Counterfeit Protection - Amendment of Delegated Regulation (EU) 2016/161

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

Delegated Regulation (EU) 2016/161 is adapted with regard to Article 47 (Evaluation of notifications by national competent authorities to the Commission) and Annex I (List of medicinal products that shall not bear the safety features).

Amendment of Article 47

Article 47 provides that, where rapid action is necessary to protect public health as a result of exposure to falsified medicinal products, the Commission shall evaluate the notification from the national competent authorities referred to in Article 46 without delay and at the latest within 45 days. To better achieve this objective, the reference to citizens of the Union has been replaced by a reference to people in the Union, as "as all adverse events in the Union should be considered and monitored regardless  of citizenship".

Amendment of Annex 1

Annex I of Delegated Regulation 2016/161 contains a list of prescription-only medicinal products or categories that may not bear the safety features. The medicinal product category "cicatrizants with ATC code D03AX" with the dosage form "fly larvae" was not included in this list so far. In particular, due to the specific characteristics and short shelf life of this dosage form, the risk of counterfeiting was negligible. Therefore, the product category "cicatrizants with ATC code D03AX" with the pharmaceutical form "fly larvae" shall be included in the list of Annex I of the Delegated Regulation.

The amendments were published in the Official Journal of the European Union on September 21, 2021. They become effective on the twentieth day following their publication.