SEARN reliance map

Search product in: https://www.ema.europa.eu/en/medicines

• Only valid for products approved through the EU centralized procedure.
• On the product page, go to the assessment history section
• The document ‘Procedural steps taken and scientific information after authorisation’ contains all decisions taken by the European Commission, including variations.
• Public assessment reports are only available for variations deemed to be concerning major changes.
• More information on EPAR: Link.

• Union Register of medicinal products: https://ec.europa.eu/health/documents/community-register/html/index_en.htm 
• EMA product database: https://www.ema.europa.eu/en/medicines

• Only valid for products approved through the EU centralized procedure.
• Union register:
  1. Go to Procedures for centrally authorised medicinal products / Union Register of medicinal products for human use / Withdrawn, suspended, expired or not renewed
  2. You can find all concerned product by EU number or Alphabetical.
• EPAR:
  • On the product page, go to the assessment history section
  • Public assessment reports are available when the authorization was suspended or withdrawn due to quality, efficacy or safety reasons.
  • For other reasons (e.g. commercial reasons), information can be found in the below section ‘More information on XXX’.
  • More information on EPAR: Link.

Database of authorised medicines: https://www.ema.europa.eu/en/medicines

Example: pandemic influenza vaccine (H5N1) (live attenuated, nasal) AstraZeneca

General Product page: https://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-astrazeneca-previously-pandemic-influenza-vaccine-h5n1-medimmune

Product EPAR: https://www.ema.europa.eu/en/documents/overview/pandemic-influenza-vaccine-h5n1-astrazeneca-epar-summary-public_en.pdf

• Only valid for products approved through the EU centralized procedure.
• This database lists all medicines used for human only, but not only.
• You can find these by including the medicine's name or its active substance in the search field.
• It shows you information on centrally authorised medicines - medicines that EMA evaluated.
• When searching and clicking on the product name, the user will be provided with the product page which includes
  1. all information on the product assessment outcomes, and history,
  2. product details and information
  3. Any news on the product.
• The product page provides a summary of the European public assessment report (EPAR). It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.

Search product in: https://www.ema.europa.eu/en/medicines

Example: pandemic influenza vaccine (H5N1) (live attenuated, nasal) AstraZeneca

General Product page: https://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-astrazeneca-previously-pandemic-influenza-vaccine-h5n1-medimmune

• After selecting a product using the database above, the user finds a menu on the left side where Product information tab can be found
• After clicking on the Product information tab, the user is directed to the relevant section.
• The medicine’s product information is generally  available in all official EU languages. The use can select 'available languages' to access the language needed.
• Product information documents contain:
  1. summary of product characteristics;
  2. manufacturing authorisation holder responsible for batch release;
  3. conditions of the marketing authorisation;
  4. labelling;
  5. package leaflet.

Search product in: https://www.ema.europa.eu/en/medicines

• Only valid for products approved through the EU centralized procedure.
• On the product page of interest, go to the assessment history section
• The document ‘Procedural steps taken and scientific information after authorisation’ contains all decisions taken by the European Commission, including renewals.
• More information on EPAR: Link

• PRAC recommendations on safety signals: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals

• Applicable to any medicines registered in the EU (not limited to medicines authorized through the centralized procedure).
• Published after every meeting of the EU Pharmacovigilance Risk Assessment Committee (PRAC), including the recommended changes in the products information.

• Outcome of the Periodic safety update report single assessments (PSUSA): https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_psusa&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_search_categories%3A85&landing_from=73303

• Applicable to any medicines registered in the EU (not limited to medicines authorized through the centralized procedure).

• Dear Healthcare Professional Communication (DHPC): https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_dhpc_document&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_search_categories%3A85&landing_from=73303 

• Applicable to any medicines registered in the EU (not limited to medicines authorized through the centralized procedure).
• DHPCs are also announced in the meeting highlights from the PRAC published on the Friday after every meeting and accessible from the home page.

• RMP EPAR are accessible through the database of authorised medicines (please see above) https://www.ema.europa.eu/en/medicines

• Only valid for products approved through the EU centralized procedure.

• Information about all referral: https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_referral&f%5B1%5D=ema_search_categories%3A83&f%5B2%5D=ema_search_categories%3A85&landing_from=73303
• EMA product database: https://www.ema.europa.eu/en/medicines

• EudraGMDP Guidance: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/eudragmdp-database
• EudraGMDP Database: https://eudragmdp.ema.europa.eu/inspections/displayWelcome.do
• GMP Certificates Database: https://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do
• GMP non-compliance reports: https://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do

• The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates.
• A public version of the database allows public access to the information in the database that is not of a commercially or personally confidential nature.
• It contains the following information on GMP:

1. 1. Manufacturing and import authorisations
   2. Good Manufacturing Practice (GMP) certificates.
   3. Statements of non-compliance with GMP
   4. GMP inspection planning in third countries

• Users are advised that since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate issued by an EEA authority. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP.

