Laboratory equipment purchase of which was financed through the Instrument for Pre-accession Assistance EU IPA II (2014‐2020) in the Negotiation Chapter 1 – Free movement of goods was received in December 2020:

• Modular Multipurpose Powder Diffraction System Pananalytical Empyrean 3 (X-ray diffraction spectrometry, XRD)
• Benchtop Energy Dispersive X-Ray Fluorescence (EDXRF) Spectrometer for Elemental Analysis Malvern Panalytical Epsilon 4 (X-ray fluorescence spectrometry, XRF). 

This initiated the process of development of the Laboratory equipped with highly specific and sensitive techniques for analysis based on the use of X-rays for structural characterization of materials. In line with planned activities of the Laboratory of the Institute, the procurement of laboratory equipment and consumables was carried out during 2021. Upon receiving the equipment, IQ/OQ qualifications, along with the employees training were conducted in the Institute’s Laboratory.

Objective of establishing the Laboratory is primarily to protect market and citizens of Montenegro from falsified and substandard medicines, as well as to improve scientific and research work of the Institute, as the Institute is a teaching base of the University of Montenegro.

Performance of the equipment of the Institute’s Laboratory enables rapid identification of active substance and determination of qualitative and quantitative composition of the product, which represents significant support to the quality control of medicines, especially in cases of suspected falsified and substandard medicines on the market.

Institute is fully dedicated to preserving the integrity and traceability of medicines and medical devices on Montenegrin market which is by the establishment of the Laboratory protected even more.

With the purpose of ensuring the quality of work and proving the competence to perform quality control, we actively work on the introduction and consistent application of requirements of the ISO/IEC 17025:2017 standard.

Falsified medicine is a medicine that is fraudulently presented in terms of identity and/or origin and may contain right or wrong ingredients, be without active substance, or contain wrong amount of active substance and have wrong, or fake packaging. Falsified medicines are the result of organized crime through which they are placed on the market solely for the purpose of profit making.

Substandard medicines are medicines that are manufactured in such manner that they do not meet established quality standards, or specification requirements, or both. 

Unauthorised medicines are medicines that have not undergone the registration procedure of the regulatory body in charge of the market in question.

SF medicines on the market:

Falsified medicines are a major global problem. According to World Health Organization (WHO) data, 30% of medicines on the market in developing countries are falsified. In some Eastern European countries that rate reaches 10%.

Presence and spreading of SF medicines have a negative impact on the following:

• patients safety and health treatment outcomes, 
• national economy, 
• public trust in health care system, and 
• international fight against serious health challenges, such as malaria and antimicrobial resistance.

Unregulated websites, social media platforms and smartphone applications may also be direct channels for substandard and falsified medicines. Risks for consumers get significantly higher when purchasing medicines from unlicensed and unregulated sources. WHO estimates that 50% of medicines sold via the Internet are falsified. It is important to emphasize that purchasing medicines online is forbidden in Montenegro.

Fight against SF medicines:

Vigilance of responsible institutions, such as the police, customs and regulatory bodies has increased at the global level and therefore, the number of seized medicines and closed websites gets higher every year. An example of such organization is Interpol which leads and coordinates the “Pangea” operation in cooperation with the police, customs, national agencies and other regulatory competent authorities for medicines at the global level, with the aim of fight against the sale of falsified medicines. 

According to the final report of „Pangea XIV” operation conducted in 2021:

• 92 countries participated in the operation, 
• 113 020 of websites related to the sale of fake and falsified pharmaceutical products and medicines were discovered and terminated 
• 277 persons involved in mentioned illegal activities were arrested, 
• medicines worth more than 23 million US dollars were seized. 

More than half of all medicines seized during a week-long operation (May 18-25) were fake COVID-19 test kits. Even though competent institutions work intensively to suppress the occurrence of falsified medicines and raise the awareness of citizens about risks they are exposed to by purchasing medicines from illegal distribution chains, it is a global problem of large scale that is difficult to solve.

CInMED has developed systems to prevent medicines suspected of being dangerous to health from being made available to patients. Guidelines on good distribution practice of medicinal products for human use prescribe appropriate requirements for wholesalers aimed at preventing the entry of falsified medicines into the legal supply chain. Application of Guidelines on good distribution practice of medicinal products ensures control over legal supply chain, as well as continuous supply of safe, effective and quality medicines to patients in Montenegro.

In order to follow global developments in the field of SF (substandard and falsified) medicines as well as to protect patients and the market in Montenegro, the Institute actively participates in activities of external bodies:

• WHO Member State Mechanism on Substandard and Falsified (SF) Medical Products

Since its establishment in 2012, Global focal point network for substandard and falsified medicines has become a global forum where member States convene, coordinate, decide and organize activities to address the issue of SF medicines.

• Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) – European Directorate for the Quality of Medicines (EDQM)

Primary responsibilities of this body are to develop and promote strategies for the prevention and management of risks in the area of public health protection from falsified medicines and similar crimes, facilitate networking and cooperation within member states, improve risk communication systems related to falsified medicines, maintain and further develop specific multi-sectoral expertise, develop tools supporting the exchange of information on the management, prevention and monitoring of risks posed by such crimes.

• Team for monitoring and implementation of activities related to suppressing the marketing of falsified medicines – Ministry of Health of Montenegro

Ministry of Health has formed a multi-sector team composed of representatives of numerous institutions from the system in order to deal with the problem of falsified medicines, with the aim of contributing to the territory of Montenegro being recognized for the presence of quality, safe and effective medicines.

• WHO Working group Detection technologies

Institute chairs this Working group consisted of representatives of 11 countries (Argentina, Iran, Iraq, Montenegro, Nigeria, Papua New Guinea, Russian Federation, Netherlands, Uganda, Ukraine, Zambia). In cooperation with WHO representatives, the Institute will be directly involved in the development of Guidelines on the selection of detection technologies for SF medicines.