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1
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3 POST-APPROVAL SAFETY DATA MANAGEMENT:
 
4 DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING 

5
6 ICH Harmonised Tripartite Guideline draft
 
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8
9 Recommended for  Adoption
 
10 at Step 2 of the ICH Process
 
11 on July 18, 2003
 
12 by the ICH Steering Committee
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17 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) 
18 current thinking on this topic.  It does not create or confer any rights for or on any person and 
19 does not operate to bind FDA or the public.  You can use an alternative approach if it satisfies 
20 the requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
21 approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
22 identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
23 guidance. 
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28 ICH E2D ver 3.8 
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37 Table of Contents 
38  1.  INTRODUCTION 
39  2.  DEFINITIONS  AND  TERMINOLOGY  ASSOCIATED  WITH  POST-
40  APPROVAL DRUG SAFETY EXPERIENCE 
41  2.1. Basic Terms 
42  2.1.1. Adverse Event (or Adverse Experience) 
43  2.1.2. Adverse Drug Reaction (ADR) 
44  2.2. Seriousness Criteria 
45  2.3. Unexpected Adverse Drug Reactions 
46  2.4. Other Definitions 
47  2.4.1. Healthcare Professionals 
48  2.4.2. Consumers 
49  2.5. Sources of Individual Case Reports 
50  2.5.1. Unsolicited Sources 
51  2.5.1.1. Spontaneous Reports 
52  2.5.1.1.1. Consumer Reports 
53  2.5.1.2. Literature 
54  2.5.1.3. Internet 
55  2.5.1.4. Other Sources 
56  2.5.2. Solicited Sources 
57  2.5.3. Licensor-Licensee Interaction 
58  2.5.4. Regulatory Authority Sources 
59 
60  3. STANDARDS FOR EXPEDITED REPORTING 
61  3.1. What Should Be Reported? 
62  3.1.1. Single Cases of Serious ADRs 
63  3.1.2. Reporting Guidelines for Other Observations 
64  3.1.2.1. Lack of Efficacy 
65  3.1.2.2. Overdose 
66  3.2. Reporting Time Frames 
67  3.2.1. Minimum Criteria for Reporting 
68  3.2.2. Time Clock Start Point 
69  3.2.3. Non-serious ADRs 
70 
71  4. GOOD CASE MANAGEMENT PRACTICE 
72  4.1. Assessing Patient and Reporter Identifiability 
73  4.2. The Role of the Narratives 
74  4.3. Single Case Evaluation 
75 4.4. Follow-up Information 
76   4.4.1. Follow-up Related to Pregnancy Exposure 
77  4.5. How to Report 
78 
79  Reference Sources 
80  Attachment 
81 
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82  1. INTRODUCTION 
83  It is important to establish an internationally standardized procedure in order to improve 
84  the quality of post-approval safety information and to harmonise the way to gather and 
85  report information.  ICH E2A provides guidance on pre-approval safety data 
86  management. Although many stakeholders have applied these E2A concepts to the post-
87  approval phase, there is a need to provide further guidance on the definitions and 
88  standards for post-approval expedited reporting.  This guideline is based on the content 
89  of ICH E2A with consideration as to how the terms and definitions can be applied in the 
90  post-approval phase of the product life cycle. 
91 
92  2. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH POST-
93  APPROVAL DRUG SAFETY EXPERIENCE 

