Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplemented Directive 2001/83/EC regarding the safety features appearing on the packaging of medicinal products for human use. In line with that, it is required that manufacturers place safety features consisting of a unique identifier (2D data matrix with a unique serial number) and an anti-tampering device on the packaging of certain drugs. However, the serialization process has its regulatory side. The rules for introducing the safety features were further detailed in a Q&A document by the European Commission and CMDh’s Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use.
Further to that, the Bulgarian Drug Agency published additional guidance covering some national aspects.
The new packaging mock-ups that include the safety features have to be submitted for approval by the BDA only after the concerned products have already approved updated labelling – QRD points 17 and 18.
In case the marketing authorisation holders (MAHs) do not plan any regulatory procedures affecting the product information by 09 February 2019 (e.g. renewal or variation), then the implementation of QRD points 17 and 18 (concerning the safety features) could be done by applying under article 18 of the Bulgarian Regulation 27/2007. The applicants have to provide for approval the updated labelling along with the new packaging mock-up.
In case the labelling including points 17 and 18 has already been approved by the BDA, MAHs have to apply under article 18 and to provide the new packaging mock-ups only.
The effective date for implementing the changes on the primary/secondary packaging has to be on or before 09 February 2019 (Delegated Regulation (EU) 2016/161). MAHs have to include the information regarding the effective date for the new packaging in the application form for changing the product information.
As far as the BDA expect significant workload for approving applications under article 18, they encourage MAHs to provide also a copy of the latest approved packaging mock-up as well as the approved labelling in line with the latest QRD format (in case MAHs already have included points 17 and 18 in another regulatory procedure).