News about GMP/cGMP

28.08.2020

EC: Updated version 18 of Q&A on safety features for medicinal products for human use

On August 12, 2020, the European Commission published version 18 of the Q&A on safety characteristics for medicinal products. The document, which has now grown to 34 pages, was thus the second update this year (we reported).
New are the questions 4.6, 5.12, 5.13 and 6.9, which are briefly summarized below: 

Q&A 4.6: A manufacturer may outsource the application of safety features to a packaged medicinal product to another manufacturer, provided this is done in accordance with the requirements of the EU GMP Guide Part I, Chapter 7 and the manufacturer has a manufacturing authorization. The contracted manufacturer must be included in the marketing authorization. 

Q&A 5.12: A wholesaler with multiple locations must be clearly identifiable from any location and therefore must not use a single access to the NMVS system for verification and deactivation of security features. 

Q&A 5.13: Medicinal products purchased from a third party do not need to be verified according to Article 20(b) of the Commission Delegated Regulation (EU) 2016/161 based on the unique identifier if they are shipped directly from the manufacturer, marketing authorisation holder or a designated wholesaler. 

Q&A 6.9: see question 5.12, here with reference to the pharmacy chain and the verification and deactivation of security features before dispensing medicinal products. The pharmacy branch must also be clearly identifiable when connecting to the NMVS system. 

Questions 1.8, 2.14, 4.4 were added: 

Q&A 1.8: The information has been added that the importer of a medicinal product who imports a product into a Member State according to Article 5(1) of Directive 2001/83/EC does not have to upload the unique identifiers into the national database of the country of destination. 

Q&A 2.14: If the application of the unique identifier on the packaging of a medicinal product is outsourced to third parties, this must be done in accordance with the principles described in the EU-GMP Guideline Part I Chapter 7.   

Q&A 4.4: A manufacturer may use packaging that carries a unique identifier applied by a packaging manufacturer. If pre-printed cartons are used, a written agreement is required that defines the respective responsibilities. The supplier of the packaging materials must be audited and qualified. It is expected that the manufacturer of the finished medicinal product will carry out appropriate checks on the quantity and quality of the unique identifiers in accordance with EU GMP principles. 


Source: 

EC: Safety features for medicinal products for human use Questions and Answers – Version 18 



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