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

CHAPTER VI MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY PERSONS AUTHORISED OR ENTITLED TO SUPPLY MEDICINAL PRODUCTS TO THE PUBLIC

Article 25 Obligations of persons authorised or entitled to supply medicinal products to the public

1. Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public.

2. Notwithstanding paragraph 1, persons authorised or entitled to supply medicinal products to the public operating within a healthcare institution may carry out that verification and decommissioning at any time the medicinal product is in the physical possession of the healthcare institution, provided that no sale of the medicinal product takes place between the delivery of the product to the healthcare institution and the supplying of it to the public.

3. In order to verify the authenticity of the unique identifier of a medicinal product and decommission that unique identifier, persons authorised or entitled to supply medicinal products to the public shall connect to the repositories system referred to in Article 31 through the national or supranational repository serving the territory of the Member State in which they are authorised or entitled.

4. They shall also verify the safety features and decommission the unique identifier of the following medicinal products bearing the safety features:

(a) medicinal products in their physical possession that cannot be returned to wholesalers or manufacturers;

(b) medicinal products that, while in their physical possession, are requested as samples by competent authorities, in accordance with national legislation;

(c) medicinal products which they supply for subsequent use as authorised investigational medicinal products or authorised auxiliary medicinal products as defined in Articles 2(2)(9) and (10) of Regulation (EU) No 536/2014.

Article 26 Derogations from Article 25

1. Persons authorised or entitled to supply medicinal products to the public are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products provided to them as free samples in accordance with Article 96 of Directive 2001/83/EC.

2. Persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products where that obligation has been placed on wholesalers by national legislation in accordance with Article 23.

3. Notwithstanding Article 25, Member States may decide, where necessary to accommodate the particular characteristics of the supply chain on their territory, to exempt a person authorised or entitled to supply medicinal products to the public operating within a healthcare institution from the obligations of verification and decommissioning of the unique identifier, provided that the following conditions are met:

(a) the person authorised or entitled to supply medicinal products to the public obtains the medicinal product bearing the unique identifier through a wholesaler belonging to the same legal entity as the healthcare institution;

(b) the verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution;

(c) no sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution;

(d) the medicinal product is supplied to the public within that healthcare institution.

Article 27 Obligations when applying the derogations

Where the verification of the authenticity and decommissioning of the unique identifier is carried out earlier than referred to in Article 25(1), pursuant to Articles 23 or 26, the integrity of the anti-tampering device shall be verified at the time the medicinal product is supplied to the public.

Article 28 Obligations when supplying only part of a pack

Notwithstanding Article 25(1), where persons authorised or entitled to supply medicinal products to the public supply only part of a pack of a medicinal product the unique identifier of which is not decommissioned, they shall verify the safety features and decommission that unique identifier when the pack is opened for the first time.

Article 29 Obligations in case of inability to verify the authenticity and decommission the unique identifier

Notwithstanding Article 25(1), where technical problems prevent persons authorised or entitled to supply medicinal products to the public from verifying the authenticity of and decommissioning a unique identifier at the time the medicinal product bearing that unique identifier is supplied to the public, those persons authorised or entitled to supply medicinal products to the public shall record the unique identifier and, as soon as the technical problems are solved, verify the authenticity of and decommission the unique identifier.

Article 30 Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification

Where persons authorised or entitled to supply medicinal products to the public have reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features of the medicinal product indicates that the product may not be authentic, those persons authorised or entitled to supply medicinal products to the public shall not supply the product and shall immediately inform the relevant competent authorities.