Tender for Access to Databases and Information Sources
Next to resources covering scientific subjects, the Agency is also looking to subscribe to business information tools to facilitate informed decision making as well as services that facilitate the monitoring of world and industry news.
UK-London: notice of a call for expressions of interest for the provision of access to databases and other electronic information sources — ref. EMA/2012/59/PD
Upon examination of the applications received, the Agency will draw up a list of potential contractors who may be invited to reply to specific invitations to tender in the future.
Each time a specific contract is to be concluded the Agency will send an invitation to tender and technical specifications to all or some of the applicants on the list, selected on the basis of which type of database or electronic resource (i.e. lot — see point 3) the contract concerned relates to.
The list drawn up following this notice will be used solely for contracts where the estimated value is below the thresholds stated in the relevant EU Public Procurement Directive.
Inclusion on a list of potential contractors does not guarantee in any way that the Agency will invite any contractor to tender for any contract.
The Agency is also involved in referral or arbitration procedures where there are concerns over the safety or benefit-risk balance of a medicine or a class of medicines.
Most of the Agency’s scientific evaluation work is carried out by its scientific committees, which are made up of members from EEA countries, as well as representatives of patient, consumer and health care professional organisations. These committees have various tasks related to the development, assessment and supervision of medicines in the EU. The Agency constantly monitors the safety of medicines through a pharmacovigilance network. It takes actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised.
For veterinary medicines, the Agency is also responsible for establishing safe limits for medicine residues in foods that come from animals.
The Agency plays a role in stimulating innovation and research in the pharmaceutical sector:
— it gives scientific advice and other assistance to companies for the development of new medicines,
— it publishes guidelines on the requirements for quality, safety and efficacy testing,
— it provides special assistance to micro, small and medium-sized enterprises (SMEs) through its SME office.
The aim of this call is to subscribe to a variety of databases or electronic content tools to support the Agency in fulfilling its mission as described above. Next to resources covering scientific subjects, the Agency is also looking to subscribe to business information tools to facilitate informed decision making as well as services that facilitate the monitoring of world and industry news.
Further information on the mission and responsibilities of the Agency can be found on the Agency’s public website.
The subscriptions will be managed by the Library and Information Services of the Agency. Access however shall be given to all staff concerned with the individual subjects.
This call for expression of interest concerns the following types of databases/electronic resources.
(Specific types (in brackets) serve as example only.)
— Lot 1: reference databases (e.g. bibliographic, catalogue, reference, citation).
— Lot 2: source databases (e.g. full-text, numeric, text-numeric, multimedia, journals).
— Lot 3: combination databases and other electronic content resources (e.g. evidence-based resources, peer-reviewed platforms, news services, decision making support tools).
The Agency intends to subscribe to electronic resources of any kind covered by the lots above which provide information relevant for the business of the Agency. The majority of required databases and electronic resources will cover scientific subjects relevant for the pharmaceutical and regulatory work of the Agency. However, the Agency may require access to tools providing information to support decision making in other areas within the Agency’s mission. The Agency may reject an application if the portfolio of the applicant (within the list of references) shows no product that is currently or in the near future relevant for the tasks and activities of the Agency. Please see the Agency’s public website for work programmes, mission statement and the Agency’s road map.
Applications to appear on this list may be submitted at any time during the period of validity of this list, with the exception of the last 3 months of that period.
a) they are bankrupt or being wound up, are having their affairs administered by the courts, have entered into an arrangement with creditors, have suspended business activities, are the subject of proceedings concerning those matters, or are in any analogous situation arising from a similar procedure provided for in national legislation or regulations;
b) they have been convicted of an offence concerning their professional conduct by a judgment which has the force of ‘res judicata’;
c) they have been guilty of grave professional misconduct proven by any means which the contracting authority can justify;
d) they have not fulfilled obligations relating to the payment of social security contributions or the payment of taxes in accordance with the legal provisions of the country in which they are established or with those of the country of the contracting authority or those of the country where the contract is to be performed;
e) they have been the subject of a judgment which has the force of ‘res judicata’ for fraud, corruption, involvement in a criminal organisation or any other illegal activity detrimental to the European Union’s financial interests;
f) following another procurement procedure or grant award procedure financed by the European Union budget, they have been declared to be in serious breach of contract for failure to comply with their contractual obligations and are currently subject to an administrative penalty.
Applicants must certify in writing that none of these exclusion criteria apply (see Annex I of application form).
