In the year 2001, the EU was concerned about the growing number of counterfeit medicines in European territory.

Since then, several legislative initiatives have been implemented by the European Parliament, with particular emphasis on the following publications: Directive 2001/83 / EC, DIRECTIVE 2011/62 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL and COMMISSION REGULATION 2016/161.

These proposals form the legal basis for the introduction of drug traceability technology in the EU.
THE 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 to prevent the introduction into the legal, of counterfeit medicines, points out that “there is an alarming increase in the Union of medicinal products which are falsified with regard to their identity, history or origin. These medicinal products normally contain components that are out of specification or falsified, do not contain one or more components, or contain components, including active substances, in incorrect dosages, and therefore pose a serious threat to public health.

Furthermore, COMMISSION DELEGATED (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83 / EC of the European Parliament and of the Council laying down detailed rules for the safety features on the packaging of medicinal products for human use, states that “it is necessary to lay down Union-wide rules on the application of safety features for medicinal products for human use, with special emphasis on the characteristics and technical specifications of the unique identifier, the modalities for verification of safety devices, as well as the creation and management of the system of repositories with information on security devices. ”

Medicines that are DISPENSED to have safety devices according to Delegated Regulation (EU) 2016/161, are:

Prescription medicines (MSRM) that should not have safety devices (risk assessment):

ANNEX I
a) Homeopathic Medications
b) Radionuclide generators and precursors
c) Kits
d) Advanced Therapy medicinal products containing or consisting of tissues or cells
e) Medicinal Gases
f) Solutions for parenteral feeding with an ATC code B05BA
g) Solutions affecting the electrolyte balance with an ATC code B05BB
h) Solutions that produce osmotic diuresis with an ATC code B05BC
(i) Intravenous solution additives with an ATC code B05X
(j) Solvents and diluents with an ATC code V07AB
k) Contrast media with an ATC code V08
l) Tests for allergic diseases with an ATC code V04CL
m) Extracts of Allergens with an ATC code V01AA

ANNEX II
Non-prescription medicines (MNSRM) that must have safety devices (background and risk of falsification):

a) Omeprazole, gastro-resistant hard capsule, 20 mg
b) Omeprazole, gastro-resistant hard capsule, 40 mg

In order for full harmonization between EU Member States, the period for countries to adopt the provisions laid down in Delegated Regulation (EU) 2016/161 of 2 October 2015 on the implementation of security arrangements and the verifying the authenticity of the packaging of the medicinal products, must comply with the rules laid down in Regulation (EU) 2016/161 of 2 October 2015 and ensure the full implementation of the drug verification system within 3 years, ie up to February 9, 2019.

Therefore, companies involved in the manufacture of drugs subject to traceability, has until February 2019, to adapt the Health and safety rules established by the European Parliament.

In the next post, we will cover experiences in regulated markets with effective Traceability.