IPV, 411 JE, HPV, OCV, PCV, Rotarix, TT, Td, HepB, IPV, liquid Hib and combination vaccines) 412

413 Alarm

temperature What to do with vaccines

>=45oC Contact procurement agency >=30oC Contact procurement agency

<=-0.5oC Conduct shake testa. USE vaccine if passes. Inform procurement agency of alarm and of test result.

a Shake test guidelines are given in Annex 2.

Table 6. Information to be displayed on the backing card of electronic device – Type 2 (for OPV and freeze-dried BCG, 414 measles, MR, MMR, lyophilized Hib, yellow fever and meningitis vaccines) 415

416

Alarm temperature

What to do with vaccines

OPV Other vaccines >=45oC Contact procurement agency Contact procurement agency >=30oC Contact procurement agency Contact procurement agency >=10oC Contact procurement agency Accept

417 Table 7. Information to be displayed on the backing card of electronic device – Type Rotateq 418

Alarm temperature What to do with vaccines

>=27oC Contact procurement agency >=17oC Contact procurement agency <=-25oC Contact procurement agency

419 Table 8. Information to be displayed on the backing card of electronic device – Type Prevnar 420 421

Alarm temperature What to do with vaccines

>=45oC Contact procurement agency >=30oC Contact procurement agency <=-5oC Contact procurement agency

422 423 Note on decimal rounding: During storage and distribution of vaccines, in different temperature 424 scale with 0, 1 or 2 decimal places, it is recommended to apply rounding rules to evaluate 425 reported temperature data expressed in whole numbers to be aligned with controlled cold 426 temperature limits reported without decimals as mentioned in international pharmacopeias and 427 guidelines. 428 429 When rounding is required, consider only one digit in the decimal place to the right of the last 430 place in the limit expression. If this digit is smaller than 5, it is eliminated and the preceding digit is 431

unchanged. If this digit is equal to or greater than 5, it is eliminated and the preceding digit is 432 increased by 1". In any case, numbers should not be rounded until the final calculations for 433 reportable value 434 435

3. Labelling for International 436

Shipments 437

438

This chapter describes labels that must be attached by the vaccine manufacturer to different packaging levels for international shipments.

439

3.1 Labelling for Secondary packaging 440

A label must be affixed either to the top and/or front surface of the secondary package. It should 441 indicate the type of vaccine, the name of the manufacturer, presentation, batch number, date of 442 manufacture, date of expiry, quantity and storage conditions. Labels for secondary packaging of 443 both diluents and OPV droppers must also indicate above details 444 445 3.2 Labelling for Grouping case 446

A label must be affixed either to the top and/or front surface of the grouping case. It should 447 indicate the type of vaccine, the name of the manufacturer, presentation, batch number, date of 448 manufacture, date of expiry, and storage conditions. 449 450 3.3 Labelling for Shipping unit 451

The external surface of insulated shipping units should be either white or in the natural colour of 452 corrugated carton or plastic. Dark colours must be avoided. 453

A label must be affixed to the front surface of each package indicating type of vaccine, name of 454 manufacturer, presentation, batch number, date of manufacture, date of expiry, quantity, and 455 storage conditions. The manufacture date and expiry date on all labels should be written in full, 456 not in a coded form (i.e. June 2017, not 06.17). 457

Required temperature conditions for transportation must be clearly visible on the outer carton, 458 indicating clearly where recommended transportation temperatures differ from recommended 459 storage temperatures. 460

In addition to above the following labelling requirements must be met: 461

i. “Vaccine Rush” Label 462

A label must be affixed to each face of the vaccine package in a language appropriate to 463 the country of destination (e.g., in English: “Vaccine Urgent”; in French: “Vaccin Urgent”; in 464 Spanish: “Vacuna Urgente”; in Portuguese “Vacinas – Urgente”etc.). 465

ii. “Do Not Freeze” Label 466

A label must be affixed to each face of the vaccine package in a language appropriate to 467 the country of destination as follows: 468

a) Shipping units containing freeze-sensitive vaccines (DTP,DT,DTP-HepB-Hib, IPV, 469 PCV, HPV, RV, OCV, Td, TT, IPV liquid Hib and hepatitis B vaccines, or combinations 470 containing any of these), 471

b) Shipping units containing freeze-sensitive diluents, and 472

c) Shipping units containing OPV droppers where droppers are at risk of being 473 damaged by freezing. 474

iii. IATA Time and Temperature Sensitive Label 475

The IATA Time and Temperature Sensitive Label is a shipment label specific to the 476 healthcare industry that must be affixed to all shipping units booked as time and 477 temperature sensitive cargo. It is the responsibility of the manufacturer to ensure the label 478 is applied properly to each shipping unit indicating approved transportation temperatures, 479 and in accordance with IATA Guidelines. 480

iv. Shipping documents should be included in the box labelled Number 1, and this box 481 should be clearly labelled with the words "Containing vaccine shipping documents". 482

All insulated shipping units should be numbered consecutively and box numbers shall not be 483 repeated for shipments containing boxes of droppers or diluents shipped in the same 484 consignment as vaccines. There shall be only one box Number 1 per shipment. 485

Manufacturers should indicate on the outer carton where boxes are not stackable or maximum 486 stacking height, where applicable. 487

Where dry ice is used as a coolant, labelling and marking should be in accordance with IATA 488 Dangerous Goods Regulations. 489

Note: Where diluents are required to be stored at ambient temperature, they can be booked at 490 +2°C to +8°C for the practical reason that they are shipped with the vaccine on the same Airway Bill. 491 (AWB). IATA regulations do not allow two or more different temperatures on the same AWB. 492

493

3.4 Bar-coding 494 495 WHO does not currently require bar codes on the shipping units but vaccine manufacturers should 496 comply with GS1 standards and associated specifications if used. Bar code data should include: 497 Purchase order number, Purchase order item, Material Number, quantity, Batch Number, Batch 498 manufacturing date and Batch expiry date. 499

500

501

502

503

504

505

506

507

508

509

4. International Shipping Procedures 510

The arrival of a vaccine shipment in a country, its subsequent clearance through customs and 511 transportation to the central vaccine store are the most critical stages in the shipping process. These 512 are frequently the times when mistakes and delays occur, resulting in damage to the vaccines. The 513 smooth arrival and handling of vaccine shipments depends on the manner in which each step in the 514 delivery process is performed. Because numerous parties are involved (UNICEF Supply Division, 515 other UN agencies, the manufacturer, the forwarder, the airline, the UN country office, customs 516 authorities, clearing agents, or the national immunization service, etc.), and because of the need to 517 communicate accurate, time-sensitive information, it is essential to have strict guidelines to 518 determine and assign responsibilities at every step of the process. These are described in the 519 general terms and conditions of the tender documents and are further detailed in individual 520 contracts. The specific conditions depend on the country of destination. 521

5.1 Temperature Control during international Transportation 522

Vaccines must be kept in temperature-controlled environments at all times throughout the 523 shipment process including in transit storage points/warehousing. Carriers selected for vaccine and 524 temperature controlled shipments must be able to provide a reliable temperature control service. 525

All vaccines must be booked and shipped at +2°C to +8°C ambient temperature, or otherwise as 526 specified by manufacturer or indicated on shipping unit labels. 527

It is prohibited to send vaccines or diluents by general cargo. Shipment of droppers as general cargo 528 must be agreed in advance with the UN agency and manufacturer. 529

Vaccines should not be transported with radioactive products, fish or meat. 530

Re-icing of shipments must be performed in accordance with the written instructions of the 531 manufacturer of each shipment whenever deemed necessary. 532

5.2 Route and arrival dates 533

Vaccines should travel by the fastest and most direct route wherever possible. Where trans-534 shipment is unavoidable, the journey should be planned through airports that have adequate cold 535 storage facilities. 536

If the route deviates significantly from the standard routing, or delays are expected, the Logistics 537 Service Provider shall contact the UN agency in advance. 538

