Working document QAS/18.773

May 2018

Draft document for comment

GUIDELINES ON IMPORT PROCEDURES FOR 1

PHARMACEUTICAL PRODUCTS 2

3

(May 2018) 4

DRAFT FOR COMMENT 5

6

7

8

9

10

© World Health Organization 2018 11

All rights reserved. 12

This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The 13 draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, 14 in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and 15 member organizations) without the permission of the World Health Organization. The draft should not be displayed on any 16 website. 17

Please send any request for permission to: 18

Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, Department of Essential 19 Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730; 20 email: kopps@who.int 21 22 The designations employed and the presentation of the material in this draft do not imply the expression of any opinion 23 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or 24 of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate 25 border lines for which there may not yet be full agreement. 26

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or 27 recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors 28 and omissions excepted, the names of proprietary products are distinguished by initial capital letters. 29

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this 30 draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The 31 responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health 32 Organization be liable for damages arising from its use. 33

This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. 34 35

Should you have any comments on the attached text, please send these to Dr S. Kopp,

Group Lead, Medicines Quality Assurance, Technologies Standards and Norms

(kopps@who.int) with a copy to Mrs Xenia Finnerty (finnertyk@who.int)

by 30 June 2018.

Medicines Quality Assurance working documents will be sent out electronically

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Working document QAS/18.773

page 2 36

SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/18.773: 37

GUIDELINES ON IMPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS 38

39

Proposal for revision of WO Guidelines on import

procedures for pharmaceutical products during the

consultation onGood practices for health products

manufacture and inspection

25–28 April 2017

Presentation of a proposal for update to the 52nd

WHO Expert Committee on Specifications for

Pharmaceutical Preparations

16–22 October 2017

Preparation of draft for revision by Dr V. Gigante,

WHO Medicines Quality Assurance Group

February 2018

Review of draft by Dr A.J. van Zyl, member of the

Expert Advisory Panel for the International

Pharmacopoeia and Pharmaceutical Preparations

April 2018

Finalization of draft for mailing and public

consultation

May–June 2018

Consolidation of comments received beginning of July 2018

Discussion of working document and feedback

received during the informal consultation on Good

practices for health products manufacture and

inspection

10–12 July 2018 (tbc)

Revision based on feedback received during the

informal consultation on Good practices for health

products manufacture and inspection and mailing for

public consultation

August–September 2018

Consolidation of comments received during public

consultation

September 2018

Presentation to the 53rd meeting of the WHO Expert

Committee on Specifications for Pharmaceutical

Preparations

22–26 October 2018

Any other follow-up action as required

Working document QAS/18.773

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[Note from Secretariat: the new text of this document is presented in track-change mode, including 40

editorial revision, except for the Introduction, and Objective and Scope paragraphs.] 41 42

GUIDELINES ON IMPORT PROCEDURES FOR PHARMACEUTICAL 43

PRODUCTS1 44

45

46

1. INTRODUCTORY NOTE 47

48

1.1 Public health considerations demand that medicines should not be treated in the same way as 49

ordinary commodities. Their manufacturing and subsequent handling within the distribution 50

chain, both nationally and internationally, must conform to prescribed standards and be 51

rigorously controlled. These precautions serve to assure that patients receive high standard 52

quality medicines, and to prevent the infiltration of substandard and suspected falsified 53

medicine into the supply system. 54

55

1.2 The availability of pharmaceutical products is sometimes limited due to economic constraints, 56

difficulty in meeting norms and standards in their production, and lack of resources in their 57

supply chain. The market penetration by substandard and suspected falsified medicines poses 58

hazards for public health and forces the diversion of public health resources from other uses. 59

