Verification of the authenticity of the unique identifier by wholesalers
A wholesaler shall verify the authenticity of the unique identifier of at least the following medicinal products in his physical possession:
(a)
medicinal products returned to him by persons authorised or entitled to supply medicinal products to the public or by another wholesaler;
(b)
medicinal products he receives from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorisation nor a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.
Derogations from Article 20(b)
Verification of the authenticity of the unique identifier of a medicinal product is not required under Article 20(b) in any of the following situations:
(a)
that medicinal product changes ownership but remains in the physical possession of the same wholesaler;
(b)
that medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place.
Decommissioning of unique identifiers by wholesalers
A wholesaler shall verify the authenticity of and decommission the unique identifier of the following medicinal products:
(a)
products which he intends to distribute outside of the Union;
(b)
products which have been returned to him by persons authorised or entitled to supply medicinal products to the public or another wholesaler and cannot be returned to saleable stock;
(c)
products which are intended for destruction;
(d)
products which, while in his physical possession, are requested as a sample by competent authorities;
(e)
products which he intends to distribute to the persons or institutions referred to in Article 23, where required by national legislation in accordance with the same Article.
Provisions to accommodate specific characteristics of Member States' supply chains
Member States may require, where necessary to accommodate the particular characteristics of the supply chain on their territory, that a wholesaler verifies the safety features and decommissions the unique identifier of a medicinal product before he supplies that medicinal product to any of the following persons or institutions:
(a)
persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;
(b)
veterinarians and retailers of veterinary medicinal products;
(c)
dental practitioners;
(d)
optometrists and opticians;
(e)
paramedics and emergency medical practitioners;
(f)
armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;
(g)
universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions;
(h)
prisons;
(i)
schools;
(j)
hospices;
(k)
nursing homes.
Actions to be taken by wholesalers in case of tampering or suspected falsification
A wholesaler shall not supply or export a medicinal product where he has reason to believe that its packaging has been tampered with, or where the verification of the safety features of the medicinal product indicates that the product may not be authentic. He shall immediately inform the relevant competent authorities.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
