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Learn about the market complaint handling process for EU products and pharmacovigilance on our website. Expert guidance and resources available. 2. Discover best practices for managing market complaints for EU products and pharmacovigilance on our website. Stay informed and compliant with regulations. 3. Access valuable information on market complaint procedures for EU products and pharmacovigilance on our website. Enhance your understanding and ensure compliance.

Discover best practices for managing market complaints for EU products and pharmacovigilance on our website. Stay informed and compliant with regulations.

Access valuable information on market complaint procedures for EU products and pharmacovigilance on our website. Enhance your understanding and ensure compliance.

Handling market complaints for EU products & Pharmacovigilance

1.0   Purpose :

• • To define the procedure for handling of market complaints for EU products and Pharmacovigilance.

2.0   Scope :  

• • This SOP applies to the drug products that are registered in the EU countries.

3.0   Responsibility :

• • Location Quality Assurance shall be responsible to:

  • Log in the complaint in the market complaint register.

• • Prepare PIR in case of quality-related complaints where the investigation may take time to prepare a final report.

• • Prepare an action plan for the investigation of quality-related complaints & to get it approved.

• • Conduct market complaint investigation as per the action plan.

• • Assure physical checks of the retention of samples and, if required, provide a sample(s) to the Quality Control department for testing.

• • Prepare investigation report and get it reviewed and approved by concerned persons.

• • Send a copy of the investigation report to CQ.

• • Location Quality Head shall be responsible to:

• • Receive complaints from CQ or any other source & hand them over to QA for investigation.

• • Approve the action plan/to provide guidance for the investigation of market complaints.

• • Approve the investigation report.

• • Location Quality Control shall be responsible to:

• • Monitor the analysis of the complaint sample & / or control sample as per the approved action plan.

• • Provide analytical results or any other data with the conclusion.

• • Location/Factory head shall be responsible to:

• • Approve the action plan/to guide the investigation of market complaints.

• • Approve the investigation report.

• • Corporate quality shall be responsible to :

• • Receive & log-in the market complaint in the market complaint register.

• • Collect the adequate information required for complaint investigation if not available.

• • Intimate the Regulatory Affairs Department, Medical Department, and other concerned manufacturing locations departments.

• • Evaluate the adverse drug reaction and produce the final decision or report on the adverse drug reaction.

• • Receive and review market complaint investigation reports or Preliminary Investigation Reports (PIR) from location.

• • Send the investigation details to QP.

• • Regulatory Affairs shall be responsible to:

• • Evaluate the submitted label and patient information leaflet to check the need for inclusion of additional information based on ADR/(s) or safety information as retrieved from literature or other relevant sources by the Medical Department.

• • Qualified Person – Pharmacovigilance (QP-Pharmacovigilance):

• • Ensuring the safety and quality of medicinal products during the manufacturing process.

• • Collaborate closely with other departments, such as quality assurance and regulatory affairs, to establish robust safety measures.

• • Ensures that the manufacturing facility complies with GMP standards and that appropriate measures are in place to address any product quality complaints or recalls.

• • Implement the SOP to the point of reporting Adverse Drug Reactions to the concerned authorities and organizations.

• • Responsible for the distribution of information on the ADR occurrence and report to all concerned, based on the distribution list, at _<Company Name>_ Europe B.V. (Netherlands) and to the Corporate Quality Department of _<Company Name>_.

• • The Medical Department shall be responsible to:

• • Retrieve and review updated information from published literature or as retrieved from the Internet or other related sources and forward relevant information \to Regulatory Affairs and Corporate Quality Assurance Departments.

• • Recommend the need for field alerts or recalls based on adverse reaction data.

4.0   Procedure for Handling Market Complaints (EU) and Pharmacovigilance

• • A complaint may be received at CQ from consumers, regulatory agencies, trade sources & health care professionals, or any other source, through QP or directly.

• • All employees of the Company and also representatives acting on its behalf shall adhere to the following guidelines to handle the complaint.

• • Upon receipt of a notification about ADR, a Company employee shall,

• • • Obtain acceptance for processing personal data in the scope necessary to take measures in order to obtain information about adverse reaction of drugs registered, manufactured or sold by the Company, and by all other entities connected via capital (e.g. Corporation…) participating in this process.

• • • If an e-mail, forward it to the QP-Pharmacovigilance immediately.