In light of this, investments towards strengthening strategies at the customs level are deemed 60

crucial to ensure high-quality medicines to patients (1, 2). 61

62

1.3 The global economy of scale and scope that characterize modern trade require continuous 63

improvement in border control. This includes a departure from the traditional reactive control 64

system to a risk-based and pro-active approach. The risk-based surveillance scheme should 65

identify risks and define the controls that will protect patients from substandard, falsified and 66

unregulated medicines. A risk-based approach can improve the cost-benefit ratio with existing 67

or reduced resources through more effective and efficient controls. 68

69

1.4 Within the context of its revised medicines strategy adopted in 1986 by the Thirty-ninth 70

World Health Assembly (WHA) in resolution WHA39.27, the World Health Organization 71

(WHO) developed Guiding principles for small national drug regulatory authorities (3) 72

which established a regulatory approach in line with the resources available within a small 73

national regulatory authority, and were intended to assure not only the quality, but also the 74

safety and efficacy of pharmaceutical products distributed under its aegis. 75

76

1.5 The principles emphasize the need for the effective use of the WHO Certification Scheme on 77

the Quality of Pharmaceutical Products Moving in International Commerce (4, 5). This 78

constitutes a formal agreement between participating Member States to provide information 79

on any product under consideration for export, notably on its marketing authorization in the 80

country of origin and whether or not the manufacturer complies with WHO guidelines on 81

good manufacturing practices for pharmaceutical products (6). 82

83

1 This was first published in 1996 in the WHO Technical Report Series, No. 863, Annex 12.

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1.6 To be fully effective, the Scheme needs to be complemented by administrative and other 84

safeguards aimed at ensuring that consignments of imported products are in conformity with 85

all particulars with the relevant marketing authorization and that they remain secure within 86

the distribution chain. Storage and transit facilities must provide protection against tampering 87

and adverse conditions, and relevant controls must be applied at every stage of transportation 88

(7, 8). 89

90

1.7 Pharmaceutical products containing substances controlled under international conventions 91

have long been subjected to rigorous border control. Some of these controls, and particularly 92

those designed to prevent the diversion and illicit interchange of products during transit, are 93

relevant to all pharmaceutical products, and are therefore included in these guidelines. Full 94

details of the special import controls required for narcotic drugs and psychotropic substances 95

are given in the Appendix. 96

97

2. OBJECTIVES AND SCOPE 98

99

2.1 These guidelines, which stem from the above considerations, had been developed first in 1996 100

in consultation with national regulatory authorities (NRAs), the pharmaceutical industry, the 101

World Customs Organization, and the United Nations International Drug Control Programme.2 102

103

2.2 The guidelines are directed to all parties involved in the importation of pharmaceutical 104

products, including NRAs, competent trade ministries, customs authorities, port authorities, and 105

importing agents. 106

107

2.3 They are intended to promote efficiency in applying relevant regulations, to simplify the 108

checking and handling of consignments of pharmaceutical products in international transit and, 109

inter alia, to provide a basis for collaboration between the various interested parties. 110

111

2.4 They are applicable to any pharmaceutical products destined for use within the country of 112

import and are intended to be adopted into prevailing national procedures and legal requirements. 113

114

3. GLOSSARY 115

116

The definitions given apply to the terms used in these guidelines. They may have different meanings 117

in other contexts. 118

authorization. See Note. 119

120

counterfeit product. A pharmaceutical product that is deliberately and fraudulently 121

mislabelled with respect to identity and/or source. Both branded and generic products can be 122

counterfeited, and counterfeit products may include products with the correct ingredients, with the 123

wrong ingredients, without active ingredients, with insufficient quantity of active ingredients or 124

with fake packaging.falsified product. A product that deliberately/fraudulently misrepresents its 125

identity, composition or source, and which therefore requires testing beyond the routine quality 126

control testing. Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, 127

2 Since 1997 part of the UN Office for Drug Control and Crime Prevention.

Working document QAS/18.773

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product. 129

130

drug national regulatory authority. The national agency responsible for the 131

registrationmarketing authorization of, and other regulatory activities concerning pharmaceutical 132

products. 133

134

import authority. The national agency responsible for authorizing imports (e.g. the ministry 135

or department of trade or of imports and exports). 136

137

importation. The act of bringing or causing any goods to be brought into a customs territory 138

