Proposed change: documented risk assessment (e.g. manufacturing ‘A process risk and/or medical risk as appropriate) has been performed by, …’ Comment: Statement, part I The of Non-Compliance with GMP” is a mechanism “Statement 2nd paragraph for the exchange of information between National Competent Authorities of the EEA. With complex global supply chains there may be impact on the supply of critical medicines from the manufacturer to non-EEA countries. Proposed change: To avoid interruption of supply of critical medicines, add a second note. Note to issuing authorities: If the statement is shared with non-EEA authorities, the Manufacturing Authorisation Holder should be informed to facilitate a conversation regarding impact and critical supply in non-EEA markets. Comment: Statement, part I The receiving authorities shall contact the issuing authority 2nd paragraph within working days’ in case there are critical medicinal ‘20 products potentially affected by this statement. Proposed change: We recommend to change to 30 calendar days as working days are different per member state due to various bank holidays. Comment: Statement, part I Companies could have a QP structure and not only one QP, 4th paragraph and therefore it is important to be more precise. Proposed change: In exceptional circumstances there may be no objection to the Qualified Person in the scope of the non-compliance
Proposed change: ‘A documented risk assessment (e.g. manufacturing process risk and/or medical risk as appropriate) has been performed by, …’ Statement, part I 2nd paragraph Comment: The “Statement of Non-Compliance with GMP” is a mechanism for the exchange of information between National Competent Authorities of the EEA. With complex global supply chains there may be impact on the supply of critical medicines from the manufacturer to non-EEA countries. Proposed change: To avoid interruption of supply of critical medicines, add a second note. Note to issuing authorities: If the statement is shared with non-EEA authorities, the Manufacturing Authorisation Holder should be informed to facilitate a conversation regarding impact and critical supply in non-EEA markets. Statement, part I 2nd paragraph Comment: The receiving authorities shall contact the issuing authority within ‘20 working days’ in case there are critical medicinal products potentially affected by this statement. Proposed change: We recommend to change to 30 calendar days as working days are different per member state due to various bank holidays. Statement, part I 4th paragraph Comment: Companies could have a QP structure and not only one QP, and therefore it is important to be more precise. Proposed change: In exceptional circumstances there may be no objection to the Qualified Person in the scope of the non-compliance
efpia-comments-eu-template-for-gmp-non-compliance-statement_final.docx