Australia Pharmacovigilance Guidance you need to know

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Australia Pharmacovigilance Complete Guidance

In this guidance, the words such as ‘must’ or ‘required’ to describe something MAH are legally obliged to do by MAH. Word ‘should’ to recommend an action that will assist MAH to meet the legal requirements.

Q: To whom this guidelines applies?

A: Applies to all sponsors who have medicines registered or listed on the Australian Register of Therapeutic Goods (ARTG).

Q: What are responsibilities of MAH in Australia as per TGA Guidelines?

A: MAH MUST meet the pharmacovigilance reporting responsibilities for all the medicines that MAH have registered or listed on the Australian Register of Therapeutic Goods (ARTG). This is regardless of their Australian marketing status—that is, whether they are currently available for purchase, withdrawn from sale or otherwise supplied.

MAH must let TGA know who MAH Australian pharmacovigilance contact person is

Submit any serious adverse reaction reports to TGA       

Notify TGA of any significant safety issues MAH identifies

Keep records pertaining to the reporting requirements and safety for the medicines Answer any request from TGA for additional information fully and within the specified timeframe. This includes situations where

1. Separate sponsors market two or more separately registered or listed medicines that are considered identical in all respects apart from their trade names.
2. sponsors share or outsource marketing or distribution arrangements
3. Pharmacovigilance activities are contracted to external organisations. TGA expect MAH to have an effective pharmacovigilance system in place in order to:
   • monitor and take responsibility for the safety of MAH medicine
   • meet legislative requirements for reporting serious adverse reactions and significant safety issues
   • identify any changes to the benefit–risk balance of your medicine
   • take appropriate action in a timely manner when necessary
   • Update product labels and product information (PI) with new safety information in a timely way.

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Q: How MAH deal with spontaneous reports?

A: For regulatory reporting purposes, if an adverse event is spontaneously reported, even if the causal relationship is unknown or unstated, it meets the definition of an adverse reaction. Therefore all spontaneous reports notified by healthcare professionals or consumers are considered suspected adverse reactions, since they convey the suspicions of the primary sources, unless the reporter specifically state they believe the events to be unrelated or that a causal relationship can be excluded.

Q: What is expected and unexpected adverse reactions?  How MAH deal with expedited and non-expedited reports?

A: An expected adverse reaction is an adverse reaction known to be associated with the use of the medicine, as reflected in the product information document or label warning statement.

An unexpected adverse reaction is an adverse reaction in which its nature, severity or frequency is either not identified, or not consistent with the term or description used, in the product information document or label warning statement.

Regulatory reporting requirements apply to both expected and unexpected adverse reactions.

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Q: What is significant safety issue?

A: A significant safety issue is a new safety issue or validated signal considered by you in relation to your medicines that requires urgent attention of the TGA. This may be because of the seriousness and potential major impact on the benefit-risk balance of the medicine

Q: How MAH need to deal with reporting about Australian pharmacovigilance contact person to TGA?

A: MAH need to submit the details of contact person via TGA Business Services within ≤ 15 calendar days of first ARTG entry or of any detail updates.

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Q: How MAH need to deal with reporting of Significant safety issues?

A: MAH need to submit any significant safety issues to TGA in writing to the PSAB Signal Investigation Coordinator, via email to: si.coordinator@health.gov.au within ≤ 72 hours of notification (awareness)

Q: What to be included while reporting significant safety issues?

A: When MAH report significant safety issues to TGA, MAH must indicate the points of concern and whether any plan to take any regulatory action in Australia for the medicine. This may include changes to the risk management plan, amendments to the package label or product information document, or distribution of a ‘Dear Healthcare Professional’ Letter. If no regulatory action is planned in response to the significant safety issue, MAH should provide justification for why this is the case in the Australian context. MAH MUST provide TGA with any additional information they ask for within a specified timeframe to assist to evaluate the benefits and risks of the medicine.