• • • If a phone call, put the call through to the QP-Pharmacovigilance. If the call can’t be put through, complete a telephone memorandum to the fullest extent possible, obtain the name and telephone number (including extension) of the reporter and a date of obtaining the information. If possible, obtain and note the information mentioned in point 6.8 of this procedure. Within one calendar day send the telephone memorandum to the QP-Pharmacovigilance.

• • • If it is an oral report, prepare a note according to the principles specified in the previous sub-point concerning phone communication.

• • • If it is a fax, letter, or any written message, this shall be delivered to the QP-Pharmacovigilance within one calendar day. Note the date of receipt on the letter.

• • • The date of receipt of the ADR information and the date of delivery of the report to the QP-Pharmacovigilance must be recorded in the report prepared by the QP-Pharmacovigilance.

• • • On the receipt of the complaint, CQ shall register the complaint and allot the registration number & forward it to the concerned location with a copy to MDO, QP (if not received through QP) Corporate Regulatory and Medical.

• • • If the location receives the complaint from any other source than CQ, a copy of the complaint shall be sent to CQ for registration.

• • • CQ, QP, Corporate Regulatory, and Medical departments shall asses the complaint for ADR.

• • • Complaints can be categorized as:

• • A flow chart for the market complaint handling procedure is given in attachments 1A & 1B.

• Receipt and Evaluation of ADR / Market Complaint by Person Responsible (QP-Pharmacovigilance) :

  • Post-Authorisation :

  • The QP-Pharmacovigilance upon receipt of written communication on ADR allocates to it a successive number and date of receipt by the company employee.

• • The Responsible Person forwards a written confirmation that the information had been received by the employee who collected the information.

• • If ADR information is delivered in another way than in writing, QP-Pharmacovigilance composes a detailed memorandum from ADR communication and allocates a successive number and date to it. After allocating a number and date, all memoranda are archived.

• • Based on obtained information the QP-Pharmacovigilance evaluates the seriousness of ADR and classifies the ADR as a suspected adverse reaction, serious or expected / unexpected adverse reaction.

• • In the event the information is inadequate to assess the ADR or does not fulfill the minimum requirements, QP-Pharmacovigilance contacts the reporter to obtain additional ADR information.

• • Before Authorisation :

  • Before authorization, during clinical trials of a new drug or clinical trial with a marketed drug for a new indication, the QP-Pharmacovigilance has to collect and evaluate all adverse effects.

• • In case of a serious adverse reaction, the clinical trial has to be stopped, and the serious adverse reaction has to be reported to the authorities immediately according to EC regulations.

• • Investigation of the complaint :

• • Any investigation shall be over within 10 days from the date of complaint receipt if does not demand any additional work.

• • In case of a critical complaint where the investigation may take time, location QA shall prepare PIR & send it to CQ.

• • CQ shall subsequently forward the same to QP.

• • Location QA shall attach the PIR with the complaint, which shall be part of the investigation report.

• • QA shall prepare an action plan for detailed investigation & get it approved by production, quality & location heads.

• • QA shall investigate with the help of concerned departments.

• • QA shall arrange for the physical inspection of the control sample if required & shall prepare a report of the same, which shall be part of the investigation report.

• • Production & QC shall provide the required information (as mentioned in the action plan) to QA for the preparation of the investigation report.

• • QA shall provide the required quantity of control sample to QC for analysis as mentioned in the action plan if required.

• • QA shall provide required batch manufacturing documents to production or QC for review & data collection.

• • QA shall prepare an investigation report & shall get it reviewed and approved by the concerns.

• • QA shall send a copy of the investigation report to CQ along with necessary attachments like control sample physical inspection report, trial batch report, quality control analytical data (in-process trend, Finished Product trend, stability data, complaint sample analytical results, control sample analytical results, trial batch results) or any other data suggested in the investigation action plan and the samples for replacement, where applicable.

• • CQ shall review the investigation report & ask for further investigation details if required.

• • CQ shall send investigation details to the QP.

• Evaluation of Information on ADR Compiled by Person Responsible (QP-Pharmacovigilance) in association with other departments as detailed before, and Reporting

  • In the event, that ADR occurs in a country within the European Union:

• • If it is a serious reaction, the QP-Pharmacovigilance develops a current report and sends it to the Competent Authority of the Reference Member State and that of the country/territory in which the ADR took place and to appropriate institutions in the countries outside the European Union where a drug product is registered and where notice of such reports is required by law – within 15 days from the date of notice about ADR occurrence.

