On 23 April 2018, Decree No. 2018-291 relating to safety within the medicinal supply chain entered into force. The decree follows a February 2018 information note from the Ministry of Health reminding retail pharmacists and healthcare institutions of their obligations under Commission Delegated Regulation (EU) 2016/161, which further implements the requirement of Directive 2011/62/EU that safety features (a unique identifier and anti-tampering device) be included on the packaging of human medicines.
The decree amends the French Public Health Code in order to reflect the provisions of the delegated regulation. In particular, the decree removes the obligation that all reimbursed medicinal products must bear safety features, and clarifies that:
- Prescription-only medicines must bear safety features, with the exception of those that are included in Annex I of the delegated regulation (such as homeopathic medicines).
- Over-the-counter medicines do not have to bear safety features, with the exception of those that are at risk of falsification and included in Annex II of the delegated regulation (for now, omeprazole capsules/tablets 20 and 40 mg).
- All medicines shall be required to affix an anti-tampering device, with the exception of those included in Annex I (optional).
- Any replacement of the safety features must satisfy the conditions set out in the delegated regulation to ensure equivalence.
Implementation of these requirements will require technical adaptations at the level of pharmacies and a pilot project is expected to be launched shortly.
The new measures will apply from 9 February 2019 onwards.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2018 Issue (Thomson Reuters).