Information to be provided by national competent authorities
Article 43
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.