Poland - Pituitary, hypothalamic and analogous hormones

Description

I.1 The offered medicine is registered for the treatment of recombinant IGF-1 patients with low stature as a result of severe primary deficiency of IGF-1.2: "1.3. The preparation contained in the vials or ampoules may be in the form of powder for dissolution as well as in the form of already dissolved preparation for direct use. This preparation must be administered in public syringes of small capacity and with sufficient accuracy to determine the drug dose.4 The contractor's duties include: - training of medical personnel (physicians, nurses) before the first delivery of the drug conducting the recombinant therapy IGF-1, - providing scientific and informational materials related to the implementation and monitoring of the recombinant therapy IGF-1, - providing test kits.5The Contracting Authority envisages a change in the size of the subject matter of the contract during the term of the contract, i.e. it is permissible to reduce the ordered volume - by a maximum of 20% of the basic subject matter of the contract in the event of objective and justified needs, in particular changes in demand among patients - this change depends on the internal needs of the Contracting Authority, which may arise during the contract performance and leaves it solely to its own decision. The Contractor declares that it accepts the possibility of occurrence of various circumstances affecting the changes in demand within the scope specified above and accepts the above. Subject requirements for the offer (required permits and/or certificates and/or certificates): 1. Pursuant to § 13.1.3 of the Regulation of the Minister of Development of 26.7.2016 on the types of documents that may be requested by the contracting authority from the contractor in the procurement procedure - Journal of Laws of 27.7.2016, item 1126, in relation to the Regulation of the Minister of Enterprise and Technology of 16 October 2018 amending the Regulation on the types of documents that may be requested by the contracting authority from the contractor in the procurement procedure - Journal of Laws of 17.10.2018, item 1993), in order to confirm that the offered deliveries meet the requirements specified by the contracting authority, the contractor is obliged to confirm with a relevant document, i.e. submit together with the offer (subject matter conditions): - a valid permit to market a medicinal product in Poland issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, or - a valid permit to market a medicinal product issued by the Council of the European Union or the European Commission.2The authorisation to place a medicinal product on the market must be valid and up-to-date as at the date of submitting the offers.3 The composition of the preparation and packaging must be in accordance with the content of the documents referred to in point 2.1.4. If the validity of the document expires, the economic operator is obliged to provide the contracting authority, together with the documents referred to in point 2.1. with an additional document declaring that an application to extend the validity of the marketing authorisation for the medicinal product or, in the case of obtaining a valid marketing authorisation for the medicinal product has been submitted in due time, with the documents referred to in point 2.1.The documents referred to above shall be submitted in the original in the form of an electronic document or in an electronic copy of a document or a declaration certified to be in conformity with the original.7 Documents drawn up in a foreign language shall be submitted together with a translation into Polish.

Opportunity closing date

21 August 2019

Value of contract

to be confirmed