(national territory, excluding any free zone). 139

140

importer. An individual or company or similar legal entity importing or seeking to import a 141

pharmaceutical product. A “licensed” or “registered” importer is one who has been granted a licence 142

or registration status for the purpose. In addition to a general licence or permit as an importer, some 143

countries usually require a marketing authorization an additional licence to be issued by the national 144

drug regulatory authoritynational regulatory authority if pharmaceutical products are to be imported. 145

146

licence. See note. 147

148

marketing authorization (product license, registration certificate). A legal document issued 149

by the competent medicines regulatory authority that authorizes the marketing or free distribution of a 150

pharmaceutical product in the respective country after evaluation for safety, efficacy and quality. In 151

terms of quality it establishes inter alia the detailed composition and formulation of the 152

pharmaceutical product and the quality requirements for the product and its ingredients. It also 153

includes details of packaging, labelling, storage conditions, shelf life and approved conditions of use. 154

155

national regulatory authority. The national agency responsible for the marketing 156

authorization of, and other regulatory activities concerning pharmaceutical products. 157

158

pharmaceutical product. Any medicine intended for human or veterinary use, presented in its 159

finished dosage form, that is subject to control by pharmaceutical legislation in both the exporting 160

state and the importing state. 161

registration. See Note. 162

163

screening technologies. The qualitative and/or semi-quantitative technologies which could 164

rapidly acquire the analytical information or data for preliminary identification of suspect medical 165

products in the field. 166

167

standard operating procedure. An authorized written procedure giving instructions for 168

performing standardized operations both general and specific. 169

170

starting material. Any substance of defined quality used in the production of a 171

pharmaceutical product, but excluding packaging materials. 172

173

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substandard product. For the purposes of this document, a substandard product is an 174

authorized product that fails to meet either its quality standards or its specifications, or both according 175

to the requirements in the territory of use. These standards and specifications are normally reviewed, 176

assessed and approved by the applicable national or regional medicines regulatory authority before the 177

product is authorized for marketing 178

179

unauthorized product. A product that is not in compliance with national and regional 180

regulations and legislation, being unknown to the authorities, and which therefore requires testing 181

beyond the routine quality control testing. 182

Note Because of a lack of uniformity in national legal requirements and administrative 183

practices, the terms “registered”, “licenced” and “authorized” have been used in these guidelines as if 184

they were interchangeable. When the guidelines are being used as a basis for drawing up national 185

guidelines, more precise terminology applicable to the country concerned should be used. In some 186

countries, for example, “certificate of drug registration” has been replaced by terms such as 187

“marketing authorization”. 188

189

4. LEGAL RESPONSIBILITIES 190

191

4.1 The importation of pharmaceutical products should be done effected in accordance conformity 192

with national legislation regulations promulgated under the national drugs act or other relevant 193

legislation and should be enforced by the NDRANRA and other relevant authorities. National 194

guidelines providing recommendations on the implementation of these regulations legislation 195

should be drawn up by the NDRANRA, or by the ministry of health, or if an NRA is not formally 196

established, in collaboration with the customs authority and other responsible interested 197

entitiesagencies and organizations. 198

199

4.2 All transactions relating to the importation of consignments of pharmaceutical products 200

should be conducted either through the governmental drug procurement agency or through 201

independent wholesale dealers specifically designated and licensed by the NDRANRA for this 202

purpose. 203

204

4.3 The importation of all consignments of pharmaceutical products should be channelled 205

exclusively through customs posts or ports specifically authorized designated for this purpose. 206

