Working document QAS/18.

773
May 2018
Draft document for comment

1 GUIDELINES ON IMPORT PROCEDURES FOR

2 PHARMACEUTICAL PRODUCTS
3
4 (May 2018)
5 DRAFT FOR COMMENT

6 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
([email protected]) with a copy to Mrs Xenia Finnerty ([email protected])
7 by 30 June 2018.
Medicines Quality Assurance working documents will be sent out electronically
8 only and will also be placed on the Medicines website for comment under “Current
projects”. If you do not already receive our draft working documents please let us
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10

11 © World Health Organization 2018

12 All rights reserved.
13 This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The
14 draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole,
15 in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and
16 member organizations) without the permission of the World Health Organization. The draft should not be displayed on any
17 website.
18 Please send any request for permission to:
19 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, Department of Essential
20 Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730;
21 email: [email protected]
22
23 The designations employed and the presentation of the material in this draft do not imply the expression of any opinion
24 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or
25 of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate
26 border lines for which there may not yet be full agreement.
27 The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or
28 recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors
29 and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
30 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this
31 draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The
32 responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health
33 Organization be liable for damages arising from its use.
34 This draft does not necessarily represent the decisions or the stated policy of the World Health Organization.
35
 Working document QAS/18.773
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36
37 SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/18.773:
38 GUIDELINES ON IMPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS
39
Proposal for revision of WO Guidelines on import 25–28 April 2017
procedures for pharmaceutical products during the
consultation onGood practices for health products
manufacture and inspection
Presentation of a proposal for update to the 52nd 16–22 October 2017
WHO Expert Committee on Specifications for
Pharmaceutical Preparations
Preparation of draft for revision by Dr V. Gigante, February 2018
WHO Medicines Quality Assurance Group
Review of draft by Dr A.J. van Zyl, member of the April 2018
Expert Advisory Panel for the International
Pharmacopoeia and Pharmaceutical Preparations
Finalization of draft for mailing and public May–June 2018
consultation
Consolidation of comments received beginning of July 2018

Discussion of working document and feedback 10–12 July 2018 (tbc)

received during the informal consultation on Good
practices for health products manufacture and
inspection
Revision based on feedback received during the August–September 2018
informal consultation on Good practices for health
products manufacture and inspection and mailing for
public consultation
Consolidation of comments received during public September 2018
consultation
Presentation to the 53rd meeting of the WHO Expert 22–26 October 2018
Committee on Specifications for Pharmaceutical
Preparations
Any other follow-up action as required
 Working document QAS/18.773
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40 [Note from Secretariat: the new text of this document is presented in track-change mode, including
41 editorial revision, except for the Introduction, and Objective and Scope paragraphs.]
42
43 GUIDELINES ON IMPORT PROCEDURES FOR PHARMACEUTICAL
44 PRODUCTS1
45
46
47 1. INTRODUCTORY NOTE
48
49 1.1 Public health considerations demand that medicines should not be treated in the same way as
50 ordinary commodities. Their manufacturing and subsequent handling within the distribution
51 chain, both nationally and internationally, must conform to prescribed standards and be
52 rigorously controlled. These precautions serve to assure that patients receive high standard
53 quality medicines, and to prevent the infiltration of substandard and suspected falsified
54 medicine into the supply system.
55
56 1.2 The availability of pharmaceutical products is sometimes limited due to economic constraints,
57 difficulty in meeting norms and standards in their production, and lack of resources in their
58 supply chain. The market penetration by substandard and suspected falsified medicines poses
59 hazards for public health and forces the diversion of public health resources from other uses.
60 In light of this, investments towards strengthening strategies at the customs level are deemed
61 crucial to ensure high-quality medicines to patients (1, 2).
62
63 1.3 The global economy of scale and scope that characterize modern trade require continuous
64 improvement in border control. This includes a departure from the traditional reactive control
65 system to a risk-based and pro-active approach. The risk-based surveillance scheme should
66 identify risks and define the controls that will protect patients from substandard, falsified and
67 unregulated medicines. A risk-based approach can improve the cost-benefit ratio with existing
68 or reduced resources through more effective and efficient controls.
69
70 1.4 Within the context of its revised medicines strategy adopted in 1986 by the Thirty-ninth
71 World Health Assembly (WHA) in resolution WHA39.27, the World Health Organization
72 (WHO) developed Guiding principles for small national drug regulatory authorities (3)
73 which established a regulatory approach in line with the resources available within a small
74 national regulatory authority, and were intended to assure not only the quality, but also the
75 safety and efficacy of pharmaceutical products distributed under its aegis.
76
77 1.5 The principles emphasize the need for the effective use of the WHO Certification Scheme on
78 the Quality of Pharmaceutical Products Moving in International Commerce (4, 5). This
79 constitutes a formal agreement between participating Member States to provide information
80 on any product under consideration for export, notably on its marketing authorization in the
81 country of origin and whether or not the manufacturer complies with WHO guidelines on
82 good manufacturing practices for pharmaceutical products (6).
83

