Standard operating procedure

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1 Standard operating procedure Title: How to conduct a procurement procedure Status: PUBLIC Document no.: SOP/EMA/0121 Lead author Approver Effective date: Name: Caroline Maignen Name: Stefano Marino Review date: Signature: On file Signature: On file Supersedes: SOP/EMA/0121 and SOP/EMA/0122 Date: Date: TrackWise record no.: Purpose This SOP describes the procedure for the preparation of a procurement contract and the role of the Contracts and Procurement Support Officer or her replacement therein. 2. Scope This SOP applies to all procurement procedures of all values concluded by the European Medicines Agency except for those with a value of less than 15,000. The choice of procurement procedures available is set out in the Agency s Financial Regulation and Implementing rules applicable to the budget of the EMA. It is the responsibility of the Authorising Officer to choose the appropriate procedure. Each procedure will be conducted slightly differently according to the rules governing it but all will be conducted in accordance with the principles of transparency, equal treatment and non-discrimination. In order to avoid a different SOP for each procurement procedure, this SOP sets out the main common steps involved in all procedures (except for value less than 15,000) indicating the cases where particular important variations in procedure occur. 3. Responsibilities It is the overall responsibility of each Authorising Officer to ensure that this procedure is adhered to for each procurement contract. The responsibility for the execution of a particular part of this procedure is identified in the right-hand column. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 4. Changes since last revision This SOP consolidates and streamlines SOP/EMA/0121 and SOP/EMA/0122 and updates references. 5. Documents needed for this SOP The following forms for this SOP are required and can be found in the location identified: Standard procurement contracts are available in Word, New, Contracts tab. Recommended templates for invitations to, documents and appointment of committees can be found on the Procurement webpage. Standard ACPC report is available in Word, File, New, Contracts tab. 6. Related documents Public Procurement Directive DIR/2004/18/EC Financial Regulation applicable to the budget of the European Medicines Agency applicable as of 1 January 2014 in particular Title V Procurement thereof Rules for the implementation of certain provisions of the Agency s Financial Regulation applicable as of 1 January 2014 Vade Mecum on Public Procurement Procedures in the European Commission Article 7 of Rules of Procedure of the Advisory Committee on Procurement and Contracts of 3 September 2012 (or as may be updated) Charter of tasks and responsibilities of authorising officers by delegation of 1 June 2004 Charter of tasks and responsibilities of the verifying officer and verifying assistant(s) of 30 September 2009 Regulation (EC) No 45/2001 on the protection of individuals with regard the processing of personal data by the European Union institutions and bodies 7. Definitions Advisory Committee on Procurement and Contracts: The ACPC gives its opinion in an advisory capacity on procurement contracts and supplementary agreements. Authorising Officer: The Authorising Officer of the Agency is the Executive Director but powers may be delegated by the Executive Director to an Authorising Officer by delegation. The Authorising Officer implements the Agency s budget in accordance with the financial rules of the Agency, on his/her own responsibility and within the limits of the appropriations authorised. The Authorising Officer is responsible for implementing revenue and expenditure in accordance with the principles of sound financial management and for ensuring that the requirements of legality and regularity are complied with. The Authorising Officer acts in accordance with the Charter of tasks and responsibilities of authorising officers by delegation. Award criteria: The award criteria are intended to assess the quality of a. SOP/EMA/0121, Page 2/10