Shipments should be scheduled to arrive outside weekends and/or public holidays in the recipient 539 country and airline bookings should be made well ahead of the date of departure and as specified 540 by the UN procurement agency. Any additional requirements regarding arrival times must be 541

stated in the contract between UNICEF and/or the other UN agencies or manufacturers and the 542 designated freight forwarder. 543

Consolidation or splitting of consignments is not permitted unless approved in advance by the UN 544 agency. 545

5.3 Advance shipment arrival notification 546

It is the obligation of the Logistics Service Provider to inform the consignee and all requested 547 “notify parties” of all shipment details in advance of the shipment, in a format pre-defined by the 548 UN agency. Required documentation for the shipment must be sent at least seven days2 in 549 advance of arrival of the shipment, or as otherwise specified by the UN agency. 550

The documentation must include the following: 551

▪ Pre-advice cover page defined by UNICEF, PAHO and/or the other UN agencies; 552

▪ Airway Bill (AWB); 553

▪ Supplier’s Invoice; 554

▪ Packing List; Packing slip correlating information of electronic shipping devices with the 555 insulated shipping unit (PAHO). 556

▪ Lot Release Certificate (LRC) issued by the national regulatory authority (NRA) of the 557 country of manufacture for each lot of vaccine supplied; and 558

▪ Certificate of Pharmaceutical Product 559

▪ Summary protocol of production and quality control 560

▪ any other document, certificate or instruction specified in the purchase order. 561

The documents should be sent by e-mail by the Logistics Service Provider to the consignee, the 562 UNICEF or UN agency country office in the receiving country, Vaccine Centre, UNICEF Supply 563 Division for UNICEF shipments and any other parties specified in the individual contract. 564

The pre-advice must contain the following information: 565

▪ Purchase Order reference; 566

▪ consignee requisition reference; 567

▪ number of packages, gross weight (in kilograms) and volume (in cubic metres); 568

▪ type of vaccine, total number of primary containers and number of doses per primary 569 container; 570

▪ value of shipment (in US$); 571

▪ AWB and flight number(s); 572

▪ date and time for place of departure, transit (if applicable), and arrival; 573

▪ instructions for collection; 574

▪ any other information specified in the purchase order must also be included for the 575 consignee. 576

2 This period must include at least five working days.

The following information shall be stated on the AWB: 577

▪ consignee’s name, address and telephone number; 578

▪ Purchase Order reference; 579

▪ consignee’s requisition reference; 580

▪ type of vaccine and quantity; 581

▪ Handling information: “Vaccine – For human use – Highly perishable – Not to be delayed”. 582

For all vaccines the following instruction should be stated in the AWB: “Throughout shipment, 583 pending reshipment and prior to collection by the consignee, the vaccine must be transported at 584 +2°C to +8°C”. 585

House Airway Bills (HAWB) are not permitted unless approved in writing in advance by UNICEF, 586 PAHO and/or other UN agencies. 587

Vaccines are not to be advance shipped or arrive earlier than notified ETA. 588

Insulated shipping units are not to be opened in transit by the Logistics Service Provider, with the 589 exception of the requirement for re-icing as agreed with manufacturer. Electronic devices are not 590 to be stopped by the LSP until receipt by consignee in recipient country, unless otherwise agreed 591 by , PAHOUN agency. 592

If any shipment incurs loss or damage during transit, the Logistics service provider, manufacturer, 593 freight forwarder or consignee shall inform UNICEF, PAHO or UN agency immediately to provide 594 the shipment details and the estimation of the loss and damage to initiate the insurance claims 595 process. 596

5.4 Documents that accompany shipment 597

The following original documents must accompany the consignment when it is shipped. One set of 598 the following original documents must also be placed inside the shipping unit numbered “1”: 599

▪ Signed and/or stamped supplier’s invoice; 600

▪ Packing List; 601

▪ Lot Release Certificate and lot summary protocol issued by the national regulatory 602 authority of the country of manufacture for each lot of vaccine supplied; (signed and/or 603 stamped) 604

▪ Vaccine Arrival Report (VAR) for UNICEF shipments 605

▪ any other documents, certificates or instructions specified in the purchase order. 606

The shipping unit containing the documents should be clearly labelled with the words "Containing 607 vaccine shipping documentation". 608

The lot release certificate/s from the national regulatory authority (or from the national control 609 laboratory) of the producing country should be included for each lot contained in the shipment. 610 The lot release certificates are considered to be the only evidence that the lots received have 611 been released by the regulatory authority of the producing country. Vaccines delivered without a 612 lot release certificate cannot be accepted and must be kept on hold under appropriate storage 613 conditions. In such cases, the lot release certificate/s should be requested and provided 614 immediately by the manufacturer. 615

5. Vaccine Arrival Report 616

Vaccine Arrival Report (VAR) is a means of monitoring international shipments of vaccines in order 617 to ensure that shipping guidelines are followed and that vaccine quality is maintained. The VAR 618 provides a means of indicating any inadequacies in the shipping process and problems relating to 619 the condition of vaccines at the time of delivery (see Annex 5). UNICEF and/or WHO officers 620 should support with recipient governments to ensure that the VAR is duly completed by 621 authorized staff, checked and verified by the immunization program manager, and forwarded to 622 UNICEF within three working days of the arrival of the vaccine. In the case of combined shipments, 623 a separate report should be filled in for each vaccine in the shipment. 624

For countries receiving vaccines through UN agencies, all complaints should be sent immediately 625 to the local country office of the procurement agency for them to follow up with their 626 procurement organization. Depending on the nature of the complaint, the procurement agency 627 may handle the issue itself or may request assistance from WHO. For countries procuring vaccine 628 directly, all complaints should be handled directly with the vaccine manufacturer; WHO assistance 629 can, however, be sought if required, for WHO prequalified vaccines (?). 630

Table 9 sets out the vaccine arrival and complaints procedures for vaccines procured by UNICEF. 631 These procedures may be adapted for other procurement routes. 632 633 Table 9. Procedure for reporting UNICEF vaccine arrivals 634 635

Arrival of vaccines and customs clearance ↓

Inspection at Central cold stores. VAR completed and signed. ↓

Copy of VAR sent to UNICEF country office or Supply Division (SD), Copenhagen. ↓

INDICATOR OK DEFECTIVE Advance notification Recorded UNICEF to follow up with Freight Forwarder Vaccine type/expiry Recorded UNICEF to follow-up with manufacturer

Eventual report to WHO Pre-Qualification Team Biologicals (PQT) for further investigation if necessary.

Documents accompanying the shipment

Recorded UNICEF to follow-up with Freight Forwarder or manufacturer. Eventual report of problems related to lot release certificate to WHO PQT.

Quantities received Recorded UNICEF to follow-up with Freight Forwarder/manufacturer Status of temperature indicators

Recorded UNICEF to report to WHO PQT; investigation to be carried out. UNICEF to initiate claims process. Temperature monitors to be retained by consignee.

Any defect in the process can lead to a complaint, claim and/or rejection of a shipment. Each 636 individual situation will be investigated and dealt with by all involved parties. 637

If the quantity of damaged vaccine is substantial it could affect immunization delivery. In such 638 cases, emergency measures will have to be taken to obtain sufficient vaccine to maintain the 639 program’s scheduled activities. 640

Annex 1: 641

Guidelines to confirm that packaging 642

complies with WHO recommendations 643 644 645

1. Introduction 646

This procedure referred to as “qualification” is the measurement and/or confirmation that temperatures inside the shipping containers of every vaccine shipment remain within the defined temperature range (for the specific vaccine/s being transported) for a period of 48 hours according to the packaging class A,B or C

647

As part of the WHO vaccine prequalification process, vaccine manufacturers must document the 648 qualification of their packaging. 649

Qualification data should be produced for three successful consecutive tests at the defined 650 ambient temperatures for the period of time mentioned in the Table 10. If changes are introduced 651 either in the packaging or the shipment procedures, the shipment must be validated again and 652 submitted to WHO PQT (for review/file/information). 653

Table 10: Test temperature and established criteria for class A, B and C vaccines for validation of the packaging 654

Class Type of vaccine (see

annex 7 for complete list)