This additional information may include

1. the volume of sales or prescriptions of the medicine
2. details of the frequency assessment
3. copies of any relevant foreign adverse reaction reports MAH hold

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Q: How MAH need to deal with reporting of Serious adverse reaction reports that occurred in Australia?

A: MAH need to report the serious adverse reaction via Blue card/CIOMS form/E2B reports through

• Email: adr.reports@health.gov.au      or
• Online: TGA Business Services    within ≤ 15 calendar days of receipt of minimum information.

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Q: How MAH need to deal with reporting of Quality defect issues that occurred in Australia?

A: Reporting time frame for Quality defects is same as serious or significant safety issue reporting scenario as applicable.

For notifications of significant safety issues associated with medicine quality defect issues, email: si.coordinator@health.gov.au

For reports of serious adverse reactions associated with medicine quality issues or confirmed medicine quality issues unlikely to warrant a recall, email: adr.reports@health.gov.au

For notifications of medicine quality defect issues that is likely to warrant a recall, email: recalls@health.gov.au

For notifications of GMP compliance issues, email: GMPCompliance@health.gov.au

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Q: How MAH need to deal with Non-serious adverse reaction reports and overseas adverse reaction reports?

A: These are not required to be routinely reported. However, they must be presented as a cumulative table in a Periodic Safety Update Report (PSUR) as per PSUR reporting requirements.

Q: Who is Australian pharmacovigilance contact person?

A: MAH need to nominate a person in Australia to be responsible for fulfilling the reporting requirements for all medicines that MAH has in Australia. This person will be the primary direct contact for all pharmacovigilance correspondence between MAH and the TGA.

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Q: How many contact persons may MAH maintain?

A: TGA prefer that MAH have only one Australian Pharmacovigilance contact person. However, MAH may have more.

Q: Is it required for MAH to check their TBS profile?

A: MAH should regularly check their TBS profile to ensure the Australian pharmacovigilance contact person’s details remain correct

Q: What is TBS Profile?

A: TGA Business Services profile

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Q: What is difference between Pharmacovigilance contact person and the qualified person responsible for pharmacovigilance in Australia (QPPVA)?

A:  Please note that the Australian Pharmacovigilance contact person may be different to the qualified person responsible for pharmacovigilance in Australia (QPPVA), although ideally, they are the same person

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Q: What serious adverse reactions need to be reported to TGA?

• A: Following scenarios
  • expected and unexpected serious adverse reactions associated with the use of MAH  medicines that occurred in Australia
  • expected and unexpected serious adverse reactions associated with the use of MAH  medicines that occurred in Australia and were reported in the published international or local scientific and medical literature
  • all clinical and medically relevant follow-up information related to serious adverse reaction reports occurring in Australia

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Q: How MAH need to deal with submission of reports which do not comes under ICSR category?

A: For the individual adverse reaction reports not required to be reported to TGA (such as non-serious adverse reaction reports, serious adverse reaction reports from overseas, and invalid adverse reaction reports) need to be submitted in PSURs

Q: Is weekends and public holidays to be counted as calendar days?

A: Reporting timelines are based on calendar days, including weekends and public holidays, and relate to the Australian sponsor.

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Q: How MAH need to deal with Adverse reactions from literature?

A: MAH MUST report all serious adverse reaction cases occurring in Australia that are identified through screening the worldwide literature as soon as possible and no later than 15 calendar days from receipt.  MAH need to provide the respective article.

However if the article is not available at this time, you should provide it within 15 calendar days of submitting your report. If you have difficulty meeting this timeframe, notify us in writing prior to the 15 day period ending.

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Q: How MAH need to deal with invalid cases?

A: If a report cannot be validated it should still be retained and recorded in MAH pharmacovigilance system.

All reports of adverse reactions, regardless of their validity, should be recorded in MAH pharmacovigilance system for use in ongoing safety analysis activities

Q: If MAH got any report with missing of patient identifiers. Then how to deal with those kind of reports?

A: If MAH believe that there is a real patient involved (without any identifiers), it is considered sufficient for reporting.