1
This was first published in 1996 in the WHO Technical Report Series, No. 863, Annex 12.
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84 1.6 To be fully effective, the Scheme needs to be complemented by administrative and other
85 safeguards aimed at ensuring that consignments of imported products are in conformity with
86 all particulars with the relevant marketing authorization and that they remain secure within
87 the distribution chain. Storage and transit facilities must provide protection against tampering
88 and adverse conditions, and relevant controls must be applied at every stage of transportation
89 (7, 8).
90
91 1.7 Pharmaceutical products containing substances controlled under international conventions
92 have long been subjected to rigorous border control. Some of these controls, and particularly
93 those designed to prevent the diversion and illicit interchange of products during transit, are
94 relevant to all pharmaceutical products, and are therefore included in these guidelines. Full
95 details of the special import controls required for narcotic drugs and psychotropic substances
96 are given in the Appendix.
97
98 2. OBJECTIVES AND SCOPE
99
100 2.1 These guidelines, which stem from the above considerations, had been developed first in 1996
101 in consultation with national regulatory authorities (NRAs), the pharmaceutical industry, the
102 World Customs Organization, and the United Nations International Drug Control Programme.2
103
104 2.2 The guidelines are directed to all parties involved in the importation of pharmaceutical
105 products, including NRAs, competent trade ministries, customs authorities, port authorities, and
106 importing agents.
107
108 2.3 They are intended to promote efficiency in applying relevant regulations, to simplify the
109 checking and handling of consignments of pharmaceutical products in international transit and,
110 inter alia, to provide a basis for collaboration between the various interested parties.
111
112 2.4 They are applicable to any pharmaceutical products destined for use within the country of
113 import and are intended to be adopted into prevailing national procedures and legal requirements.
114
115 3. GLOSSARY

116
117 The definitions given apply to the terms used in these guidelines. They may have different meanings
118 in other contexts.
119 authorization. See Note.
120
121 counterfeit product. A pharmaceutical product that is deliberately and fraudulently
122 mislabelled with respect to identity and/or source. Both branded and generic products can be
123 counterfeited, and counterfeit products may include products with the correct ingredients, with the
124 wrong ingredients, without active ingredients, with insufficient quantity of active ingredients or
125 with fake packaging.falsified product. A product that deliberately/fraudulently misrepresents its
126 identity, composition or source, and which therefore requires testing beyond the routine quality
127 control testing. Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration,