94
 
95  2.1. Basic Terms 
96  2.1.1. Adverse Event (or Adverse Experience) 
97  An adverse event (AE) is any untoward medical occurrence in a patient administered a 
98  medicinal product and which does not necessarily have to have a causal relationship 
99  with this treatment.  An adverse event can therefore be any unfavorable and unintended 
100  sign (for example, an abnormal laboratory finding), symptom, or disease temporally 
101  associated with the use of a medicinal product, whether or not considered related to this 
102  medicinal product. 
103 
104  2.1.2. Adverse Drug Reaction (ADR)  
105  All noxious and unintended responses to a medicinal product related to any dose should 
106  be considered adverse drug reactions. 
107 
108  The phrase responses to a medicinal product means that a causal relationship between 
109  a medicinal product and an adverse event is at least a possibility (refer to ICH E2A). 
110 
111  A reaction, in contrast to an event, is characterized by the fact that a causal relationship 
112  between the drug and the occurrence is suspected. If an event is spontaneously reported, 
113  even if the relationship is unknown or unstated, it meets the definition of an adverse 
114  drug reaction. 
115 
116  2.2. Seriousness Criteria 
117  The most internationally agreed seriousness criteria appear in ICH guideline E2A. A 
118  serious adverse event (experience) or reaction is any untoward medical occurrence that 
119  at any dose: 
120  * results in death 
121  * is life-threatening 
122  (NOTE: The term life-threatening in the definition of serious refers to an 
123  event/a reaction in which the patient was at risk of death at the time of the 
124  event/reaction; it does not refer to an event/a reaction which hypothetically 
125  might have caused death if it were more severe), 
126  * requires inpatient hospitalisation or results in prolongation of existing 
127  hospitalisation, 
128  * results in persistent or significant disability/incapacity, 
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129  * is a congenital anomaly/birth defect, 
130 
131  * is a medically important event or reaction. 
132  Medical and scientific judgment should be exercised in deciding whether other 
133  situations should be considered as serious such as important medical events 
134  that may  not be immediately life-threatening or result in death or 
135  hospitalisation but may jeopardise the patient or may  require intervention to 
136  prevent one of the other outcomes listed in the definition above. These should 
137  also be considered serious. 
138  Examples of such events are intensive treatment in an emergency room or at 
139  home for allergic bronchospasm; blood dyscrasias or convulsions that do not 
140  result in hospitalisation; or development of drug dependency or drug abuse. 
141 
142  2.3. Unexpected Adverse Drug Reactions 
143  An ADR whose nature, severity, specificity, or outcome is not consistent with the term 
144  or description used in the official product information should be considered unexpected. 
145 
146  An ADR with a fatal outcome should be considered unexpected, unless the official 
147  product information specifies a fatal outcome for the ADR.  In the absence of special 
148  circumstances, once the fatal outcome is itself expected, reports involving fatal 
149  outcomes should be handled as for any other serious expected ADR in accord with 
150  appropriate regulatory requirements. 
151 
152  Please note that the term listedness is not applicable for expedited reporting (refer to 
153  ICH E2C for definition). 
154 
155  Additional considerations: 
156  Class ADRs should not automatically be considered to be expected for the subject 
157  drug. Class ADRs should be considered to be expected only if described as 
158  specifically occurring with the product in the official product information, as illustrated 
159  in the following examples: 
160    As with other drugs of this class, the following undesirable effect occurs with Drug 
161  X. 

162    Drugs of this class, including Drug X, can cause...
 
163

164  If the ADR has not been documented with Drug X, statements such as the following are
 
165  likely to appear in the official product information:  

166    Other drugs of this class are reported to cause...
 
167    Drugs of this class are reported to cause..., but no reports have been received to
 
168  date with Drug X.. 

169  In these situations, the ADR should not be considered as expected for Drug X. 

170

171  In the absence of sufficient documentation and in the face of uncertainty, a reaction
 
172  should be regarded as unexpected.
 
