FAQs about Pharmacovigilance

1. Periodic Safety Update Reports (PSUR)

For which kinds of medicinal products should PSURs be submitted?

  1. for all pure NAP procedures where the active substance is only authorised in Austria (including homeopathic medicinal products)
  2. for all active substances and combinations of active substances which are according to the EURD list required to submit a PSUR. These products are part of the PSUSA process.

 

Generics, bibliographic (“well established use”) authorisations as well as traditional herbal medicinal products are exempted from the submission of a PSUR. Nevertheless these products must submit PSURs as well if 2. applies or if:

  • such an obligation was issued as a condition or requirement for granting an authorization or registration
  • the Austrian Federal Office for Safety in Health Care requests a submission due to safety concerns.

Are amendments to the EURD-list possible?

 

Yes – the marketing authorisation holder can submit requests for amendment on one of the following grounds:

  • for reasons relating to public health;
  • in order to avoid a duplication of the assessment;
  • in order to achieve international harmonisation.

 

Requests for amendments should be submitted using the template (available on the EMA-homepage) and sent to eurdlistema.europaeu.

Do homeopathic medicinal products require a PSUR?


Homeopathic medicinal products (Austrian marketing authorisation numbers beginning with 3-...) are required to submit PSUR.

Only homeopathic medicinal products authorised under Austrian Medicinal Products Act §11 are exempt from submitting a PSUR (marketing authorisation numbers beginning with HOM-...).

What to consider when submitting a PSUR for a homeopathic medicinal product (AT Number of approval: 3-XXXX)?

Although a PSUR for a homeopathic should be structured in accordance with GVP module VII, a few simplifications are possible.


The most important sections are:


Worldwide marketing authorisation status:
It should be presented in which / how many countries the product is approved / marketed.


Actions taken in the reporting interval for safety reasons
It should be stated if there have been any important events, such as recalls, suspensions due to safety reasons etc.


Changes to reference safety information:
Safety relevant SmPC changes should be mentioned. Purely formal changes need not be presented.


Estimated exposure:
A statement about the number of sold units is important, but a transversion into patient years or any other unit is not required.


Data in summary tabulations:
A statement, if there have been adverse event reports during the PSUR period and if YES, the completion of the table by SOC  (serious and non-serious, in accordance with the table provided by GVP module VII) is expected.


Literature:
In case that relevant literature was published in the PSUR period for a homeopathic product , it should be mentioned and commented, however not for a single homeopathic substance, when the PSUR concerns a homeopathic combination.


Summaries of safety concerns:
These should be provided on the basis of the SmPC and other known safety data. It is acceptable even if the number of safety concerns is very small.

For the following sections only very rarely data are to be expected:
Clinical trials, non-interventional studies, non-clinical data, other periodic reports, lack of efficacy in controlled clinical trials, overview of signals.
Then a short statement, that the respective data do not apply, is considered sufficient. In case that such data exist, this should be provided.
All other sections should be mentioned and completed on a risk based approach and when there is no data available this should be mentioned accordingly.


These recommendations do not apply for any other medicinal drugs needing a PSUR submission.


Detailed information see: Guideline on good pharmacovigilance practices (GVP)
Module VII - Periodic safety update report (Rev1)

Do herbal medicinal products require a PSUR?


Only traditional herbal medicinal products registered under Austrian Medicinal Products Act §12 are exempt from submitting a PSUR.


If the herbal active substance or combinations of active substances is listed on the EURD list, the submission of a PSUR is required as laid out by the list.
If the active substance or combination of active substances in herbal medicinal product is not listed on the EURD list, PSURs should be submitted in accordance with the frequencies specified in the marketing authorisation.

If specific safety monitoring measures (eg. cumulative reviews of specific suspected adverse events) have been imposed on a reference product, do these measure also apply to generic medicinal products? Do these reviews have to be submitted to the Austrian Federal Office for Safety in Health Care (BASG)?


