European Medicines Agency Standard Operating Procedure

Transcription

1 European Medicines Agency Standard Operating Procedure Title: Procedure to be followed by the EMEA in case of mechanical, programme, electronic or communication failure, which prevents a Sender from generating ICH M2 Safety or Acknowledgement Messages (failure at the Sender s database) PUBLIC Document no.: SOP/H/3154 Lead Author Approver Effective Date: 03-AUG-07 Name: Aniello Santoro Name: Panos Tsintis Review Date: 03-AUG-10 Signature: on File Date: 31-JUL-07 Signature: on File Date: 02-AUG-07 Supersedes: Not Applicable 1. Purpose To describe the procedure to be followed by the EMEA in case of mechanical, programme, electronic or communication failure, which prevents a Sender from generating ICH M2 Safety or Acknowledgement Messages, i.e. the Sender cannot create Individual Case Safety Reports (ICSR(S)s), in order to meet the mandatory electronic reporting obligations of suspected serious adverse reactions as defined in Regulation (EC) No. 726/2004 and Directive 2001/83/EC, as amended, and of Suspected Unexpected Serious Adverse Reactions (SUSARs), as defined in Directive 2001/20/EC. 2. Scope This SOP applies to the Staff Members responsible for EudraVigilance in the Pharmacovigilance and Post-Authorisation Safety & Efficacy of Medicines Sector of the Post-Authorisation Evaluation of Medicines for Human Use Unit. 3. Responsibilities It is the responsibility of the Head of Sector to ensure that this procedure is adhered to within his/her Sector. The responsibility for the execution of each step of this procedure is identified under point 9. Procedure. 4. Changes since last revision New SOP. 5. Documents needed for this SOP All the templates relevant to this SOP are specified below. Template 3, 5 and 6 are available on the EudraVigilance website, under the section e-reporting: what to do in case of system failure, since they are in common with the document e-transmission of ICSRs to the EMEA: Steps to follow in case of system failure, which has been published there. They are meant to be used by the users in case of system failure and are retrievable as hyperlinks, as specified below. The complete list of templates relevant to this SOP is provided below: - Template entitled Form 3: NFG - Notification of mechanical, programme, electronic or communication Failure which prevents the Sender from Generating ICH M2 Safety or Acknowledgement Messages. This template is to be used by the Sender to inform the EMEA about the above failure and the consequent initiation of paper transmission via fax. - Template entitled Form 4 (for internal use): NPM - Notification to the Sender that Paper reports are not correctly Marked. This template is to be used to notify the Sender that the paper reports received as part of the failure of the ICH M2 Safety or Acknowledgement Message generation are not clearly marked with the sentence Failure of electronic Safety Message generation at Sender s side and to remind the Sender to comply with this requirement for future transmissions. Page 1/6

2 - Template entitled Form 5: NCF - Notification of Correction of mechanical, programme, electronic or communication Failure, which had prevented the Sender from generating ICH M2 Safety or Acknowledgement Messages This template is to be used by the Sender to inform the EMEA that the failure of ICH M2 Safety or Acknowledgement Message generation has been corrected and therefore electronic transmission of ICH M2 Safety or Acknowledgement Messages is restarted. - Template entitled Form 6: NDR - Notification of all the necessary Details to Retrieve the electronically retransmitted reports This template is to be used by the Sender in order to provide the EVTM with all the information needed to retrieve the electronically retransmitted report(s) and to change their message receive date (manual recode) through the recoding interface. This will allow to update the compliance receipt dates of the electronically retransmitted ICSR(s) with the submission dates of the ICSR(S)s previously sent by fax. 6. Related documents - Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRS) and Medicinal Product Reports (MPRS) in Pharmacovigilance during the pre- and post- Authorisation phase in the European Economic area (EEA). - Volume 9A of the Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use. - SOP/H/ Procedure to be followed by the EMEA in case of failure of EVWEB at the level of the EMEA. 7. Definitions Acknowledgement Message: is an EDI Message with the information on the result of the Acknowledgement of Receipt procedure to acknowledge the receipt of one Safety Message and the Safety Report(s) contained in the Safety File in line with the ICH M2 Specifications. Acknowledgement of Receipt: the procedure by which the syntax and semantics of a Safety Message are checked upon receipt. Applicant: is a pharmaceutical company applying for a marketing authorisation in the EEA. Case Number: is called the Worldwide unique case identification number (ICH E2B(M) A or A ). No case should have more than one of these items completed. The contents of whichever item is used should remain unchanged for any transmissions subsequent to the original transmission. When a regulator is the initial Sender, ICH E2B(M) A should be used. When an entity other than a regulator is the initial Sender, ICH E2B(M) A should be used. When a Sender has not previously received a valid E2B/M2 report electronically, the identifiers (content and format) in ICH E2B(M) A and A or A should be identical. Retransmitters should use their own Sender s (case) safety report unique identifier (ICH E2B(M) A.1.0.1), but not change ICH E2B(M) A or A Competent Authority: an authority within the EEA responsible for granting the authorisation to conduct a clinical trial in at least one Centre located within the Community in accordance with the relevant laws and regulations established under Community law. EDI Partner: an organisation exchanging EDI Messages in the area of pharmacovigilance in the preand post-authorisation phase with another organisation. For the purpose of this SOP, EDI partners in the pre- and post-authorisation phase in pharmacovigilance are as follows: - Competent Authorities in the EEA - Marketing Authorisation Holders in the EEA - Applicants - Sponsors in the EEA Eudralink: is the secure electronic system designed to enable files to be sent securely over the Internet. Access to Eudralink is available to the EMEA, Member State Agencies, Pharmaceutical Companies, Members of Working Parties/Committees and Experts. PUBLIC Page 2/6