• • If it is not a serious reaction, the QP-Pharmacovigilance reports this in an expedited manner on request and otherwise attaches the ADR data to the Periodic Safety Update Report (PSUR).

• • This report is forwarded to the Department for ADR Monitoring of Medicinal Products, at the OGYI and to relevant institutions in countries where the medicinal product is registered.

• • In the event, that ADR occurs outside the European Union:

• • If it is a serious unexpected reaction, the QP-Pharmacovigilance develops a current report and sends it to the European Medicines Agency, to the Competent Authorities of all the countries in the European Union countries where the given drug product is authorized, and to appropriate institutions in the countries outside the European Union where the drug product is registered and where the notice of such reports is required by law – within 15 days from the date of notice about ADR occurrence.

• • If it is a serious and expected reaction, the QP-Pharmacovigilance develops a current report and sends it to relevant institutions in the countries outside the European Union where the medicinal product is registered and where the notice of such reports is required by law. Though not a legal requirement, MAHs are encouraged to report all expedited serious ADRs occurring outside the EU on an expedited basis to the Agency provided that reporting takes place electronically.

• • If it is not a serious reaction, the QP-Pharmacovigilance shall only report it in an expedited manner on request and attach information on ADR to the Periodic Safety Update Report.

• • In the case of ADR of medicinal products registered by other companies, but sold or produced by the Company, the rules of QP-Pharmacovigilance’s proceeding depend on regulations between the Company and these companies, but QP-Pharmacovigilance has to report every ADR to the MAH within 15 days via courier mail from the date of notice about ADR occurrence.

• • The QP-Pharmacovigilance has to prepare the PSUR according to the requirements.

• • Minimum information required for ADR Reporting:

• • Patient’s identification (may be identified by initials, patient number, date of birth, age, age group, or sex) such that the information is as complete as possible, taking into account EU legislation on data protection (Directive 95/46/EC, Regulation (EC) No 45/2001) and relevant national legislation;

• • Reporter’s identification (an identifiable healthcare professional identified by name or initials, address or qualification, and contact details) taking into account EU legislation on data protection (Directive 95/46/EC, Regulation (EC) No 45/2001) and relevant national legislation;

• • At least one suspected active substance/medicinal product the use of which caused suspicious adverse reaction;

• • At least one suspected adverse reaction description.

• • Furthermore, key data elements for inclusion in the follow-up of expedited reports of serious adverse drug reactions are recommended in the ‘Note for guidance on definitions and standard terms for expedited reporting (CPMP/1CH/3945/03)’.

• • PSUR reporting requirements

• • PSURs shall be submitted at the following times from the Birth Date, for all medicinal products unless the marketing authorization makes different provisions immediately upon request

• • 6-monthly for the first 2 years after authorization

• • annually for the subsequent 2 years

• • At the first renewal and thereafter 5 years at renewal

• • Each PSUR shall cover the period since the last update report and shall be submitted within 60 days after the last lock point.

• • Mandatory electronic reporting

• • In accordance with articles 24 and 90 of Regulation (EC) No 724/2004, adverse drug reactions have to be transmitted electronically.

• • Requirements and implementation of electronic transmission of individual case safety reports post-authorization in the EEA have been outlined in the communication letter to marketing authorization holders in the EEA (EMEA/H/15994/03).

• • Additional reporting requirements are to be followed as outlined referring to the relevant Community legislation, i.e., Council Regulation (EEC 2309/93 and Directive 2001/83/EC) and Volume 9 of ‘The Rules Governing Medicinal Products in the European Union’.

• • Source of Safety Reports:

• • ADR can be received through the following sources :

• • Unsolicited Source :

• • Spontaneous Reports:

• • A spontaneous report is an unsolicited communication by a healthcare professional or consumer to a company. regulatory authority or other organization (e.g. WHO, Regional Centre, Poison Control Centre) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.

• • Stimulated reporting can occur in certain situations, such as notification by a “Dear Healthcare Professional” letter, publication in the press, or questioning of healthcare professionals by company representatives.

• • These reports shall be considered spontaneous. Consumer adverse reaction reports shall be handled as spontaneous reports irrespective of any subsequent “medical confirmation”.

• • Regulatory Authorities might require medical confirmation for the purpose of expedited reporting.

• • Literature :

• • QP Pharmacovigilance shall regularly screen the worldwide scientific literature by accessing widely used systematic literature reviews or reference databases.

• • The frequency of the literature searches shall be once every two weeks. Cases of ADRs from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, shall qualify for expedited reporting.