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Q: If MAH got a case report in which the reporter does not wish to provide contact details. Ten how to deal with this kind of scenarios?

A: If the reporter does not wish to provide contact details, the adverse reaction is still considered valid if you can confirm the case directly with the reporter at the point of the initial report.

Q: What scenarios, MAH consider the case as invalid?

• A: Invalid scenarios
  • Only an outcome or consequence, such as hospitalisation or death, has been reported, with no further information provided.
  • Adverse reaction is mentioned as unspecified.

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Q: What scenarios of ICSR s must be followed-up?

• A: Scenarios as follows
  • Initial reports received by the MAH that do not include the minimum four data elements
  • monitored events of special interest such as potential risks
  • reports of pregnancy and breast feeding.
  • Cases notifying the death of a patient.
  • Cases of new risks or changes of known risks

MAH should document the attempts to obtain follow-up information

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Q: What are Key data elements for adverse reaction reports?

A: TGA recommend that MAH try to collect and include as many of the below key data elements about the adverse reaction.

1. Reporter details such as Name, Mailing address and/or Electronic mail address, Telephone and/or facsimile number, Reporter type (consumer, healthcare professional, etc.),  Profession (specialty e.g. physician, pharmacist, other healthcare professional; lawyer, consumer or other non-healthcare professional)
2. Patient details such as
   • initials or any other relevant identifier such as patient number
   • gender, age, age category (adolescent, adult or elderly) or date of birth
   • concomitant conditions, the patient’s medical history including relevant past medicine history, relevant family history
   • weight,  height, ethnicity, aboriginal and/or Torres Strait Islander origin
   • for reports about maternal/paternal or foetal
     • the gestation period at time of exposure
     • information about the parent such as their identity, age or date of birth, date of last menstrual period, weight, height, sex, relevant medical history and concurrent conditions, relevant past medicine history.
3. Details of the suspected medicines such as
   • brand name as reported, batch or lot number
   • International Non-Proprietary Name (INN) or Australian Approved Name (AAN)
   • the AUST R or AUST L number on the label
   • indication(s) for which suspect medicine was prescribed or tested
   • dosage form, strength, daily dose in units e.g. mg, ml, mg/kg and regimen
   • administration route, administration site, starting date and time
   • Stopping date and time or duration of treatment, any additional relevant information on medicine, other treatment drugs, Concomitant drugs, relevant medical devices.
   • changes to medicine administration e.g. medicine withdrawn, dose reduced, dose increased, dose not changed, unknown or not applicable
   • if the reaction is suspected to be the result of an interaction with alcohol, food or another medicine, the names and active ingredients of the suspected interacting medicines or substances.
4. Details of the adverse reaction(s)
   • a full description of the reaction(s), including body site and severity
   • the primary source’s description of the reaction
   • a description of the reaction using the Lowest Level Terms in the MedDRA terminology.
   • why the report is considered serious, a description of the signs and symptoms
   • a specific diagnosis of the reaction, the date and time of the reaction’s onset
   • when the reaction ceased, or its duration
   • interval between when the suspect medicine was administered and the reaction
   • de challenge and re challenge information, results and laboratory data from relevant tests
   • location, e.g. hospital, outpatient clinic, home or nursing home
   • the outcome of the reaction when last observed eg recovered/resolved, recovering/resolving, not recovered/ unresolved or recovered/resolved with sequelae (describe the sequelae)
   • if relevant, date of death, cause of death, relatedness
   • autopsy details if performed or post-mortem findings, including coroner’s report
   • assessment of reaction: source of assessment (e.g., initial reporter, investigator, regulatory agency, company), method of assessment (e.g. global introspection, algorithm, Bayesian calculation) and result
   • case narrative including clinical course, therapeutic measures, outcome
   • sponsor’s comments (e.g., diagnosis/syndrome and/or reclassification of reaction/event)
   • whether the case was medically confirmed, including medical documentations e.g. laboratory or other test data provided by either a consumer confirming the AR occurred, or an identifiable healthcare professional
   • document the whole report as a medically confirmed spontaneous report if:
     • a consumer initially reports more than one reaction and at least one reaction was medically confirmed.
     • if a medically qualified patient, friend, relative of the patient or carer submits a report
5. Administrative and sponsor details
   • Source of report (spontaneous, epidemiological study, patient survey, literature, etc.)
   • Date the event report was first received by sponsor
   • 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 sponsor
   • Name, address, electronic mail address, telephone number, and facsimile number of pharmacovigilance contact person at the sponsor’s Australian address
   • Company/manufacturer’s identification number for the case (the same number should be used for the initial and follow-up reports on the same case)
   • The ADR identification number (if known) of possible duplicate reports initially submitted to the TGA by a consumer, healthcare professional or other primary source.