This is also applicable to pharmaceuticals moving through the networking global commerce (i.e. 207

world wide web/internet). 208

209

4.4 All formalities undertaken on importation should be coordinated by the customs 210

serviceauthority, which should have the authority to for request the services of an official 211

pharmaceutical inspector or enforcement officer on as occasion, when required demands. When 212

justified by the workload, a pharmaceutical inspector may be stationed in a full-time position at 213

one or more of the designated ports of entry. 214

215

4.5 The customs authority should utilize have itsthe discretionary powers to request technical 216

advice and opinions from other appropriately qualified persons, when required. 217

should this be warranted by particular circumstances. 218

5. LEGAL BASIS OF CONTROL 219

220

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5.1 Subject to the exemptions specified in paragraph 4.4 below, only pharmaceutical products 221

proved by appropriate documentation to be duly licensed for marketing or specific intended use 222

such as inas clinical trials, named patient programs or other means as appropriate etc. withiin the 223

importing country, should be cleared by customs. 224

225

5.2 The NDRANRA should compile comprehensive and frequently updated lists of licensed 226

products authorized for marketing and authorized importing agents, which are frequently updated, 227

and issue notifications of any product licenses withdrawn or temporarily suspended on grounds of 228

safety, quality or efficacy or safety. These withdrawals or suspensions ; the latter sshould be 229

rapidly communicated to health-care providers and patients and presented in a timely manner 230

designed to attract attention. Allmanner. All lists and notifications of a temporary suspension or 231

withdrawal of a product licencemarketing authorization should be published accessible, 232

preferably on the NRA or mMinistry of hHealth websitethrough a computerized database, and 233

should be easily accessible forto designated customs posts, authorized importing agents and all 234

drug wholesalers. In case of risks to for public health, patients should be advised to contact their 235

doctors or practitioners before suspending their treatments and receive appropriate instructions on 236

how to continue their therapy. 237

238

5.3 NRAs should be empowered to take legal actions and shouldall closely collaborate closely 239

with customs, police, judiciary and others etc. to detect substandard and falsified productsfalsified 240

products and to avoid the circulation of those products in the local and international trade. 241

Efficient and confidential channels for communicating information on these counterfeitfalsified 242

products and other illicit activities should be established between all responsible interested official 243

bodies without undue delay. 244

245

5.4 In countries where no formal system of products licensing marketing authorization has been 246

established, importation of products is most effectively controlled by issuing permits in the name 247

of the NDRANRA to the authorized importing agency or agent. Within the framework of the 248

Certification Scheme framework the WHO provides a list with names and full addresses of those 249

government organizations authorized to sign and issue a certificate of a pharmaceutical product 250

(CPP). NMRAs receiving a CPP can use this list to check and verify if the certificate they are 251

receiving has been issued by the authorized organization (4, 5). Additional measures that may be 252

taken under these conditions include: 253

254

the provision by the NDRANRA to the customs authorities s aand to the importing 255

agency and agents of official lists of pharmaceutical products permitted and/or prohibited 256

to be imported; 257

the provision by the importing agent of certified information to establish that the product 258

is authorized by license for sale in the country of export. 259

260

5.5 The NDRANRA should reserve discretionary powers to waive product licencing authorization 261

requirements in respect of consignments of pharmaceutical products imported in response to 262

emergency situations and, exceptionally, in response to requests from clinicians for limited 263

supplies of an unlicensed product needed for the treatment of a specific named patient. 264

265

6. REQUIRED DOCUMENTATION 266

267

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6.1 As a prerequisite to customs clearance, the importing agency or agent should be required to 268

furnish the customs authority with the following documentation in respect of each consignment: 269

270

certified copies of documents issued by the NDRANRA in the importing country, 271

attesting that: 272

(a) the importer is duly authorized by licenceauthorized to undertake the transaction, 273

andand 274

(b) the product is duly authorized by licenceauthorized to be marketed in the 275

importing country; or otherwise so anyway authorized for use in clinical trial or for a 276

named patient use; 277

a batch certificate issued by the manufacturer, in line consonant with the requirements of 278

the WHO Certification Scheme, that documents the results of the final quality analytical 279

control of the batch(es) constituting the consignment; 280

safety data sheet; 281

a relevant invoice or bill and, when applicable, an authorization for the release of foreign 282

exchange granted by the competent national authority in the country of import; 283

any other documentation required by national legislation for customs clearance. 284