• • The regulatory reporting time clock starts as soon as it is established that the case meets the minimum criteria for reportability.

• • If the product source, brand, or trade name is not specified, the it shall be  assumed that it was XXX’s product. However, the report shall indicate that the specific brand was not identified.

• • If multiple products are mentioned in the article, the report shall be be submitted only if XXX’s product is suspected. The suspect product is that identified as such by the article’s author.

• • Internet :

• • QP Pharmacovigilance shall regularly screen websites under their management or responsibility for potential ADR case reports.

• • External websites shall not be screened collecting ADR information. However, if QP Pharmacovigilance becomes aware of an adverse reaction on a website that is not managed by _______, the case shall be reviewed and determine whether it should be reported.

• • Unsolicited cases from the Internet shall be handled as spontaneous reports.

• • For the determination of reportability, the same criteria shall be applied as for cases provided via other ways.

• • ADR reported by website or e. mail, identifiability of the reporter shall be established for the existence of a real person, i.e., verification of the patient or the reporter shall be established.

• • Other Sources :

• • If a QP Pharmacovigilance becomes aware of a case report from non-medical sources, e.g. the press or other media, it shall be handled as a spontaneous report.
  • For the determination of reportability, the same criteria shall be applied as for other reports.

• • Solicited Sources :

• • Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance.

• • Adverse event reports obtained from any of these shall not be considered as spontaneous.

• • For the purposes of safety reporting, solicited reports shall be classified as study reports, and therefore shall have an appropriate causality assessment by a healthcare professional.

• • Further guidance on study-related issues, such as managing blinded therapy cases, can be found in the ICH E2A guideline.

• • Regulatory Authority Sources :

• • Individual serious unexpected adverse drug reaction reports originating from foreign regulatory authorities are subject to expedited reporting to EU authorities by QP Pharmacovigilance.

• • Standards for the expedition of reporting :

• • ADR shall be reported in the following Cases.

• • Serious ADRs :

• • Cases of adverse drug reactions that are both serious and unexpected are subject to expedited reporting.

• • The reporting of serious expected reactions in an expedited manner varies among countries.

• • Non-serious adverse reactions, whether expected or not, would normally not be subject to expedited reporting.

• • For reports from studies and other solicited sources, all cases judged by either the reporting healthcare professional or by _________as having a possible causal relationship to the medicinal product would qualify as ADRs.

• • For purposes of reporting, spontaneous reports associated with approved drugs imply a suspected causal relationship.

• • Other Observations :

• • In addition to single case reports, any safety information from other observations that could change the risk-benefit evaluation for the product shall be communicated as soon as possible to the regulatory authorities.

• • Examples include any significant unanticipated safety findings from an in vitro, animal, epidemiological, or clinical study that suggest a significant human risk, such as evidence of mutagenicity, teratogenicity, carcinogenicity, or lack of efficacy with a drug used in treating life-threatening or serious disease.

• • Lack of Efficacy :

• • Evidence of lack of efficacy shall not normally be expedited but shall be discussed in the relevant periodic safety update report.

• • Medicinal products used for the treatment of life-threatening or serious diseases, vaccines, and contraceptives are examples of classes of medicinal products where lack of efficacy shall be considered for expedited reporting.

• • Clinical judgment shall be used in reporting, with consideration of the local product labeling and the disease being treated.

• • Overdose :

• • Reports of overdose with no associated adverse outcome shall not be reported as adverse reactions.

• • Cases associated with serious adverse reactions are considered subject to expedited reporting unless otherwise specified by local regulation.

• • Such cases shall be routinely followed up to ensure that the information is as complete as possible about symptoms, treatment, and outcome.

• • QP Pharmacovigilance shall collect any available information on overdose related to its products.

• • Minimum Criteria for Reporting:

• • All efforts shall be made to collect as much information as possible at the time of the initial report. However, for regulatory reporting, the minimum data elements for an ADR case are an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect product.

• • Lack of any of these four elements means that the case is considered incomplete; however, ________ shall exercise due diligence to collect the missing data elements.

• • Reporting Time Frames :

• • Expedited reporting of serious and unexpected ADRs shall be done as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the QP Pharmacovigilance or ________.

• • The reporting time clock shall be considered as start on the date when any personnel of the _______ first receive a case report that fulfills minimum criteria as well as the criteria for expedited reporting. This date shall be considered as day 0.

• • When additional medically relevant information is received for a previously reported case, the reporting time clock shall be considered to begin again for submission of the follow-up report.