Independent of the type of authorisation procedure, all MAH are obliged by law (AMG §75i(1)) to submit pharmacovigilance data, in order to determine whether

  • new risks have been identified,
  • known risks have changed, or
  • the risk-benefit balance for the medicinal product has changed,

necessitating the implementation of  additional surveillance measures. Measures such as “close monitoring” or “cumulative review” can be part of this obligation.

Usually medicinal products authorised under Articles 10a of Directive 2001/83/EC are exempted from routine submission of PSURs. However,
PSURs may become obligatory, if pharmacovigilance data raise concerns about the risk-benefit balance of the product (see §75m AMG)

Which submission intervals apply?


The Austrian Federal Office for Safety in Health Care (BASG) specifies the frequency of submission of PSURs in the marketing authorisation documentation.

The due date for submission is calculated based on the PSUR frequency specified in the marketing authorisation documentation, starting on the date the marketing authorisation comes into force.

If the intervals for submission have not been specified in the marketing authorisation documentation (applicable to products authorised before Austrian federal law BGBl. I Nr. 110/2012 came into force), PSURs should be submitted in according with the following:

 

  • If the medicinal product has not been marketed: minimum of 6-monthly intervals after authorisation;
  • If the product has been marketed: minimum of 6-monthly intervals for the first 2 years after authorisation, followed by yearly submissions for the next 2 years, followed by 3-yearly intervals;
  • Immediately upon request by the Austrian Federal Office for Safety in Health Care (BASG)

 

If, however, the active substance or combinations of active substances of the medicinal product is listed on the EURD list, the submission of a PSUR is required as laid out by the list.
European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission.

The specifications outlined above are valid unless other intervals for submission are specified in the conditions of the marketing authorisatio or other deadlines for submission are defined.


How are changes to the frequency of submission of PSURs announced and how can amendments be requested?



For medicinal products, whose active substances or combinations of active substances are listed in the EURP-list, the frequency of submission of PSURs and date for submission is determined by the Data Lock Point (DLP) given in the EURD-list.
Normally, notifications of changes to the PSUR submission are not necessary as long as these changes are in line with the DLP of the EURD-list. If, however, other intervals for submission are specified in the conditions of the marketing authorisation or a pre-existing risk management plan, changes to the frequency of submission have to be announced.
The MAH is obliged to keep up to date with potential changes to the EURD-list on a monthly basis.
For medicinal products, whose active substances or combinations of active substances are not listed in the EURP-list, changes to the frequency of submission of PSURs can be requested from the department of pharmacovigilance by using the form F_B23 PSUR Zyklus Änderung in accordance with Austrian Medicinal Products Act §24.

What about medicinal products (generic, hybrid or well-established use) containing active substances or combinations of active substances not listed in the EURD-list?

A PSUR for an active substance or a combination, which is not on the EURD list, should generally be submitted nationally, however if the active substance / combination is authorised in more than one country and it is a full application/hybrid application the EMA should be informed.(eurdlist@ema.europa.eu)

How to submit the PSUR?

PSUR submission to the PSUR repository became mandatory on June 13, 2016. The PSUR Repository offers a secure electronic submission point for Marketing Authorisation Holders (MAH) and acts as a common storage place for PSURs, PSUR Assessment Reports (ARs), comments and final outcomes.
Both PSURs for PSUSA-procedures ("EU-single assessments") and PSURs for national PSUR submissions ("non-EU single assessments") have to be uploaded in the PSUR repository. CESP-Submissions, CD-ROMs etc. are considered as not submitted.

 

For more detailed information and help for electronical submission please refer to PSUR Repository website, numerous webinars and MAH user guide:
http://esubmission.ema.europa.eu/psur/psur_repository.html 

Which requirements apply to the content and format of a PSUR?


The format and content of the PSUR, is described in the Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report.