3 EV - EudraVigilance: the European data processing network and management system, which has been developed according to internationally agreed standards and which allows the European Medicines Agency (EMEA) to manage the electronic data exchange of Individual Case Safety Reports (ICSRs) and to support the pharmacovigilance activities at Community level. EudraVigilance Gateway: the data-processing network as defined in the Community Legislation. It provides a single point of contact between MAHs, Applicants, Sponsors and Competent Authorities in the EEA. By doing so, the EudraVigilance Gateway is considered a hub and all connections to the EDI Partners are known as spokes. Safety, Acknowledgement and Medicinal Product Report Messages are routed through the hub to the desired spoke. EVTM - EudraVigilance team member: refers to the person working in the EudraVigilance team in the Pharmacovigilance and Post-Authorisation Safety & Efficacy of Medicines Sector of the Post- Authorisation Evalution of Medicines for Human Use Unit. ICSR - Individual Case Safety Report: a document providing the most complete information related to an individual case at a certain point of time. An ICSR may be also referred to as Safety Report. Local report number: the local Message number in the ICH ICSR M2 Version 2.3 Specification Document. The local Message number is a value assigned to the ICH ICSR Message by the receiving organisation. The length, data type, and value are determined by the receiving organisation. Marketing Authorisation Holders: all Marketing Authorisation Holders (MAHs) holding a valid marketing authorisation for a medicinal product in the EEA including any part thereof, independent of the authorisation procedure of this medicinal product. Receiver: the intended recipient of the EDI Message. Safety Message: a Safety Message is an EDI Message including the information provided for one/more ICSRs contained in one Safety File exchanged between one Sender and one Receiver in one Message Transaction. Safety report ID: is called the Sender s (case) safety report unique identifier (ICH E2B(M) A.1.0.1). This identifier is assigned by the sending organisation and should remain constant in subsequent transmissions of the case by the same Sender. Retransmitters should replace this value with their own unique identifier. The value should be a concatenation of country code-company or regulator namereport number. Country code is the country of the primary source of the report (ICH E2B(M) A.1.1). The company or regulator name is an internationally unique abbreviation or code for the Sender s organisation. The report number is the organisation s international case number. Each component is separated from the other by a hyphen. For example, a report transmitted by a company to a regulatory authority concerning a case from France would populate ICH E2B(M) A with FRcompanyname where is a company s unique case report number. In the case of an organisational change, (e.g. a merger between companies or a name change), follow up reports should be identified in ICH E2B(M) A by the identifier of the newly named organisation. However, the worldwide unique case identifier number (ICH E2B(M) A.1.10) used in previous transmissions of the case should remain the same. Sender: it is the person/entity creating an EDI Message for transmission. Sponsor: an individual, company, institution or organisation, which takes responsibility for the initiation, management and/or financing of a clinical trial. PUBLIC Page 3/6

