News about GMP/cGMP

07.05.2019

Q&A on Safety Features for Medicinal Products in Version 14

The European Commission published Version 14 of the Q&A document on Safety Features for Medicinal Products for Human Use at the beginning of this month. The document complements the Counterfeiting Directive 2011/62/EU and the Delegated Regulation (EU) 2016/161.

What has changed?

  • Question 5.9 is new. It regulates the distribution of medicinal products without safety features in Italy and Greece during the transitional period.
  • Questions 1.6, 1.28, 7.15, 8.9 have been revised. They deal, e. g., with safety features for medicinal products used in research and development or parallel imports. Question 8.9 clarifies the remains on the market of medicinal products without safety features.

The Q&A is continuously updated and supplemented with questions that arise during the implementation of the legal requirements in practice.

 


Source:

EC: Q&A



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