173

174  2.4. Other Definitions
 
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175  2.4.1. Healthcare Professionals 
176  Healthcare professionals are medically-qualified persons such as physicians, dentists, 
177  pharmacists, nurses, coroners, or as otherwise specified by local regulations. Preferably, 
178  information about the case should be collected from the healthcare professionals who 
179  are directly involved in the patients care. In some regions, the healthcare professional 
180  status of the reporter is immaterial to reporting practices. 
181 
182  2.4.2. Consumers 
183  A consumer is defined as a person who is not a healthcare professional.  
184 
185  2.5. Sources of Individual Case Reports 
186  2.5.1. Unsolicited Sources 
187  2.5.1.1. Spontaneous Reports 
188  A spontaneous report is an unsolicited communication by healthcare professionals or 
189  consumers  to  a  company,  regulatory  authority  or  other  organization  (e.g.  WHO, 
190  Regional Centers, Poison Control Center) that describes one or more adverse drug 
191  reactions in a patient who was given one or more medicinal products and that does not 
192  derive from a study or any organized data collection scheme. 
193 
194  Stimulated reporting may occur in certain situations, such as a notification by a Dear 
195  Healthcare Professional letter, a publication in the press, or questioning of healthcare 
196  professionals  by  company  representatives.   These  reports  should  be  considered 
197  spontaneous. 
198 
199  2.5.1.1.1. Consumer reports 
200  Consumer  adverse  reaction  reports  should  be  handled  as  spontaneous  reports 
201  irrespective of any subsequent medical confirmation, a process required by some 
202  authorities for reportability. Even if reports received from consumers do not qualify for 
203  regulatory reporting, the cases should be retained. Emphasis should be placed on the 
204  quality of the report and not on its source. 
205 
206  2.5.1.2. Literature 
207  The  Marketing  Authorisation  Holder  (MAH)  is  expected  to  regularly  screen  the 
208  worldwide scientific literature, by accessing widely used systematic literature reviews 
209  or reference databases.  Cases of ADRs from the scientific and medical literature, 
210  including  relevant  published  abstracts  from  meetings  and  draft  manuscripts,  might 
211  qualify for expedited reporting. DA regulatory reporting form with relevant medical 
212  information  should  be  provided  for  each  identifiable  patient.  The  publication 
213  reference(s) should be given as the report source; additionally a copy of the article 
214  might be requestedDby the local regulatory authority to accompany the report.  All 
215  company offices are encouraged to be aware of publications in their local journals and 
216  to bring them to the attention of the company safety department as appropriate. 
217 
218  The regulatory reporting time clock starts once it is determined that the case meets 
219  minimum criteria for reportability.  MAHs should search the literature according to 
220  local regulation or at least once a month.  If the product source, brand, or trade name is 
221  not specified, the MAH should assume that it was its product, although reports should 
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222  indicate that the specific brand was not identified. 
223 
224  2.5.1.3 Internet 
225  MAHs are not expected to screen external websites for ADR information. However, if 
226  an MAH becomes aware of an adverse reaction on a website that it does not manage, 
227  the  MAH  should  review  the  adverse  reaction  and  determine  whether  it  should  be 
228  reported. Unsolicited cases from the Internet should be handled as spontaneous reports.  
229  MAHs should regularly screen their websites for potential ADR case reports. MAHs 
230  and regulators should consider utilising their websites to facilitate ADR data collection, 
231  e.g. by providing ADR forms for direct reporting or by providing appropriate contact 
232  details  for  direct  communication.    For  the  determination  of  reportability  the  same 
233  criteria should be applied as for cases provided via other ways. 
234 
235  2.5.1.4 Other Sources 
236  If MAHs become aware of a case report from non-medical sources, it should be handled 
237  as a spontaneous report. 
238 
239  2.5.2. Solicited Sources 
240  Solicited  reports  are  those  derived  from   organized  data  collection  systems,  which 
241  include clinical trials, post-approval named patient use programs, other patient support 
242  and  disease  management  programs,  surveys  of  patients  or  healthcare  providers,  or 