PSUR submission and eCTD

MAH, who have not yet submitted their documents in eCTD format, but in NeeS format, should prepare the next PSUR submission in the following way:
•    Create a baseline in eCTD with the sequence 0000, which includes at least the documents of module 3.
•    Submit the PSUR to the PSUR repository. In eCTD the PSUR will then be assigned to the next available sequence (0001 in this case).
Please keep in mind that – as soon as eCTD format has been used once – NeeS cannot be used any further.
NeeS will not be available from Jan 01, 2019!

The change should be made as soon as possible, not necessarily waiting until the end of the year.
For further information see the BASG Homepage https://www.basg.gv.at/eservices/ectdvnees/

 

Fees for PSUR submission - please refer to Fee Regulation

1.1. PSUR Repository

 

What is the PSUR Repository?

The PSUR Repository is a common storage place for the PSURs, the regulators’ PSUR Assessment Reports (ARs), comments and final outcomes. National Competent Authorities (NCAs) have direct, secure access to the Repository. More information on the PSUR Repository can be found here: http://esubmission.ema.europa.eu/psur/psur_repository.html.

 

How are PSUR submissions changing?

From 13 June 2016, it is mandatory for all MAHs in the EU to submit PSURs for human medicines directly to the PSUR Repository.  This means that companies have to use the Repository as a single point for all submissions and should no longer submit PSURs to NCAs directly.

The PSUR repository is mandatory for both centrally and nationally authorised medicines whether they follow the EU single assessment or a purely national assessment procedure. The PSUR Repository is intended for PSURs for human medicines only.

 

 

After 13 June 2016, what happens if a PSUR is not submitted to the PSUR Repository?

PSURs that have not been sent to the PSUR Repository are considered as not submitted and will not be assessed. PSURs not sent to the PSUR repository will not fulfil the MAH’s legal obligation to submit PSURs.

 

How do I submit a PSUR?

All PSURs are submitted to EMA’s PSUR Repository using the eSubmission Gateway/ Web Client: http://esubmission.ema.europa.eu/esubmission.html

In order to submit a PSUR to the PSUR Repository via the eSubmission Gateway / Web Client all users must register using the self-registration functionality. PSURs must be submitted as an Electronic Common Technical Document (eCTD) or non-eCTD electronic submission (NeeS). PSURs submitted in any other electronic format cannot be uploaded into the PSUR Repository and will be rejected.

Information on the Repository, guidance on how to register and multimedia tutorials for MAHs on how to submit a PSUR, as well as on the correct structured electronic formats, can be found on the EMA’s PSUR Repository web pages here:  http://esubmission.ema.europa.eu/psur/psur_repository.html.

 

What steps do I have to take before I can submit a PSUR to the PSUR Repository?

Prior to submission to the PSUR Repository, MAHs must ensure that the information on their authorised medicines is entered correctly in the Article 57 database. This is a legally binding requirement from the EU pharmaceutical legislation.

The PSUR Repository product selection is connected to the Article 57 database. If a product has not been correctly included in this database, it will not be displayed in the PSUR Repository.

More information about the submission of information on medicines in the Article 57 database is available here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000496.jsp&mid=WC0b01ac058078fbe0

 

 

Who can I contact to help me with my queries on PSUR Repository?

Users can contact the EMA to send their questions or report any issues they have with the PSUR repository and/or the eSubmission Gateway/ Web Client to the EMA Service Desk portal: https://servicedesk.ema.europa.eu.

 

 

Questions asked at the AGES Gespräch on 30. 05. 2016  

 

Which cover letter should be used for the PSUR submission to the PSUR repository? What should be observed using the cover letter?


For PSUSA procedures: EMA provides a cover letter, which can be used for PSUSA submissions, however an update is planned for the near future.
In section 7 “PSUR Single Assessment” should be ticked.

Purely national procedures (non-EU single assessments): also for these procedures the above mentioned cover letter should be used.
Furthermore the GZ (Grundzahl) for products approved in Austria should be inserted. The GZ should be inserted in Annex I under „Authorisation Number of product in the member state“ in addition to the authorisation number.

In section 7 of the cover letter, the type of document should be selected, e.g. PSUR Single Assessment, Worksharing and a lot of other procedures are available in the list.