• • In addition, a case initially classified as a non-expedited report shall qualify for expedited reporting upon receipt of follow-up information that indicates the case shall be re-classified (e.g., from nonserious to serious).

• • Non-serious ADRs :

• • Cases of non-serious ADRs, whether expected or not, shall normally be considered as not reportable on an expedited basis.

• • Non-serious ADRs shall be included in the periodic safety update report. 

• • Clinical Case Evaluation:

• • A careful medical review to ensure the correct interpretation of medical information shall be done with the help of the Medical department. Preferably, information about the case shall be collected from the healthcare professionals who are directly involved in the patient’s care.

• • Regardless of the source of an ADR report, each report shall be carefully reviewed for the quality and completeness of the medical information.

• • The review shall include, but is not limited to, the following considerations :

• • • Is a diagnosis possible?

• • • Have the relevant diagnostic procedures been performed?

• • • Were alternative causes of the reaction(s) considered?

• • • What additional information is needed?

• • ADR terms shall be used consistently and in accordance with recommended standards for diagnosis.

• • The ADR report shall include the verbatim term as used by the reporter or an accurate translation of it.

• • The report recipient shall actively query the reporter to elicit the most complete account possible. Inferences and imputations shall be avoided in report submission.

• • When a case is reported by a consumer, his/her description of the event shall be retained, although confirmatory or additional information from any relevant healthcare professionals can be included if required.

• • Follow-up Information:

• • The information from ADR cases when first received is generally incomplete. Ideally, comprehensive information would be available on all cases, but in practice, efforts shall be made to seek additional information on selected reports, including second–hand reports (see Attachment 2 – Recommended Key Data Elements, of this guideline).

• • The priority for follow-up shall be as follows: cases that are 1) serious and unexpected, 2) serious and expected, and 3) non-serious and unexpected. In addition to seriousness and expectedness as criteria, cases “of special interest” also deserve extra attention as a high priority (e.g., ADRs under active surveillance at the request of the regulators), as well as any cases that might lead to a labeling change decision.

• • Follow-up information shall be obtained, via a telephone call and/or site visit and/or a written request.

• • For follow up specific questions shall be provided for which _______ would like to have answered.

• • Methods of followup shall be tailored towards optimizing the collection of missing information. Written confirmation of details given verbally shall be obtained whenever possible.

• At the time of the original report, All possible details about the patient and reporter shall be collected and retained to enable future investigations

5.0   Definition & abbreviations:

• • Market Complaint :

  • A market complaint is a notification that a product in distribution,
    • May violate the laws or regulations administered by the FDA.
    • May have caused an illness, injury or death.
    • Is alleged to have caused problems not covered by the above

  • Medicinal product :

  • Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances that may be used in or administered to human beings either to restore, correct, or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis.

• • Experimental product :

• • Substance or combination of substances in a given pharmaceutical form of an active substance or placebo, tested or used as a reference product in the clinical trial, including the product authorized for marketing, which is used or prepared differently from the marketed form or which is used for indications that are not covered by marketing authorization, or which is used to obtain additional information about the already marketed form.

• • Adverse Event :

• • An adverse event is any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have to have a causal relationship with this treatment.

• • An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

• • ADR (Adverse Drug Reaction) :

• • A response to a medicinal product that is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.

• • In the context of Pharmacovigilance, the term adverse reaction is considered synonymous with suspected adverse reaction and adverse drug reaction.

• • Serious Adverse Drug Reaction :

• • An adverse reaction that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.

• • For reporting purposes, any suspected transmission via a medicinal product of an infectious agent is also considered a serious ADR and shall be reported in an expedited manner.

• • Unexpected Adverse Reaction:

• • An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.

• • Adverse Reaction to Experimental Product :

• • Any unfavorable and unintended reaction to the product, related to any dose of the product.

• • Pharmacovigilance :

• • All activity – of laws, drug authorities, marketing authorization holders, and so on – for the safety of drug administration.

• • International Birth Date (IBD) :

• • The date of first marketing authorization for a medicinal product granted to the marketing authorization holder in any country in the world.

• • EU Birth Date (EBD) :

• • The date of first marketing authorization for a medicinal product granted in the EU to the marketing authorization holder:

• • For medicinal products authorized through the centralized procedure, the EBD is the date of the marketing authorization granted by the EC, i.e. the date of the Commission Decision.

