Legal Framework for Falsified Medicines Directives

Posted by loreen on May 24th, 2019

The falsified medicines may contain ingredients of toxic or bad quality or has the wrong composition and wrong dosage. They can easily pose to great health risks as they are not checked properly for the safety, efficacy and quality as required by the strict authorization. The falsified medicines are more and more sophisticated and thus their risks of reaching the patients also increase, representing the serious threat to the global health. Thus for preventing the entry of falsified medicines in the supply chain, the Falsified Medicines Directive makes a comprehensive strategy as follows:

Legal Framework for Prevention of Falsified Medicines Entry

The Falsified Medicines Directives was published in 2013 January and it introduces the harmonized safety measures to find the medicines falsifications ensuring that medicines are safe and secured. The various safety measures include the following:

• It strengthens the record keeping requirements of the Pharma Wholesale Software for the wholesale distributors.
• The rules and regulations on the import of medicines and the active pharmaceutical ingredients have been toughened and strict.
• A common wide logo of EU is there for identifying the legal online pharmacies.
• There are many obligatory safety measures which includes a unique identifier and the anti – tampering device on the outer packing of medicines.

Active Substances Importation

The falsified medicines directives introduce the rules for the importation of the active substances. These substances can be imported if there is written confirmation from competent authority of the exporting countries which attests the standards of the good manufacturing practices and control of the manufacturing sites.

Counterfeit Medicines VS Falsified Medicines

The Counterfeit Medicines are the medicines which do not comply with the intellectual property rights while the Falsified Medicines are the fake medicines which are designed to the mimic real medicines. The falsified medicines are on the increase with more and more medicines now being falsified includes expensive medicines, anticancer medicines and the medicines which are highly demanded like anti virals.

Obligatory Logo

It allows the patients as well as consumers for identifying the authorized online pharmacies and the approved retailers providing them authentic as well as authorized medicines.