3 Buyer s profile: Area on the Agency s external website where information on s is published. Contracts and Procurement Support Officer: The Contracts and Procurement Support Officer provides advice and support to Authorising Officers, Initiating Agents and all other staff members as required with all procurement procedures and the subsequent conclusion of contracts. The Contracts and Procurement Support Officer provides centralised reports on procurement contracts concluded to third parties (e.g. Court of Auditors) on the basis of information maintained by Initiating Agents. The Contracts and Procurement Support Officer may be replaced during absence by the Assistant to the Contracts and Procurement Support Officer. Contracts database: This database contains data on contracts concluded by Authorising Officers on behalf of the Agency for purchases of goods, services, works as well as building contracts. Cooling-off period: This applies to contracts covered by the Public Procurement Directive 2004/18/EC and is a period of 14 calendar days after dispatch of award and rejection notifications or after a pre-award notice is published in the Official Journal of the European Union, in case of negotiated procedures without prior publication of a contract notice. During these 14 calendar days no contract can be signed. Evaluation committee: a board appointed by the Authorising Officer to evaluate s. Ex post evaluation: This refers to the activities indicated in the Agency s Financial Regulation which are conducted to evaluate in terms of the human and financial resources allocated and the results obtained in order to verify that they were consistent with the objectives set. Exclusion criteria: These criteria determine whether an economic operator is authorised to participate in a procurement procedure and not in an exclusion situation such as bankruptcy. Initiating Agent: The Initiating Agent assists the Authorising Officer with the duties mentioned. The Initiating Agent maintains valid data on procurement contracts concluded by the Authorising Officer. The Initiating Agent files all original signed procurement contracts in the Division/Department concerned and makes available, as required, copies to the Contracts and Procurement Support Officer. Mandatory filing plan: This is the filing plan for procurement procedures available on the Procurement webpage. Negotiated procedure: a procedure whereby the contracting authorities shall consult ers of their choice who satisfy the stipulated selection criteria, and negotiate the terms of the contract with one or more of them. Open procedure: a procedure whereby all interested economic operators may submit a when the contract value is over the threshold of the Public Procurement Directive. Opening committee: a board appointed by the Authorising Officer to open s. Pre-qualification questionnaire: This is a questionnaire recommended to be sent to candidates applying to be considered for a restricted and relates to exclusion and selection criteria. Procurement contract: A procurement contract is any contract for pecuniary interest concluded in writing by the Agency in order to obtain goods, services or the execution of works. Procurement decision: This is a document signed by the Authorising Officer of his/her decision to start a procurement procedure. It will refer to the strategic and/or legal context of the procurement (e.g. Work Programme, Heads of Division decision etc). It will indicate the expected deliverables of the contract and objectives to be achieved, any particular risks or milestones. In SOP/EMA/0121, Page 3/10

4 case of re-ing it shall indicate whether or not an ex post evaluation of the performance of the contract to date has been carried out. Procurement procedure: a call for using an open, restricted or negotiated procedure with or without publication of a contract notice in the Official Journal of the European Union as appropriate. Restricted procedure: a procedure whereby all economic operators may ask to take part but only short-listed candidates satisfying the stipulated selection criteria are invited simultaneously and in writing by the contracting authorities to submit a. Such is used when the contract value exceeds 60,000. Selection criteria: The selection criteria are designed to check whether an operator is capable of performing the contract. Tender documentation: Includes any documentation necessary for the execution of a procurement procedure. This will normally include an invitation to letter, technical specifications including costing sheet and a draft contract. Verifying Officer and Verifying Assistant(s): At the request of the Authorising Officer, the Verifying Officer and/or Assistant verifies the operational and financial aspects of an operation in an ex ante capacity, in order to control the risks involved. The VO checks conformity of a procurement procedure and the contract to be concluded with the Financial Regulation and the Implementation Rules. The Verifying Officer acts in accordance with the Charter of tasks and responsibilities of the verifying officer and verifying assistant(s). Abbreviations used in this SOP: ED = Executive Director = Contracts and Procurement Support Officer = Authorising Officer VO = Verifying Officer and Verifying Assistant(s) IA = Initiating Agent ACPC = Advisory Committee on Procurement and Contracts FR = Financial Regulation IR = Implementation Rules of the Financial Regulation OJEU = Official Journal of the European Union Charter of tasks and responsibilities of the verifying officer and verifying assistants(s) = Charter VO SOP/EMA/0121, Page 4/10

