23 October 2014 EMA/635992/2014 Questions and answers relating to open procurement procedure – Eudravigilance data management – EMA/2014/30/BD Table of contents Questions and answers ............................................................................... 2 Document history........................................................................................ 4 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. Questions and answers No. Question Answer 1. Our software factory is located in one of the EU member states and we would The majority of the work will be performed at the contractor’s like to know the possibilities that exist to develop fully or partially the project premises using EMA tools; however a tracking tool for the work from our installations. is expected to be developed by the contractor. Was your organisation successful, you could perform your work at your installations. 2. Regarding the question above, we would like to know if you already have Estimates for the workload and person-hours are included in estimation about the profiles to include in the project and the effort the technical specifications, available from the above link or at man/month, man days or man/ hours per profile Intramuros and Extramuros. http://www.ema.europa.eu/docs/en_GB/document_library/Proc urement/2014/10/WC500175333.pdf 3. Section 4 (Participation in the tender; pg. 19) of ‘Technical specifications’ Yes, a joint tender is permitted by EMA for this procurement document refers only to the possibility of subcontracting (Section 4.2). However procedure. there are several references to ‘Joint Tenders’ (in Sections 12, 13, 14 and 15) in the same document. EMA’s “guidebook for tenderers” also mentions about joint tenders and subcontracting as two options for collaborating with other companies - in Section 5. Therefore, if we wished to collaborate with another organisation, could you please confirm if a joint tender will be allowed by the EMA? 4. Our organisation is registered in a country that does not have a public Tenderers must meet the requirements in section 4.1 of the procurement agreement with the European Union. However, we are considering specifications, namely must be from the EU Member States, collaborating with another organisation which does meet the public EEA countries and any other country which has an international procurement requirement. In such a case, must both tenderers be from agreement with the Union in the field of public procurement. countries which have a public procurement agreement, or will it be sufficient if This applies to all tenderers, including all joint tenderers. If a Questions and answers relating to open procurement procedure – Eudravigilance data management – EMA/2014/30/BD EMA/635992/2014 Page 2/4 No. Question Answer only one of the tenderers meets this requirement? We ask because, in a joint joint tender is successful then one contract will be signed with tender, we believe that only one contract will be signed/required by the EMA. all joint tenderers unless a Power of Attorney is in place authorising one tenderer to sign on behalf of the others. However, this does not change the requirement in section 4.1. 5. Please also confirm if both the tenderers are required to send in the “Tender For a joint tender it is sufficient to send one tender acknowledgement form” in case of joint tender? Or if it is sufficient that only acknowledgement form. one of the tenderers submits this form? Questions and answers relating to open procurement procedure – Eudravigilance data management – EMA/2014/30/BD EMA/635992/2014 Page 3/4 Document history Version When What 0.1 23/10/2014 Questions 1 - 5 Questions and answers relating to open procurement procedure – Eudravigilance data management – EMA/2014/30/BD EMA/635992/2014 Page 4/4