Bulgaria – Pharmaceutical products – „Доставка на лекарствени продукти за нуждите на МБАЛ „Д-р Киро Попов“- Карлово ЕООД – ЧАСТ ПЪРВА“

The subject of this procedure is the supply of medicinal products by pharmaceutical form and unit of measurement, included in Appendix No. 2 of the Positive Drug List (PDL). In the Technical Specification, the medicinal products are distributed in separate distinct positions, depending on their group by ATC (Anatomical Therapeutic Chemical) code, INN (International Nonproprietary Name) and pharmaceutical form/application form (e.g. oral, parenteral or other form). The medicinal products are from various groups of medicines, necessary for the comprehensive therapeutic activity of the hospital. The quality of the medicinal products should comply with the requirements set by the standardising documents of the European Union, R. Bulgaria and the manufacturer or equivalent, as follows: DIRECTIVE (EU) 2017/1572 OF THE COMMISSION of 15 September 2017 amending Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use, the Law on Medicinal Products in Human Medicine and Ordinance No. 15 of 17 April 2009 on the conditions for issuing a permit for production/import and the principles and requirements for good manufacturing practice of all types of medicinal products, medicinal products for clinical trials and active substances. The quantities indicated are forecast, calculated on the basis of consumption, the number of patients and the needs of the Beneficiary in accordance with the expected period for the execution of the order. The Beneficiary reserves the right not to claim the total forecast quantities.