Frequently asked questions
Is it permissible to print the legible code on a different side of the packaging?
It is only permissible to print on the other side if the packaging is too small or if there is no other printing option.
Is it permissible to print the abbreviations (PC/SN/EXP/LOT) on a different side, in other words the abbreviations on one side and the codes on the other side?
If, due to the limited space available, it is not possible to print the abbreviations (PC/SN/EXP/LOT) on the same side as the codes, it is permissible to print them on a different side, in which case they should be printed next to each other on the other side of the packaging. However, the abbreviations and codes must remain legible.
Is it permissible to attach an anti-tampering device (ATD) to an OTC packaging or a packaging containing medicinal products with the GS status?
Yes, that is permitted.
An OTC product cannot have a unique identifier unless it is exempted and listed on the Annex II List of non-prescription medicinal products or categories of nonprescription medicinal products that do carry safety features, as referred to in Article 45, paragraph 2.
Is it possible to request an exemption for a prescription medicinal product (with a small target market) from the obligation to carry safety features? As a marketing authorisation holder, how can I be added to the Annex I List of prescription medicinal products or categories of prescription medicinal products that do not carry the appropriate safety features, as referred to in Article 45, paragraph 1?
The Ministry of Health, Welfare and Sport (VWS) submits such a request to the European Commission. However, the European Commission has stated that the Annex I List will not be revised before February 2019.
Is it allowed for the Anti Tampering Device (ATD) to be partly superimposed over the printed text?
Yes, but the ATD may not affect the legibility. The seal must therefore be transparent if the ATD is superimposed over the printed text. You should also take into account that the patient has to remove the seal/ATD in order to open the packaging. This may not damage the legible section (expiry date et cetera).
Does a parallel merchant have to register with the NMVO? Does a parallel merchant have to apply safety features?
Yes, if the parallel importer markets prescription medicinal products in the Netherlands, the parallel merchant must register with the NMVO and pay the initial fee of €25,000 to the NMVO plus the annual fees.
The parallel merchant must request the unique identifier from the NMVO and apply a new 2D matrix code (with the newly granted unique identifier) over the old 2D matrix code that is no longer valid as well as a new Anti Tampering Device (ATD). This can be done by using a new packaging container, but it can also be done with a sticker that contains the 2D matrix code as well as the seal.
The 2D data matrix code on the packaging contains a unique serial number in combination with a product ID (GTIN), a lot code, and an expiry date. Can a QR link also be added to the 2D data matrix code?
Yes, that is permitted.
Our product comes in a package containing 3 months’ worth of individually packaged single-administration units. These individually packaged units state that they are part of a “larger” package and that the individually packaged single administration units may not be sold separately as such. In this case, do the safety features need to be displayed only on the outer packaging?
Yes. For this type of packaging (which contains individually packaged single-administration units) it is allowed in the Netherlands to only display the safety features on the outer packaging if the pharmacist provides the patient with a package containing individually packaged units sufficient for 3 months, as is the case here. The information can be displayed on a sticker on the outer packaging (instead of being printed).
Safety features implementation
The delegated Regulation on the characteristics of the safety features and the new medicine verification system will apply as of 9 February 2019. More information for marketing authorisation holders, wholesalers or pharmacies is available in the joint letter drafted by DG Santé, HMA and EMA.
The European Commission currently do not plan to exempt additional prescription medicines or product categories from the requirements to bear safety features (“whitelisting”). All stakeholders must be ready to meet their obligations on 9th February 2019.