Ambient temperature Minimum Maximum Time Criteria

A OPV +43oC no limit +8oC >=48 hours

B

BCG Hib (freeze-dried)

measles MR

MMR meningococcal

A&C yellow fever

+43oC no limit +30oC >=48 hours

C

DTP DTP–HepB

DTP–Hib (liquid) DTP-HepB-Hib

DT IPV HPV OCV

JE PCV RV

HepB Hib (liquid)

+43oC n/a +30oC >=48 hours

-5oC +2oC n/a hours

Td TT

As above

Temperatures within the container should be continuously monitored within an accuracy of ± 655 0.5ºC; the sensors used for this purpose must not be allowed to influence the test in any way. A 656 minimum of 8 simultaneous temperature measurements are required for an insulated box (see 657 figure below). The ambient temperatures at which the insulated box is tested must remain within 658 a tolerance of ± 1ºC. 659

Locations of temperature sensors for insulated containers 660 a) Insulated container: top view 661

x 1, 2 3, 4 x

x 6, 7 8, 9 x

662

b) Insulated container: side view 663

664

Lid

x 1, 6 3, 8 x

x 5

x 2, 7 4, 9 x

2. Loading 665

The qualification must be done with a minimum vaccine thermal mass representative of a full 666 transportation load configuration. Coolant packs and product temperature must be conditioned as 667 per normal use. Water-based placebo can be used to mimic the vaccine thermal mass. 668

In the case of a vaccine manufacturer having more than one type of vaccine in one category, 669 testing with any of the listed vaccine is acceptable. The validation does not need to be repeated 670 with other presentations. 671

Insulated boxes should be fully loaded with vaccine vials conditioned at +5ºC ±3ºC. Loads can be 672 pre-fitted with thermocouples. Loading should be carried out as quickly as possible and the time 673 taken for loading should be recorded and reported for each container. 674

3. Temperature recording 675

The internal temperature of an insulated container is recorded at specified points within the load 676 during the validation tests. The figure above shows the position of these points, each of which is 677 2.5/3.0 cm from the nearest icepack surface, with the exception of the central points. 678

Thermocouples should be attached to the outside of the vials and should not be inserted into the 679 vials. Thermocouple leads can be introduced into the secondary packaging container either: 680

▪ through the seal – taking care not to affect the quality of the seal; or 681

▪ through a hole in the geometric centre of the lid or of one of the sides of the container – 682 taking care to adequately seal the outer and inner openings. 683

4. Reporting 684

An initial validation report should be sent to WHO along with the dossier submitted for 685 prequalification or in case of changes for reassessment or as part of a variation submission 686 relating to a change in packaging configuration. It should include: 687

▪ standard operating procedure (or test protocol) used for the validation; 688

▪ start date, end date and time of the three consecutive validation runs; 689

▪ conditioning temperature of the product and gel packs used in the test 690

▪ detailed information on external and internal dimensions of insulated container, type of 691 material it is made of, weight empty and weight fully loaded (total weight); information on 692 the probes distance from the nearest icepack surface should also be provided 693

▪ detailed temperature history for all tests in tabular format (for all internal and external 694 ambient channels). 695

696

Annex 2: 697

Shake test protocol 698 699

Purpose 700

The shake test is designed to determine whether some adsorbed vaccines with aluminum 701 phosphate/hydroxide formulations have been affected by freezing. After freezing, the lattice 702 (bond between adsorbent and antigen) gets broken. Separated adsorbent tends to form granules 703 that get bigger in particle size and weight then gradually settle to the bottom after the vial has 704 been shaken. The size of the granules seems to increase after repeated freezing and thawing 705 cycles. Sedimentation occurs faster in a vaccine vial that has been frozen than in a vaccine vial 706 (from the same manufacturer) that has never been frozen. 707

Individual batches of vaccine may behave differently from one another. The test procedure 708 described below should, therefore, be repeated with all suspect batches. In the case of 709 international arrivals, whenever there is an indication that temperatures have dropped below 710 zero, the shake test should be conducted on a random sample of vaccines. However, if there is 711 more than one lot of vaccine in the shipment, the random sample must include a vial taken from 712 each and every lot. 713

Test procedure 714

1. Take a vial of vaccine of the same type and batch number as the vaccine you want to test, and 715 made by the same manufacturer. This is your control vial. 716

2. Clearly mark the control vial: “FROZEN.” 717

3. Freeze the control vial at -20oC overnight, until the contents are completely solid. 718

4. Let the control vial thaw. Do not actively heat it! 719

5. Take a “test” vial from the batch that you suspect has been frozen. 720

6. Hold the control (“frozen”) vial and the “test” vial together in one hand. 721

7. Shake both vials vigorously for 10–15 seconds. 722

8. Place both vials on a flat surface side-by-side and start continuous observation of the vials until 723 the test is finished. (If the vials have large labels that conceal their contents, turn both vials 724 upside down and observe sedimentation in the neck of each vial.) Observation period must be 725 a minimum period of 24 hours. 726

9. Use an adequate source of light to compare the sedimentation rates between vials. 727

Conclusion 728

If sedimentation is slower in the “test” vial than in the control (“frozen”) vial, the vaccine has not 729 been damaged. Use the vaccine. 730

If sedimentation is similar in both vials, or if sedimentation in the “test” vial is faster than in the 731 control (“frozen”) vial, the vaccine has been damaged. Do NOT use the vaccine. Notify your 732 supervisor. 733

734 The figure below shows the difference between a control (“frozen”) vial and a (non-frozen) test 735 vial. 736 737

Seeing the difference in sedimentation rates during a shake test 738 739 740 741

742

743

744

745

746

747

748

749

750

751

752

753

754

755

756

757

758

759

760

761

762

763

764

765

766

767

768

769

4 minutes after placing the vials on the table

10:25 am

Frozen control vial

Test vial

1

3

10:31 am

10:33 am 4

Sedimentation in test vial is slower than in the frozen control

vial. Test vial has not been damaged and can be used.

10:28 am 2

Annex 3: 770

List of contact points for national regulatory authorities in 771

countries producing vaccines prequalified for purchase by 772

United Nations agencies 773 774 American Region 775 776 Argentina 777 Administración Nacional de Medicamentos, 778 Alimentos y Tecnología Médica (ANMAT) 779 Ministerio de Salud y Acción Social 780 Avenida de Mayo 869 (C1084AAD) 781 Ciudad Autónoma de Buenos Aires 782 T: 54 11-4340-0800 / 5252-8200 783 F: 54 1 342 1997 784 Website: http://www.anmat.gov.ar/ 785 786 Canada 787 Bureau of Biologics and Radiopharmaceuticals (BBR) 788 Health Protection Branch (HPB) 789 Health Canada 790 L.C.D.C Building # 6 (0603 C) 791 Tunney’s Pasture 0603C 792 Ottawa, Ontario K1A OL2 793 794 United States of America 795 Food and Drug Administration 796 Center for Biologics Evaluation and Research 797 1401 Rockville Pike, Suite 2000 798 Rockville, MD 20852 799 800 Brazil 801 Agencia Nacional da Vigilancia Sanitaria (ANVISA) 802 Esplanada dos Ministerios, Bloco G, 9o andar, sala 900 803 cep: 70058-900 Brasilia DF 804 T: 882 5328 F: 801 5330 805 E-mail: [email protected] 806 Website: http://www.anvisa.gov.br 807 808 Cuba 809 Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED) 810 Calle 5ta A #6020 e/ 60 y 62. Miramar, Playa. Código postal: 11300 811 La Habana 812

