Source: https://www.basg.gv.at/en/companies/pharmacovigilance/faqs-pharmacovigilance
Timestamp: 2020-04-08 21:30:58
Document Index: 160199000

Matched Legal Cases: ['§12', '§75', '§75', '§24', '§10', '§11', '§10', '§ 75']

FAQs pharmacovigilance - BASG
PHV documents for renewal procedure
Consultants tracking PSUR-procedure - 15.09.2016
Questions and Answers - 12.06.2018
Implementation of PHV issues / DHPC and Educational Material
What pharmacovigilance obligations does the holder of a parallel import marketing authorisation have?
For which kinds of medicinal products should PSURs be submitted?
for all pure NAP procedures where the active substance is only authorised in Austria.
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, homeopathic products and officinal formulations 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.
Marketing authorisation holders of homeopathic human medicinal products are informed that from 01.01.2020 [i.e. from the Data Lock Point: 30.09.2019] no further PSUR submissions are necessary, unless they are ordered by the BASG on a case-by-case basis.
Are amendments to the EURD-list possible?
Yes – the marketing authorisation holder can submit requests for amendment on one of the following grounds:
Requests for amendments should be submitted using the template (available on the EMA-homepage) and sent to eurdlistema.europaeu.
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.
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.
Fees for PSUR submission - please refer to Fee Regulation
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.
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.
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?
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.
What steps do I have to take before I can submit a PSUR to the PSUR Repository?
More information about the submission of information on medicines in the Article 57 database is available here.
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.
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:
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:
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.
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.
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.
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.
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:
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).
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.
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”)
Registered Homoeopathics
PHV=Pharmacovigilance
We have received a request to implement a safety-relevant word in the productinformation, which is already contained in our texts. How should we proceed?
In this case, please send us an e-mail.
Are the MAHs always informed by the BASG when a safety-relevant wording has to be included in the productinformation?
If it has been decided during the PRAC referral, a PRAC signal recommendation or a PSUSA e.g. to include new safety-relevant information in the productinformation, marketing authorisation holders of nationally (and MRP/DCP, if AT=RMS) approved medicinal products usually receive a request to adapt the texts. However, this does not release marketing authorisation holders from their obligation to screen the relevant sources regularly.
We have received a request to implement PRAC signal recommendations into the productinformation. The specified deadline for submission cannot be met. How should we proceed?
In this case, please send us an e-mail in a timely manner.
We have received a request to implement PRAC signal recommendations into the productinformation. However, the texts of the concerned products are currently under medical review due to another change. How should we proceed?
In this case, please state in the coverletter and in the application form that another textrelevant variation is ongoing.
How should DHPC Letter and Educational Materials be submitted?
The submission should be done by e-mail to the following addresses: dhpc-embasg.gvat.
Necessary documents are: German translation and English original version, communication plan
Would it be possible, to make educational material of the individual MAHs available on the homepage of the AGES (possibly with access only for experts)?
It is currently not planned to publish the Educational Material on the BASG website.
Is a joint design or sending of DHPC or Educational Material, which refers to an active substance (cross-company) or to a Class Labelling, controlled and coordinated by the BASG?
The cooperation of the companies concerned is supported by the BASG. A coordination by the BASG is not possible.
What are the requirements with regard to the distribution list? The companies will certainly define different distribution groups / address lists for the same active substance. How can it be ensured that all affected physicians are reached?
The distribution list must only be proposed to the BASG in form of groups (as also indicated at the EMA communication plan). E.g. general practitioners, internists ...
The responsible MAH must ensure that a current address list is used.
The "Blaue Hand" symbol has already been implemented in Germany. Can we expect the same for Austria?
In Austria, the "Blaue Hand" symbol is currently not implemented and in use.
What would be acceptable distribution methods for training materials for the AGES? Only by mail, or also via emails, homepages?
In principle, distribution is possible via all these channels. Which way the distribution of DHPC / Educational Materials can take place is a case-by-case decision. Therefore, the desired distribution method should already be specified at the time of submission.
Can also patient/ relatives report adverse reactions to the Federal Office for Safety in Health Care?
Yes, the following possibilties are available:
Via paper form
Literature cases have to be submitted electronically to the European Medicines Agency. The copy of the original literature article should be sent to evlit @ema.europa.eu.
Pursuant to Section 10c para. 3 no. 13 AMG, the holder of a parallel import license must also have a pharmacovigilance system and, if necessary, a risk management system.
Although the holder of a parallel import license is not obliged to submit a periodic assessment report (PSUR), pursuant to Section 94h (9) of the Medicines Act (AMG), he must record and report to the Federal Office for Safety in Health and the Agency on
suspected side effects, or
suspected side effects in humans, or
the improper use, or
the absence of expected efficacy, or
insufficient waiting time, or
frequently observed improper use and serious misuse, or
quality defects, or
any suspected transmission of pathogens by the medicinal product that has occurred in a third country.
In addition, he has to inform the Federal Office for Safety in Health Care of all observations and data that may be of significance for drug safety.
Pursuant to Section 75q (6) of the Medicines Act (AMG), the holder of a licence for parallel import marketing must also record quality defects that have occurred in Austria and that have been brought to his attention in accordance with (2) or otherwise come to his attention and report them to the Federal Office for Safety in Health Care without delay, but no later than 15 days after they become known.
The holder of a licence for parallel import distribution shall document the original wording of the relevant notification made to him and keep it for five years and, upon request, forward it without delay to the Federal Office for Safety in Health Care. Furthermore, the holder of a marketing authorisation for parallel imports must inform the marketing authorisation holder or the holder of a registration of this notification within the specified period.
If a notification pursuant to § 75g (notification by health professionals) concerns a medicinal speciality which has been brought to Austria on the basis of a licence for parallel import marketing, the Federal Office for Safety in Health must inform the holder of the licence for parallel import marketing immediately, but no later than 15 days after it becomes known. The information must be provided in anonymous form.
Page last modified: 28. August 2019