On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
FDA Announces Enforcement Discretion in Implementing the DSCSA’s Product Tracing Requirements, Delaying Enforcement until May 1, 2015
FDA made clear, however, that it will not exercise enforcement discretion regarding the other requirements in the DSCSA that are scheduled to take effect on January 1, 2015, or regarding those that have already gone into effect. Among the provisions that FDA expects to be implemented by January 1, 2015 are the requirements that trading partners have systems in place to verify whether suspect products are illegitimate and that trading partners engage in transactions only with authorized trading partners.
The Compliance Policy Guidance does not address how trading partners should handle potential conflicts in obligations that might arise under this policy. For example, under the DSCSA’s verification provisions, wholesale distributors must validate any applicable transaction history and transaction information in their possession while investigating suspect products, in coordination with trading partners. Under FDA’s announced enforcement discretion, however, wholesale distributors’ trading partners are not required to start retaining transaction information and history until May 1. The Guidance does not address how a wholesale distributor should validate any transaction information or history in its possession if the trading partners from whom it received that tracing information have not retained that information.
Consequently, all parties subject to the DSCSA’s requirements would be wise to communicate with their trading partners regarding DSCSA implementation. At a minimum, they should determine by when their trading partners will comply fully with the DSCSA’s product tracing requirements and they should coordinate on applicable aspects of DSCSA’s compliance.
If you have questions about FDA compliance policy or about the DSCSA, please contact the author or the Hogan Lovells attorney with whom you work.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017