T: (+53) 7 216 4100 813 E-mail: [email protected] 814 Website: http://www.cecmed.cu/ 815 816 817 818 Europe 819 820 Belgium 821 General Pharmaceutical Inspectorate 822 Ministry of Social Affairs, Public Health and Environment 823 Bd Bishoffsheim 33 824 1000 Brussels 825 826 Bulgaria 827 Bulgarian Drug Agency 828 26 Yanko Sakazov Blvd 829 1504 Sofia 830 831 Denmark 832 Danish Medecines Agency 833 Axel heides Gade 1 834 2300 Kobenhavn 5 835 836 France 837 Agence française de Sécurité Sanitaire des Produits de Santé 838 Direction de l'Inspection et des Etablissements 839 143-147 Boulevard Anatole France 840 93285 Saint Denis Cedex 841 842 Hungary 843 Italy 844 Ministero della Salute 845 Lungo Tevere Ripa 1 846 00153 Roma 847 848 Germany 849 Paul-Ehrlich-Institut 850 Paul Ehrlich Strasse 51–59 851 Postfach 1740 852 D-63225 Langen 853 854 Switzerland 855 856 United Kingdom 857 Medicines and Healthcare Products Regulatory Agency (MHRA) 858 Department of Health 859

mailto:[email protected]

Market Towers 860 1 Nine Elms Lane 861 London SW8 5NQ 862 863 Oceania 864 865 Australia 866 Therapeutic Goods Laboratories (TGAL) 867 Therapeutic Goods Administration 868 P.O. Box 100, 869 Woden ACT 2606 870 871 872 873

Asia 874 875 India 876 Drugs Controller General of India, DCG(I) 877 Directorate General of Health Services 878 Ministry of Health and Family Welfare 879 Nirman Bhawan, New Delhi 110 011 880 Government of India 881 882 Indonesia 883 Directorate General of Drug and Food Control 884 Ministry of Health 885 Jalan Percetakan Negara 23 886 Jakarta Pusat 10560 887 888 Japan 889 Pharmaceutical and Medical Safety Bureau 890 Ministry of Health, Labour and Welfare 891 1-2-2 Chome, Kasumigaseki 892 Chiyoda-ku 893 Tokyo 100–8916 894 895 Republic of Korea 896 The Korea Food and Drug Administration (KFDA) 897 5 Nokbun-Dong Eunpyung-Ku 898 Seoul 899 900 China 901 China Food and Drug Administration (CFDA) 902 Building 2 903 26 Xuanwumen Xidajie 904 Beijing 100053 905 People's Republic of China 906 Website: http://www.sfda.gov.cn/eng/ 907 908 Africa 909 910 Senegal 911 Direction de la Pharmacie et du Medicament (DPM) 912 Ministere de la Sante Publique 913 153 rue Mousse Diop 914 B.P 6150, Dakar 915 Tel: +2218224470 916 Fax: +2218210910 917 918 919 920

921

Annex 5: 922

Vaccine Arrival Report (VAR) 923 This report is to be filled in by authorized staff, ratified by the Store Manager or the EPI Manager, and forwarded to the UNICEF within 924 three working days of vaccine arrival. Use one report for each vaccine in the shipment. 925 926

COUNTRY

REPORT No. Date of report

927 Place, date and time of inspection Name of cold store, date and time vaccines entered into cold store

928 PART I — ADVANCE NOTICE 929 930

MAIN DOCUMENTS Date received by consignee

Copy airway bill (AWB)

Copy of packing list

Copy of invoice Copy of release certificate

Pre-advice shipment notification Yes No Yes No Yes No Yes No

931 List other documents (if requested)

932 PART II — FLIGHT ARRIVAL DETAILS 933 934

AWB Number Airport of

destination Flight No ETA as per notification Actual time of arrival

Date Time Date Time

935 NAME OF CLEARING AGENT: _____________________________ ON BEHALF OF: _______________________________ 936 937 PART III — DETAILS OF VACCINE SHIPMENT 938 939

Purchase Order No.

Consignee Vaccine description (Type and doses/vial)

Manufacturer Country

940 Vaccine Diluent/droppers

Lot Number Number of

boxes Number of

vials Expiry date Lot Number Number of

boxes Number of

units Expiry date

(Continue on separate sheet if necessary) 941 942

Yes No Comments

Was quantity received as per shipping notification?

If not, were details of short-shipment provided prior to vaccine arrival?

943 1 Adopted from the Standard UNICEF Vaccine Arrival Report from WHO Guidelines on the international packaging and shipping of 944 vaccines (WHO/IVB/05.23) 945 No. = Number 946 WHO recommends all UN agencies, countries and non-governmental organizations procuring vaccines adopt this report. 947

Report No. 948 PART IV — DOCUMENTS ACCOMPANYING THE SHIPMENT 949 950

Invoice Packing list Release certificate Vaccine Arrival Report Other Yes No Yes No Yes No Yes No

Comments

951 PART V — STATUS OF SHIPPING INDICATORS 952 953

Total number of boxes inspected:

Coolant type: Dry ice Icepacks No coolant

Temperature monitors present:

VVM Cold-chain card Electronic device Type: _______________

954 955 PROVIDE BELOW DETAILS OF STATUS ONLY WHEN PROBLEMS ARE OBSERVED 956 (in addition fill in ALARM REPORTING FORM if there are any ALARMS in electronic devices): 957 958

Box Number

LOT NO Alarm in electronic device Cold-chain monitor

Date/time of inspection >=450C >=300C >=100C <=-0.50C A B C D

(Continue on separate sheet if necessary) 959 Note: For shipments of certain types of PCV and Rotavirus, alarm settings on the temperature monitor device may be different than those listed above. If different alarms are 960 recorded, please provide comments in General Conditions of Shipment section. 961 962 PART VI — GENERAL CONDITIONS OF SHIPMENT 963 964

What was the condition of boxes on arrival?

Were necessary labels attached to shipping boxes?

Other comments including description of alarms in electronic devices: (continue on separate sheet if necessary)

965 PART VII — NAME AND SIGNATURE 966 967

968 Authorized Inspection Supervisor DATE Central store or EPI Manager DATE 969 970

For UNICEF Country Office use only Date received by Country Office: ______________________________ Contact Person:______________________________

Guidelines for completing the Vaccine Arrival Report 971 972 The Vaccine Arrival Report (VAR) is a comprehensive record of cold-chain conditions during transport and of required compliance 973 with shipping instructions. Recipient governments and procurement agencies (UNICEF country offices, UNICEF Supply Division, 974 PAHO Revolving Fund), are responsible for the report, and for taking appropriate action if problems are reported (e.g. follow-up 975 with the manufacturer, forwarding agent, WHO, etc.). 976 Use one report form for each shipment and for each vaccine in the shipment. In the case of short-shipments (where parts of the 977 original quantities are not delivered), complete a separate report for each part delivered. 978 Complete the form as described below. In the header boxes at the top of the form, enter the name of the recipient country, the 979 report number, and details of place and date of inspection and storage. The report number is an internal number for organizing 980 records; compile it as follows: country code; year; number for each report (e.g. BUR–2005–001 for one vaccine; BUR–2005–002 for 981 a second vaccine, etc.). In the case of a short-shipment, the numbers for the separate deliveries would be, for example, BUR–982 2005–003.1, BUR-2005-003.2, etc. 983 984

Part I — Advance notice I.1 Enter dates and details of documents received

in advance of the vaccine shipment. Part II — Flight arrival details II.1 Fill in details of expected and actual arrival

times for the shipment. II.2 Fill in the name a) of the clearing agent and b)

for whom the agent acts (e.g. the Ministry of Health, UNICEF or WHO).

Part III — Details of vaccine shipment III.1 Fill in details of the order (purchase order

number, consignee, vaccine description etc.). III.2 For each batch of vaccine included in the

shipment, record: a) the number of shipping boxes; b) the number of vials; c) the expiry date.

The number of boxes you enter should always match the number of boxes shown in the packing list. If it does not, note under Comments if advance notice of a change in the quantity was provided. It is not necessary to count the number of individual vaccine packs in each shipping box for this report. III.3 For the diluents and droppers (if included) in

the shipment, record: a) the number of shipping boxes; b) the number of vials; c) the expiry date.

The information for III.2 and III.3 is also in the packing list. Note: Diluents for freeze-dried vaccine and droppers for oral polio vaccine (OPV) are integral parts of the vaccine, so always include them on the same form. If diluent/droppers are delivered separately, consider it a short-shipment. Part IV — Documents accompanying shipment The packing list should indicate which box contains the shipping documents (usually Box 1). IV.1 If this information is not included in the

packing list or in documents sent separately by courier, pouch or other means, note this under Comments.