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Q: Does case narrative need to be in logical chronological sequence?

• A: Yes. MAH should present the information in a logical chronological sequence as the patient experienced it, including
  • the clinical course, any therapeutic measures, the outcome
  • relevant follow-up information.
  • MAH should summarise any relevant autopsy or post-mortem findings. MAH may include their opinion on whether there is a causal association between the suspected medicine(s) and reaction(s), and details of the criteria MAH used to make the assessment.
  • Where MAH cannot obtain consent to disclose the personal details of the patient or reporter, or to contact the treating doctor for medical confirmation of consumer reports, indicate this in the report as a sponsor comment.
  • For follow-up reports, MAH should clearly highlight what follow-up information has been provided and reference the unique TGA adverse event record number designated to the initial report (stated in the acknowledgment letter from the TGA).
  • If the report is likely to be a duplicate—for instance, if MAH is aware the reporter has reported the adverse reaction to the TGA or it involves multiple suspected medicines, then MAH need to inform about this in the report.
  • MAH should provide all available details to help TGA to identify the duplicate including the TGA adverse event record number allocated to the initial report, if known.
  • If the reaction is suspected to be the result of an interaction with alcohol, food or another medicine, MAH should state this clearly in the report and list the suspected interacting products or substances.
  • For combination medicines that contain more than one active ingredient, list each active ingredient. If the primary source suspects a possible causal role of one of the ingredients in the medicine, provide this information in the report.

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Q: How to submit the serious adverse reaction reports to the TGA?

A: MAH can submit individual reports of serious adverse reactions occurring in Australia for their medicine on the ARTG via the following avenues:

• Via Online through TGA Business Services Electronic Data Interchange (E2B Reports)
• Via e-mail adr.reports@health.gov.au (CIOMS form)
• Via Fax 02 6232 8392
• Via mail  Address as  
  • Adverse Event and Medicine Defect Section, Pharmacovigilance and Special Product Access Branch, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia

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Q: How to submit significant safety issues report?

A: To notify TGA in writing of significant safety issues with MAH medicine on the ARTG, submit the report to the PSAB Signal Investigation Coordinator via:

• Via e-mail  si.coordinator@health.gov.au  Note: all emails will receive an automated response as an acknowledgement of receipt for your significant safety issue notification.
• Via Phone           1800 044 114
• Via Fax                  02 6232 8392
• Via mail  Address as        
  • Signal Investigation Coordinator, Pharmacovigilance and Special Product Access Branch, Therapeutic Goods Administration, PO Box 100 Woden ACT 2606

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Q: How MAH need to deal with Reports from post-registration studies?

A: MAH MUST report all serious suspected adverse reactions, of which are aware, relating to the studied (or supplied) medicine, that occur in post-registration studies undertaken in Australia, in accordance with the reporting time frames for serious adverse reactions.

• MAH do not need to routinely submit individual adverse reaction reports for:
  • non-serious adverse reactions
  • adverse events not suspected to be related to the medicine by the investigator
  • adverse reactions that occurred overseas during post-registration studies

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Q: What are other post-marketing initiatives that include collecting information related to adverse events of MAH?