5 8. Process map(s)/ flow chart(s) Start 1.1 provides procurement planning and updates to 1.2 passes information to for ex ante publication 1.3 selects appropriate procurement procedure, plans time frame and nominates person to run 1.4 Allocation of reference number for 1.5 informs relevant Agency staff of plan to procure 2.1. appoints opening and evaluation committees (if applicable) 2.2 makes all decisions on draft documentation. to be sent to for review 2.3 reviews all Documentation and provides comments 2.4 Update of draft documents according to comments 2.5 Preparation and dispatch of text for OJEU & publication by (f applicable) 2.6 Procurement Procedure is executed 2.9 decision to proceed with a contract or abandon procedure? Above ACPC threshold End Abandon/cancel 2.10 Above or below ACPC threshold? 2.11 ACPC report prepared and sent to for review 2.12 reviews draft report and may make comments 2.13 ACPC report finalised Proceed 2.7 Draft committee report prepared and sent to for comments and review prior to signature 2.14 ACPC gives opinion 2.15 makes contract award decision and nominates contract manager 2.8 Committee report finalised Go to 2.16 SOP/EMA/0121, Page 5/10

6 4.3 IA enters into contracts database (except under EUR 15K) 3.2 VO Charter Workflow applies for nonframework contracts From 2.15 Under Finalisation of filing of documents 4.5 conducts procurement debriefing 4.6 prepares reports on Contracts concluded 3.2 VO Charter Workflow applies for nonframework contracts 3.3 reviews draft contract and makes comments with copy to VO 3.4 Comments by VO to? 2.16 reviews contract award decision 2.17 signs final award decision 2.18 Draft letters prepared to ers 4.7 Conduct of contract management 4.8 Update contracts database with addenda 4.9 Ex post evaluation reports conducted as required 4.10 Review of future requirements, taking into account lessons learned and ex post evaluation reports End No comments Yes 3.5 Upon receipt of comments of VO, contacts to advise and assist 3.6 IA actions commitment (for nonframework contract) and contract signature occurs 4.1 If award notice is needed, IA informs of date of signature & publishes award notice 4.2 IA files original contract in Department concerned 2.19 reviews draft letters 2.20 Letters finalised. Bank details requested & exclusion criteria proof (if applicable) 2.21 Standstill period Implemented (if applicable) Requests for further information responded to 3.1 IA raises commitment (if applicable) & sends final draft contract to for review SOP/EMA/0121, Page 6/10

7 9. Procedure Step Action Responsibility 1.0 Procurement Planning 1.1 provides advance information and on any planned procurement procedure prior to the beginning of the financial year and for the subsequent two financial years to and updates as required for publication to management. 1.2 For contracts up to EUR 60,000 where ex ante publication is required on the Agency s buyer s profile, passes relevant information to for publication. 1.3 decides the appropriate type of procurement procedure and plans the timeframe, consulting with if required for advice. nominates staff member responsible for running the procurement procedure. 1.4 Allocation of reference number from the Agency s contract numbering system and creation of procurement folder in DREAM with restricted access. 1.5 informs relevant Agency staff of the plan to procure. 2.0 Execution of the procurement procedure 2.1 Mandatory appointment of opening and evaluation committees for procedures over 60,000. For procedures under 60,000 appointment of committees as decided by. 2.2 makes all decisions on draft documentation necessary including draft contract, making use of Agency s standard procurement contracts and other relevant standard documents and templates. The person running the sends all documentation for for review. 2.3 reviews all documentation and provides comments to the person running the in writing. 2.4 The person running the updates finalises draft documentation in light of s comments, consulting with the as needed, and where the is to be advertised in the OJEU the person running the provides the documents in the correct format for publication on the Agency s external webpage. 2.5 Preparation and dispatch of text for publication of contract notice in Official Journal of the European Union and on the Agency s buyer s profile. Publication of notice in OJEU and on Agency s buyer s profile. 2.6 executes relevant procurement procedure in accordance with the FR and IR, Regulation (EC) No 45/2001 and any other relevant Standard Operating Procedure and/or internal step-by-step guides provided by, consulting with the during the procedure as needed. 2.7 At the end of the evaluation, the draft evaluation committee report ranking the s is sent to for comment and review prior to signature by the committee members. 2.8 The person running the updates finalises draft evaluation committee report in light of s comments, consulting with the evaluation committee as needed. 2.9 Upon the basis of the finalised evaluation committee report the decides whether to proceed with a contract or abandon the procedure. If decision is to abandon or cancel, procedure ends. /Person running the / SOP/EMA/0121, Page 7/10