IV.2 Verify that all necessary documents are present and complete the form accordingly.

Note: If the lot release certificate is missing, do not use the vaccines; keep them on hold in cold storage until the relevant document has been obtained from the vaccine manufacturer. PART V — Status of shipping indicators

Inspect the temperature monitors in all boxes before putting vaccines into cold storage. For very large shipments, or when immediate storage in the shipping boxes is required, check a representative number of boxes before placing the shipment in the cold store. Complete inspection of all boxes the next day, or as soon as possible thereafter; under Comments, note the date and time when the complete inspection took place. Note: In this report, enter the information below (V.1) only for boxes in which the temperature monitor shows a change that indicates potential damage to vaccines (alarm indication in the electronic device, or cold-chain monitor card as per vaccine/threshold table in card). V.1 Enter:

a) the number of boxes inspected (this should equal the total number in the shipment);

b) the type of coolant used; c) details of any temperature exposure

detected. V.2 Photocopy or scan LCD screens in electronic

devices that show alarm status and attach to the report.

V.3 Clearly identify vaccines in boxes in which the indicator shows exposure to temperatures that risk damage and keep them in the cold room for further assessment of their condition. Do not discard vaccines until assessment is completed.

PART VI — General conditions of shipment VI.1 Indicate if the shipping boxes were received in

good condition and if all necessary labels on the outside of the shipping boxes were present; add any comments.

PART VII — Name and signature VII.1 The authorized person responsible for the

inspection and the Central Store Manager or the EPI Manager should sign this report.

VII.2 Send the form, completed and signed, to the UNICEF within three days of arrival of the vaccine.

1

Electronic Alarm Report Form Reporting alarm details in UNICEF international vaccine shipments A special form has been designed for the purpose of reporting alarm details displayed in electronic devices. This form should ONLY be filled in if any alarms have occurred, and should be attached to the Vaccine Arrival Report (VAR). A clear photocopy and/or printed copy of the scanned image of the electronic devices displaying alarm status should be attached to this form.

Country: Date of Report:

Vaccine: Compiled by:

Type of device Q-Tag2Plus ☐ Q-Tag Clm ☐ VaxAlert ☐

TIC20 ☐ Other ☐

Box No

Serial No Time stopped

Elapsed transit time

>=450C 1 hour

>=300C 10 hrs

>=100C 20 hrs

<=-0.50C 1 hr

Other

Time oC Time oC Time oC Time oC Time oC

Note: For shipments of certain types of PCV and Rotavirus, alarm settings may be set at different thresholds than those listed on the VAR and alarm reporting form. In the case of these alarms, please comment in “Other” column. Use additional pages if necessary. Guidelines for completing the Electronic Device Alarm Report Form

Country Enter name of the country Date of report Enter date of report Type of device Mark the type of device by ticking the appropriate box Type of vaccine Enter the type of vaccine, e.g. BCG, OPV, HepB, etc.

Box number Write the number of the box (carton) that the electronic device was taken out of, e.g. 001, 002…099.

Serial number Write down the serial number of the electronic device from the bar code/serial number, e.g. 10000001

Time stopped Enter the local time you stopped this particular device in 00hrs:00min format

Elapsed transit time Enter elapsed transit time

Time Enter time displayed in HISTORY mode for each alarm. oC Enter minimum or maximum temperatures displayed for each alarm, e.g. 34.7oC, 13.5oC, or -0.5oC

If any of the alarms are repeated in the same electronic device, enter this information in a new row.

2

Annex 6: PAHO Form 183 - Confirmation of Arrival of Shipments

Acknowledgement of Shipment Arrival. Within 24 hours of the shipment’s arrival at the destination airport, the consignee must acknowledge via email the arrival of goods to PAHO’s Country Office. Acknowledgement does not imply acceptance of the goods; it simply indicates arrival of the goods. Therefore, acknowledgement should not be delayed pending final determination of acceptance. If subsequently the goods are found to be damaged or incomplete, the prior acknowledgment of arrival will not interfere with the claim process, provided the claim is reported within 72 hours of the delivery of the shipment.

Confirmation of Arrival. The consignee will confirm arrival of shipment by filling electronically or by hand PAHO Form 183 (the last page of the purchase order) or a statement written on the consignee’s letterhead. The consignee will email this form to the PAHO Country Office Procurement Focal Point. This acknowledgement will reference the purchase order (PO) number, awb information, date of arrival and any remarks about the shipment conditions on the bottom of the form. The clearance and claim of vaccines from customs facilities must be immediate.

Delayed Arrival. Consignees shall acknowledge vaccines’ arrival as described above. For shipments that have not arrived within 24 hours after the date indicated in the shipping details, the consignee will initiate tracing of shipments locally with the responsible airline or freight agent. The consignee immediately will notify the PAHO Country Office, via email.

Verification of Shipment. Complete verification of vaccines shipments will take place within 72 hours of delivery. Verification means the act of opening boxes and confirming that the contents are in good order. The consignee also will inform the PAHO Country Office of any alarm being displayed on temperature monitors or if monitors are not included in shipment as required.

Cold Chain Rupture of Vaccines. The consignee should take the following actions:

1. Verify the condition of the shipment and stop the electronic temperature monitors in each box within 24 hours of arrival of the shipment.

2. Retain temperature devices. 3. If the electronic temperature monitors have set off an alarm, send the readings to the PAHO Country Office Procurement Focal

Point. 4. Separate the insulated shipping units with temperature deviation from the ones in good conditions. 5. Keep all shipment under the manufacturer’s recommended temperature range. 6. Review insurance policy clauses and follow the insurance claim instructions. 7. Report the situation to the carrier. 8. PAHO will advise the member state of the technical concept for the use of the concerned shipment.

3

PAHO 183 (1-02) PAGE/PAGINA:

PAN AMERICAN HEALTH ORGANIZATION

Regional Office of the World Health Organization Procurement Services (PRO)

525 Twenty-third Street, N.W., Washington, D.C. 20037 Telephone (202) 974-3433

Fax: (202) 974-3615 E-Mail: [email protected]

PURCHASE ORDER

No: APO Date:

Confirmation of Arrival of Shipment Confirmación de la Llegada del Embarque

Dear Sir/Madam, Estimados Señores,

We hereby confirm the arrival of the following shipment:

Por la presente confirmamos la llegada del siguiente embarque:

Order Number Orden Número

AWB Guía aérea

Pieces Bultos

Weight Peso

Date of arrival Fecha de llegada

Complete shipment Embarque completo

The shipment was received at: / El embarque fue recibido en: Airport / Aeropuerto

Port / Puerto

Customs Warehouse / Bodega de la aduana

Consignee's facility / Bodega del consignatario

Name/Signature/Title/Date Nombre/Firma/titulo/Fecha

Please mark the last column if the shipment was received complete.

Please send this confirmation to your counterpart at PAHO/WHO Representative Office.

Sírvase marcar la última columna si el embarque llego completo.

Agradecemos enviar esta confirmación a su contraparte en la representación de la OPS/OMS.

4

Annex 7: Complete list of WHO prequalified vaccines, their recommended class of shipping boxes and their recommended types of electronic temperature monitors to be used (as of May 2019)

Prequalified Type Commercial Name Pharmaceutical Form Presentation No. of Doses

Manufacturer WHO Class of shipping

Electronic device Type

1 01/01/1987 Hepatitis B Engerix Liquid: ready to use Vial 1 GlaxoSmithKline Biologicals SA Class C Type 1



4 01/01/1987 BCG BCG Freeze Dried Glutamate vaccine

Lyophilised active component to be reconstituted with excipient diluent before use

Ampoule 20 Japan BCG Laboratory Class B Type 2

5 01/01/1987 Yellow Fever STAMARIL Lyophilised active component to be reconstituted with excipient diluent before use

Vial 10 Sanofi Pasteur SA Class B Type 2

6 01/01/1987 BCG BCG Freezed Dried Glutamate vaccine


Ampoule 10 Japan BCG Laboratory Class B Type 2

7 01/02/1991 BCG BCG Vaccine Lyophilised active component to be reconstituted with excipient diluent before use

Ampoule 10 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class B Type 2


Ampoule 20 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class B Type 2

9 01/04/1998 Haemophilus influenzae type b

Act-HIB Lyophilised active component to be reconstituted with excipient diluent before use


10 01/06/2011 Typhoid (Polysaccharide)

Typhim-Vi Liquid: ready to use Vial 20 Sanofi Pasteur SA

11 01/09/2006 Rubella Rubella Vaccine, Live, Attenuated


Vial 1 Serum Institute of India Pvt. Ltd. Class B Type 2










15 01/09/2011 Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus influenzae type b

None used on labelling for supply through UN agencies. Also marketed with labelled commercial name ComBE Five (Reconstituted).

