EC Revises Drug Safety Features Q&A

Regulatory NewsRegulatory News | 16 July 2019 |  By 

The European Commission last week issued a revised questions and answers guideline on implementing safety features for medicinal products detailed in Commission Delegated Regulation (EU) 2016/161.
The revised document includes three new questions and answers as well as one revised answer from the previous version.
New and Revised Questions
The three new questions are covered in sections 3.7, 5.10 and 8.10, while the only revised question can be found in section 1.6.
Question 3.7 clarifies who is responsible for verifying and decommissioning investigational medicines with safety features used in clinical trials and authorized auxiliary medicinal products.
According to the Q&A, “manufacturers, wholesalers or persons entitled to authorised to supply to the public before use as authorised investigational medicinal products (IMPs) or authorised auxiliary medicinal products” are responsible for verifying and decommissioning the unique identifier for those medicines.
Medicines repackaged or relabeled for clinical trial use should verify and decommission the unique identifier before the products are repackaged or relabeled. Medicines that are not repackaged or relabeled should have their unique identifier verified and decommissioned by the person entitled or authorised to supply the product to the public.
Question 5.10 provides clarification as to how wholesalers can ensure that medicines they receive without safety features were released prior to the requirement for those features entering into effect on 9 February 2019.
“Wholesalers may request that manufacturers include the batch release date in the delivery note of non-serialised medicines in order to confirm that the medicines were released before the safety features became mandatory,” the document states.
Question 8.10 pertains to parallel distributors who wish to distribute products with unique identifiers to Greece and Italy and must remove the EU unique identifier and replace it with a Greek or Italian unique identifier.
According to the document, manufacturers should verify the authenticity of the EU unique identifier before decommissioning the number and replacing it.
In the revised Question 1.6, the guideline explains how safety feature requirements apply to authorized medicines intended for use in clinical trials, depending on whether the product is manufactured and packaged for use in a clinical trial or whether the medicine was sourced from the regulated supply chain.


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