2
Since 1997 part of the UN Office for Drug Control and Crime Prevention.
 Working document QAS/18.773
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128 reproduction of an authorized product or the manufacture of a product that is not an authorized
129 product.
130
131 drug national regulatory authority. The national agency responsible for the
132 registrationmarketing authorization of, and other regulatory activities concerning pharmaceutical
133 products.
134
135 import authority. The national agency responsible for authorizing imports (e.g. the ministry
136 or department of trade or of imports and exports).
137
138 importation. The act of bringing or causing any goods to be brought into a customs territory
139 (national territory, excluding any free zone).
140
141 importer. An individual or company or similar legal entity importing or seeking to import a
142 pharmaceutical product. A “licensed” or “registered” importer is one who has been granted a licence
143 or registration status for the purpose. In addition to a general licence or permit as an importer, some
144 countries usually require a marketing authorization an additional licence to be issued by the national
145 drug regulatory authoritynational regulatory authority if pharmaceutical products are to be imported.
146
147 licence. See note.
148
149 marketing authorization (product license, registration certificate). A legal document issued
150 by the competent medicines regulatory authority that authorizes the marketing or free distribution of a
151 pharmaceutical product in the respective country after evaluation for safety, efficacy and quality. In
152 terms of quality it establishes inter alia the detailed composition and formulation of the
153 pharmaceutical product and the quality requirements for the product and its ingredients. It also
154 includes details of packaging, labelling, storage conditions, shelf life and approved conditions of use.
155
156 national regulatory authority. The national agency responsible for the marketing
157 authorization of, and other regulatory activities concerning pharmaceutical products.
158
159 pharmaceutical product. Any medicine intended for human or veterinary use, presented in its
160 finished dosage form, that is subject to control by pharmaceutical legislation in both the exporting
161 state and the importing state.
162 registration. See Note.
163
164 screening technologies. The qualitative and/or semi-quantitative technologies which could
165 rapidly acquire the analytical information or data for preliminary identification of suspect medical
166 products in the field.
167
168 standard operating procedure. An authorized written procedure giving instructions for
169 performing standardized operations both general and specific.
170
171 starting material. Any substance of defined quality used in the production of a
172 pharmaceutical product, but excluding packaging materials.
173
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174 substandard product. For the purposes of this document, a substandard product is an
175 authorized product that fails to meet either its quality standards or its specifications, or both according
176 to the requirements in the territory of use. These standards and specifications are normally reviewed,
177 assessed and approved by the applicable national or regional medicines regulatory authority before the
178 product is authorized for marketing
179
180 unauthorized product. A product that is not in compliance with national and regional
181 regulations and legislation, being unknown to the authorities, and which therefore requires testing
182 beyond the routine quality control testing.
183 Note Because of a lack of uniformity in national legal requirements and administrative
184 practices, the terms “registered”, “licenced” and “authorized” have been used in these guidelines as if
185 they were interchangeable. When the guidelines are being used as a basis for drawing up national
186 guidelines, more precise terminology applicable to the country concerned should be used. In some
187 countries, for example, “certificate of drug registration” has been replaced by terms such as
188 “marketing authorization”.
189
190 4. LEGAL RESPONSIBILITIES
191
192 4.1 The importation of pharmaceutical products should be done effected in accordance conformity
193 with national legislation regulations promulgated under the national drugs act or other relevant
194 legislation and should be enforced by the NDRANRA and other relevant authorities. National
195 guidelines providing recommendations on the implementation of these regulations legislation
196 should be drawn up by the NDRANRA, or by the ministry of health, or if an NRA is not formally
197 established, in collaboration with the customs authority and other responsible interested
198 entitiesagencies and organizations.
199
200 4.2 All transactions relating to the importation of consignments of pharmaceutical products
201 should be conducted either through the governmental drug procurement agency or through
202 independent wholesale dealers specifically designated and licensed by the NDRANRA for this
203 purpose.
204
205 4.3 The importation of all consignments of pharmaceutical products should be channelled
206 exclusively through customs posts or ports specifically authorized designated for this purpose.
207 This is also applicable to pharmaceuticals moving through the networking global commerce (i.e.
208 world wide web/internet).
209
210 4.4 All formalities undertaken on importation should be coordinated by the customs
211 serviceauthority, which should have the authority to for request the services of an official
212 pharmaceutical inspector or enforcement officer on as occasion, when required demands. When
213 justified by the workload, a pharmaceutical inspector may be stationed in a full-time position at
214 one or more of the designated ports of entry.
215
216 4.5 The customs authority should utilize have itsthe discretionary powers to request technical
217 advice and opinions from other appropriately qualified persons, when required.
218 should this be warranted by particular circumstances.

