Draft guideline on manufacture of the veterinary finished dosage form (修订1）

beiwei5du

Executive summary
This guideline replaces the veterinary note for guidance on the manufacture of the finished dosage form (EMEA/CVMP/126/95). The note for guidance has been updated to reflect the requirements as laid down in the current legislation (Directive 2001/82/EC, as amended and its Annex I (ref. 1, ref. 2 respectively)). It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, applicants for EU marketing authorisations (MAs) of veterinary medicinal products may voluntarily choose to follow enhanced concepts in the manufacturing process of the final dosage forms as outlined in the ICH guidelines Q8, Q9 and Q10 (formally applicable to medicinal products for human use, refs 3, 4 and 5 respectively). The revised guideline takes this option into account although it is highlighted that the traditional approach is still acceptable. This guideline does not introduce new requirements for authorised medicinal products for veterinary use. However as stated in Article 27 of Directive 2001/82/EC as amended, after a marketing authorisation has been approved, the authorisation holder should, in respect of the methods of manufacture and control, take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and controlled by means of generally accepted scientific methods.
Note for guidance on the manufacture of the finished dosage form (EMEA/CVMP/126/95)(旧）
Draft guideline on manufacture of the veterinary finished dosage form - Revision 1（新）

syhorchid

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小金库

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小树冲冲

小金库 发表于 2023-1-17 18:31
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金库哥，你是蒲公英的水军吗