Checking Of Submitted Periodic Safety Update Reports
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European Medicines Agency Work Instructions
Title: Checking of submitted Periodic Safety Update Reports (PSURs) Applies to: Product Team Leaders in Pharmacovigilance and Post-Authorisation Safety and Efficacy of Medicines sector Document no.: WIN/H/3198
PUBLIC Lead Author
Approver
Effective Date: 21-NOV-07
Name: Christine Bugge
Name: Panos Tsintis
Review Date: 21-NOV-10
Signature: on File
Signature: on File
Date: 14-NOV-07
Date: 15-NOV-07
Supersedes: SOP/H/3011 (06-Oct-05)
1. Changes since last revision New WIN. 2. Records The PTL is to forward the following documents in hard copy to Central Information Group (CIG): • Request to the Marketing Authorisation Holder (MAH) for revised or missing documentation • Revised or missing application documentation submitted by MAH during validation phase These documents will be filed in the product Master File by CIG. If the documents exist electronically they should also be stored electronically in a specific folder under the product folder: EDMS/Products/H-C/Product name/05-Post-authorisation/Post activities/SO FUMs PSURs and subfolder by PSUR submission If documents are received electronically both the attachments and Eudralink message/email should be printed out for the Master File and saved electronically as described above. 3. Instructions Documents needed for this WIN Template for checking of PSUR is available under WORD/File/New/H-Validation. The letter to MAH requesting additional information is available in SIAMED. Related documents • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol1/reg_2004_726/reg_2004_726_en.pdf •
ICH topic E2C - Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (CPMP/ICH/288/95 adopted December 96). http://www.emea.eu.int/pdfs/human/ich/028895en.pdf
•
Addendum to ICH topic E2C (CPMP/ICH/4679/02, adopted February 2003) http://www.emea.eu.int/pdfs/human/ich/467902en.pdf
•
Eudralex, Volume 9A of the rules governing medicinal products in the European Union (Pharmacovigilance for Medicinal Products for Human Use (January 2007)) http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9A_2007-01.pdf
Page 1/3
•
Position paper on compliance with pharmacovigilance regulatory obligations (CPMP/PhVWP/1618/01) http://www.emea.eu.int/pdfs/human/phvwp/161801en.pdf
•
Transitional measures for submission of PSURs for Centrally authorised medicinal products for human and veterinary use http://www.emea.europa.eu/pdfs/human/euleg/33861205en.pdf
•
Post-Authorisation Guidance on PSURs, see EMEA website: http://www.emea.europa.eu/htms/human/postguidance/list.htm.
•
SOP/H/3007 – Management of Post-approval Commitments of a Marketing Authorisation Holder for a Centrally Authorised Medicinal Products for Human Use
Definitions Abbreviations: CHMP: CIG : CIG PAGs Group: HoS: MAH: MIS: PhVWP: PSUR: PTL: SGL:
Committee of Medicinal Products for Human Use Central Information Group Central Information Group, Post-Approval Commitment Group Head of Sector Marketing Authorisation Holder Medical Information Sector Pharmacovigilance Working Party Periodic Safety Update Reports Product Team Leader Specialised Group Leader
Step
Action
Responsibility
1.
Receive PSUR from CIG (see SOP/H/3007 – Management of PostAuthorisation commitment of a Marketing Authorisation Holder for Centrally Authorised Products for Human Use). Check that CIG-PACs group has also been informed of the submission of the PSUR. Check: • That the PSUR has also been submitted to the Rapporteurs and to the rest of the distribution list for PSURs. • The validity of the submission (the cycle of submission respected, no gap between this PSUR and the previous one, all authorisations for the product are included and it complies with CHMP’s previous requests). • The PSUR must be signed by the Person Responsible for Pharmacovigilance for the product as the PSUR is seen as an expert report and therefore needs to be signed.
PTL
2. 3.
4.
Fill in the checking form and save it in EDMS. Decide whether a request for revised or missing information is necessary. It may be necessary in the following situations: • Non compliance with the EU legislation (e.g. cycle of submission not respected, not all the marketing authorisations for the products are covered). • Time period covered: e.g. existence of a gap with the previous PSUR. • Non compliance with previous requests from the CHMP. • PSUR not signed by person responsible for Pharmacovigilance for the concerned product.
PUBLIC WIN/H/3198, 21-NOV-07
PTL PTL
PTL
Page 2/3
Step
Action
Responsibility
In case of major validation issues discuss with SGL and HoS and if necessary also with the Rapporteur before requesting revised or missing information from the MAH. Discuss with HoS whether regulatory action is necessary.
4.1 4.2
If a request is necessary, go to 4.1 If a request is not necessary, continue with the management of the procedure according to SOP/H/3007 – Management of PostAuthorisation commitment of a Marketing Authorisation Holder for Centrally Authorised Products for Human Use. Inform the MAH with copy to Rapporteur that submission of revised or missing information is required. Receive the revised or missing documentation and save any electronically received documents in the product folder (see section 2).
PTL PTL
Check the received documentation and decide whether a further request is necessary. If a request is necessary, go to 4.1 If a request is not necessary, continue with the management of the procedure according to SOP/H/3007 – Management of PostAuthorisation commitment of a Marketing Authorisation Holder for Centrally Authorised Products for Human Use.