Lyophilised active component to be reconstituted with liquid active component before use

Two vial set (active + active)

1 Biological E. Limited


None used on labelling for supply through UN agencies. Also marketed with labelled commercial name ComBE Five (Reconstituted).



10 Biological E. Limited

17 01/10/2018 Polio Vaccine - Inactivated (IPV)

ShanIPV Liquid: ready to use Vial 5 Shantha Biotechnics Private Limited (A Sanofi Company)

Class C Type 1

18 01/12/2009 Influenza, pandemic H1N1

Panvax Liquid: ready to use Vial 10 Seqirus Limited Class C Type 1

19 02/02/2006 Polio Vaccine - Oral (OPV) Trivalent

Polioviral vaccine Liquid: ready to use Vial 20 Haffkine Bio Pharmaceutical Corporation Ltd

20 02/08/2011 Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3

none Liquid: ready to use Vial 20 Sanofi Pasteur SA


Easyfive-TT Liquid: ready to use Vial 10 Panacea Biotec Ltd. Class C Type 1

22 02/10/2013 Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-

Easyfive-TT Liquid: ready to use Vial 1 Panacea Biotec Ltd. Class C Type 1

5

Haemophilus influenzae type b

23 02/10/2018 Japanese Encephalitis Vaccine (Inactivated) 6µg

JEEV® (6µg) Liquid: ready to use Vial 5 Biological E. Limited

24 02/10/2018 Japanese Encephalitis Vaccine (Inactivated) (3µg Pediatric)


25 03/04/2017 Influenza, seasonal Quadrivalent

GCFLU Quadrivalent Multi inj.

Liquid: ready to use Vial 10 Green Cross Corporation

26 03/08/2016 Japanese Encephalitis Vaccine (Inactivated) (3µg Pediatric)


27 03/11/2009 Polio Vaccine - Oral (OPV) Monovalent Type 1

Monovalent type 1 Oral Poliomyelitis vaccine, IP (mOPV1)

Liquid: ready to use Vial 20 Haffkine Bio Pharmaceutical Corporation Ltd


Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)

Liquid: ready to use Vial 20 PT Bio Farma (Persero)


Poliomyelitis Vaccine (Oral), Bivalent types 1 and 3

Liquid: ready to use Vial 20 Serum Institute of India Pvt. Ltd.

30 04/04/1995 Diphtheria-Tetanus

Diphtheria and Tetanus Vaccine Adsorbed (Paediatric)

Liquid: ready to use Ampoule 1 Serum Institute of India Pvt. Ltd. Class C Type 1


Diphtheria and Tetanus Vaccine Adsorbed (Pediatric)

Liquid: ready to use Vial 10 Serum Institute of India Pvt. Ltd. Class C Type 1


Diphtheria and Tetanus Vaccine Adsorbed (Pediatric)


33 04/04/1995 Diphtheria-Tetanus (reduced antigen content)

Diphtheria and Tetanus Vaccine Adsorbed for Adults and Adolescents








36 04/04/1995 Diphtheria-Tetanus-Pertussis (whole cell)

Diphtheria-Tetanus-Pertussis Vaccine Adsorbed








39

04/04/1995 Tetanus Toxoid Tetanus Toxoid Vaccine Adsorbed


40 04/04/1995 Tetanus Toxoid Tetanus Toxoid Vaccine Adsorbed


41 04/04/1995 Tetanus Toxoid Tetanus Toxoid Vaccine Adsorbed


42 04/09/2006 Measles Measles vaccine Lyophilised active component to be reconstituted with excipient diluent before use

Vial 20 PT Bio Farma (Persero) Class B Type 2


Fluzone Quadrivalent

Liquid: ready to use Vial 1 Sanofi Pasteur-USA


Fluzone Quadrivalent


45 05/01/2018 Rotavirus (live, attenuated)

Rotavac Liquid: ready to use Vial 5 Bharat Biotech International Limited


Rotavac Liquid: ready to use Vial 10 Bharat Biotech International Limited


Afluria® Quadrivalent

Liquid: ready to use Vial 10 Seqirus Limited Class C Type 1

6


Poliorix Liquid: ready to use Vial 1 GlaxoSmithKline Biologicals SA


Poliorix Liquid: ready to use Vial 2 GlaxoSmithKline Biologicals SA


Polio Sabin Mono Three (oral)

Liquid: ready to use Vial 10 GlaxoSmithKline Biologicals SA


Polio Sabin Mono Three (oral)



Bivalent Oral Poliomyelitis Vaccine Type 1&3 (bOPV 1&3)


53 06/01/2009 Measles, Mumps and Rubella

rHA M-M-R II Lyophilised active component to be reconstituted with excipient diluent before use

Vial 1 Merck Vaccines Class B Type 2

54 06/02/2019 Rabies VaxiRab N Lyophilised active component to be reconstituted with excipient diluent before use

Vial 1 Cadila Health Care Ltd Class B Type 2


DTP Vaccine Liquid: ready to use Vial 10 PT Bio Farma (Persero) Class C Type 1


none Liquid: ready to use Vial 10 PT Bio Farma (Persero) Class C Type 1

57 06/11/2015 BCG BCG vaccine (Freeze Dried) - Intradermal


Vial + Ampoule 20 GreenSignal Bio Pharma Limited


Poliomyelitis vaccine

Liquid: ready to use Vial 1 Bilthoven Biologicals B.V.

59 07/10/2008 Rotavirus Rotateq Liquid: ready to use Plastic Tube 1 Merck Vaccines Class C Type Rotateq

60 07/11/2012 Influenza, seasonal

GC FLU Multi inj. Liquid: ready to use Vial 10 Green Cross Corporation Class C Type 1


Bivalent OPV Type 1 and 3 Poliomyelitis Vaccine, Live (Oral)

Liquid: ready to use Vial 20 Panacea Biotec Ltd.


SKYCellflu Multi inj

Liquid: ready to use Vial 10 SK Bioscience Co., Ltd. Class C Type 1

63 08/05/2008 Polio Vaccine - Oral (OPV)Monovalent Type 1

ORAL MONOVALENT TYPE 1 POLIOMYELITIS VACCINE

Liquid: ready to use Vial 20 Sanofi Pasteur SA

64 08/05/2017 Diphtheria-Tetanus-Pertussis (acellular)

Adacel Liquid: ready to use Vial 1 Sanofi Pasteur Limited Class C Type 1

65 08/07/2009 Human Papillomavirus (Bivalent)

Cervarix Liquid: ready to use Vial 1 GlaxoSmithKline Biologicals SA Class C Type 1

66 08/07/2009 Human Papillomavirus (Bivalent)

Cervarix Liquid: ready to use Vial 2 GlaxoSmithKline Biologicals SA Class C Type 1


Measles, Mumps and Rubella Vaccine, Live, Attenuated















71 08/10/2013 Japanese Encephalitis Vaccine (live, attenuated)

Japanese Encephalitis Vaccine Live (SA14-14-2)


Two vial set (active + excipient)

1 Chengdu Institute of Biological Products Co.,Ltd


Japanese Encephalitis Vaccine Live (SA14-14-2)



5 Chengdu Institute of Biological Products Co.,Ltd

73 09/02/2018 Human Papillomavirus (Ninevalent)