A: Other programs such as

• patient support, product familiarisation and disease-management programs
• surveys of patients or healthcare providers
• collecting information on efficacy or patient compliance
• market research programs
• voluntary patient registries

Q: How MAH need to deal with Reports of exposure during pregnancy and breastfeeding?

A: For reports involving pregnancies where the embryo or foetus could have been exposed to one of MAH medicines, either through maternal exposure or transmission via semen following paternal exposure, then MAH should make reasonable attempts to follow up all individual cases and collect as much information as possible on the outcome of the pregnancy and development of the child after birth

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Q: A premature delivery (i.e. earlier than 37 weeks) can be considered as adverse reaction?

A: A premature delivery (i.e. earlier than 37 weeks) is not considered an abnormal outcome unless it resulted in adverse reactions to the neonate or mother.

Q: Is it necessary to include pregnancy reports in PSURs?

A: All drug exposure during pregnancy cases without adverse reactions need to be included in PSURs.

Q: How MAH need to deal with lack of efficacy cases?

A: MAH should record and, if incomplete, follow up all reports of a lack of therapeutic efficacy. MAH do not need to routinely report individual cases of suspected lack of efficacy. However, MAH MUST retain the reports and provide them to TGA upon request. There are certain circumstances when reports of lack of efficacy must be treated as serious adverse reactions for reporting purposes.

• Such as
  • medicines used for critical conditions or life-threatening diseases
  • vaccines
  • contraceptives
  • anti-infectives

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Q: How MAH need to deal with Reports of transmission of an infectious agent?

A: The transmission of an infectious agent via a medicine is also considered a serious adverse reaction for reporting purposes.

Q: How MAH need to deal with Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure?

A: MAH MUST report all serious adverse reactions and significant safety issues in accordance with the prescribed reporting requirements that relate to overdose (accidental and intentional), abuse, off-label use, misuse, medication error, occupational exposure.

MAH should routinely follow up these cases to ensure collection of much information.

If there is no associated adverse event or the adverse reaction is not serious, MAH do not need to report these to TGA. However, these MUST be recorded and should be considered in any applicable PSURs. Additionally, these MUST be provided on request by the TGA within the requested timeframe.

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Q: How MAH need to deal with Reports of non-serious adverse reactions?

A: MAH do not need to routinely report individual reports of non-serious adverse reactions that occur in Australia

Q: How MAH need to deal with reports of reactions whether serious or not, that occur outside Australia?

A: MAH do not need to routinely report individual reports of any adverse reactions, whether serious or not, that occur outside Australia. MAH is not required to report individual adverse reactions that occur overseas to TGA, but MAH should include them in ongoing monitoring activities.

However, serious adverse reactions occurring overseas in Australian patients using medicines supplied from Australia, for example while the patient is travelling on holiday, should be treated as an Australian case and MUST be reported to TGA.

Q: How MAH need to deal with Reports related to orphan drugs?

A: MAH MUST report all serious adverse reactions and significant safety issues related to orphan drugs in line with reporting requirements.

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Q: How MAH need to deal with Reports related to suspended or discontinued products?

A: MAH MUST continue to collect and report suspected serious adverse reactions and significant safety issues for suspended medicines as per the requirements for any approved medicine in Australia.

If a medicine has been removed from the ARTG, MAH must report serious adverse reactions occurring after a medicine was discontinued until the last batch expiry. After this date, MAH should report any new significant follow-up information on reported cases and continue to collect (but not report) safety information for review.

Q: How MAH need to deal with reports of medicines which are supplied after they have been removed from ARTG?

A: Any medicines that are supplied after they have been removed from the ARTG (and after the date of final batch expiry) will adhere to the reporting requirements for unapproved medicines

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Q: How long MAH need to retain the records of reports?

• A: The reports MUST be retained indefinitely for the life of the medicine and for
  • period of 10 years after removal from the ARTG for registered medicines
  • period of 5 years after removal from the ARTG for listed medicines

Q: What are obligations and requirements of Qualified person responsible for pharmacovigilance (QPPV) for MAH in Australia?