• • For medicinal products authorized through mutual recognition or decentralized procedure, the EBD is the date of the marketing authorization granted by the Reference Member State.

• • For products authorized through purely national procedures (outside the mutual recognition or decentralized procedure), the Marketing Authorisation Holder may propose a birth date that can be applied to reporting requirements across the Member States.

• • Abbreviations :

CQ	:	Corporate quality department
RA	:	Regulatory affairs department
QP	:	Qualified Person,
QP – Pharmacovigilance	:	Qualified Person, Pharmacovigilance
PSUR	:	Periodic Safety Update Report
MDO	:	Managing Director’s Office
ADR	:	Adverse Drug Reaction
PIR	:	Preliminary Investigation Report
MAH	:	Marketing Authorisation Holder.
EU	:	European Union
PSUR	:	Periodic Safety Update Report

 

6.0   Reference & Attachments :

• References :

• • EudraLex – The Rules Governing Medicinal Products in the European Union: Volume 9 – Pharmacovigilance (Medicinal Products for Human and Veterinary use.

• • Pharmacovigilance in the European Union: http://evtraining.emea.europa.eu/ct/

• • Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module),

• • Hungarian law about medicines for human use, No.: XCV.

• • Regulation of Minister of Health on distribution of human medicines, No.: 52/2005 (XI. 18. MH).

• • Regulation of Minister of Health on clinical tests of human medicines and good clinical practice, 35/2005. (VIII. 26. MH).

• • EMEA (2006): CPMP/ICH/3945/03. ICH Topic E 2 D. Post Approval Safety Data Management, Step 5: Note for guidance on definitions and standards for expedited reporting.

• • Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use,

• • Regulation of European Council on medicines for human and veterinary use, No.: 726/2004/EC.

• • EMEA Post-authorisation Evaluation of Medicines for Human Use. Communication addressed to all Marketing Authorisation Holders in the European Economic Area: EMEA/H/15994/03.

• Attachments :

Attachment 1A & 1 B : Flow Chart for market complaint handling procedure

Attachment 2 : Recommended Key Data Elements, of this SOP.

Some data elements might not be relevant, depending on the circumstances. Attempts shall be made to obtain follow-up information on as many other listed items as are pertinent to the case.

1. Patient Details

• Initials
• Other relevant identifier (patient number, for example)
• Gender
• Age, age category (e.g., adolescent, adult, elderly), or date of birth
• Concomitant conditions
• Medical history
• Relevant family history

2. Suspected Medicinal Product(s)

• Brand name as reported
• International Non-Proprietary Name (INN)
• Batch/lot number
• Indication(s) for which suspect medicinal product was prescribed or tested
• Dosage form and strength
• Daily dose (specify units – e.g., mg, ml, mg/kg) and regimen
• Route of administration
• Starting date and time
• Stopping date and time, or duration of treatment

3. Other Treatment(s)

The same information as in item 2 shall be provided for the following:

• Concomitant medicinal products (including non-prescription, over-the-counter medicinal products, herbal remedies, dietary supplements, complementary and alternative therapies, etc.) .
• Relevant medical devices

4. Details (all available) of Adverse Drug Reaction(s)

• Full description of reaction(s), including body site and severity
• The criterion (or criteria) for regarding the report as serious
• Description of the reported signs and symptoms
• Specific diagnosis for the reaction
• Onset date (and time) of reaction
• Stop date (and time) or duration of reaction
• Dechallenge and rechallenge information
• Relevant diagnostic test results and laboratory data
• Setting (e.g., hospital, out-patient clinic, home, nursing home)
• Outcome (recovery and any squeal)
• For a fatal outcome, stated cause of death
• Relevant autopsy or post-mortem findings
• Relatedness of product to reaction(s)/event(s)

5. Details on Reporter of an ADR

• Name
• Mailing address
• Electronic mail address
• Telephone and/or facsimile number
• Reporter type (consumer, healthcare professional, etc.)
• Profession (specialty

6. Administrative and MAH Details

• Source of report (spontaneous, epidemiological study, patient survey, literature, etc.)
• Date the event report was first received by manufacturer/company
• Country in which the event occurred
• Type (initial or follow-up) and sequence (first, second, etc.) of case information reported to authorities
• Name and address of MAH
• Name, address, electronic mail address, telephone number, and facsimile number of contact person of MAH
• Identifying regulatory code or number for marketing authorisation dossier

Company/manufacturer’s identification number for the case (the same number shall be used for the initial and follow-up reports on the same case)