219 5. LEGAL BASIS OF CONTROL

220
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221 5.1 Subject to the exemptions specified in paragraph 4.4 below, only pharmaceutical products
222 proved by appropriate documentation to be duly licensed for marketing or specific intended use
223 such as inas clinical trials, named patient programs or other means as appropriate etc. withiin the
224 importing country, should be cleared by customs.
225
226 5.2 The NDRANRA should compile comprehensive and frequently updated lists of licensed
227 products authorized for marketing and authorized importing agents, which are frequently updated,
228 and issue notifications of any product licenses withdrawn or temporarily suspended on grounds of
229 safety, quality or efficacy or safety. These withdrawals or suspensions ; the latter sshould be
230 rapidly communicated to health-care providers and patients and presented in a timely manner
231 designed to attract attention. Allmanner. All lists and notifications of a temporary suspension or
232 withdrawal of a product licencemarketing authorization should be published accessible,
233 preferably on the NRA or mMinistry of hHealth websitethrough a computerized database, and
234 should be easily accessible forto designated customs posts, authorized importing agents and all
235 drug wholesalers. In case of risks to for public health, patients should be advised to contact their
236 doctors or practitioners before suspending their treatments and receive appropriate instructions on
237 how to continue their therapy.
238
239 5.3 NRAs should be empowered to take legal actions and shouldall closely collaborate closely
240 with customs, police, judiciary and others etc. to detect substandard and falsified productsfalsified
241 products and to avoid the circulation of those products in the local and international trade.
242 Efficient and confidential channels for communicating information on these counterfeitfalsified
243 products and other illicit activities should be established between all responsible interested official
244 bodies without undue delay.
245
246 5.4 In countries where no formal system of products licensing marketing authorization has been
247 established, importation of products is most effectively controlled by issuing permits in the name
248 of the NDRANRA to the authorized importing agency or agent. Within the framework of the
249 Certification Scheme framework the WHO provides a list with names and full addresses of those
250 government organizations authorized to sign and issue a certificate of a pharmaceutical product
251 (CPP). NMRAs receiving a CPP can use this list to check and verify if the certificate they are
252 receiving has been issued by the authorized organization (4, 5). Additional measures that may be
253 taken under these conditions include:
254
255  the provision by the NDRANRA to the customs authorities s aand to the importing
256 agency and agents of official lists of pharmaceutical products permitted and/or prohibited
257 to be imported;
258  the provision by the importing agent of certified information to establish that the product
259 is authorized by license for sale in the country of export.
260