Gardasil 9 Liquid: ready to use Vial 1 Merck Vaccines

74 09/02/2018 Varicella Varivax Lyophilised active component to be reconstituted with excipient diluent before use


1 Merck Vaccines Class B Type 2


Priorix Lyophilised active component to be reconstituted with excipient diluent before use

Vial 1 GlaxoSmithKline Biologicals SA Class B Type 2

7


Oral polio Liquid: ready to use Vial 10 PT Bio Farma (Persero)


Oral polio Liquid: ready to use Vial 20 PT Bio Farma (Persero)

78 09/04/1997 Measles Measles vaccine Lyophilised active component to be reconstituted with excipient diluent before use

Vial + Ampoule 10 PT Bio Farma (Persero) Class B Type 2

79 09/05/2006 Tetanus Toxoid Tetatox Liquid: ready to use Vial 10 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class C Type 1

80 09/05/2006 Tetanus Toxoid Tetatox Liquid: ready to use Vial 20 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class C Type 1


Diftet Liquid: ready to use Vial 10 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class C Type 1


Diftet Liquid: ready to use Vial 20 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class C Type 1


Tetadif Liquid: ready to use Vial 10 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class C Type 1


Tetadif Liquid: ready to use Vial 20 BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)

Class C Type 1


Influenza Vaccine (Split virion, inactivated)

Liquid: ready to use Vial 1 Hualan Biological Bacterin Co., Ltd Class C Type 1

95 09/07/2013 Diphtheria-Tetanus-Pertussis (acellular)

Boostrix Liquid: ready to use Vial 1 GlaxoSmithKline Biologicals SA Class C Type 1


IMOVAX POLIO Liquid: ready to use Vial 10 Sanofi Pasteur SA


Fluvirin Liquid: ready to use Vial 10 Seqirus Vaccines Limited Class C Type 1


Fluvirin-H1N1 Liquid: ready to use Vial 10 Seqirus Vaccines Limited Class C Type 1


Eupenta Liquid: ready to use Vial 1 LG Chem Ltd Class C Type 1


Eupenta Liquid: ready to use Vial 10 LG Chem Ltd Class C Type 1

101 10/04/2018 Rabies Rabipur Lyophilised active component to be reconstituted with excipient diluent before use

Vial 1 Chiron Behring Vaccines Private Ltd. Class B Type 2

102 10/12/2007 Yellow Fever Yellow Fever Lyophilised active component to be reconstituted with excipient diluent before use


10 Bio-Manguinhos/Fiocruz Class B Type 2


Adsorbed DT Vaccine

Liquid: ready to use Vial 10 PT Bio Farma (Persero) Class C Type 1

104 11/03/1999 Tetanus Toxoid TT vaccine Liquid: ready to use Vial 10 PT Bio Farma (Persero) Class C Type 1

105 11/03/1999 Tetanus Toxoid TT vaccine Liquid: ready to use Vial 20 PT Bio Farma (Persero) Class C Type 1


Green Flu-S Liquid: ready to use Vial 1 Green Cross Corporation Class C Type 1


Polio Sabin Mono Two (oral)



Polio Sabin Mono Two (oral)


109 11/08/2017 cholera: inactivated oral

Euvichol-Plus Liquid: ready to use Plastic Tube 1 EuBiologics Co., Ltd.

110 11/12/2001 Hepatitis B Heberbiovac HB Liquid: ready to use Vial 1 Centro de Ingenieria Genetica y Biotecnologia

Class C Type 1

111 11/12/2001 Hepatitis B Heberbiovac HB Liquid: ready to use Vial 10 Centro de Ingenieria Genetica y Biotecnologia

Class C Type 1

112 12/03/2009 Rotavirus Rotarix Liquid: ready to use Plastic Tube 1 GlaxoSmithKline Biologicals SA

113 12/03/2009 Rotavirus Rotarix Liquid: ready to use Applicator 1 GlaxoSmithKline Biologicals SA


GC FLU inj Liquid: ready to use Vial 1 Green Cross Corporation Class C Type 1

115 12/07/2012 Tetanus Toxoid None used on labelling for supply through

Liquid: ready to use Vial 1 Biological E. Limited

8

UN agencies. Also marketed with labelled commercial name BEtt.

116 12/07/2012 Tetanus Toxoid None used on labelling for supply through UN agencies. Also marketed with labelled commercial name BEtt.


117 12/07/2013 Japanese Encephalitis Vaccine (Inactivated) 6µg


118 12/11/2004 Hepatitis B Hepatitis B Vaccine (rDNA) (Adult)


119 12/11/2004 Hepatitis B Hepatitis B Vaccine (rDNA) (Adult)

Liquid: ready to use Ampoule or Vial 1 Serum Institute of India Pvt. Ltd. Class C Type 1

120 12/11/2004 Hepatitis B Hepatitis B Vaccine (rDNA) (Paediatric)


121 12/11/2004 Hepatitis B Hepatitis B Vaccine (rDNA) (Paedriatic)

Liquid: ready to use Ampoule or Vial 1 Serum Institute of India Pvt. Ltd. Class C Type 1

122 13/05/2004 Hepatitis B Hepatitis B Vaccine Recombinant

Liquid: ready to use Uniject 1 PT Bio Farma (Persero) Class C Type 1


ORAL MONOVALENT TYPE 2 POLIOMYELITIS VACCINE (mOPV2)


124 14/02/2019 Rotavirus Rotarix Liquid: ready to use Plastic Tube 5 GlaxoSmithKline Biologicals SA

125 14/07/2016 Pneumococcal (conjugate)

Prevenar 13 Multidose Vial

Liquid: ready to use Vial 4 Pfizer Class C Type Prevnar

126 15/02/1993 Measles Measles Vaccine, Live, Attenuated













OPVERO Liquid: ready to use Vial 10 Sanofi Pasteur SA






Synflorix Liquid: ready to use Vial 4 GlaxoSmithKline Biologicals SA


Focetria Liquid: ready to use Vial 10 Seqirus Vaccines Limited


None used on labelling for supply through UN agencies. Also marketed with labelled commercial name BE Td



None used on labelling for supply through UN agencies. Also marketed with labelled commercial name BE Td












9

Conjugate Vaccine


Celtura Liquid: ready to use Vial 17 Seqirus GmbH Class C Type 1


None used on labelling for supply through UN agencies. Also marketed with labelled commercial name ComBE Five (Liquid).

Liquid: ready to use Vial 1 Biological E. Limited Class C Type 1




143 18/07/2000 Measles and Rubella

Measles and Rubella Vaccine, Live, Attenuated
















Vaxem HIB Liquid: ready to use Vial 1 Novartis Vaccines and Diagnostics S.r.l


IMOJEV MD Lyophilised active component to be reconstituted with excipient diluent before use


4 GPO-MBP Co., Ltd. Class B Type 2


Synflorix Liquid: ready to use Vial 2 GlaxoSmithKline Biologicals SA Class C Type 1


Bivalent type 1&3 Oral Poliomyelitis vaccine, IP (bOPV1&3)

Liquid: ready to use Vial 20 Haffkine Bio Pharmaceutical Corporation Ltd

151 19/07/2013 Hepatitis A (Human Diploid Cell), Inactivated (Adult)

Havrix 1440 Adult Liquid: ready to use Vial 1 GlaxoSmithKline Biologicals SA Class C Type 1

152 19/07/2013 Hepatitis A (Human Diploid Cell), Inactivated (Paediatric)

Havrix 720 Junior Liquid: ready to use Vial 1 GlaxoSmithKline Biologicals SA Class C Type 1

153 19/12/2014 Diphtheria-Tetanus-Pertussis (acellular)-Hepatitis B-Haemophilus influenzae type b-Polio (Inactivated)