243  information  gathering  on  efficacy  or  patient  compliance.    Adverse  event  reports 
244  obtained from any of these should not be considered spontaneous. 
245 
246  For the purposes of safety reporting, solicited reports should be handled as if they were 
247  study reports, and therefore should have an appropriate causality assessment.  Further 
248  guidance on study-related issues such as managing blinded therapy cases can be found 
249  in ICH E2A. 
250 
251 
252 
253  2.5.3. Licensor-Licensee Interaction 
254  When companies co-develop, co-market, or co-promote products, it is considered very 
255  important that explicit contractual agreements specify the processes for exchange of 
256  safety information, including timelines and regulatory reporting responsibilities. 
257  Whatever the contractual arrangement, the MAH is ultimately responsible for regulatory 
258  reporting. 
259 
260  It is particularly important to ensure that processes are in place to avoid duplicate 
261  reporting to the regulatory authority, e.g. assigning responsibility to one company for 
262  literature screening. The time frame for expedited regulatory reporting should normally 
263  be no longer than 15 calendar days from the first receipt of a case meeting minimum 
264  criteria by any of the partners, unless otherwise specified by local regulation.  Any 
265  subsequent follow-up information sent to the regulators should be submitted by the 
266  same MAH that reported the case originally.   
267 
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268  2.5.4. Regulatory Authority Sources 
269  Individual serious unexpected adverse drug reaction reports originating from  foreign 
270  regulatory authorities are always subject to [F1]expedited reporting.  Re-submission of 
271  serious ADR cases without new information to the originating regulatory authority is 
272  not usually required, unless otherwise specified by local regulation. 
273   
274  3. STANDARDS FOR EXPEDITED REPORTING 
275  3.1. What Should Be Reported? 
276  3.1.1. Single Cases of Serious ADRs 
277  Cases of adverse drug reactions from all sources that are both serious and unexpected 
278  are subject to expedited reporting.  The reporting of serious expected reactions in an 
279  expedited manner varies among countries.  Non-serious adverse reactions, whether 
280 expected or not, would normally not be subject to expedited reporting.  
281    For reports from studies and other solicited sources, all cases judged by either the 
282  reporting healthcare professional or the MAH as having a possible causal relationship to 
283  the medicinal product qualify as ADRs.  For the purposes of reporting, spontaneous 
284  reports associated with approved drugs imply a possible causality. 
285 
286  3.1.2. Reporting Guidelines for Other Observations 
287  In addition to single case reports, any safety information from other observations that 
288  could change the risk-benefit evaluation for the product should be promptly 
289  communicated to the regulatory authorities. 
290 
291  3.1.2.1. Lack of Efficacy 
292  Reports of lack of efficacy should not normally be expedited, but should be discussed in 
293  the relevant periodic safety update report. However, in certain circumstances reports of 
294  lack of efficacy should be treated as expedited cases for reporting purposes. Medicinal 
295  products used for the treatment of life-threatening or serious diseases, vaccines, and 
296  contraceptives are examples of classes of medicinal products where lack of efficacy 
297  should be considered for expedited reporting. Clinical judgment should be used in 
298  reporting, with consideration of the approved product labeling/prescribing information.  
299 
300  3.1.2.2 Overdose 
301  Reports of overdose with no associated adverse outcome should not be reported as 
302  adverse reactions.  They should be routinely followed up to ensure that information is as 
303  complete as possible with regard to symptoms, treatment, and outcome.  The MAH 
304  should collect any available information related to its products on overdose, and report 
305  cases of these that lead to serious adverse reactions according to expedited reporting 
306  criteria. 
307 
308  3.2. Reporting Time Frames 
309  In general, expedited reporting of serious and unexpected ADRs refers to 15 calendar 
310  days. Time frames for other types of reports vary among countries.  
311 
312  3.2.1.Minimum Criteria for Reporting 
313  Minimum required data elements for an ADR case are: an identifiable reporter, an 
314  identifiable patient, an adverse reaction, and a suspect product.  Lack of any of these 
