Pharmacies need to prepare for the introduction of 2D coding on a par with pharmaceutical manufacturers - opinions

Interfax-Ukraine, 31st of July, 2019.

Pharmacies should prepare for the introduction of a 2D coding system for pharmaceutical packaging, along with pharmaceutical manufacturers, believe representatives of foreign pharmaceutical companies interviewed by Interfax-Ukraine.

"Every pharmacy must be connected to the Internet and have appropriate software and an electronic reader," said Dmytro Tytov, quality manager of Rosh Ukraine LLC.

According to Mr. Tytov, at the moment of introduction of the two-dimensional code in the European Union in February 9, 2019 many pharmacies were not ready for it. In particular, in Poland, about a third of pharmacies were connected to the 2D coding system, and about 700 Bulgarian pharmacies protested against the new rules of operation.

"According to European experts in the field of medicine testing, illegal business bypassing legitimate supply channels brings huge profits, about 500 times higher than the legal turnover," he said.

At the same time, Mr. Tytov noted that with the introduction of the 2D coding system in Ukraine, importers will grow operational load.

"For us, as importers, there is no need to invest in equipment because it is already installed on Roche's packaging lines in Switzerland and Germany. However, our workload will increase. In the first phase, it will increase for the regulatory department as we need to make changes to the printed materials for all products that will receive a 2D code. In addition, we will need to amend the existing contracts with distributors", he said.

According to Mr. Tytov, the operational load on the pharmacy warehouse will grow on a permanent basis.

"Both during the acceptance of the goods, as it will be necessary to scan each individual package for a limited amount of time, which can increase the time of release for sale of individual batches, and at the shipment of products, especially large volumes for tenders," he said.

Titov noted that currently Roche uses 2D Matrix code. This coding system is applied to the secondary (cardboard) packaging of medicines manufactured for markets where 2D coding has already been introduced (European countries, Turkey, etc.).

At the same time, for the products that are shipped to Ukraine, this coding will not be applied.

"Innovation can become an effective tool against counterfeit products and 'gray imports', and it will make it easier for the regulator to monitor the circulation of medicines in the market," Mr. Tytov said.

In turn, representatives of Sanofi company noted that before the introduction of serialization (2D-coding) in Ukraine, first of all, it is necessary to introduce amendments to the Law "On Medicines", however, according to preliminary forecasts, this will happen no earlier than the third quarter of 2021.

"We, as a drug manufacturing company, need to have a clear understanding of what kind of information the government wants to see under this code. From a technical point of view, any information can be encrypted in the code. For example, the batch number and expiration date are the easiest to implement. If it the physical way of delivering the goods to Ukraine – it is already a more complicated process, "the company emphasized.

At the same time, Sanofi believes that the term "serialization" or "2D coding" should be introduced as part of the legislative update.

"Only then will we, and the State Security Service of Ukraine, as a regulatory body, understand what kind of information is to be encoded and what kind of serialization should be presented on the packaging. With these requirements, we will be able to implement 2D coding in our production sites and packaging of Sanofi's portfolio», - said the experts of the pharmaceutical company.

However, the company fears that since the code will be affixed to the secondary packaging, "this may affect the registration process, however, we do not yet have a clear understanding of exactly how serialization should be interpreted in regulatory materials."

The company was informed that Sanofi has already implemented 2D coding for its three products manufactured by Ankleshwar (Sanofi India Limited) production site, however, as the company does not have an understanding of what data are required to be entered in the code, "so far is just a piece of graphic design that is not informative. "

"Additionally, at all levels of the chain of production and sale of medicines there should be special equipment for reading the code. At the moment it is also missing. From our point of view, it is too early to talk about the implementation of serialization in Ukraine until the relevant draft laws are approved," in the company.

At the same time, Sanofi stresses its readiness to introduce serialization.

"At the moment, it is already implemented at most of our enterprises, as required by the EU law. This means that the plants already have special equipment and are potentially ready to perform the necessary serialization for Ukraine," the company said.

Senior Associate at Legal Alliance Company Natalia Spivak, commenting on the introduction of 2D coding of drug packs, noted that "it took more than three years to implement such a system in the EU countries, therefore introducing new labeling requirements for drug packs in Ukraine just can't be a one-year process. "

She clarified that, according to the Concept of Implementation of the State Policy on Prevention of Medication Counterfeiting, pursuant to which the resolution to launch a pilot 2D coding project was adopted, it is envisaged that this system should become mandatory in Ukraine from 2023.

The introduction of the system requires amendments to a number of regulations, including the Law on Medicines. The implementation of the pilot project by the end of 2020 envisages the introduction of an automated system for monitoring of drug circulation at all levels.

"In simple terms, there must be a technical ability to scan the barcode on the packaging throughout the drug turnover chain in order to track the movement of goods from the manufacturer to the end consumer. According to the plan, all information will have to be entered into the general database, responsible for the development and the functioning of which is one of the state enterprises of the Ministry of Economic Development of Ukraine," the lawyer said.

Ms Spivak also stressed that work on the implementation of the pilot project on the application of additional protection measures to the packaging would start in 2019 with some active substances. However, the list of such has not yet been approved.

"By the end of 2020, participation in such a project is planned on a voluntary basis, since the labeling of packages with additional elements requires manufacturers to prepare their production lines. That is, in order to launch the pilot project, the MoH of Ukraine and MEDT will have to negotiate with potential participants of this initiative, having their consent for participation. It should be noted that the vast majority of pharmaceutical market participants share the need for and support such innovations," she said.

As reported, the Cabinet of Ministers of Ukraine on July 24th approved a pilot project to introduce a 2D-coding system for medicines and to monitor their turnover. The government adopted the relevant resolution at the meeting on Wednesday, taking into account the comments of the Ministry of Economic Development and Trade. The control (identification) mark to be affixed to the packaging of the medicinal product must include the medicinal product registration number, the unique packaging number, the batch number and the expiry date. Each control mark shall be introduced by the manufacturer of the medicinal products to the single state monitoring system.

Applications for participation in the pilot project from drug manufacturers will be accepted by September 1st, 2019.

The pilot for the implementation of the 2D coding system for liquids is part of the Concept of the Implementation of the State Policy on Preventing the Falsification of Medicines.

The Association of Manufacturers of Medicines of Ukraine supported the decision to introduce a 2D coding system for medicinal product packaging and confirmed its readiness to participate in the implementation of this system.

Since February 2019, the EU Member States have been required to label each package of prescription medicines with an individual code to ensure their safety. By verifying unique identifiers or serial numbers and by connecting to monitoring systems, various players in the delivery system can make sure that the drugs that pass through them are not counterfeit, stolen, recalled, or unusable. In addition, in the EU countries, a special sticker is now affixed to the packaging to see if the packaging has been opened before - an indicator of unauthorized disclosure.