Hexaxim Liquid: ready to use Vial 1 Sanofi Pasteur SA Class C Type 1


Pentabio Liquid: ready to use Vial 5 PT Bio Farma (Persero) Class C Type 1


Pentabio Liquid: ready to use Vial 10 PT Bio Farma (Persero) Class C Type 1

156 20/03/2001 Yellow Fever Stabilized Yellow Fever Vaccine


Vial 5 Institut Pasteur de Dakar Class B Type 2








BIOPOLIO B1/3 Liquid: ready to use Vial 20 Bharat Biotech International Limited


BIOPOLIO Liquid: ready to use Vial 20 Bharat Biotech International Limited

10


BIOPOLIO Liquid: ready to use Vial 10 Bharat Biotech International Limited

162 20/05/2009 Human Papillomavirus (Quadrivalent)

Gardasil Liquid: ready to use Vial 1 Merck Vaccines


Prevenar 13 Liquid: ready to use Vial 1 Pfizer

164 20/12/2018 Rabies (Inactivated)

Rabies Vaccine Inactivated (Freeze Dried)


Vial + Ampoule 1 Serum Institute of India Pvt. Ltd. Class B Type 2


Fluzone Liquid: ready to use Vial 1 Sanofi Pasteur-USA Class C Type 1


Fluzone Liquid: ready to use Vial 10 Sanofi Pasteur-USA Class C Type 1

167 21/03/2014 Meningococcal ACYW-135 (conjugate vaccine)

Menactra Liquid: ready to use Vial 1 Sanofi Pasteur-USA Class C Type 1

168 21/07/2006 Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B

Diphtheria ,Tetanus, Pertussis and Hepatitis B Vaccine Adsorbed









ROTASIIL Lyophilised active component to be reconstituted with excipient diluent before use


1 Serum Institute of India Pvt. Ltd. Class B Type 2


ROTASIIL Lyophilised active component to be reconstituted with excipient diluent before use


2 Serum Institute of India Pvt. Ltd. Class B Type 2

173 21/12/2009 Tetanus Toxoid None used on labelling for supply through UN agencies. Also marketed with labelled commercial name BEtt.



Priorix Lyophilised active component to be reconstituted with excipient diluent before use

Vial 2 GlaxoSmithKline Biologicals SA Class B Type 2


GCFLU Quadrivalent inj.

Liquid: ready to use Vial 1 Green Cross Corporation


Poliomyelitis Vaccine (live, oral attenuated, human Diploid Cell), type 1 and 3

Liquid: ready to use Vial 20 Beijing Institute of Biological Products Co.,Ltd


Panenza Liquid: ready to use Vial 10 Sanofi Pasteur SA Class C Type 1

178 22/06/2005 Rabies VERORAB Lyophilised active component to be reconstituted with excipient diluent before use



IMOVAX dT adult Liquid: ready to use Vial 10 Sanofi Pasteur SA

180 22/07/1997 Tetanus Toxoid TETAVAX Liquid: ready to use Vial 10 Sanofi Pasteur SA

181 22/07/1997 Tetanus Toxoid TETAVAX Liquid: ready to use Vial 20 Sanofi Pasteur SA

182 22/07/1997 Meningococcal A+C

POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE



10 Sanofi Pasteur SA Class B Type 2


Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed





11





Poliomyelitis Vaccine (Oral), Bivalent types 1 and 3


187 22/11/1996 Hepatitis B Euvax B Liquid: ready to use Vial 1 LG Chem Ltd

188 22/11/1996 Hepatitis B Euvax B Liquid: ready to use Vial 10 LG Chem Ltd

189 22/12/2017 Typhoid (Conjugate)

Typbar-TCV Liquid: ready to use Vial 1 Bharat Biotech International Limited

190 22/12/2017 Hepatitis A (Human Diploid Cell), Inactivated (Adult)

HEALIVE Liquid: ready to use Vial 1 Sinovac Biotech Co. Ltd

191 22/12/2017 Hepatitis A (Human Diploid Cell), Inactivated (Paediatric)

HEALIVE Liquid: ready to use Vial 1 Sinovac Biotech Co. Ltd

192 22/12/2017 Typhoid (Conjugate)

Typbar-TCV Liquid: ready to use Vial 5 Bharat Biotech International Limited

193 23/06/2010 Meningococcal A Conjugate 10 µg

Meningococcal A Conjugate MenAfriVac



194 23/06/2010 Diphtheria-Tetanus-Pertussis (whole cell)-Haemophilus influenzae type b

Diphtheria, Tetanus, Pertussis and Haemophilus influenzae type b Conjugate Vaccine




IPV Vaccine SSI Liquid: ready to use Vial 1 AJ Vaccines A/S


Euvichol Liquid: ready to use Vial 1 EuBiologics Co., Ltd.


AGRIFLU Liquid: ready to use Vial 10 Seqirus Vaccines Limited


ORAL MONOVALENT TYPE 3 POLIOMYELITIS VACCINE



Influenza A (H1N1) 2009 monovalent vaccine

Liquid: ready to use Sprayer 1 MedImmune


IL-YANG FLU Vaccine INJ.

Liquid: ready to use Vial 1 IL-YANG PHARMACEUTICAL CO., LTD.


Serinflu Liquid: ready to use Vial 1 Abbott Biologicals BV


BIOPOLIO B1/3 Liquid: ready to use Vial 10 Bharat Biotech International Limited


Dukoral Liquid: ready to use Vial + Buffer Sachet

1 Valneva Sweden AB


Quimi-Hib Liquid: ready to use Vial 1 Centro de Ingenieria Genetica y Biotecnologia


Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine




Bivalent Oral Poliomyelitis Vaccine Type 1&3 (bOPV 1&3)



Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine


Vial + Ampoule 2 Serum Institute of India Pvt. Ltd.

208 26/05/2010 Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-

Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus


Vial + Ampoule 10 Serum Institute of India Pvt. Ltd.

12


influenzae type b Conjugate Vaccine


Quinvaxem Liquid: ready to use Vial 1 Janssen Vaccines Corp.


NASOVAC Influenza Vaccine, Live Attenuated (Human) Freeze-Dried




NASOVAC Influenza Vaccine, Live Attenuated (Human) Freeze-Dried



212 27/09/1994 BCG BCG Vaccine SSI Lyophilised active component to be reconstituted with excipient diluent before use


10 AJ Vaccines A/S Class B Type 2














Poliomyelitis Vaccine (Inactivated)









Poliomyelitis vaccine multidose, suspension for injection 2.5 mL

Liquid: ready to use Vial 5 Bilthoven Biologicals B.V.


Shan-5 Liquid: ready to use Vial 1 Shantha Biotechnics Private Limited (A Sanofi Company)


Shan-5 Liquid: ready to use Vial 10 Shantha Biotechnics Private Limited (A Sanofi Company)




Shanchol Liquid: ready to use Vial 1 Shantha Biotechnics Private Limited (A Sanofi Company)

225 29/10/2003 Tetanus Toxoid TT vaccine Liquid: ready to use Uniject 1 PT Bio Farma (Persero)


Polio Sabin Mono T1



Polio Sabin Mono T1



Polio Sabin One and Three


13


Polio Sabin One and Three



Vaxigrip Liquid: ready to use Vial 10 Sanofi Pasteur SA

231 30/08/2007 Tetanus Toxoid ShanTT Liquid: ready to use Vial 10 Shantha Biotechnics Private Limited (A Sanofi Company)

232 30/08/2007 Tetanus Toxoid ShanTT Liquid: ready to use Vial 20 Shantha Biotechnics Private Limited (A Sanofi Company)


Nasovac-S Influenza Vaccine, Live, Attenuated (Human)




Synflorix Liquid: ready to use Vial 1 GlaxoSmithKline Biologicals SA

235 30/12/2014 Meningococcal A Conjugate 5 µg

Meningococcal A Conjugate 5 micrograms MenAfriVac 5µg




Menveo Lyophilised active component to be reconstituted with liquid active component before use


1 GlaxoSmithKline Vaccines S.r.l. Class B Type 2


None used on labelling for supply through UN agencies. Also marketed with labelled commercial name TRIPVAC



None used on labelling for supply through UN agencies. Also marketed with labelled commercial name TRIPVAC



Nimenrix Lyophilised active component to be reconstituted with excipient diluent before use

Vial + Ampoule 1 Pfizer Class B Type 2