261 5.5 The NDRANRA should reserve discretionary powers to waive product licencing authorization
262 requirements in respect of consignments of pharmaceutical products imported in response to
263 emergency situations and, exceptionally, in response to requests from clinicians for limited
264 supplies of an unlicensed product needed for the treatment of a specific named patient.
265
266 6. REQUIRED DOCUMENTATION
267
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268 6.1 As a prerequisite to customs clearance, the importing agency or agent should be required to
269 furnish the customs authority with the following documentation in respect of each consignment:
270
271  certified copies of documents issued by the NDRANRA in the importing country,
272 attesting that:
273 (a) the importer is duly authorized by licenceauthorized to undertake the transaction,
274 andand
275 (b) the product is duly authorized by licenceauthorized to be marketed in the
276 importing country; or otherwise so anyway authorized for use in clinical trial or for a
277 named patient use;
278  a batch certificate issued by the manufacturer, in line consonant with the requirements of
279 the WHO Certification Scheme, that documents the results of the final quality analytical
280 control of the batch(es) constituting the consignment;
281  safety data sheet;
282  a relevant invoice or bill and, when applicable, an authorization for the release of foreign
283 exchange granted by the competent national authority in the country of import;
284  any other documentation required by national legislation for customs clearance.
285
286 7. IMPLEMENTATION OF CONTROLS
287
288 7.1 A visual and physical examination should be routinely undertaken by the customs authorities.
289 Where possible, this should be done , if possible in collaboration with an inspector or enforcement
290 officer of the national drug regulatory authority NDRANRA. The size of the consignment should
291 be checked against invoices, and particular aattention should be accorded given to the nature and
292 conditions of the packaging and labelling. The external package should can be compared with a
293 standard when this is possible. (Note: spelling errors, low-quality printing and other defects may
294 be signs indicative of a substandard or falsified product. (2).)
295
296 7.2 Arrangements should be made with the inspector or enforcement officer of the national drug
297 regulatory authority NDRANRA for the routine physical and chemical sampling and subsequent
298 physical and chemical analysis of exceptionally large and/or valuable consignments and any other
299 consignment that may appear to have has apparently deteriorated, or that is damaged or is of
300 doubtful authenticity. (Note: The external package should be intact and should do not show any
301 signs of damages or infiltrations that may change able to alter the inner content (2, 11,13,14).)
302
303 7.2 3 When samples are taken for analysis to a governmental or other accredited drug quality
304 control laboratory, the consignment should be placed in quarantine. During this procedure, and
305 throughout the time that the consignment is held in customs, particular care must be taken to
306 ensure that packages do not come into contact with potential contaminants. In addition, the
307 package should be stored under appropriate conditions as recommended on the label or in the
308 safety data sheet such as ; taking care of monitoring the optimal temperature limits (i.e. if the cold
309 chain has to be maintained), protection from light, humidity and temperature excursions (12, 13,
310 14).
311
312 7.3 4 A consignment suspected of being substandard, unregistered/unlicensed, or counterfeit
313 falsified or unnot registered (unlicensed)authorized should be placed in quarantine pending the
314 analysis of samples and forensic investigation. Time is often saved if materials and reagents
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315 needed to undertake simple analytical tests and screening technologies are available at the port of
316 entry.customs border.
317
318 7.4 5 Representatives of the manufacturer of the authentic product, and/or the owner of the
319 trademark, and the consignee should immediately be advised of such action.
320
321 7.5 6 National regulations should define the responsibilities of the respective interested parties
322 and the precise procedures to be followed by . In particular, the provisions should identify the
323 agency body (i.e local representatives from the police service, border control, ministery of health,
324 as appropriate, ) responsible for the relevant coordinating the investigation and legal
325 actionsbringing prosecutions.
326
327 7.6 7 CounterfeitFalsified products and or other products which have been imported in
328 contravention of the law must be forfeited and destroyed, or otherwise dealt with in accordance
329 with legal procedures. Such procedures should be available, recorded and appropriately
330 savedrecordedarchived (9).
331
332 7.7 8 The relevant authorities must be indemnified against any consequent legal actions and
333 proceedings.
334
335 7.8 9 NDRANRAs should urged to notify are not later than a working day urged to notify other
336 national authorities of confirmed cases of imported substandard or counterfeitfalsified
337 pharmaceutical products without delay, through the WHO Global Surveillance and Monitoring
338 System, onDivision of Drug Management and Policies Essential Medicines and Health Products
339 of WHO through the appropriate form. The form is provided as a template to trained focal points
340 within NRAs. The WHO Global Surveillance and Monitoring System collects reports from focal
341 points in the NRAs ational Regulatory Authorities and iInternational procurement agencies which
342 o if necessary will forward the report Once the mandatory fields are completed, the document can
343 be saved and sent as an attachment via email to [email protected] where necessary. Focal points
344 are encouraged to send any photographs, laboratory reports or other relevant documents as
345 attachments. (http://www.who.int/medicines/regulation/ssffc/medical-products/en/
346
347 8. PROCEDURES APPLICABLE TO PHARMACEUTICAL STARTING MATERIALS
348
349 8.1 When considering finished pharmaceutical products, in In accordance with good
350 manufacturing practices (GMP), theformal responsibility for the quality analytical control of
351 starting materials used in that product is vested in the manufacturer of the finished pharmaceutical
352 product (FPP). ConsequentlyUnfortunately, only a few countries have introduced formal licensing
353 requirements for active pharmaceutical substances ingredients (APIs) (8).
354
355 8.2 Exceptionally, however, sSome national authorities now exercise documentary and (in some
356 cases) also quality analytical control, through laboratory testing of starting materials, as a
357 prerequisite to customs clearance.
358
359 8.3 Each imported consignment of a pharmaceutical starting material should be
360 accompaniesdaccompanied by a warranty (or batch certificate) prepared by the manufacturer as
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361 recommend by the WHO Certification Scheme (WHICH SCHEME? Refer to SMACS?).WHO
362 pharmaceutical starting materials certification scheme (SMACS) (10).