4 8. Process Map(s)/ Flow Chart(s) Start 1. Receive Notification of Communication Failure (Form 3: NFG) 2. Receive the report(s) submitted by fax 3. Are paper report(s) properly marked? yes 4. Sender notifies that failure has been solved (Form 5: NCF) and electronically transmits reports reported by fax no 3.1 Send an to Sender which specifies the case identification number(s) plus an explanatory note (Form 4: NPM) 5. Automatic acknowledgement of receipt is sent by the EudraVigilance System 6. Is the acknowledgement code 01 at message level? yes 7. Receive notification of local report numbers and date of faxes (Form 6: NDR) no 6.1 If acknowledgement code is 02: Sender to resend corrected electronic ICSR. If acknowledgement code is 03: Sender to resubmit corrected message. 8. Recode the electronic report(s) 9. Archiving of all paper documents End PUBLIC Page 4/6

5 9. Procedure Step Action Responsibility 1 Receive notification of communication failure from the Sender by fax EVTM to: +44(0) using the appropriate template Form 3: NFG. 2 Receive paper reports in an internationally acknowledged format (e.g. EVTM CIOMS1) from the Sender at the dedicated fax line: +44(0) Are the reports clearly marked with the statement Failure of Safety EVTM Message generation at Sender s side? If yes: go to step 4, If not: go to Step Using the template Form 4: NPM, send an via Eudralink to the EVTM Sender which specifies the case identification number(s) and the missing information. Inform the Sender that the reports he/she sent were not properly marked and that in the future he/she will need to adhere to this marking requirement. 4 The Sender notifies by fax to +44(0) that the failure at Sender the Sender s side has been restored by using the template Form 5: NCF, and that, as a result, electronic transmission has restarted. The Sender submits electronically the reports previously transmitted via fax. 5 An automatic acknowledgement of receipt is sent by the EudraVigilance system. 6 Is the acknowledgement code 01 at Message level (ICH M2 A.1.6)? Sender If yes: go to Step 7. If the acknowledgement code is either 02 or 03 at Message level (ICH M2 A.1.6)? go to Step If the acknowledgement code is 02 at Message level (ICH M2 A.1.6), Sender the Sender will need to resubmit a corrected electronic version of the specific ICSR(s) which is/are itself/themselves identified by a code 02 at ICSR level (ICH M2 B.1.8). Continue with Step 5. If the acknowledgement code at Message level is 03 (ICH M2 A.1.6), the Sender will need to resubmit a corrected Message. Continue with Step 5. 7 Receive a notification (Form 6: NDR) from the Sender, via fax, providing the following details: EVTM - Date when the paper reports were faxed - Date of electronic transmission of ICSR(s) - Local Report Number(s) of the report(s) retransmitted electronically - ICSR safety report identifier(s) The above details will allow updating the compliance receipt dates of the electronically retransmitted ICSR(s) with the submission dates of the ICSR(s) previously sent by fax. 8 Recode the date of the electronically retransmitted ICSR(s) by EVTM changing the message receive date (manual recode) via the recoding interface to the date when the paper report was received by the EMEA, via fax. 9 Archiving of all paper documents. EVTM PUBLIC Page 5/6

6 10. Records ICH M2 acknowledgement Message(s) for the ICSR(S)s referred to in steps 6 of point 9 Procedure are stored in the EudraVigilance system and can be retrieved using the local report number, the safety report ID and the case number. A master file will be created for each Organisation which experiences a communication failure and will be entitled: Name of the Organisation Communication Failure. Each master file will be divided in 4 sections entitled as follows: I) Failure of Message transmission II) Failure of Message generation III) Failure of Message receipt on the Gateway level IV) Failure of EVWEB at the level of the EMEA All the documents pertaining to this SOP will be stored in section II, in chronological order, as follows: - Fax notification (Form 3: NFG) by the Sender, informing about the failure in the Message generation. - The reports received by fax. - notification (Form 4: NPM) to the Sender as referred to in step 3.1 of point 9 Procedure. - Fax notification (From 5: NCF) from the Sender, informing that the failure has been restored. - Fax notification (Form 6: NDR) from the Sender, containing details requested in step 7 of point 9 Procedure. PUBLIC Page 6/6