Update to the EU drug precursor’s list

EFPIA supports the Commissions objective of preventing designer precursors from being used for the illicit manufacture of drugs and acknowledges the need for effective and proactive controls. At the same time, the proposed scheduling of 148 substances as Category 1 precursors should be implemented in a way that avoids unintended barriers to legitimate pharmaceutical research and development.

In pharmaceutical research, a large number of substances are used in the synthesis of drug candidates. Many of the substances used for the synthesis of drug candidates can also potentially be used to synthesize narcotic drugs. In some Member States, applications for authorization to handle substances classified as drug precursors must be submitted annually.

BG supports the objective of strengthening the prevention and control of the diversion of drug precursors for illicit drug production, in line with the recommendations of the INCB and the action plan against drug trafficking. At the same time, we would respectfully suggest that the proposal to place these 148 substances under Category 1 controls be subject to further consideration.

DE would like to thank the Commission for the opportunity to give an opinion on the initiative at this early stage. In our view, there is currently no sufficient evidence regarding all of the 148 substances in question to justify their inclusion in Regulations (EC) No. 111/2005 and No. 273/2004, with exception of the following 9 substances: 1.

Fecc notes the European Commission initiative that would include additional drug precursors in the list of controlled substances used in the production of illicit drugs - specifically targeting substances that can only be used for drug production, known as designer precursors - and welcomes the opportunity to provide feedback (see file attached).

Cefic supports the objective of strengthening controls against designer precursors under the EU Drug Precursor Regulations, while ensuring that any new controls remain legally clear, implementable and enforceable for legitimate operators and authorities. In particular, substances should be scheduled individually and identified through clear, unique identifiers such as CAS numbers.

1. Executive Summary: The Vulnerability of Digital Tracking Registries The draft initiative rightly highlights the urgent security and public health imperative to proactively contain the proliferation of "designer precursors" across the Union.

Mosae Zorg Industries UG (Berlin; EMA SME-registered) supports the proactive scheduling of designer precursors and welcomes this initiative. We contribute one point on the enforcement challenge under "detection." The core difficulty that designer precursors are deliberately engineered structural variants designed to fall outside list-based controls is well suited to structural and physical-chemistry methods.