For purely national procedures “other” should be ticked in section 7, whereas in section 8 in the free text section “national PSUR-submission” should be indicated.

Link to Cover letter („Formatted table template to be inserted in each procedural submission cover letter“), which should be inserted into the company cover letter:
www.ema.europa.eu/ema/index.jsp

A single cover letter for all countries, where a product has a marketing authorisation, is sufficient.

As soon as further information is available, it will be published on this website.

Further information about the PSUR repository can be found here:
esubmission.ema.europa.eu/psur/psur_repository.html
Please pay attention to the new „MAH PSUR repository User Guidance document“.


Can delivery files be re-used?

The delivery file describes the meta data of a PSUR submission (e.g. the respective product). As the PSUSA number is part of this information and future format changes of the delivery file cannot be excluded, delivery files should not be re-used.

Could EMA inform, how many MAHs are going to participate in a starting PSUSA procedure?

No, not at the moment. Only information about chargeable units for the respective marketing authorisation holder will be sent out.

1.2. PHV documents for renewal procedure

Requirements for PHV renewal documents:

Irrespective of the “CMDh BEST PRACTICE GUIDE ON THE PROCESSING OF RENEWALS IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES” submission of the following data is required for a renewal procedure in Austria:


AT=RMS:  
An “Addendum to the clinical overview“ should be submitted
AT=CMS:   An “Addendum to the clinical overview“ is currently only required if requested by the RMS.
Nationally approved:
An addendum is required, irrespective of a generic, well-established use, traditional herbal or homeopathic application.


The “Addendum to the clinical overview “ should cover the period from the date of approval to the date of submission of the renewal.


„Apothekeneigene Zulassungen“are exempted from PSUR submission. However, identification of safety relevant aspects requires the submission of pharmacovigilance data.

1.3. Consultants tracking PSUR-procedure - 15.09.2016

Questions and answers from AGES-Gespräch on 15. September 2016

Who can view the status of a PSUR-procedure on the eService platform "Marketing Authorisation & Lifecycle Management of Medicines"?

The Marketing Authorisation Holder can track the PSUR-procedure status after the procedure has been started.
To use the eService a singular registration under the following link is necessary: https://forms.ages.at/kundenregistrierung/startup.do.

How does a consultant get the authorization to track the PSUR-procedure status on the eService platform "Marketing Authorisation & Lifecycle Management of Medicines"?

The consultant can track the PSUR-procedures for which he or she has been authorized after a written notification by the Marketing Authorization Holder to: pharm-vigilanz@ages.at.
Please take into consideration that the consultant also needs to be registered on the eService platform: https://forms.ages.at/kundenregistrierung/startup.do.

1.4. Questions and Answers - 12.06.2018

Questions and answers from BASG -Gespräch on 12. Juni  2018

Can the MAH of a generic product, for which no PSUR is requested, receive the assessment report of a PSUSA procedure?


No, but the outcome of the PSUSA will be published on the EMA homepage:
Information on the outcome of centrally authorised medicinal products is made available in the European Public Assessment Report (EPAR) page of the relevant medicine.
Information regarding the variation of NAPs that are part of a CAP/NAP procedure is available in the Community Register for nationally authorised products.
Information on the outcome of the EU single assessment of PSURs involving nationally authorised medicinal products only is made available on the EMA web page under 'Home/Find medicine/Human medicines/Periodic safety update report single assessments' until the EU web' portal is fully functional.


Is a PSUR period of more than 3 years possible also for homeopathics?

A 3 year period is the longest period which can be granted for homeopathics in accordance with the Austrian law (AMG).

 

2. Risk Management Plans (RMP)

Which medicinal products require RMPs?

At the time of application for a marketing authorisation, companies must submit an RMP as part of the dossier to the Agency. This also applies to medicinal products applying for marketing authorisation using referencing pathways (§10 of the Austrian Medicinal Products Act).

