We are contacted with Spanish Authority regarding the Levetiracetam dossier. In summary for get dossier approval we have to provide the additional documentation or justification:
1. We should add Lomapharm as drug product manufacturer (not only as drug product manufacturer during the product development). For this reason AEMPS asks us to provide signed annex 5.22 by Lomapharm ( VERY IMPORTANT). We propose to negotiate with Lomapharm to sign annex 5.22 with the same audit date as Lindopharm declaration .
2. We should provide justification that the excipients quality are the same in Lomapharm and Lindopharm. Please confirm if the excipients suppliers are the same?
3. Justify that the medicinal product manufactured by Lomapharm is the same
1. We should add Lomapharm as drug product manufacturer (not only as drug product manufacturer during the product development). For this reason AEMPS asks us to provide signed annex 5.22 by Lomapharm ( VERY IMPORTANT). We propose to negotiate with Lomapharm to sign annex 5.22 with the same audit date as Lindopharm declaration .
2. We should provide justification that the excipients quality are the same in Lomapharm and Lindopharm. Please confirm if the excipients suppliers are the same?
3. Justify that the medicinal product manufactured by Lomapharm is the same