363
364 9. STORAGE FACILITIES
365
366 9.1 Many pharmaceutical products tend to degrade during on storage and some need to be stored
367 kept under specified conditionsin such as 2–8 degrees °Celsiuscold storage. All customs posts
368 designated to handle consignments of pharmaceutical products should consequently be provided
369 with secure storage facilities, with the required conditions including cold storage areas, where
370 required. refrigerated compartments. If no pharmaceutical inspector or enforcement officer is
371 employed on site, these facilities should be inspected periodically by the NDRANRA to ensure
372 that all equipment is maintained and in good working order.
373
374 9.2 The importing agency or agent should alert the customs authorities in advance of the
375 anticipated arrival of consignments in order that they may be transferred from the international
376 carrier to the designated storage facility with the minimum ofout delay and, in appropriate cases,
377 without breaking the cold chain.
378
379 9.3 Consignments of pharmaceutical products and pharmaceutical starting materials should be
380 accorded high priority for clearance through customs.
381
382 9.4 When several different consignments await clearance the customs authorities should be
383 guided by the pharmaceutical drug inspector or enforcement officer as to which should be
384 accorded priority.
385
386 10. TRAINING REQUIREMENTS
387
388 10.1 Performance is When implementing the guidelines, the performance of the quality system
389 (including but not limited to personnel, documentation, procedures, and and equipment) should
390 be reviewed on an open-ended basis and , if necessary, improved in the light of on-site monitoring
391 and evaluation. Workshops designed to facilitate efficient implementation of the guidelines and
392 quality systems, and to foster collaborative approaches between the various responsible parties,
393 should be organized at intervals s circumstances demand, by the NDRANRA in collaboration
394 with the customs authority and other parties.
395
396 11 AUDIT AND SELF- INSPECTION
397
398 11.1 SAudit from third party and/or self-inspections should be conducted on a routine basis to
399 verify the correct functionality of the quality system standard operating procedures in place at the
400 entry port. C to allow the introduction of corrective and preventive actions measures should be
401 implemented for any potential deficiencies identified. Audits by third parties are further
402 recommended. Audits and self-inspection records should document compliance of personnel to
403 both the standard operating procedures adopted and the equipment used in as the screening
404 technologies (i.e. measuring and monitoring devices, instrument for sampling, testing, etc.) (15).
405
406 REFERENCES
407
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408 1. Guidelines on the conduct of surveys of the quality of medicines (WHO Technical Report
409 Series, No. 996, 2016, Annex 7).
410 2. WHO guidance on testing of “suspect” falsified medicines (WHO Technical Report Series, No.
411 1010, Annex 5, 2018).
412 3. National Drug Regulatory Legislation: Guiding Principles for Small Drug Regulatory
413 Authorities (WHO Technical Report Series, No. 885, 1999, Annex 8).
414 4. WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in
415 International Commerce. In: Fiftieth World Health Assembly, Resolution WHA50.3, Geneva.
416 5. Guidelines on the implementation of the WHO certification scheme on the quality of
417 pharmaceutical products moving in international commerce (in Working document
418 QAS/18.768 April 2018)
419 http://www.who.int/medicines/areas/quality_safety/quality_assurance/WHOCertificationSche
420 me-QAS18-768_06042018-wb-09042018.pdf?ua=1.
421 6. WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles (WHO
422 Technical Report Series, No. 986, 2014, Annex 2).
423 7. WHO Good distribution practices for pharmaceutical products (WHO Technical Report Series,
424 No. 957, 2010, Annex 5).
425 8. Good trade and distribution practices for starting materials (revision) (WHO Technical
426 Report Series, No. 996, 2016, Annex 6).
427 9. Guidance on good data and record management practices (WHO Technical Report Series, No.
428 996, 2016, Annex 5).
429 10. WHO pharmaceutical starting materials certification scheme (SMACS)
430 (WHO Technical Report Series, No 917, 2003, Annex 3).
431 11. Considerations for requesting analysis of medicines samples (WHO Technical Report Series,
432 No. 1010 , 2018, Annex 3).
433 12. WHO guide to good storage practices for pharmaceutical (WHO Technical Report Series, No.
434 908, 2003, Annex 9).
435 13. Technical supplements to Model guidance for the storage and transport of time and
436 temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 992, 2015,
437 Annex 5).
438 14. Model guidance for the storage and transport of time- and temperature-sensitive
439 pharmaceutical products (jointly with the Expert Committee on Biological Standardization)
440 (WHO Technical Report Series, No. 961, 2011, Annex 9).
441 15. Available authentication technologies for the prevention and detection of SSFFC medical
442 products. Appendix 2 of the Report by the Director-General on Member State mechanism on
443 substandard/spurious/falsely-labelled/falsified/counterfeit medical products (WHA A70/23).
444