Applicants must also provide proof regarding situations mentioned in points (a), (b) or (e) in the form of a recent extract from the judicial record, or failing that, a recent equivalent document issued by a judicial or administrative authority in the country of origin or provenance showing that these requirements are satisfied.
The Agency will accept a recent certificate issued by the competent authority of the Member State concerned as satisfactory evidence that the applicant is not in the situation mentioned in point (d) above. Where no such certificate is issued in the country concerned, it may be replaced by a sworn or a solemn statement made by the applicant before a judicial or administrative authority, a notary or a qualified professional body in the country of origin or provenance.
Applicants must also certify in writing that they are not subject to any conflict of interest and that they are not guilty of any serious misrepresentation in supplying the information required by the Agency (see Annex II of application form).
Applicants which are legal entities should also note that they must provide, if requested by the Agency at a later stage, any further information on the ownership or on the management, control and power of representation of the legal entity.
Applicants must be established in the European Economic Area (European Union, Iceland, Liechtenstein and Norway) or in any country having concluded an agreement on public procurement contracts with European Union in the field covered by the present call for expressions of interest.
A duly completed application form (see item 8) indicating the name, address, telephone number and e-mail address of the applicant together with the legal status and VAT number. The applicant should also provide proof of authorisation to be commercially active in the field involved in this call for expressions of interests (e.g. a copy of the certificate of membership on a professional or trade register, VAT certificate or similar).
7.1. Economic and financial capacity:
Applicants must be in a stable financial position and have the economic and financial capacity to perform any specific contract arising from this call.
Applicants must prove their economic and financial capacity by presenting the following documents.
If the applicant is a company and is otherwise required under the law of the State in which it is established to publish its accounts, please provide the following information:
1. a copy of the most recent audited accounts that cover the last 3 years of trading or for the period that is available if trading for less than 3 years;
2. a statement of the company’s turnover, profit & loss and cash flow position for the most recent full year of trading (or part year if full year not applicable) and an end period balance sheet, where this information is not available in audited form at 1 above.
If the applicant is not obliged to publish its accounts under the law of the State in which it is established, please supply copies of such accounting information as the applicant is willing to provide relating to the last 3 financial years or any period since the end of the last financial year, or a signed declaration regarding the applicant’s financial situation.
7.2. Technical and professional capacity:
Applicants must demonstrate:
— their experience in dealing with clients within field, sector or industry and/or of the scale of the Agency and the availability of a (range of) product(s) for the respective lot to be able to make an offer as and when required,
— that they work at a high professional and technical standard applying quality management and providing excellent customer service.
Proof of technical and professional capacity shall be demonstrated by applicants as follows:
— provide a list of 3 recent or current reference contracts showing details of the customer and the product(s) purchased/subscribed to by the customer relevant to the respective lot applying for,
— provide a description of the measures employed to ensure the quality of the services including service capacity and down-time as well as usual customer services response time. If providing statistics on system capacity, please indicate exact period reflected by data, preferably not older than 24 months.
Applicants must also indicate if they intend to subcontract any part of the required services. The Agency reserves the right to request the applicant at a later stage to provide documentation for exclusion criteria and proof for selection criteria for any subcontractor. Should no reference to subcontracting be made in the application, the Agency shall assume that no subcontracting is foreseen.
The application form is available for download on the Agency’s website in the Procurement category under menu point ‘About us’:
Applications including all the required information may be submitted in any European Union language. However, the Agency prefers to receive all documentation in English. Applications and documentation should be sent by mail to the address mentioned in point 1 above, for the attention of Beatrice Fayl. The documents which are required to be submitted are listed under point 6 (‘Exclusion criteria’) and point 7 (‘Selection criteria’) as well as in the checklist of the application form.
The application should clearly indicate for which lot(s) the candidate wishes to apply (see item 2 of the application form). Applicants do not have to submit a separate application for each lot. However, applicants must provide at least 1 reference relevant for each lot they apply for.
An evaluation committee will decide, in accordance with the criteria stated in points 6 and 7, which applications will be accepted or rejected. Successful applicants will be entered on the list. All applicants will be informed whether or not they are included on the list.
Questions regarding this call for expressions of interest may be submitted in writing only to the e-mail address indicated in point 1. Questions may be sent to the Agency at any time during the period of validity of this call with the exception of the last 3 months of that period. The answers to questions and any modification to this call for expressions of interest will be made electronically on the Agency’s website.
Please note that it is the responsibility of the successful applicants to inform the Agency immediately of any changes to their administrative, technical or financial details which would result in a change to their original application.