A: MAH should have a qualified person responsible for pharmacovigilance undertakings in Australia. Ideally, this person will also be the Australian pharmacovigilance contact person responsible for reporting to the TGA and coordinating pharmacovigilance-related communications.

• Recommendations from the TGA about the QPPV
  • lives in Australia
  • is permanently and continuously available (or at least within the hours of 9am–5pm AEST Monday to Friday), with a back-up person nominated should the primary QPPVA be absent
  • is trained and experienced in pharmacovigilance and relevant legislation in Australia
  • is medically qualified, or if not, have ready access to a medically qualified person for any clinical assessments necessary.
  • TGA prefer that this medically qualified person reside and are medically registered in Australia so they can address adverse reactions, significant safety issues and the benefit–risk balance of medicines in the Australian context.

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Q: What responsibilities of MAH need to be involved in training of staff?

A: Pharmacovigilance training should be conducted at induction of employment, with an annual refresher at a minimum for all relevant staff as appropriate based on their roles and responsibilities.

Q: What are Sources for collection of reports?

A: Below are the sources for collection of reports

1. spontaneous reports of adverse reactions (including consumer reports to you, or to people who work for you or have a contractual relationship with you)
2. internet and social media reports
3. reports from non-medical sources
4. solicited reports, such as from post-registration studies or post-market initiatives
5. reports in international and local literature
6. individual adverse drug reaction reports in the TGA’s Database of Adverse Event Notifications (DAEN)

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Q: How MAH need to deal with Spontaneous reports?

A: Spontaneous reports of adverse events are considered to be adverse reactions for regulatory purposes. MAH must report these adverse reactions to TGA if they are considered serious, even if MAH do not agree with the reporter’s assessment of the cause. A report is only exempt if the reporter specifically states they believe the events to be unrelated or that a causal relationship can be excluded, and MAH agree with this assessment.

Q: How MAH need to deal with Internet and digital media reports?

• A: MAH should regularly screen
  • Internet (such as websites, webpages, blogs, vlogs, social networks, internet forums, chat rooms and health portals)                       or
  • Digital media you own, fund, manage

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Q: How often, the internet or digital media need to be screened?

A: MAH should screen these media often enough to allow to report valid adverse reactions

Q: Do MAH need to have a system in place to screen the internet or their company website?

A: Yes. MAH should also consider setting up mechanisms for collecting adverse reaction reports through their company website by providing reporting forms or contact details for direct communication

Q: Do MAH need to review internet and digital media not sponsored by their company?

A: MAH do not need to review internet and digital media not sponsored by their company. However, if MAH become aware of an adverse experience on an internet or digital site that you do not sponsor, then report should be reviewed to determine if it must be reported to TGA or not.

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Q: The reports of adverse reactions obtained from internet or digital media are considered spontaneous?

A: Yes. Reports of adverse reactions obtained from internet or digital media are considered spontaneous.

Q: What can be considered as Primary source country?

A: The country for occurrence of event need to be considered as primary source country. If that country is not known in a report, then considered the country where the information was received as primary source country.

Q: What are reports from other non-medical sources?

A: Reports from lay press or other media are called as non-medical sources.

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Q: Are reports from other non-medical sources comes under category of spontaneous reports?

A: Yes. These comes under spontaneous reports category.

Q: What are solicited reports?

• A: Solicited adverse event reports can arise from:
  • clinical trials
  • non-interventional post-registration studies
  • other post marketing initiatives such as patient support programs, product familiarisation programs, market research programs and surveys.

Q: Do MAH need to deal with Agency reports?

A: MAH do not routinely report adverse reactions to their medicine that MAH learn of from TGA. However, if the adverse reaction reports could lead to a change in the benefit-risk balance of the medicine, then MAH MUST notify TGA of this change as a significant safety issue

Q: Do MAH need to check the local as well as International literature search?

Yes: The international and local scientific and medical literature are a significant source of information for monitoring the safety profile and benefit-risk balance of medicines.

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Q: How frequent, the literature search need to be conducted?