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315  four elements means that the case is incomplete; however, MAHs are expected to 
316  exercise due diligence to collect the missing data elements.  It is recommended that as 
317  much information as possible be collected at the time of the initial first report.  
318 
319  3.2.2. Time Clock Start Point 
320  The regulatory reporting time  clock (in calendar days) starts on the date when any 
321  personnel of the MAH first receive a case report that fulfills minimum criteria as well as 
322  the criteria for expedited reporting. In general, this date should be considered as day 0. 
323  When additional medically significant information is received for a previously reported 
324  case, the regulatory reporting time clock begins again for submission of the follow-up 
325  report. 
326 
327  3.2.3 Non-serious ADRs 
328  Cases of non-serious ADRs are not normally reportable on an expedited basis.  The 
329  spontaneous reports of non-serious ADRs should be reported in the periodic safety 
330  update report. 
331 
332  4. GOOD CASE MANAGEMENT PRACTICE 
333  Accurate, complete and bona fide information is very important for MAHs and 
334  regulatory agencies identifying and assessing ADR reports.  Both are faced with the 
335  task of acquiring sufficient information to help ensure that the reports are authentic, 
336  accurate, as complete as possible, and non-duplicative. 
337 
338  4.1. Assessing Patient and Reporter Identifiability 
339  Patient and reporter identifiability is necessary to avoid case duplication, detect fraud, 
340  and facilitate follow-up of appropriate cases.  The term identifiable in this context refers 
341  to the verification of the existence of a patient and a reporter. 
342 
343  One or more of the following automatically qualifies a patient as identifiable: age (or 
344  age category, e.g., adolescent, adult, elderly), gender, initials, date of birth, name, or 
345  patient identification number.  Additionally, in the event of second-hand reports, every 
346  effort should be made to verify the report source.  All parties supplying case 
347  information (or approached for case information) are subject to the notion of 
348  identifiability: not only the initial reporter (the initial contact for the case), but also 
349  others supplying information. 
350 
351  In the absence of qualifying descriptors, a report referring to a definite number of 
352  patients should not be regarded as a case  until the minimum four criteria for case 
353  reporting are met.  For example, Two patients experienced... or  a few patients 
354  experienced should be followed up for patient-identifiable information before 
355  regulatory reporting. 
356 
357  4.2. The Role of the Narratives 
358  The objective of the narrative is to summarize all relevant clinical and related 
359  information, including patient characteristics, therapy details, medical history, clinical 
360  course of the event(s), diagnosis, and ADR(s) (including the outcome, laboratory 
361  evidence and any other information that supports or refutes an ADR).  The narrative 
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362  should serve as a comprehensive, stand-alone medical story. The information should 
363  be presented in a logical time sequence; ideally this should be presented in the 
364  chronology of the patients experience, rather than in the chronology in which the 
365  information was received.  In follow-up reports, new information should be clearly 
366  identified. 
367 
368  Abbreviations and acronyms should be avoided, with the possible exception of 
369  laboratory parameters and units.  Key information from supplementary records should 
370  be included in the report, and their availability should be mentioned in the narrative and 
371  supplied on request. Any autopsy or other post-mortem findings (including a coroners 
372  report) should also be provided when available if allowed by local privacy protection 
373  laws. Terms in the narrative should be accurately reflected by appropriate coding.  
374 
375  4.3. Single Case Evaluation  
376  The purpose of careful medical review is to ensure correct interpretation of medical 
377  information.  Regardless of the source of an ADR report, the recipientDshould 
378  carefully review the report for the quality and completeness of the medical information. 
379  This should include, but is not limited to, consideration of the following: 
380    Is a diagnosis possible?  
381     Have the relevant diagnostic procedures been performed?  
382     Were alternative causes of the reaction(s) considered? 
383     What additional information is needed? 