285

7. IMPLEMENTATION OF CONTROLS 286

287

7.1 A visual and physical examination should be routinely undertaken by the customs authorities. 288

Where possible, this should be done , if possible in collaboration with an inspector or enforcement 289

officer of the national drug regulatory authority NDRANRA. The size of the consignment should 290

be checked against invoices, and particular aattention should be accorded given to the nature and 291

conditions of the packaging and labelling. The external package should can be compared with a 292

standard when this is possible. (Note: spelling errors, low-quality printing and other defects may 293

be signs indicative of a substandard or falsified product. (2).) 294

295

7.2 Arrangements should be made with the inspector or enforcement officer of the national drug 296

regulatory authority NDRANRA for the routine physical and chemical sampling and subsequent 297

physical and chemical analysis of exceptionally large and/or valuable consignments and any other 298

consignment that may appear to have has apparently deteriorated, or that is damaged or is of 299

doubtful authenticity. (Note: The external package should be intact and should do not show any 300

signs of damages or infiltrations that may change able to alter the inner content (2, 11,13,14).) 301

302

7.2 3 When samples are taken for analysis to a governmental or other accredited drug quality 303

control laboratory, the consignment should be placed in quarantine. During this procedure, and 304

throughout the time that the consignment is held in customs, particular care must be taken to 305

ensure that packages do not come into contact with potential contaminants. In addition, the 306

package should be stored under appropriate conditions as recommended on the label or in the 307

safety data sheet such as ; taking care of monitoring the optimal temperature limits (i.e. if the cold 308

chain has to be maintained), protection from light, humidity and temperature excursions (12, 13, 309

14). 310

311

7.3 4 A consignment suspected of being substandard, unregistered/unlicensed, or counterfeit 312

falsified or unnot registered (unlicensed)authorized should be placed in quarantine pending the 313

analysis of samples and forensic investigation. Time is often saved if materials and reagents 314

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needed to undertake simple analytical tests and screening technologies are available at the port of 315

entry.customs border. 316

317

7.4 5 Representatives of the manufacturer of the authentic product, and/or the owner of the 318

trademark, and the consignee should immediately be advised of such action. 319

320

7.5 6 National regulations should define the responsibilities of the respective interested parties 321

and the precise procedures to be followed by . In particular, the provisions should identify the 322

agency body (i.e local representatives from the police service, border control, ministery of health, 323

as appropriate, ) responsible for the relevant coordinating the investigation and legal 324

actionsbringing prosecutions. 325

326

7.6 7 CounterfeitFalsified products and or other products which have been imported in 327

contravention of the law must be forfeited and destroyed, or otherwise dealt with in accordance 328

with legal procedures. Such procedures should be available, recorded and appropriately 329

savedrecordedarchived (9). 330

331

7.7 8 The relevant authorities must be indemnified against any consequent legal actions and 332

proceedings. 333

334

7.8 9 NDRANRAs should urged to notify are not later than a working day urged to notify other 335

national authorities of confirmed cases of imported substandard or counterfeitfalsified 336

pharmaceutical products without delay, through the WHO Global Surveillance and Monitoring 337

System, onDivision of Drug Management and Policies Essential Medicines and Health Products 338

of WHO through the appropriate form. The form is provided as a template to trained focal points 339

within NRAs. The WHO Global Surveillance and Monitoring System collects reports from focal 340

points in the NRAs ational Regulatory Authorities and iInternational procurement agencies which 341

o if necessary will forward the report Once the mandatory fields are completed, the document can 342

be saved and sent as an attachment via email to rapidalert@who.int where necessary. Focal points 343

are encouraged to send any photographs, laboratory reports or other relevant documents as 344

attachments. (http://www.who.int/medicines/regulation/ssffc/medical-products/en/ 345

