FAQ

The purpose of the medicines verification system is to prevent unsafe, falsified and low-quality medicines from reaching the consumers through legal chains of distribution. It requires assigning a unique code for each packaging of a medicinal product in the EU already during the manufacturing process. This unique code will allow the final vendor or user to verify the authenticity and safety of a particular medicine.

The new authenticity verification system will include all the prescription medicines (apart from a few exceptions, such as homoeopathic medicines) and over-the-counter medicine omeprazole. A full list is provided in this regulation.

Each packaging of a medicine is labelled with a special code (unique identifier) during the manufacturing process. This information is stored in a unified European database. Pharmacies, hospitals, health centres and other healthcare institutions should check (verify) each packaging of a medicinal product.

The procedure allows to verify the name of the medicine, its dose form and strength, the size and type of the packaging, the lot number, the expiration date and other information.

Yes, the medicine supply chains in the EEA countries are quite complicated and long. Therefore, the regulation requires that each packaging should be verified in a wholesaler's warehouse, starting with the second wholesaler. However, the unique identifier is deleted only at the very end of the distribution chain.

It will not be allowed to sell or use this medicine for patients, and the system will notify about this case. In case of suspected falsification, the new systems will allow the Health Inspection to track the specific packaging of the medical product from the manufacturer to the wholesaler, ensuring 100% safety of medicines and blocking falsified medicines.

These requirements are set in the EU Falsified Medicines Directive (2011/62/EU) and the regulation (EU 2016//161) that lays down detailed rules for the safety features appearing on the packaging of medicinal products for human use. The purpose of the system is to prevent the opportunities for distributing falsified medicines in the EU.

The consumers will be able to be even safer when purchasing medicines in the pharmacy or when receiving services with the use of medicines, e. g., vaccination or anaesthesia at a dentist's office.

The regulation stipulates that the pharmaceutical manufacturers cover the most of the expenses. They invest in the improvement of the manufacturing lines, enabling labelling of each packaging of medicinal products. Additionally, the manufacturers pay for the maintenance of the European and national medicines verification systems.

In Latvia, the Health Inspection will inspect the pharmacies and healthcare institutions.

Falsified medicines are any medicines with a false:

• identity (packaging, labelling, name, content, strength);
• origin (manufacturer, manufacturing country, country of origin, marketing authorisation holder);
• history (manufacturing documents and documents related to the employed distribution networks).

The medicines verification system does not change anything in the Latvian regulations on splitting the packagings of the medicinal products. The packaging of the medicinal product should be verified and the code should be deleted upon the first opening of the packaging.

The most common cases of suspected falsification:

• Unrecognised product code
• Unknown lot number
• The expiry date on the packaging of the medicinal product is different from that in the LMVS
• Inactive status of the packaging of the medicinal product
• Unrecognised serial number of the packaging of the medicinal product

Warnings will be generated in following error scenarios:

• Unknown product code
• Selected batch was not found
• The entered expiry date does not match the date saved in the LMVS
• The batch identifier does not match the serial number in the LMVS
• The packaging of the medicinal product is already inactive
• Unknown lot number
• The actual status of the packaging of the medicinal product does not match the cancellation operation (the set and cancellation status should be the same)
• The packaging of the medicinal product is already inactive
• The permitted period of cancellation has been exceeded
• The cancellation can be performed by the user who performed the initial transaction
• The packaging of the medicinal product is already inactive

According to Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, safety features and their verification are not mandatory required for medicinal products that have been authorised in the market according to Directive 2001/83/EC of the European Parliament and of the Council, Article 5 (i.e., an unregistered medicine for individual use supplied in response to a bona fide unsolicited order), because the aforementioned regulation (see Article 2) applies only to medicines that have been registered according to the requirements of the aforementioned directive.

The exception does not apply to the distribution of registered medicines in packaging that is intended for other countries.

Sergejs Akuličs
Deputy Manager,
Department of Information on Medicines Distribution

State Agency of Medicines
Jersikas 15, Riga, LV-1003, Latvia
Phone: 67078485, fax: 67078428
www.zva.gov.lv

The unique identifier is a safety feature that allows to identify a packaging of a medical product and verify its authenticity. The manufacturer encodes the unique identifier into a two-dimensional bar code. A bar code is a data matrix that a machine can read. The code is scanned and compared with the unique identifiers stored in the repository system to identify medicines and verify their authenticity.

• A unique identifier is a series of numbers or alphanumerics that are unique to the specific packaging of the medicinal product.
• The unique identifier consists of following data elements:
  • the medicine code which allows to identify at least the name of the medicine, its non-proprietary name, its dose form and strength and the size and type of the packaging of the medicinal product labelled by the unique identifier;
  • the lot number;
  • the expiry date;
  • the serial number – a randomly generated series of numbers or alphanumerics with no more than 20 characters;
• the probability of guessing the serial number is extremely low and, in any case, lower than 1 to 10,000;
• the series of characters ensures its uniqueness to the specific packaging of the medicinal product at least for 1 year after the end of its expiry date or for 5 years after the release of the packaging for sales or distribution.

The medicinal products that were released for sales or distribution without safety features in one of the member states before the implementation of this regulation in the respective country are allowed to be sold, distributed and supplied to the citizens in that country before the medicinal product has expired.