445
446
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447 APPENDIX
448 Special import controls for narcotic drugs and psychotropic substances3
449
450 In accordance with the requirements of the international drug control treaties (i.e. the Single
451 Convention on Narcotic Drugs, 1961, and that Convention as amended by the 1972 Protocol, and the
452 Convention on Psychotropic Substances, 1971, referred to subsequently as the 1961 Convention and
453 the 1971 Convention), each state must adopt national legislation and administrative regulations and
454 establish administrative structures to ensure the full implementation of the provisions of these treaties
455 on its territory and cooperation with other states.
456
457 Most of the requirements specified in these guidelines on import procedures for pharmaceutical
458 products also apply to the border control of narcotic drugs and psychotropic substances. In addition,
459 detailed information on the control of international trade in narcotic drugs and psychotropic
460 substances can be found in Article 31 of the 1961 Convention and Article 12 of the 1971 Convention,
461 respectively. The guidelines provided in this Appendix are intended to facilitate the operation of
462 control at entry points, and can be expanded by taking into account the legislation and administrative
463 regulations in force in each country.
464
465 The customs authorities and, if applicable, any other law enforcement authorities assigned to border
466 control and customs should cooperate closely with the competent authorities for the control of
467 narcotic drugs and psychotropic substances designated by the government (subsequently referred to as
468 the competent authorities). It should be noted that, while the competent authorities in some countries
469 are different from the NDRANRA, in others they may be one and the same.
470
471 The customs authorities, or any other competent law enforcement authorities, should be well trained
472 and equipped (e.g. with drug identification kits) so that they can distinguish consignments of narcotic
473 drugs and psychotropic substances from other pharmaceutical products. They should be provided
474 with lists of narcotic drugs and psychotropic substances under international control, e.g. the “Yellow
475 List” and “Green List” published by the International Narcotics Control Board, which include, inter
476 alia, trade names of pharmaceutical products containing narcotic drugs and psychotropic substances.
477 They may also make use of the Multilingual dictionary of narcotic drugs and psychotropic substances
478 under international control (1) (ST/NAR/1 Rev.2ST/NAR/1/REV.1) published by the United Nations
479 in 2006 (sales number M.06.XI.) with its Addendum-2015 and Supplement-2016. Furthermore, they
480 should be provided with lists of narcotic drugs and psychotropic substances whose importation into
481 the country has been prohibited.
482
483 Checks conducted during the border control of narcotic drugs and of psychotropic substances listed in
484 Schedules I and II of the 1971 Convention should ensure that each consignment has been duly
485 authorized by the competent authorities of the importing country. The competent authorities expresses
486 theirits consent to each import by issuing an import certificate (for narcotic drugs) or an import
487 authorization (for psychotropic substances). When presented with the original of this document, the
488 competent authorities of the exporting country may issue an export authorization permitting the