General information on GCP inspections:

• https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice/coordination-gcp-inspections
• https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice/good-clinical-practice-gcp-inspection-procedures#ema-inpage-item-17256

• No database identified

• EudraGMDP Guidance: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/eudragmdp-database
• EudraGMDP Database: https://eudragmdp.ema.europa.eu/inspections/displayWelcome.do
• GDP Certificates Database: https://eudragmdp.ema.europa.eu/inspections/view/gdp/searchGDPCertificates.xhtml
• GDP non-compliance reports:
• https://eudragmdp.ema.europa.eu/inspections/view/gdp/searchGDPNcr.xhtml?search=nonCompliance

• The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates.
• A public version of the database allows public access to the information in the database that is not of a commercially or personally confidential nature.
• It contains the following information on GSDP:

1. 1. Wholesale Distribution Authorisations
   2. Good Distribution Certificates (GDP)
   3. Statements of non-compliance with GDP
   4. Registration of manufacturers, importers and distributors of active substances for human use located in the EEA

• Rapid alerts and recalls information: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/quality-defects-and-recalls#ema-inpage-item-12417
• Compilation of Union procedures on inspections and exchange of information: https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/coup_rev191_en.pdf
• Results of sampling and testing conducted over the years: https://www.ema.europa.eu/en/compliance-marketing-authorisation-0/sampling-and-testing#ema-inpage-item-10742

• Marketing and manufacturing authorisation holders should report a quality defect of a centrally authorised medicine, including suspected defects, to EMA following the instructions provided.
• If the nature of a product quality defect of a medicinal product presents a serious risk to public and animal health, national competent authorities inform each other through the rapid alert system.
• EMA is responsible for maintaining a rapid alert list of contact points, which includes national competent authorities in EEA Member States, the European Commission and international partner regulatory authorities and organisations.
• No centralised database found for product recalls
• There are lists of products sampling and testing conducted in each year, which can provide relevant information on product compliance

Database of authorised medicines:

The ARTG is the public database of therapeutic goods that can be legally supplied in Australia.

The ARTG can be used to search for medicines and medical devices.

Products remain on the ARTG unless:

• the sponsor requests that the product be cancelled.
• concerns are raised about the safety of the product that result in regulatory action.
• the sponsor does not pay the necessary charges.

The ARTG can be searched by entering the search term into the search box. Searches can be completed using:

• the product name
• active ingredient names
• the ARTG identifier number
• licence details (product category and status)
• sponsor details

The Public ARTG summary describes the type of product, the Australian sponsor (market authorization holder), the responsible approval area, the start date of inclusion into the ARTG, conditions applied to the product, dosage form, container type, pack size, shelf life, storage conditions, visual description of the product, active ingredients and other ingredients.

The results also include links to Consumer Medicines Information (CMI) and Product Information (PI) documents, when available.

Australian Public Assessment Reports for prescription medicines (AusPARs)

An AusPAR provides information about the evaluation of certain prescription medicines and the considerations that led the TGA to approve or not approve an application.

AusPARs are generally available for submissions for products containing new chemical and biological entities, biosimilar medicines, major variations and extensions of indications.

Various links for more information on AusPARs including questions/answers, guidance and summaries are also provided on the page.

To search for an AusPAR, select ‘Search Australian Public Assessment Reports for prescription medicines (AusPARs)’

The search can completed using the:

• medicine or trade name
• active ingredient

The entry includes information regarding the product, sponsor, as well as pdf and word versions of the AusPAR and PI.

Australian Prescription Medicine Decision Summaries (AusPMDS)

An AusPMDS document provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

They are published for new chemical entities, new biological entities as well as biosimilar medicines included in the ARTG from 1 September 2019. The first AusPMDS was published on 10 September 2019.

An AusPMDS is a static document that is submission specific. It is not updated to reflect variations to a prescription medicine after its first ARTG entry (approval).

A product may have one, or both of an AusPAR and AusPMDS.

Searches can performed using the:

• medicine or trade name
• active ingredient

Product information (PI)

https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/product-information

The Product Information (PI) contains a summary of the product characteristics and is published for use by healthcare professionals.

A PI is generally equivalent to the SmPC in the EU.

Searches can performed using the:

• medicine or trade name
• active ingredient

Consumer Medicines Information (CMI)

https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/consumer-medicines-information-cmi

A Consumer Medicine Information (CMI) document is published for the general public. CMI documents are leaflets that contain information on the safe and effective use of a prescription medicine, as well as some non-prescription medicines and some biologicals.

Search can performed using the:

• medicine or trade name
• active ingredient

TGA does not have a renewal process for Marketing Authorisation (MA). Where there are no changes to a product (i.e. the MA details), the product remains on the ARTG unless:

• the sponsor requests that the product be cancelled.
• concerns are raised about the safety of the product that result in regulatory action.
• the sponsor does not pay the necessary charges.