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387  iinnffoorrmmaattiioonn  ffrroomm  tthhee  rreeppoorrtteerr..    WWhhiillee  tthhee  rreeppoorrtt  rreecciippiieenntt  iiss  eennccoouurraaggeedd  ttoo  aaccttiivveellyy  
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390  eevvaalluuaattiioonnss  bbyy  tthhee  MMAAHH  aarree  ccoonnssiiddeerreedd  aacccceeppttaabbllee  aanndd,,  ffoorr  ssoommee  aauutthhoorriittiieess,,  rreeqquuiirreedd..  
391  EEnnccoouurraaggiinngg  ggoooodd  ccoommmmuunniiccaattiioonn  oonn  mmeeddiiccaall  iinnffoorrmmaattiioonn  wwiitthh  tthhee  rreeppoorrtteerr  wwiillll  sseerrvvee  
392  ttoo  iimmpprroovvee  tthhee  qquuaalliittyy  ooff  ccaassee  ddooccuummeennttaattiioonn..    
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397  ppaattiieenntt..  
398 
399  4.4. Follow-up Information 
400  The information from ADR cases when first received is generally incomplete. Ideally, 
401  comprehensive information would be available on all cases, but in practice efforts 
402  should be made to seek additional information on selected reports (see Attachment). In 
403  any scheme to optimize the value of follow-up, the first consideration should be 
404  prioritization of case reports by importance. 
405  The priority for follow-up should be as follows: cases which are 1) both serious and 
406  unexpected, 2) serious and expected, and 3) non-serious and unexpected. In addition to 
407  seriousness and expectedness as criteria, cases of special interest also deserve extra 
408  attention as a high priority (e.g., ADRs under active surveillance at the request of the 
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409  regulators), as well as any cases that might lead to a labeling change decision. 
410  Follow-up information should be obtained, via a telephone call and/or site visit and/or 
411  via a written request. Efforts should be tailored toward optimising the chances to obtain 
412  the new information. Written confirmation of details given verbally should be obtained 
413  whenever possible. In exceptional circumstances, a regulatory authority might be able to 
414  assist an MAH to obtain follow-up data if requests for information have been refused by 
415  the reporter. The company should provide specific questions it would like to have 
416  answered. 
417 
418  In order to facilitate the capture of clinically relevant and complete information, use of a 
419  targeted questionnaire is encouraged, preferably at the time of the initial report. Ideally, 
420  healthcare professionals with thorough pharmacovigilance training and therapeutic 
421  expertise should be involved in the collection and the direct follow up of reported cases 
422  (particularly those of medical significance).  For serious ADRs, it is important to 
423  continue follow-up and report new information until the outcome has been established 
424  or the condition is stabilized.  How long to follow-up such cases will require judgment. 
425 
426  MAHs should collaborate on follow-up if more than one MAHs drug is suspected as a 
427  causal agent in a case. 
428  It is important that, at the time of the original report, sufficient details about the patient 
429  and reporter be collected and retained to enable future investigations, within the 
430  constraints imposed by local data privacy legislation. 
431 
432  4.4.1. Follow-up Related to Pregnancy Exposure 
433  MAHs  are  expected  to  follow  up  all  reports,  from  healthcare  professionals  or 
434  consumers, of pregnancies where the embryo/foetus could have been exposed to one of 
435  its medicinal products.  When an active substance, or one of its metabolites, has a long 
436  half-life, this should be taken into account when considering whether a foetus could 
437  have been exposed (i.e. medicinal products taken before the gestational period need to 
438  be  considered).  If  a  pregnancy  results  in  an  abnormal  outcome  that  the  reporter 
439  considers might be due to the drug, this should be treated as an expedited report if the 
440  criteria for expedited reporting are met. 
441 
442  4.5. How to Report 
443  The CIOMS I (Council of International Organisations for Medical Sciences) form has 
444  been a widely accepted standard for expedited adverse event reporting.  However, no 
445  matter what the form or format used, it is important that certain basic information/data 
446  elements, when available, be included with any expedited report, whether in a tabular or 
447  narrative presentation. It is recommended that the Medical Dictionary for Regulatory 
448  Activities (MedDRA) be used for coding medical information.  The standards for 
449  electronic submission of Individual Case Safety Reports (ICSR), according to ICH 
