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Commission Delegated Regulation (EU) 2016/161Show full title
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)
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CHAPTER III GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES
Article 10Verification of the safety features
When verifying the safety features, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall verify the following:
(a)
the authenticity of the unique identifier;
(b)
the integrity of the anti-tampering device.
Article 11Verification of the authenticity of the unique identifier
When verifying the authenticity of a unique identifier, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall check the unique identifier against the unique identifiers stored in the repositories system referred to in Article 31. A unique identifier shall be considered authentic when the repositories system contains an active unique identifier with the product code and serial number that are identical to those of the unique identifier being verified.
Article 12Unique identifiers which have been decommissioned
A medicinal product bearing a unique identifier which has been decommissioned shall not be further distributed or supplied to the public except in any of the following situations:
(a)
the unique identifier was decommissioned in accordance with Article 22(a) and the medicinal product is distributed for the purpose of exporting it outside the Union;
(b)
the unique identifier was decommissioned earlier than the time of supplying the medicinal product to the public, pursuant to Articles 23, 26, 28 or 41;
(c)
the unique identifier was decommissioned in accordance with Article 22(b) or (c) or Article 40, and the medicinal product is provided to the person responsible for its disposal;
(d)
the unique identifier was decommissioned in accordance with Article 22(d) and the medicinal product is provided to the national competent authorities.
Article 13Reversing the status of a decommissioned unique identifier
1.Manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public may only revert the status of a decommissioned unique identifier to an active status if the following conditions are fulfilled:
(a)the person performing the reverting operation is covered by the same authorisation or entitlement and operates in the same premises as the person that decommissioned the unique identifier;
(b)the reverting of the status takes place not more than 10 days after the unique identifier was decommissioned;
(c)the pack of medicinal product has not expired;
(d)the pack of medicinal product has not been registered in the repositories system as recalled, withdrawn, intended for destruction or stolen and the person performing the reverting operation does not have knowledge that the pack is stolen;
(e)the medicinal product has not been supplied to the public.
2.Medicinal products bearing a unique identifier which cannot be reverted to an active status because the conditions set out in paragraph 1 are not fulfilled shall not be returned to saleable stock.
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