Bulgaria – Various medicinal products – „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 – Appendix No. 1 to the documentation. Requirements for medicinal products Medicinal products must meet the requirements of the Medicines in Human Medicine Act (MHMA) and must have a valid marketing authorisation in the country, issued under the MHMA or Regulation (EC) No 726/2004 of the European Parliament and of the Council /Art. 23, para. 1 of the MHMA/ and a certificate of release for each batch, issued by a qualified person under the MHMA, certifying that the batch of medicinal product has been manufactured and controlled in accordance with the requirements of the marketing authorisation under the MHMA. In case 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 the MHMA, that the quantities of the medicinal product are available for the term of the contract. They must have an approved price, in accordance with Art. 261a, para. 1 of the MHMA; For all separate positions for which there are medicinal products included in the Positive Medicinal Product List (PLP) – Appendix 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 PLP – Appendix 2 are allowed, in which case the proposed price may not exceed the reference price of the corresponding equivalent product from the PLP – Appendix 2. They must be within the expiry date, with the remaining expiry date to be agreed with the Beneficiary before each delivery. The packaging of the medicinal products must meet the requirements of Chapter VI "Packaging and Leaflets of Medicinal Products" of the MHMA.