GMP News - Counterfeit Medicines

Yesterday the amendments on the Directive EC 2001/83/EC to combat counterfeit medicines (The Pharma Package) have been discussed in the European Parliament. Today, the EU Parliament adopted the amendments with an overwheling majority of votes.

The proposed amendments, which will have to be transferred into national law within two years include

introduction of safety features (serial numbers and/or tamper-evident seals) more stringent rules for importation of APIs better controls of the supply chain (traders and wholesalers) Rules for the internet sale of medicines Harmonisation of GMP inspections

For further information please see the complete news.

The Rx-360 Consortium held a meeting at Merck KGaA in Darmstadt. Ms. Joanne Lewers, Partner at Drinker Biddle & Reath, the consortium's Legal Counsel and Secretary, announced that the U.S. Federal Trade Commission (FTC) has provided a positive advisory opinion pertaining to the organization's shared auditing programs. You will find more here.

The USA is still systematically evaluating the experience in the Heparin case. More precisely this means that the former FDA inspections at Heparin manufacturers in China were analysed. Read more here.

In March, the FDA published the final version of its guidance on the standardised numerical identification for prescription medicinal products. Read more.

Germany is now starting a pilot project for the introduction of an identification/authentification system for the traceability of medicines. Read more.

The Secure Trace Consortium has introduced an interesting case study for a pilot project on presenting a safe supply chain. Additional details can be read here.

The RX-360 Consortium is an industry initiative aiming at making the pharmaceutical supply chain more secure, especially with its efforts to combat counterfeit medicines. Rx-360 is meant to set internationally harmonised standards. More information on RX-360's activities and objectives can be read here.