8 Step Action Responsibility 2.10 The person running the checks whether contract value is above ACPC threshold and if an opinion is required from ACPC. If opinion is not required go directly to If over threshold of ACPC, the person running the prepares a draft ACPC report and annexes and submits this to for review reviews the draft ACPC report and may make comments in writing to finalises the ACPC report in light of s comments and submits to ACPC ACPC gives an Opinion, if applicable. ACPC 2.15 makes the contract final award decision to proceed or abandon the procedure and nominates the responsible person(s) for (i) general administration of the contract e.g. price review and (ii) monitoring of performance of supplier. prepares draft award decision. /person running the 2.16 reviews draft award decision signs final award decision, taking into account s comments prepares draft letters to inform successful and unsuccessful ers accordingly and submits to for review reviews draft letters finalises letters for signature by and requests successful ers to provide bank details if not already held by the Agency and proof regarding exclusion criteria if required. Letters are dispatched implements the ten day standstill period where applicable. If any challenge is made, reviews and decides whether or not to proceed with contract signature or suspend contract signature. obtains proof regarding exclusion criteria from successful er, where applicable Requests for further information from unsuccessful ers are responded to within the legal deadlines. 3.0 Contract Conclusion 3.1 In case of non-framework contracts, IA raises the financial commitment and sends the dossier with the final draft contract to the VO for ex ante verification and in parallel IA sends the final draft contract to for review. In case of framework contracts, IA sends IA sends only the final draft contract to for review as no financial commitment is required. 3.2 VO Charter workflow applies for non-framework contracts. VO//IA/ED 3.3 In all cases reviews draft contract and may make comments to with copy to VO. indicates to any required suggestions or changes to the final draft contract electronically in track-changes mode and sends a copy to the VO. 3.4 If VO makes comments to go to 3.5. If VO does not make any comments, go to Upon receipt of a copy of comments raised by VO relating to an ex ante check of a contract, contacts to initiate a discussion to advise and assist. 3.6 Upon completion of contract checks, IA actions the commitment for non-framework contracts and in all cases the contract is signed. IA VO IA SOP/EMA/0121, Page 8/10

9 Step Action Responsibility 4.0 Post Contract Award 4.1 If award notice in OJEU is required, IA informs of the date of signature of the contract within 40 days of such signature and prepares and publishes award notice in the OJEU and on the Agency s external website. IA/ 4.2 IA files all original signed contracts in the Department concerned. IA 4.3 As soon as possible and within a maximum of 48 days of signature of contract by both parties, IA completes the entry of all relevant data on the contract into the contracts database, except for contracts under 15,000 in value. 4.4 Finalisation of filing of all procurement documents using mandatory filing plan. For contracts under 60,000 go to For contracts over 60,000 conducts debriefing of procurement procedure and provides feedback to. 4.6 prepares all annual reports on contracts concluded for the whole Agency and other centralised reports as and when required using the data entered by IA in the contracts database. 4.7 Conduct of contract management at suitable intervals of execution of the contract (document performance reviews, update of service level agreements, price reviews, renewals etc) and signature of addenda. IA /delegated Project Manager/IA 4.8 Update of contracts database with signed addenda. IA 4.9 Conduct of ex post evaluation reports as requested by. Project Manager or 4.10 Before contract expiry, reviews future requirements, taking into account any lessons learned and any ex post evaluation reports. Review if new procurement procedure is required. End of Process. IA 10. Records All documentation and other records relating to procurement procedures involved in this procedure will be collected and maintained by the electronically in Document Records Electronic Archive Management, ensuring appropriate levels of security, and in hard copy in the Division of the Authorising Officer or in the Agency s official off-site storage facility. The shall conserve the supporting documentation for the relevant period as stated in the Agency s Business Classification Scheme. IA shall file all original signed contracts in the Division concerned. SOP/EMA/0121, Page 9/10

10 SOP/EMA/0121, Page 10/10

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