346

8. PROCEDURES APPLICABLE TO PHARMACEUTICAL STARTING MATERIALS 347

348

8.1 When considering finished pharmaceutical products, in In accordance with good 349

manufacturing practices (GMP), theformal responsibility for the quality analytical control of 350

starting materials used in that product is vested in the manufacturer of the finished pharmaceutical 351

product (FPP). ConsequentlyUnfortunately, only a few countries have introduced formal licensing 352

requirements for active pharmaceutical substances ingredients (APIs) (8). 353

354

8.2 Exceptionally, however, sSome national authorities now exercise documentary and (in some 355

cases) also quality analytical control, through laboratory testing of starting materials, as a 356

prerequisite to customs clearance. 357

358

8.3 Each imported consignment of a pharmaceutical starting material should be 359

accompaniesdaccompanied by a warranty (or batch certificate) prepared by the manufacturer as 360

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recommend by the WHO Certification Scheme (WHICH SCHEME? Refer to SMACS?).WHO 361

pharmaceutical starting materials certification scheme (SMACS) (10). 362

363

9. STORAGE FACILITIES 364

365

9.1 Many pharmaceutical products tend to degrade during on storage and some need to be stored 366

kept under specified conditionsin such as 2–8 degrees °Celsiuscold storage. All customs posts 367

designated to handle consignments of pharmaceutical products should consequently be provided 368

with secure storage facilities, with the required conditions including cold storage areas, where 369

required. refrigerated compartments. If no pharmaceutical inspector or enforcement officer is 370

employed on site, these facilities should be inspected periodically by the NDRANRA to ensure 371

that all equipment is maintained and in good working order. 372

373

9.2 The importing agency or agent should alert the customs authorities in advance of the 374

anticipated arrival of consignments in order that they may be transferred from the international 375

carrier to the designated storage facility with the minimum ofout delay and, in appropriate cases, 376

without breaking the cold chain. 377

378

9.3 Consignments of pharmaceutical products and pharmaceutical starting materials should be 379

accorded high priority for clearance through customs. 380

381

9.4 When several different consignments await clearance the customs authorities should be 382

guided by the pharmaceutical drug inspector or enforcement officer as to which should be 383

accorded priority. 384

385

10. TRAINING REQUIREMENTS 386

387

10.1 Performance is When implementing the guidelines, the performance of the quality system 388

(including but not limited to personnel, documentation, procedures, and and equipment) should 389

be reviewed on an open-ended basis and , if necessary, improved in the light of on-site monitoring 390

and evaluation. Workshops designed to facilitate efficient implementation of the guidelines and 391

quality systems, and to foster collaborative approaches between the various responsible parties, 392

should be organized at intervals s circumstances demand, by the NDRANRA in collaboration 393

with the customs authority and other parties. 394

395

11 AUDIT AND SELF- INSPECTION 396

397

11.1 SAudit from third party and/or self-inspections should be conducted on a routine basis to 398

verify the correct functionality of the quality system standard operating procedures in place at the 399

entry port. C to allow the introduction of corrective and preventive actions measures should be 400

implemented for any potential deficiencies identified. Audits by third parties are further 401

recommended. Audits and self-inspection records should document compliance of personnel to 402

both the standard operating procedures adopted and the equipment used in as the screening 403

technologies (i.e. measuring and monitoring devices, instrument for sampling, testing, etc.) (15). 404

405

REFERENCES 406

407

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1. Guidelines on the conduct of surveys of the quality of medicines (WHO Technical Report 408

Series, No. 996, 2016, Annex 7). 409

2. WHO guidance on testing of “suspect” falsified medicines (WHO Technical Report Series, No. 410

1010, Annex 5, 2018). 411

3. National Drug Regulatory Legislation: Guiding Principles for Small Drug Regulatory 412

Authorities (WHO Technical Report Series, No. 885, 1999, Annex 8). 413

4. WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in 414

International Commerce. In: Fiftieth World Health Assembly, Resolution WHA50.3, Geneva. 415

5. Guidelines on the implementation of the WHO certification scheme on the quality of 416

pharmaceutical products moving in international commerce (in Working document 417

