The Medicines Verification System will bring changes to prescription medicines packs. By February 2019 most medicine packs will have a 2D-matrix which contains some key data elements:
- product code
- unique serial number
- batch number
- expiry date
If changes are made to the placement of the expiry data and batch number, mock-ups must be sent to the Finnish Medicines Agency Fimea for approval. In addition to abbreviations EXP and LOT, other terms such as Käyt. viim. may be used. The abbreviations must however be consistent throughout the pack.
The European associations for the pharma industry EFPIA and Medicines for Europe have published a Pack Coding Guideline. The guideline describes how the information on the unique identifier should be put together.
Some countries also require a national reimbursement number to be placed on the pack but this is not applicable in Finland.
In addition to the 2D matrix and its information, medicine packs must have a tamper evidence mechanism (anti-tampering device, ATD). The mechanism should indicate if the package has been unlawfully opened before dispensing. The mechanism can be decided by the pharmaceutical company. The CEN standard prEN 16679 Tamper verification features for medicinal product packaging gives guidance on technical aspects.
The ATD can also be added on self-care medicines if the company chooses. However, OTC products may not be serialized with a unique serial number. If a company decides to voluntarily add an ATD on an OTC pack, it must inform the National Medicines Agency Fimea .
The ATD will be checked before dispense.
NEW PACKAGES ON THE MARKET
Unselrialised packs in scope on the market may be sold until their expiry date. During the transitional period, there will be packs with different labels on the market. Medicines go through strict quality control, and packs without the 2D matrix are also safe when purchased from a legal pharmacy or online pharmacy.