Falsified medicines

China announces serialization requirements for the first group of pharmaceutical products. Meanwhile, the European Union passes the Falsified Medicines Act, which could lead to harmonized serialization requirements In Europe by the middle of this decade. In the United States, the EDA conducts the Track and Trace Public Workshop PRMA (Pharmaceutical Research Manufacturers Association), advocating for national preemption of state pedigree laws. 

Falsified Medicines Directive 2011/62/EU of the Etffopean Parliament and of the Council of 8 June 2011, L174/74, Official Journal of the European Union 1 Jun 2011... 

The prime purposes of medicines legislation is to ensure the quality, efficacy and traceability of products throughout the supply chain. The manufacturer, wholesaler and pharmacies are pivotal in ensuring those objectives remain with the product when received by the patient. Falsified medicines (see Sect. 36.13) enter the supply chain when parts of this chain do not adhere to the agreed rules. The... 

Falsified medicines (the term falsified is used to distinguish the issue from patent violations, so-called counterfeits ) are a major threat to public health and safety [14]. 

The pharmacist must be alert to the occurrence of falsified medicinal products (counterfeit) and is aware of his role in preventing falsified medicines reaching the patient. Patients should be informed of the dangers of ordering medicinal products through internet sites which have not been validated. 

The pharmacist can contribute to a safe supply chain as to falsified medicines by ... 

Validating their supply chain and being aware that falsified medicines can also enter the legal supply chain... 

Any product suspected of being a falsified medicine should be immediately segregated and stored in a dedicated area and the Competent Authority should be informed at once. 

European Commission. Falsified medicines, http //ec.europa.eu/ health/human-use/falsified medicines/index en.htm... 

European Parliament and the Council of the European Union. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, http //ec.europa.eu/health/files/eijdralex/vol-l/ dir 201 l 62/dir 201 l 62 en.pdf... 

New scientific knowledge, in medicine, chemistry, molecular biology, and other fields important to pharmaceutical research, is not the product of massive private investment. Instead it arises from the "work of creative academic or government researchers" that can manipulate the science, and have the intellectual curiosity and dedication to expand and falsify knowledge hypotheses (Love 2004). 

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