QAS/18.768 April 2018) 418

http://www.who.int/medicines/areas/quality_safety/quality_assurance/WHOCertificationSche419

me-QAS18-768_06042018-wb-09042018.pdf?ua=1. 420

6. WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles (WHO 421

Technical Report Series, No. 986, 2014, Annex 2). 422

7. WHO Good distribution practices for pharmaceutical products (WHO Technical Report Series, 423

No. 957, 2010, Annex 5). 424

8. Good trade and distribution practices for starting materials (revision) (WHO Technical 425

Report Series, No. 996, 2016, Annex 6). 426

9. Guidance on good data and record management practices (WHO Technical Report Series, No. 427

996, 2016, Annex 5). 428

10. WHO pharmaceutical starting materials certification scheme (SMACS) 429

(WHO Technical Report Series, No 917, 2003, Annex 3). 430

11. Considerations for requesting analysis of medicines samples (WHO Technical Report Series, 431

No. 1010 , 2018, Annex 3). 432

12. WHO guide to good storage practices for pharmaceutical (WHO Technical Report Series, No. 433

908, 2003, Annex 9). 434

13. Technical supplements to Model guidance for the storage and transport of time and 435

temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 992, 2015, 436

Annex 5). 437

14. Model guidance for the storage and transport of time- and temperature-sensitive 438

pharmaceutical products (jointly with the Expert Committee on Biological Standardization) 439

(WHO Technical Report Series, No. 961, 2011, Annex 9). 440

15. Available authentication technologies for the prevention and detection of SSFFC medical 441

products. Appendix 2 of the Report by the Director-General on Member State mechanism on 442

substandard/spurious/falsely-labelled/falsified/counterfeit medical products (WHA A70/23). 443

444

445

446

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APPENDIX 447

Special import controls for narcotic drugs and psychotropic substances3 448

449

In accordance with the requirements of the international drug control treaties (i.e. the Single 450

Convention on Narcotic Drugs, 1961, and that Convention as amended by the 1972 Protocol, and the 451

Convention on Psychotropic Substances, 1971, referred to subsequently as the 1961 Convention and 452

the 1971 Convention), each state must adopt national legislation and administrative regulations and 453

establish administrative structures to ensure the full implementation of the provisions of these treaties 454

on its territory and cooperation with other states. 455

456

Most of the requirements specified in these guidelines on import procedures for pharmaceutical 457

products also apply to the border control of narcotic drugs and psychotropic substances. In addition, 458

detailed information on the control of international trade in narcotic drugs and psychotropic 459

substances can be found in Article 31 of the 1961 Convention and Article 12 of the 1971 Convention, 460

respectively. The guidelines provided in this Appendix are intended to facilitate the operation of 461

control at entry points, and can be expanded by taking into account the legislation and administrative 462

regulations in force in each country. 463

464

The customs authorities and, if applicable, any other law enforcement authorities assigned to border 465

control and customs should cooperate closely with the competent authorities for the control of 466

narcotic drugs and psychotropic substances designated by the government (subsequently referred to as 467

the competent authorities). It should be noted that, while the competent authorities in some countries 468

are different from the NDRANRA, in others they may be one and the same. 469

470

The customs authorities, or any other competent law enforcement authorities, should be well trained 471

and equipped (e.g. with drug identification kits) so that they can distinguish consignments of narcotic 472

drugs and psychotropic substances from other pharmaceutical products. They should be provided 473

with lists of narcotic drugs and psychotropic substances under international control, e.g. the “Yellow 474

List” and “Green List” published by the International Narcotics Control Board, which include, inter 475

alia, trade names of pharmaceutical products containing narcotic drugs and psychotropic substances. 476

They may also make use of the Multilingual dictionary of narcotic drugs and psychotropic substances 477

under international control (1) (ST/NAR/1 Rev.2ST/NAR/1/REV.1) published by the United Nations 478

in 2006 (sales number M.06.XI.) with its Addendum-2015 and Supplement-2016. Furthermore, they 479

should be provided with lists of narcotic drugs and psychotropic substances whose importation into 480

the country has been prohibited. 481

482

Checks conducted during the border control of narcotic drugs and of psychotropic substances listed in 483

