Bulgarien – Varia – „ДОСТАВКА НА ЛЕКАРСТВЕНИ ПРОДУКТИ /СЪГЛАСНО СПЕЦИФИКАЦИЯ/ ЗА НУЖДИТЕ НА „УНИВЕРСИТЕТСКА МНОГОПРОФИЛНА БОЛНИЦА ЗА АКТИВНО ЛЕЧЕНИЕ – БУРГАС” АД – ЧАСТ 3”

Separate positions – 88 according to the Technical Specification – Annex No. 1 to the documentation. Requirements for medicinal products The medicinal products must comply with the requirements of the Law on Medicinal Products for Human Use (ZLPMH) and must have a valid marketing authorisation in the country, issued in accordance with ZLPMH or Regulation (EC) No 726/2004 of the European Parliament and of the Council /Art. 23, para. 1 of ZLPMH/ and a certificate of release for each batch, issued by a qualified person under ZLPMH, certifying that the batch of medicinal product has been manufactured and controlled in accordance with the requirements of the marketing authorisation under ZLPMH. In the event of expiry of the marketing authorisation of a medicinal product during the respective year/years for which the public procurement is conducted, the participant declares, in accordance with Art. 55, para. 6 of ZLPMH, that the quantities of the medicinal product are available for the term of the contract. They must have a fixed price, in accordance with Art. 261a, para. 1 of ZLPMH; For all separate positions for which there are medicinal products included in the Positive Medicinal List (PML) – Annex 2, current as of the date of submission of the offer, such are offered. Proposals for generically equivalent medicinal products included in the PML - Annex 2 are permitted, in which case the proposed price may not exceed the reference price of the corresponding equivalent product from the PML - Annex 2. They must be within the expiry date, with the remaining expiry date to be agreed with the Contracting Authority before each delivery. The packaging of the medicinal products must comply with the requirements of Chapter VI "Packaging and Leaflets of Medicinal Products" of ZLPMH.