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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 IX OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES
Article 43Information to be provided by national competent authorities
National competent authorities shall make the following information available to the marketing authorisation holders, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public, upon their request:
(a)
the medicinal products placed on the market on their territory which shall bear the safety features in accordance with Article 54(o) of Directive 2001/83/EC and this Regulation;
(b)
the medicinal products subject to prescription or subject to reimbursement for which the scope of the unique identifier is extended for the purposes of reimbursement or pharmacovigilance, in accordance with Article 54a(5) of Directive 2001/83/EC;
(c)
the medicinal products for which the scope of the anti-tampering device is extended for the purpose of patient safety, in accordance with Article 54a(5) of Directive 2001/83/EC.
Article 44Supervision of the repositories system
1.National competent authorities shall supervise the functioning of any repository physically located in their territory, in order to verify, if necessary by means of inspections, that the repository and the legal entity responsible for the establishment and management of the repository comply with the requirements of this Regulation.
2.A national competent authority may delegate any of its obligations under this Article to the competent authority of another Member State or to a third party, by means of a written agreement.
3.Where a repository not physically located in the territory of a Member State is used for the purpose of verifying the authenticity of medicinal products placed on the market in that Member State, the competent authority of that Member State may observe an inspection of the repository or perform an independent inspection, subject to the agreement of the Member State in which the repository is physically located.
4.A national competent authority shall communicate reports of supervision activities to the European Medicines Agency, which shall make them available to the other national competent authorities and the Commission.
5.National competent authorities may contribute to the management of any repository used to identify medicinal products and verify the authenticity of or decommission the unique identifiers of medicinal products placed on the market in the territory of their Member State.
National competent authorities may participate to the management board of the legal entities managing those repositories to the extent of up to one third of the members of the board.
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