Introduction of safety features on the packaging of medicinal products authorised via the national, CP, MRP and DCP procedure
In order to help applicants and marketing authorisation holders in the fulfilment of requirements of the Commission Delegated Regulation (EU) 2016/161 for the placing of safety features on the packaging of medicinal products for human use, in addition to the previously published Measures for additional protection of patients from falsified medicinal products based on the Commission Delegated Regulation (EU) 2016/161 and plans for introduction of new safety features, HALMED published the Instruction for the introduction of safety features on the packaging of medicinal products authorised via the national procedure (in Croatian).
The Instruction for the introduction of safety features on the packaging of medicinal products authorised via the national procedure should be applied together with the Implementation plan for the introduction of the safety features on the packaging of medicinal products for human use authorised via the national, mutual recognition or decentralised procedure, published by CMD(h).
Further to the Instruction for the introduction of safety features on the packaging of medicinal products authorised via the national procedure, marketing authorisation holders for medicinal products authorised via the centralised procedure (CP), decentralised procedure (DCP) and mutual recognition procedure (MRP) do not have to indicate the national number (NN) on the external packaging of a medicinal product for Croatian market, although it will remain indicated in the authorised product information, in accordance with the current QRD templates for CP and MRP/DCP procedures.