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.
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489 consignment containing narcotic drugs or psychotropic substances to leave the exporting country. In
490 free ports and zones governments should exercise the same supervision and control as in other parts of
491 their territory, provided, however, that they may apply more drastic measures if appropriate.
492
493 The competent authorities of the importing country may wish to inform the customs, or any other
494 competent law enforcement authorities, of authorized imports of narcotic drugs and psychotropic
495 substances before the entry of the consignment into the country.
496
497 In addition to the other documents referred to in section 5 of the guidelines, the customs authorities
498 should require the importer or importer’s agent to provide them with a copy of the respective import
499 authorization (certificate) issued by the competent authorities of the importing country. This
500 document should be compared with the export authorization issued by the competent authorities of the
501 exporting country, a copy of which must accompany each consignment. The authenticity of these
502 documents must be carefully checked. In case of doubt, the competent authorities should be consulted
503 immediately.
504
505 Import and expert export authorizations (certificates) should contain the following information:
506
507  the name of the narcotic drug or psychotropic substance (if available, the International
508 Nonproprietary Name (INN));
509  the quantity to be imported/exported, expressed in terms of anhydrous base content;
510  the pharmaceutical form and, if in the form of a preparation, the name of the preparation;
511  the name and address of the importer and exporter;
512  the period of validity of the authorization.
513
514 In addition, the exporter authorization should contain the number and date of the corresponding
515 import authorization/certificate and the name of the competent authority of the importing country by
516 whom it was issued.
517
518 The competent authorities of the importing country may wish to specify in the import
519 authorization/certificate the entry point through which they importation must be effected.
520
521 During the visual and physical examination of the imported consignment, the quantity of narcotic
522 drugs or psychotropic substances contained in it should be carefully checked. If the quantity exceeds
523 the amount authorized, the consignment should be stopped by the customs and the matter brought to
524 the attention of the competent authorities for the control of narcotic drugs and psychotropic
525 substances in the importing country. If the quantity imported is the same as, or less than, the amount
526 authorized, the quantity should be recorded on the copy of the export authorization accompanying the
527 consignment and communicated to the competent authorities of the importing country.
528
529 All consignments containing psychotropic substances included in Schedule III of the 1971
530 Convention must be accompanied by a separate export declaration. This document should indicate the
531 name and address of the exporter and importer, the name of the substance, the quantity and the
532 pharmaceutical form in which the substance is exported, including, if applicable, the name of the
533 preparation and the date of dispatch.
534
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535 Pursuant to the recommendations contained in resolutions of the Economic and Social Council of the
536 United Nations, many governments now require import authorizations not only for psychotropic
537 substances in Schedules I and II but also for those in Schedules III and IV of the 1971 Convention.
538 This strengthening of the control requirements has proved to be very useful in preventing attempts to
539 divert psychotropic substances, such as stimulants, sedative-hypnotics and tranquilizers, into illicit
540 traffic.
541
542
543 REFERENCES
544
545 1. Multilingual Dictionary of Narcotic Drugs and Psychotropic Substances under International
546 Control https://www.unodc.org/unodc/en/scientists/multilingual-dictionary-of-narcotic-drugs-and-
547 psychotropic-substances-under-international-control.html.
548
549 ***
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