PUBLIC WIN/H/3198, 21-NOV-07
Page 3/3
Title: Checking of submitted Periodic Safety Update Reports (PSURs) Applies to: Product Team Leaders in Pharmacovigilance and Post-Authorisation Safety and Efficacy of Medicines sector Document no.: WIN/H/3198
PUBLIC Lead Author
Approver
Effective Date: 21-NOV-07
Name: Christine Bugge
Name: Panos Tsintis
Review Date: 21-NOV-10
Signature: on File
Signature: on File
Date: 14-NOV-07
Date: 15-NOV-07
Supersedes: SOP/H/3011 (06-Oct-05)
1. Changes since last revision New WIN. 2. Records The PTL is to forward the following documents in hard copy to Central Information Group (CIG): • Request to the Marketing Authorisation Holder (MAH) for revised or missing documentation • Revised or missing application documentation submitted by MAH during validation phase These documents will be filed in the product Master File by CIG. If the documents exist electronically they should also be stored electronically in a specific folder under the product folder: EDMS/Products/H-C/Product name/05-Post-authorisation/Post activities/SO FUMs PSURs and subfolder by PSUR submission If documents are received electronically both the attachments and Eudralink message/email should be printed out for the Master File and saved electronically as described above. 3. Instructions Documents needed for this WIN Template for checking of PSUR is available under WORD/File/New/H-Validation. The letter to MAH requesting additional information is available in SIAMED. Related documents • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol1/reg_2004_726/reg_2004_726_en.pdf •
ICH topic E2C - Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (CPMP/ICH/288/95 adopted December 96). http://www.emea.eu.int/pdfs/human/ich/028895en.pdf
•
Addendum to ICH topic E2C (CPMP/ICH/4679/02, adopted February 2003) http://www.emea.eu.int/pdfs/human/ich/467902en.pdf
•
Eudralex, Volume 9A of the rules governing medicinal products in the European Union (Pharmacovigilance for Medicinal Products for Human Use (January 2007)) http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9A_2007-01.pdf
Page 1/3
•
Position paper on compliance with pharmacovigilance regulatory obligations (CPMP/PhVWP/1618/01) http://www.emea.eu.int/pdfs/human/phvwp/161801en.pdf
•
Transitional measures for submission of PSURs for Centrally authorised medicinal products for human and veterinary use http://www.emea.europa.eu/pdfs/human/euleg/33861205en.pdf
•
Post-Authorisation Guidance on PSURs, see EMEA website: http://www.emea.europa.eu/htms/human/postguidance/list.htm.
•
SOP/H/3007 – Management of Post-approval Commitments of a Marketing Authorisation Holder for a Centrally Authorised Medicinal Products for Human Use
Definitions Abbreviations: CHMP: CIG : CIG PAGs Group: HoS: MAH: MIS: PhVWP: PSUR: PTL: SGL:
Committee of Medicinal Products for Human Use Central Information Group Central Information Group, Post-Approval Commitment Group Head of Sector Marketing Authorisation Holder Medical Information Sector Pharmacovigilance Working Party Periodic Safety Update Reports Product Team Leader Specialised Group Leader
Step
Action
Responsibility
1.
Receive PSUR from CIG (see SOP/H/3007 – Management of PostAuthorisation commitment of a Marketing Authorisation Holder for Centrally Authorised Products for Human Use). Check that CIG-PACs group has also been informed of the submission of the PSUR. Check: • That the PSUR has also been submitted to the Rapporteurs and to the rest of the distribution list for PSURs. • The validity of the submission (the cycle of submission respected, no gap between this PSUR and the previous one, all authorisations for the product are included and it complies with CHMP’s previous requests). • The PSUR must be signed by the Person Responsible for Pharmacovigilance for the product as the PSUR is seen as an expert report and therefore needs to be signed.
PTL
2. 3.
4.
Fill in the checking form and save it in EDMS. Decide whether a request for revised or missing information is necessary. It may be necessary in the following situations: • Non compliance with the EU legislation (e.g. cycle of submission not respected, not all the marketing authorisations for the products are covered). • Time period covered: e.g. existence of a gap with the previous PSUR. • Non compliance with previous requests from the CHMP. • PSUR not signed by person responsible for Pharmacovigilance for the concerned product.
PUBLIC WIN/H/3198, 21-NOV-07
PTL PTL
PTL
Page 2/3
Step
Action
Responsibility
In case of major validation issues discuss with SGL and HoS and if necessary also with the Rapporteur before requesting revised or missing information from the MAH. Discuss with HoS whether regulatory action is necessary.
4.1 4.2
If a request is necessary, go to 4.1 If a request is not necessary, continue with the management of the procedure according to SOP/H/3007 – Management of PostAuthorisation commitment of a Marketing Authorisation Holder for Centrally Authorised Products for Human Use. Inform the MAH with copy to Rapporteur that submission of revised or missing information is required. Receive the revised or missing documentation and save any electronically received documents in the product folder (see section 2).
PTL PTL
Check the received documentation and decide whether a further request is necessary. If a request is necessary, go to 4.1 If a request is not necessary, continue with the management of the procedure according to SOP/H/3007 – Management of PostAuthorisation commitment of a Marketing Authorisation Holder for Centrally Authorised Products for Human Use.
PUBLIC WIN/H/3198, 21-NOV-07
Page 3/3
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