Traditional herbal medicinal products and homeopathic medicinal products authorised under Austrian Medicines Act §11 are exempt from submitting an RMP.

Furthermore, existing authorisations are required to submit RMPs and are obliged to continually modify and update their RMPs:
when significant changes to the marketing authorisation are applied for, such as:

  • new dosage,
  • new type of application or pharmaceutical form,
  • new manufacturing processes (for biotechnologically produced substances),
  • paediatric indication, or
  • other significant changes to the indications.

at the request of the Austrian Federal Office for Safety in Health Care (BASG) or the Austrian Agency for Health Care and Food Safety (AGES), as the result of new information being received that may lead to a significant change to the benefit-risk profile

  • resulting from application for renewal

 

When should RMP be updated?

RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. Companies need to submit an updated RMP whenever a significant change in the benefit-risk balance is detected or new information is being received that lead to changes in the pharmacovigilance plan or risk minimisation measures.

Please note, that alterations to the RMP should be submitted in the clean finalized version, as well as the tracking mode, which highlights all changes to the original document.

What format should the RMPs have?

The risk management system should present the identified and potential risks of the medicinal product and relate it to the need for post-authorisation safety data.

For guidance on the format for RMPs please consult Guideline on good pharmacovigilance practices: Module V – Risk-management systems. The templates for the RMPs can be taken from the respective guidance documents:


What information in connection with RMPs will be made public?

  • A public summary, issued by the MAH in accordance with the guideline of good pharmacovigilance practice, will be made public.
  • Information concerning risk minimisation measures, which are a condition of marketing authorisation (register, PASS, patient information brochures, questionnaire).


The above documents for publication need to be submitted as Word-documents.

Summaries of RMPs of centrally authorised medicines will be publicly accessible on the EMA webpage. Summaries of RMPs of nationally authorised medicines will be publicly accessible on the webpage of the Austrian Federal Office for Safety in Health Care (BASG).

 How are RMPs of existing medicinal products or RMP updates submitted?

RMPs of existing medicinal products, which have not had an RMP previously, and RMP updates are equivalent to variations of the marketing authorisation (section 1.8.2.).

All submissions will therefore be considered to be formal requests for variation. The type of variation should be clarified with Institute Life Cycle Management.

3. Pharmacovigilance System

When should a summary of the pharmacovigilance system be submitted?

Applicants for a marketing authorisation (or registration) have to submit a summary of the Pharmacovigilance-System (PSMF summary).
Applicants have to maintain a pharmacovigilance system, which is described in the pharmacovigilance system master file, of which the PSMF-summary is a short description.


•    In general for all new applications for a marketing authorisation
•    When submitting an application for the approval for sales as “parallel import” (AMG §10c Abs.3 Z 13 i.d.g.F.) a PHV-system, PSMF and the submission of a PSMF summary are required.
•    When submitting an application for a herbal traditional use product, the submission of a PSMF-summary for national application is required.

•    Pharmacy-registrations (“apothekeneigene Registrierungen”)

 

Exemption:
Registered Homoeopathics


PSMF= Pharmacovigilance system master file
PHV=Pharmacovigilance

4. Implementation of Safety Information

We received a request to implement “PRAC signal recommendations” in the product information. However, we cannot meet the deadline given for implementation. How should we proceed?

Please contact Dr. Ulrike Rehberger (+43 (0) 50 555-36258; pv-implementationbasg.gvat).

We received a request to implement “PRAC signal recommendations” in the product information. The documents are currently undergoing clinical assessment for another variation. How should we proceed?

The MAH is requested to revise the texts in accordance with the PRAC signal recommendations and to submit a separate variation. Please include a note for the assessors in the covering letter accompanying the submission that another variation is currently in progress.

5. ADR Reporting - Electronic Reporting (E2B)

How to report ICSRs?

 

With the end of the transition period (starting from 22.11.2017 “Go live” of centralized reporting to EMA), only case reports from health-care professionals and patients which occurred within Austria will be accepted by BASG / AGES MEA.