It is a requirement that the Sponsor (Market Authorisation Holder) maintains the currency of the MA details through the TGA’s variation process (see Variations section).

Australian Register of Therapeutic Goods (ARTG)

TGA has variation frameworks, and the application pathway and process will depend on the product and the variation type.

Once a product is entered in the ARTG, information cannot be changed (except for limited exceptions) without prior approval.

Details of changes made to products are not publicly available.

For a product that is included on the ARTG the public summary indicates when the last change to the register occurred for the product (details of changes are not provided):

• The start date is the date the product was added to the ARTG.
• The effective date is the date the last change to the entry came into effect.

Australian Public Assessment Reports for prescription medicines (AusPARs)

An AusPAR provides information about the evaluation of certain prescription medicines and the considerations that led the TGA to approve or not approve an application.

AusPARs are generally available for submissions for products containing new chemical and biological entities, biosimilar medicines, major variations and extensions of indications.

Various links for more information on AusPARs including questions/answers, guidance and summaries are also provided on the page.

To search for an AusPAR, select ‘Search Australian Public Assessment Reports for prescription medicines (AusPARs)’

The search can completed using the:

• medicine or trade name
• active ingredient

The entry includes information regarding the product, sponsor, as well as pdf and word versions of the AusPAR and PI.

ARTG Cancellations and Suspensions database

https://www.tga.gov.au/resources/artg-cancellations-and-suspensions

• Cancellations by sponsors https://www.tga.gov.au/resources/cancellations-by-sponsors
• Cancellations and suspensions https://www.tga.gov.au/resources/cancellations-suspensions
• Cancellations for failure to pay annual charges https://www.tga.gov.au/resources/cancellations-for-failure-to-pay

Cancellations and suspensions database records details of medicines and medical devices that have been cancelled or suspended, and no longer appear in the ARTG. Entries listed include a brief/high level description of the type of action and the grounds for regulatory action.

There are a number of ways to search for cancellations and suspensions which includes:

• Cancellation by sponsors - this database shows cancellations of Australian Register of Therapeutic Goods entries requested by sponsors.
• Cancellations for failure to pay annual charges.

Database of Adverse Event Notifications

• Medicines
  https://www.tga.gov.au/safety/safety/database-adverse-event-notifications-daen-medicines
• Devices
  https://www.tga.gov.au/safety/safety/database-adverse-event-notifications-daen-medical-devices

Adverse events can be notified by anyone. Sponsors (MAH) are required to report serious adverse events.

Searchable databases are linked on the listed pages. Accept the terms relating to the use of these forms before proceeding.

• Searches can be performed by name and active ingredient and can be filtered by year and other terms.

Medical product safety updates

Medicines Safety Update (MSU) articles provide detailed safety-related PI updates each month, although this may not include all safety-related updates. MSU articles for critical safety issues or topics of special interest are published on an as-needs basis.

Product safety updates are administered through the TGA’s variations framework (see also above).

Updated versions of Product Information (PI) and Consumer Medicine Information (CMI) documents are published on the TGA website (see also above)

• Product Information
  https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/product-information
• Consumer Medicines Information (CMI) https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/consumer-medicines-information-cmi

Not published directly.

• Medicines Safety Update (MSU) articles detail recent safety-related PI updates each month, although this may not include all safety-related updates. We publish MSU articles for critical safety issues or topics of special interest.
• Where products have an AusPAR and/or AusPMD (see 8.4.1.2) the approved version number(s) of the Risk Management Plans (RMP) are published.

The submission frequency of PSURs are also published, when they are required.

Not published directly.

In addition to Medicines Safety Updates (MSUs), see above, significant PI changes are often supported by distribution of a Dear Health Care Professional Letter on the issue, which are produced by the medicine’s sponsor and sent directly to health professionals. No public database of these letters is currently available.

Recall actions

https://www.tga.gov.au/safety/recall-actions  

System for Australian Recall Actions (SARA) database

https://apps.tga.gov.au/PROD/SARA/arn-entry.aspx   

Alerts

https://www.tga.gov.au/resources/alert   

Recall actions and alerts are published on the TGA website.

• SARA is the publicly searchable database where information is published about recall actions involving therapeutic goods in the Australian market.
• The Alert page can search safety alerts, Medicine shortage alerts and Product recalls.

AusPAR/AusPMD documents

• https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/australian-public-assessment-reports-prescription-medicines-auspars
• https://www.tga.gov.au/resources/auspmd

Not published directly.

Where products have an AusPAR and/or AusPMD the approved version number(s) of the Risk Management Plans (RMP) are published.