450  E2B/M2, should be implemented. 
451  The listing in the Attachment addresses those data elements regarded as desirable; if all 
452  are not available at the time of expedited reporting, efforts should be made to obtain 
453  them. 
454 
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455  Reference Sources 
456  1. Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V), 2001 
457  2. Rules Governing Medicinal Products in the European Union, Volume 9, 
458  PHARMACOVIGILANCE: Medicinal Products for Human Use 
459  3. Guidance for Industry: Postmarketing Safety Reporting for Human Drug and 
460  Biological Products Including Vaccines, Food and Drug Administration, March 2001 
461  (draft) 
462  4. Safety Reporting Requirements for Human Drug and Biological Products, Proposed 
463  Rule, Food and Drug Administration, March 2003 
464  5. Notifications #421 on the Enforcement of Revised Pharmaceutical Affairs Law, the 
465  Director General, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, 
466  March, 1997 
467  Attachment 
468 
469  RECOMMENDED KEY DATA ELEMENTS FOR INCLUSION 
470  IN EXPEDITED REPORTS 
471  OF SERIOUS ADVERSE DRUG REACTIONS 
472 
473 
474 
475  The following list of items has its foundation in several established precedents, 
476  including those of CIOMS Ia; the WHO Collaborating Centre for International Drug 
477  Monitoring, Uppsala; and various regulatory authority forms and guidelines. Some 
478  items mightDnot be relevant depending on the circumstances.  Attempts should be 
479  made to obtain follow-up information on as many other listed items as are pertinent to 
480  the case. 
481 
482  1.  Patient Details 
483    Initials 
484    Other relevant identifier (patient number, for example) 
485    Gender 
486    Age, age category (e.g., adolescent, adult, elderly) or date of birth 
487    Concomitant conditions 
488    Medical history 
489    Relevant family history 
490 
491  22..  SSuussppeecctteedd  MMeeddiicciinnaall  PPrroodduucctt((ss))  
492    Brand name as reported 
493    International Non-Proprietary Name (INN) 
494    Batch number 
495    Indication(s) for which suspect medicinal product was prescribed or tested 
496    Dosage form and strength 
497    Daily dose (specify units - e.g., mg, ml, mg/kg) and regimen 
498    Route of administration 
499    Starting date and time 
500    Stopping date and time, or duration of treatment 
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501 
502 3. Other Treatment(s) 
503   The same information as in item 2 should be provided for the following: 
504     Concomitant medicinal products 
505     (including non-prescription, over-the-counter medicinal products, herbal 
506  remedies, dietary supplements, complementary and alternative therapies, etc.) . 
507     Relevant medical devices 
508 
509  4. Details (all availablle) of Adverse Drug Reaction((ss))  
510     Full description of reaction(s), including body site and severity 
511     The criterion (or criteria) for regarding the report as serious 
512     Description of the reported signs and symptoms 
513     Specific diagnosis for the reaction 
514     Onset date (and time) of reaction 
515     Stop date (and time) or duration of reaction 
516     Dechallenge and rechallenge information 
517     Relevant diagnostic test results and laboratory data 
518     Setting (e.g., hospital, out-patient clinic, home, nursing home) 
519     Outcome (recovery and any sequelae) 
520     For a fatal outcome, stated cause of death 
521     Any autopsy or other post-mortem findings (including a coroner's report) 
522 
523 
524  5. Details on Reporter of an ADR 
525     Name 
526     Mailing address 
527     Electronic mail address 
528     Telephone and/or facsimile number 
529     Reporter type (consumer, healthcare professional, etc.) 
530     Profession (specialty) 
531 
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533     Source of report (spontaneous, epidemiological study, patient survey, literature, 
534  etc.) 
535     Date the event report was first received by manufacturer/company 
536     Country in which the event occurred 
537     Type (initial or follow-up) and sequence (first, second, etc.) of case information 
538  reported to authorities 
539     Name and address of MAH 
540     Name, address, electronic mail address, telephone number, and facsimile 
541  number of contact person of MAH 
542     Identifying regulatory code or number for marketing authorisation dossier 
543     Company/manufacturer's identification number for the case (this number must 
544  be the same for the initial and follow-up reports on the same case). 
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