MAHs should send all suspected serious and non-serious post-marketing case reports, which occurred within Austria, directly electronically to EVPM (EudraVigilance post-authorization module). This also includes case reports from the worldwide literature and non-interventional data collection schemes which occurred in Austria.

 

How do MAHs transmit literature cases?

 

Literature cases have to be submitted electronically to EMA. The copy of the original literature article should be sent by e-mail evlitema.europaeu.


Is any testing for MAHs with BASG / AGES MEA required?


No. Testing should be performed only with EMA. Further information:  http://www.ema.europa.eu.

 

How can health-care professionals (AMG §75g) report electronically?


After successful online registration: http://www.basg.gv.at/pharmakovigilanz/phv-meldung-online-vigiweb/registrierung-vigiweb/gesundheitsberufe/.
Further information: https://www.basg.gv.at/pharmakovigilanz/meldung-von-nebenwirkungen/meldung-fuer-angehoerige-der-gesundheitsberufen/.

 

Can also patient/ relatives report side effects to BASG/AGES MEA?


Yes, the following possibilties are available:

 

6. How to report "Emerging Safety Issues“?

Events may occur, which do not fall within the definition of reportable valid ICSRs, and thus are not subject to the reporting requirements, even though they may lead to changes in the known risk-benefit balance of a medicinal product and/or impact on public health. Examples include:

• major safety findings from a newly completed non-clinical study;
• major safety concerns identified in the course of a non-interventional post-authorisation study or of a clinical trial;
• signal of a possible teratogenic effect or of significant hazard to public health;
• safety issues published in the scientific and medical literature;
• safety issues arising from the signal detection activity (see Module IX) or emerging from a new ICSR and which impact on the risk-benefit balance of the medicinal product and/or have implications for public health;
• safety issues related to the use outside the terms of the marketing authorisation;
• safety issues due to misinformation in the product information;
• marketing authorisation withdrawal, non-renewal, revocation or suspension outside the EU for safety-related reasons;
• urgent safety restrictions outside the EU;
• safety issues in relation to the supply of raw material;
• lack of supply of medicines.

These events/observations, which may affect the risk-benefit balance of a medicinal product, are not to be submitted as ICSRs. They should be notified as emerging safety issues in writing to the competent authorities in Member States where the medicinal product is authorized via email (pharm-vigilanzagesat) and to the Agency via email (P-PV-emerging-safety-issueema.europaeu); this should be done immediately within 3 working days when becoming aware of them. The document should indicate the points of concern and the actions proposed in relation to the marketing application/authorisation for the concerned medicinal product. Those safety issues should also be analysed in the relevant sections of the periodic safety update report of the authorised medicinal product.

7. Welche Pharmakovigilanzverpflichtungen hat der Inhaber einer Genehmigung für den Vertrieb im Parallelimport?

Gemäß § 10c Abs. 3 Z 13 AMG muss auch der Inhaber einer Genehmigung für den Vertrieb im Parallelimport über ein Pharmakovigilanz- und erforderlichenfalls ein Risikomanagementsystem, verfügen.

Zwar ist der Inhaber einer Genehmigung für den Vertrieb im Parallelimport nicht verpflichtet einen periodischen Beurteilungsbericht (PSUR) vorzulegen, allerdings hat er gemäß § 94h Abs.9 AMG

 

  •  vermutete Nebenwirkungen, oder
  •  vermutete Nebenwirkungen beim Menschen, oder
  •  die nicht vorschriftsmäßige Verwendung, oder
  •  das Ausbleiben der erwarteten Wirksamkeit, oder
  •  nicht ausreichende Wartezeiten, oder
  •  häufig beobachteten unsachgemäßen Gebrauch und schwerwiegenden Missbrauch,  oder
  •  Qualitätsmängel, oder
  •  jede vermutete Übertragung von Krankheitserregern durch das Arzneimittel, die in einem Drittland aufgetreten ist, zu erfassen und dem Bundesamt für Sicherheit im Gesundheitswesen und der Agentur zu melden.

