Commission Delegated Regulation (EU) 2016/161Show full title

CHAPTER IV MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS

Article 14 Verification of the two-dimensional barcode

The manufacturer placing the safety features shall verify that the two-dimensional barcode carrying the unique identifier complies with Articles 5 and 6, is readable and contains the correct information.

Article 15 Record keeping

The manufacturer placing the safety features shall keep records of every operation he performs with or on the unique identifier on a pack of medicinal product for at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period, and shall provide those records to competent authorities on request.

Article 16 Verifications to be performed before removing or replacing the safety features

1. Before removing or covering, either fully or partially, the safety features in accordance with Article 47a of Directive 2001/83/EC, the manufacturer shall verify the following:

(a) the integrity of the anti-tampering device;

(b) the authenticity of the unique identifier and decommission it if replaced.

2. Manufacturers holding both a manufacturing authorisation according to Article 40 of Directive 2001/83/EC and an authorisation to manufacture or import investigational medicinal products to the Union as referred to in Article 61 of Regulation (EU) No 536/2014 of the European Parliament and of the Council(1) shall verify the safety features and decommission the unique identifier on a pack of medicinal product before repackaging or re-labelling it for the purpose of using it as authorised investigational medicinal product or authorised auxiliary medicinal product.

Article 17 Equivalent unique identifier

When placing an equivalent unique identifier for the purposes of complying with Article 47a(1)(b) of Directive 2001/83/EC, the manufacturer shall verify that the structure and composition of the unique identifier placed on the packaging complies, with regard to the product code and the national reimbursement number or other national number identifying the medicinal product, with the requirements of the Member State where the medicinal product is intended to be placed on the market, so that that unique identifier can be verified for authenticity and decommissioned.

Article 18 Actions to be taken by manufacturers in case of tampering or suspected falsification

Where a manufacturer has reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features shows that the product may not be authentic, the manufacturer shall not release the product for sale or distribution and shall immediately inform the relevant competent authorities.

Article 19 Provisions applicable to a manufacturer distributing his products by wholesale

Where a manufacturer distributes his products by wholesale, Article 20(a), and Articles 22, 23 and 24 shall apply to him in addition to Articles 14 to 18.

(1)

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).