Schedules I and II of the 1971 Convention should ensure that each consignment has been duly 484

authorized by the competent authorities of the importing country. The competent authorities expresses 485

theirits consent to each import by issuing an import certificate (for narcotic drugs) or an import 486

authorization (for psychotropic substances). When presented with the original of this document, the 487

competent authorities of the exporting country may issue an export authorization permitting the 488

3 “Narcotic drug” means any of the substances listed in Schedules I and II of the Single Convention on Narcotic

Drugs, 1961, as amended by the 1972 Protocol, whether natural or synthetic; “psychotic substance” means any

substance, natural or synthetic, listed in Schedule I, II, III or IV of the Convention on Psychotropic Substances,

1971.

Working document QAS/18.773

page 13 consignment containing narcotic drugs or psychotropic substances to leave the exporting country. In 489

free ports and zones governments should exercise the same supervision and control as in other parts of 490

their territory, provided, however, that they may apply more drastic measures if appropriate. 491

492

The competent authorities of the importing country may wish to inform the customs, or any other 493

competent law enforcement authorities, of authorized imports of narcotic drugs and psychotropic 494

substances before the entry of the consignment into the country. 495

496

In addition to the other documents referred to in section 5 of the guidelines, the customs authorities 497

should require the importer or importer’s agent to provide them with a copy of the respective import 498

authorization (certificate) issued by the competent authorities of the importing country. This 499

document should be compared with the export authorization issued by the competent authorities of the 500

exporting country, a copy of which must accompany each consignment. The authenticity of these 501

documents must be carefully checked. In case of doubt, the competent authorities should be consulted 502

immediately. 503

504

Import and expert export authorizations (certificates) should contain the following information: 505

506

the name of the narcotic drug or psychotropic substance (if available, the International 507

Nonproprietary Name (INN)); 508

the quantity to be imported/exported, expressed in terms of anhydrous base content; 509

the pharmaceutical form and, if in the form of a preparation, the name of the preparation; 510

the name and address of the importer and exporter; 511

the period of validity of the authorization. 512

513

In addition, the exporter authorization should contain the number and date of the corresponding 514

import authorization/certificate and the name of the competent authority of the importing country by 515

whom it was issued. 516

517

The competent authorities of the importing country may wish to specify in the import 518

authorization/certificate the entry point through which they importation must be effected. 519

520

During the visual and physical examination of the imported consignment, the quantity of narcotic 521

drugs or psychotropic substances contained in it should be carefully checked. If the quantity exceeds 522

the amount authorized, the consignment should be stopped by the customs and the matter brought to 523

the attention of the competent authorities for the control of narcotic drugs and psychotropic 524

substances in the importing country. If the quantity imported is the same as, or less than, the amount 525

authorized, the quantity should be recorded on the copy of the export authorization accompanying the 526

consignment and communicated to the competent authorities of the importing country. 527

528

All consignments containing psychotropic substances included in Schedule III of the 1971 529

Convention must be accompanied by a separate export declaration. This document should indicate the 530

name and address of the exporter and importer, the name of the substance, the quantity and the 531

pharmaceutical form in which the substance is exported, including, if applicable, the name of the 532

preparation and the date of dispatch. 533

534

Working document QAS/18.773

page 14 Pursuant to the recommendations contained in resolutions of the Economic and Social Council of the 535

United Nations, many governments now require import authorizations not only for psychotropic 536

substances in Schedules I and II but also for those in Schedules III and IV of the 1971 Convention. 537

This strengthening of the control requirements has proved to be very useful in preventing attempts to 538

divert psychotropic substances, such as stimulants, sedative-hypnotics and tranquilizers, into illicit 539

traffic. 540

541

542

REFERENCES 543

544

1. Multilingual Dictionary of Narcotic Drugs and Psychotropic Substances under International 545

Control https://www.unodc.org/unodc/en/scientists/multilingual-dictionary-of-narcotic-drugs-and-546

psychotropic-substances-under-international-control.html. 547

548

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