 

Weiters hat er dem Bundesamt für Sicherheit im Gesundheitswesen alle Beobachtungen und Daten mitzuteilen, die für die Arzneimittelsicherheit von Bedeutung sein können.

Gemäß § 75q Abs. 6 AMG hat der Inhaber einer Genehmigung für den Vertrieb im Parallelimport außerdem Qualitätsmängel, die im Inland aufgetreten sind und ihm nach Abs. 2 zur Kenntnis gebracht wurden oder sonst zur Kenntnis gelangt sind, zu erfassen und dem Bundesamt für Sicherheit im Gesundheitswesen unverzüglich, spätestens aber innerhalb von 15 Tagen nach Bekanntwerden, zu melden. Der Inhaber einer Genehmigung für den Vertrieb im Parallelimport hat den Originalwortlaut der ihm erstatteten diesbezüglichen Mitteilung zu dokumentieren und fünf Jahre aufzubewahren sowie dem Bundesamt für Sicherheit im Gesundheitswesen auf Verlangen unverzüglich zu übermitteln. Weiters hat der Inhaber einer Genehmigung für den Vertrieb im Parallelimport innerhalb der genannten Frist den Zulassungsinhaber oder den Inhaber einer Registrierung über diese Meldung zu informieren.

 

Betrifft eine Meldung nach § 75g (Meldung durch Angehörigen der Gesundheitsberufe) eine Arzneispezialität, die auf Grund einer Genehmigung für den Vertrieb im Parallelimport nach Österreich verbracht wurde, so hat das Bundesamt für Sicherheit im Gesundheitswesen den Inhaber der Genehmigung für den Vertrieb im Parallelimport unverzüglich, spätestens aber 15 Tage nach Bekanntwerden, zu informieren. Die Informationen haben in anonymisierter Form zu erfolgen.

8. Meldewege vermuteter Nebenwirkungen

 

Meldung vermuteter Nebenwirkungen

 

Im Sinne einer zielführenden Pharmakovigilanz ist es wesentlich, dass Meldungen vermuteter Nebenwirkungen bei der zuständigen Behörde einlangen.

Demgemäß sieht § 75g AMG vor, dass Angehörige der Gesundheitsberufe vermutete Nebenwirkungen unverzüglich dem BASG zu melden haben. Patienten können und sollen gemäß § 75h AMG vermutete Nebenwirkungen ebenfalls dem BASG melden.

Eine weitere Möglichkeit der Meldung vermuteter Nebenwirkungen besteht durch Meldung an den Zulassungsinhaber. Gemäß § 75j AMG darf ein Zulassungsinhaber die Annahme und Prüfung von Meldungen von Angehörigen der Gesundheitsberufe und von Patienten nicht verweigern.
Zulassungsinhaber sind verpflichtet Informationen über sämtliche vermutete Nebenwirkungen elektronisch an die Eudravigilanz-Datenbank zu übermitteln. Somit ist sichergestellt, dass die zuständigen Behörden auch von Meldungen vermuteter Nebenwirkungen, die beim Zulassungsinhaber eingehen, Kenntnis erlangen. Weiters ist der Zulassungsinhaber verpflichtet sich regelmäßig über die Meldungen gemäß §§ 75g und 75h AMG im Wege der Eudravigilanz-Datenbank zu informieren.

Weitere Arten der Meldung einer vermuteten Nebenwirkung sind im AMG nicht vorgesehen.

Die obig beschriebenen Meldewege vermuteter Nebenwirkungen stellen sicher, dass diese Verdachtsmeldungen auf Kausalität bewertet werden, in enger Zusammenarbeit mit dem EU-Behördennetzwerk laufend das Nutzen-Risiko-Verhältnis aller zugelassenen Arzneimittel überwacht wird und somit eine kontinuierliche Bewertung erfolgt, die in der jeweils aktuellen Version der Fachinformation reflektiert wird.

Created: 08.03.2009 | Page last modified: 12.03.2019

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