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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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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(d)the pack of medicinal product has not been registered in the repositories system as recalled, withdrawn, intended for destruction or stolen and the person performing the reverting operation does not have knowledge that the pack is stolen;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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