Bulgaria – Medicinali vari – „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 under the ZLPMH or Regulation (EC) No 726/2004 of the European Parliament and of the Council /Art. 23(1) of the ZLPMH/ and a certificate of release for each batch, issued by a qualified person under the ZLPMH, certifying that the batch of medicinal product has been manufactured and controlled in accordance with the requirements of the marketing authorisation under the ZLPMH. In the event of the expiry of the marketing authorisation of a medicinal product during the relevant year/years for which the public procurement is carried out, the participant declares, in accordance with Art. 55(6) of the ZLPMH, that the quantities of the medicinal product are available for the duration of the contract. They must have a fixed price, in accordance with Art. 261a(1) of the 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 proposed. Proposals for generic equivalent medicinal products of those included in the PML - Annex 2, are allowed, 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 shelf life 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 the ZLPMH.