Law no. 2020-105 of 10 February 2020 on the fight against waste and the circular economy (AGEC law) introduced, in its article 40, the possibility for the dispensing pharmacist to dispense certain medicinal products by the unit (DAU), when their pharmaceutical form allows it.
The terms and conditions for the use of unit dispensing of medicinal products in dispensing pharmacies were specified by decree no. 2022-100, published today in the official journal, which sets out the specific terms and conditions for packaging, labelling, patient information and traceability for these medicinal products.
However, the system is still not applicable: a ministerial order has yet to set the list of medicines that can be dispensed individually.
What are the impacts for manufacturers?
Only medicinal products presented either in blister pack form in an outer packaging or in sachet-dose form in an outer packaging may be dispensed by unit.
Unless they give up the single-dose dispensing market, manufacturers will have to adapt their production lines to package medicinal products in accordance with the requirements of the decree. This point raises serious questions about the compatibility of the decree with European Union law.
How can serialisation and unit dispensing be linked?
For the record, Directive 2011/62/EU on the prevention of the entry into the legal supply chain of falsified medicinal products introduced, in its Article 54a, an obligation to equip certain medicinal products with “safety features” in order to allow the verification of their integrity and authenticity. This Directive and the Commission Delegated Regulation for its implementation[1] introduced two types of mandatory safety features: (i) a tamper-proof device and (ii) a unique identifier (serialisation), corresponding to a serial number[2].
These features guarantee the authenticity of the medicinal products and the integrity of each box against tampering.
In this context, one may wonder about the compatibility of the unit dispensing device with the “Falsified Medicines” Directive: do the dispensing possibilities specified by Decree No. 2022-100 not render the protection measures put in place with serialisation useless?
[1] 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 concerning safety features on the packaging of medicinal products for human use.
[2] Article R. 5121-8 of the Public Health Code provides that all medicinal products subject to compulsory prescription are concerned by this regulation, with the exception of those on the list established in Annex I of Delegated Regulation No 2016/161. Medicines subject to optional medical prescription included in the list established in Annex II of the delegated regulation (omeprazole) are also concerned by this obligation.