AusPAR/AusPMD documents

• https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/australian-public-assessment-reports-prescription-medicines-auspars
• https://www.tga.gov.au/resources/auspmd

Australian manufacturing licences and overseas GMP certification

https://www.tga.gov.au/resources/resource/guidance/australian-manufacturing-licences-and-overseas-gmp-certification

Licensed Australian Manufacturers

• https://www.tga.gov.au/resources/australian-manufacturer-search
• https://www.ebs.tga.gov.au/

Compliance actions and outcomes

• https://www.tga.gov.au/how-we-regulate/compliance-and-enforcement-hub/compliance-actions-and-outcomes

TGA publishes a list of Licensed Australian Manufacturers only.

• A licence to Manufacture for an Australian site commences on the day specified in the licence and remains in force until revoked or suspended.

• The TGA does not publish lists of overseas sites issued a GMP clearance.
• The GMP compliance status of overseas sites assessed by the TGA is not publicly available at this time.

Search tips:

• In the ebs page (https://www.ebs.tga.gov.au/), select Australian Manufacturers from the left menu under Public TGA Information.
• Click on the Manufacturer drop down to scroll through manufacturer names.
• By clicking on the small grey arrow button (which changes to green when the mouse hovers over it) on the far left column of the list this prompts the opening of a PDF for the Australian Approved Manufacturer when selected. The pdf includes details of the site, address, manufacturing activities as well as licence conditions.

Information on GCP inspections

No database available.

Not available

Manufacturer inspections - a risk-based approach

TGA Laboratory test reports

https://www.tga.gov.au/safety/product-testing-and-investigations

Laboratory test results

https://www.tga.gov.au/resources/laboratory-test-results  

TGA laboratory testing reports

TGA Laboratories apply a risk-based process to determine how, when and if products are tested.

Periodically, test results are released as well as more detailed reports for specific testing projects

Database of authorised medicines:

All authorized medicinal products can be found in the medicines lists. The medicines lists provided on the Swissmedic website will be updated monthly.

Swiss Public Assessment Reports (SwissPARs)

database:
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/swisspar.html

Summary report on authorisation

database:
https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/public-summary-swiss-par.html

Product information (PI)

database:
https://www.swissmedicinfo.ch/?Lang=EN

database:
https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/swissmedic-journal.html

see also medicines list column J:

The approval is initially granted for 5 years. After this period, the approval has to be renewed once (administrative procedure) and is then unlimited.

database:

https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl300_00_001d_wlaenderungenundzulassungserweiterungen.pdf.download.pdf/ZL300_00_001e_WL%20Guidance%20document%20Variations%20and%20extensions.pdf

https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl300_00_003d_foaenderungenundzulassungserweiterungen.docx.download.docx/zl300_00_003e_fovariationsandextensions.docx

Swissmedic Journal:
https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/swissmedic-journal.html

SwissPAR:

The application pathway and process for variations depend on the variation type. Switzerland recognises the following application types, depending on the possible implications for quality, safety and efficacy:

• Minor variations to be reported subsequently, type IA/IAIN
• Minor variations to be reported in advance, type IB
• Major variations, type II
• Extensions

Medical product safety updates

https://www.swissmedicinfo.ch/

DHPCs

Updated versions of the product information documents (HCP and patient information) are published via https://www.swissmedicinfo.ch/

Critical safety variations updates are published via “Direct Healthcare Professional Communications (DHPC)” on the Swissmedic website:

Not published directly

DHPC

https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/health-professional-communication--hpc-.html

Newsletter safety of medicines

Critical safety variations updates are published via “Direct Healthcare Professional Communications (DHPC)” on the Swissmedic website.

Recalls

Quality defects and batch recalls

Quality Alerts

RMP summaries

Database SwissGMDP

https://www.swissgmdp.ch/

Database EudraGMDP

Information on GCP inspections:

Database SwissGMDP

https://www.swissgmdp.ch/

Swissmedic Directive

https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/inspektorat/i-smi_rl_01d_durchfuehrungvoninspektioneninbetriebendiearzneimit.pdf.download.pdf/i-smi_rl_01e_conductofinspectionsofestablishmentsmanufacturingor.pdf

PIC/S Recommendation

The tested products are documented in the internal LIMS system containing the details of the manufacturer or origin as well as the description of the product. The tested parameters and results as well as the judgements are also stored in the LIMS.

Swissmedic stopped publishing data for vaccines and stable blood products as of December 31, 2024. For information, authorized parties should contact notification@swissmedic.ch

Approved batches

The OMCL receives test orders from Swissmedic internal customers, e.g. from the market surveillance division or from the legal service. In addition, annual programs are established based on regular discussions with the market surveillance division, which are then carried out by the OMCL. The selection of samples and test parameters are risk-based and defined between the OMCL laboratory and internal customers. The Official Control Authority Batch Release (OCABR) process is used for vaccines (as well as for blood products).