SUMMARY

EudraVigilance Information

National Institute of Pharmacy, Hungary (Országos Gyógyszerészeti Intézet)

Confirmation of status

Hereby we confirm that our current Electronic submission status with the EMEA is Production. We are ready to test the sending and receiving of safety cases from Marketing Authorisation Holders.

Login and ID information

Login name: National Institute of Pharmacy – Hungary

(can be found in the group Regulatory Authorities at letter „N”)

Test ID:OGYITEST

Production ID:OGYIP

Contact persons:

Pharmacovigilance:

Linda Palinko

+36-1-8869 300 / 237

Pharmacovigilance e-mail at NIP, Hungary:

IT:

Gergely Zajzon

+36-20-2159530

Type of connection:EVWeb

We are using the system via EVWeb – WebTrader surface. That means we do not have a Gateway connection yet. The change to the gateway system is ongoing.

MedDRA upgrades after implementation

As we are using the EVWeb surface, we have exactly the same MedDRA which EMEA has in the Central system. The electronic reports we send are made through this system.

Language:

We are sending the free text fields of E2B reports in English language.

Business rules:

As we work with the WebTrader (EVWeb), we have exactly the same business rules as EMEA has.

Will there be an EVWeb training at Budapest?

We do not plan to organise an EVWeb training in Budapest, but if there isdemand for a training, we can help the MAHs with getting in contact with EMEA’s trainer, and we can also provide a small trainings room in the building of OGYI.

Testing and pilot phase:

For testing please use our test login ID: OGYITEST

We are ready to start the testing phase with all the companies.

  1. The MAH can start the test phase with our authority, if it has finished the test phase with EMEA.
  1. For the testing phase the MAH has to send 2 cases toour EVWeb ID.
  1. When sending the test cases, please send us an e-mail to d to . In the e-mail please notify: name and ID of MAH, unique identifier of the two sent test cases.
  1. As we are using the EVWeb surface, we do not need any special reports,(Eg. special MedDRA phrases, etc.), because all the information comes to us through the central EMEA system. In our case the testing is just needed for a try, if we get all the information in time. We do not need specific test case scenarios that have to be demonstrated prior to starting a pilot phase.
    All information sent to us has the same specifications, which the EMEA has for sending the information.
  1. If the test cases were sent successfully we will send an acknowledgement message via EVWeb. If you get this message, you will have to send us an e-mail about it again. Then we send a final e-mail, and you can get into the production phase with us.
  1. If any problem occurs on any side we will go back to test phase and try to solve the problem and go on with the production.

Parallel report, paper form

It is enough to send the information via EV System, the MAHs do not have to do any additional procedures,we do not need a paper form parallelly.

„Extra deadline”

In case of companies who could not get anEVWeb or gateway connection in time or for any other reasons are not able to send us the information in E2B format, we accept CIOMS forms.

Will the EMEA interchange guideline (Nov 2004) describing the measures in case of technical problems be acceptable to you?

Yes

Are there any additional procedures in case of failures or problems at the pharmaceutical company or the authority?

No.

We do not have any special, country specific guidelines.

Time stamps and reporting compliance?

We do not have any information available regarding the possible time lack for the MDN / acknowledgement.

We have no specific requirements related to the recording and storage of Safety and Acknowledgement Messages (EDI messages).

We require the following case reports:

-all (central, MR, DC, national) cases (clinical or other and spontaneous) generated in Hungary,

-cases not generated in Hungary, but Hungary is a Rapporteur/Co-rapporteurfor theproduct

All other cases have to be reported to EMEA where we can find them if needed.

October, 2007

Mariann Viranyi Gergely Zajzon