A: No less than weekly.

Q: What reference data bases must be used for literature search?

A: Reference databases such as Medline, Excerpta, Medica or Embase, including those that contain the largest number of articles about the medicine

Q: Does MAH need to maintain the search strategies?

A: Yes. MAH search strategies should be documented and reproducible. The procedures for monitoring literature should sufficiently capture up-to-date and comprehensive safety information associated with their medicines

Q: What to monitor in literature search?

A: Monitor ongoing safety and efficacy studies, including non-human teratogenicity and/or carcinogenicity studies for any relevant safety findings.

Q: What to report from Literature search?

A: MAH need to report the adverse reactions which occurred in Australia.

Q: How MAH need to deal with Literature reports which were identified from cohort studies?

A: Do not submit to TGA any literature reports of adverse reactions that occur in a cohort of patients but do not identify a patient who experienced an adverse reaction (where reasonable attempts at obtaining this information have not been successful).

Q: What are the signal Management guidelines for MAH of Australia?

A: The guideline for Practical Aspects of Signal Detection in Australia is Report of CIOMS Working Group VIII.   TGA pharmacovigilance-responsibilities-medicine-sponsors.pdf

Q: What PSUR guidelines need to be followed by MAH of Australia?

A: MAH of Australia need to follow the EMA guideline (Guideline on good pharmacovigilance practices Module VII – Periodic safety update report).  Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1) (europa.eu)

Q: How MAH need to deal with reporting requirements in the period from application submission and Registration?

A: Reporting requirements between application submission and prior to inclusion in the ARTG In the period between the submission of a registration application and the decision to register the medicine, you are not required to routinely submit individual adverse reaction reports except when the medicines is being used in Australia in a clinical trial (in accordance with the Clinical trial guidelines)

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Q: What is contact of Therapeutic Goods Administration?

• A:  Address to be contacted as below
  • Therapeutic Goods Administration, PO Box 100 Woden ACT 2606 Australia, Email: info@tga.gov.au Phone: 1800 020 653, Fax: 02 6203 1605

Q: What is PSUR guidance in Australia?

A: The TGA has adopted the EU PSUR guidelines with annotations. PSURs are not required for all registered medicines. PSUR submission is always required for provisional registration products, black triangle products and biosimilars and for vaccines.

PSUR submission may be required for other products for which the TGA evaluates RMPs and on occasion in the absence of an RMP to assist in post market safety monitoring.

Q: What is PSUR Timelines and frequency for submission?

A: Require PSUR submissions at least annually until 3 years from the date of approval.

Q: Is it required to submit the PSURs after 3 years?

A: After the end of the initial 3-year period additional PSURs may be requested if continued close monitoring of the product’s safety is warranted

Q: How PSURs need to be handled for New chemical & biological entities, high risk extensions of indication and major variations assessed under the Standard or Priority registration pathways?

A: Usually require PSUR submissions at least annually until the submitted PSURs cover a period of not less than 3 years from the date of approval. After the end of the initial 3-year period additional PSURs may be requested if continued close monitoring of the product’s safety is warranted.

Q: How PSURs need to be handled for Lower-risk extensions of indication and major variations assessed under the Standard or Priority registration pathways?

A: In this scenarios, May require PSUR to be prepared but submitted only when the TGA requests them.

Q: How PSURs need to be handled for Provisionally registered medicine?

A: Usually require PSUR submissions regularly for a period longer than the standard 3 years, to account for the provisional registration period, which may last up to 6 years. May require more frequent PSUR submissions, for example 6- monthly.

Q: What is PSUR format in Australia?

• A: Currently, the TGA accepts PSUR submitted in the following formats
  • eCTD (electronic Common Technical document) format * Preferred format
  • NeeS (Non-eCTD electronic submission) format
  • Single Electronic files (pdf) via email- *Not preferred. Accepted only when appropriately justified

Q: How to get further guidance on PSURs in Australia?

A: Please contact eSubmissions@health.gov.au  for further guidance