Publishing Contract for pharmaceutical guidance for Medicines and Healthcare products Regulatory Agency

Publishing Contract for pharmaceutical guidance for Medicines and Healthcare products Regulatory Agency

Risk-free Publishing Contract for the pharmaceutical guidance The Rules and Guidance for Pharmaceutical Manufacturers and Distributors.

UK-London: printing and related services

2012/S 22-035796

Contract notice

Services

Directive 2004/18/EC

Section I: Contracting authority

I.1)Name, addresses and contact point(s)

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, Victoria
For the attention of: David Olszowka
SW1W 9SZ London
UNITED KINGDOM
Telephone: +44 2030806573
E-mail: david.olszowka@mhra.gsi.gov.uk

Internet address(es):

General address of the contracting authority: http://www.mhra.gov.uk

Further information can be obtained from: The above mentioned contact point(s)

Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The above mentioned contact point(s)

Tenders or requests to participate must be sent to: The above mentioned contact point(s)

I.2)Type of the contracting authority

Ministry or any other national or federal authority, including their regional or local sub-divisions
I.3)Main activity

Health
I.4)Contract award on behalf of other contracting authorities

The contracting authority is purchasing on behalf of other contracting authorities: no

Section II: Object of the contract

II.1)Description
II.1.1)Title attributed to the contract by the contracting authority:

Risk-free Publishing Contract for the pharmaceutical guidance The Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
II.1.2)Type of contract and location of works, place of delivery or of performance

Services
Service category No 15: Publishing and printing services on a fee or contract basis
Main site or location of works, place of delivery or of performance: At the contractor’s own site(s).
NUTS code
II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)

The notice involves a public contract
II.1.4)Information on framework agreement
II.1.5)Short description of the contract or purchase(s)

It is the intention to create a contract for the provision of risk-free royalty based publishing for the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is to tender for the publication of two of its guides for the pharmaceutical industry. The guides are:
— the rules and guidance for pharmaceutical manufacturers and distributors, known as the “Orange Guide” and,
— the rules and guidance for pharmaceutical distributors.
The Orange Guide is the essential reference for all those who manufacture or distribute medicines in Europe. The ‘Orange Guide’ collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use.
Compliance with Good Manufacturing Practice and Good Distribution Practice requirements is essential in the production and distribution of medicines for human use to safeguard public health and to comply with legislation. It is of particular relevance to all holders of Manufacturer’s Licences and Wholesale Dealer’s Licences and to their Qualified Persons and Responsible Persons, who have a responsibility for ensuring compliance with many of these regulatory requirements.
The Rules and Guidance for Pharmaceutical Distributors reproduces those elements of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors specific to the wholesale supply and distribution of medicines for human use.
The contractor will be solely responsible for all aspects of the production, marketing, distribution, etc. of the publication at their own expense. This will include the usual copy-editing, typesetting, and proof-reading procedures.
Copyright of the publication will remain with MHRA. However, the publisher will be granted full rights to license or publish the work in any language, formats or delivery media world-wide. The printed and electronic editions of the work are to be published in paperback format annually to take account of any updated material.
The successful supplier will provide the publication and financial arrangements expressed in the contract. The agreement will be between 1 and 5 years with no extension period. The Authority may terminate the Agreement by giving twelve (12) months summary notice, in writing, to the Publisher, such notice not to be given until six (6) months after publication of the most recent print edition of the work published to allow for selling out of the work.
II.1.6)Common procurement vocabulary (CPV)

79800000

II.1.7)Information about Government Procurement Agreement (GPA)

The contract is covered by the Government Procurement Agreement (GPA): yes
II.1.8)Lots

This contract is divided into lots: no
II.1.9)Information about variants

Variants will be accepted: yes
II.2)Quantity or scope of the contract
II.2.1)Total quantity or scope:

The successful publisher will be expected to:
— publish the publication in print and electronic format, e.g. as an e-book. The text for each publication will be supplied by the MHRA to the successful publisher in electronic form (e.g. Microsoft Word) along with one complete manuscript copy of the work,
— provide an index for the publication o be solely responsible for all aspects of the production, marketing, distribution, etc. of the publication at their own expense. This will include the usual copy-editing, typesetting, and proof-reading procedures,
— design the covers for the guides. The publisher shall consult with the MHRA and be sympathetic to the MHRA design guidelines,
— the publisher’s and MHRA’s name and/or logo will be displayed appropriately on the cover,
— the electronic version is to be made available as an e-book. This may include PDF.
The value of the contract is completely dependent on the performace of the supplier and the appetite of the end user. The average revenue achieved over the current contract lifetime (5 years) has been approximately £150K per annum. This sum is not in anyway guaranteed by the MHRA.
II.2.2)Information about options

Options: no
II.2.3)Information about renewals

This contract is subject to renewal: no
II.3)Duration of the contract or time limit for completion

Duration in months: 60 (from the award of the contract)

Section III: Legal, economic, financial and technical information

III.1)Conditions relating to the contract
III.1.1)Deposits and guarantees required:

Not applicable.
III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:

Sales income received by the publisher. Royalties paid to the Medicines and Helathcare products Regulatory Agency.
III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:

Written contract – Economic operators shall form and be a single legal entity.
III.1.4)Other particular conditions

The performance of the contract is subject to particular conditions: no
III.2)Conditions for participation
III.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

Information and formalities necessary for evaluating if the requirements are met: Potential Providers will be assessed in accordance with Parts 4 and 5 of the Public Contracts Regulations 2006, as amended(implementing Title II, Chapter VII, Section 2 of Directive 2004/18/EC), on the basis of information received in response to an invitation to tender. Please refer to PQQ document.
III.2.2)Economic and financial ability

Information and formalities necessary for evaluating if the requirements are met: Potential providers will be assessed in accordance with Parts 4 and 5 of the Public Contracts Regulations 2006, as amended (implementing Title II, Chapter vii, Section 2 of Directive 2004/18/EC), on the basis of information received in response to an invitation to tender.
The Contracting Authority may take into account any of the following information:
(a) appropriate statements from banks or, where appropriate, evidence of relevant professional risk indemnity insurance;
(b) the presentation of balance-sheets or extracts from the balance-sheets, where publication of the balance-sheet is required under the law of the country in which the economic operator is established;
(c) a statement of the undertaking’s overall turnover and, where appropriate, of turnover in the area covered by the contract for a maximum of the last 2 financial years available, depending on the date on which the undertaking was set up or the economic operator started trading, as far as the information on these turnovers is available. Please refer to PQQ document.
III.2.3)Technical capacity

Information and formalities necessary for evaluating if the requirements are met:
Potential Providers will be assessed in accordance with Parts 4 and 5 of the Public Contracts Regulations 2006,as amended (implementing Title II, Chapter vii, Section 2 of Directive 2004/18/EC), on the basis of information received in response to an Invitation to Tender.
The Contracting Authority may have regard to any of the following means in its assessment:
(a) a list of the principal deliveries effected or the main services provided in the past 3 years, with the sums, dates and recipients, whether public or private;
(b) an indication of the environmental management measures that the economic operator will be able to apply when performing the contract;
(c) a statement of the average annual manpower of the service provider or contractor;
(d) an indication of the proportion of the contract which the services provider intends possibly to subcontract. Please refer to PQQ document
III.2.4)Information about reserved contracts
III.3)Conditions specific to services contracts
III.3.1)Information about a particular profession

Execution of the service is reserved to a particular profession: no
III.3.2)Staff responsible for the execution of the service

Legal persons should indicate the names and professional qualifications of the staff responsible for the execution of the service: no

Section IV: Procedure

IV.1)Type of procedure
IV.1.1)Type of procedure

Restricted
IV.1.2)Limitations on the number of operators who will be invited to tender or to participate

Envisaged minimum number 5: and maximum number 6
Objective criteria for choosing the limited number of candidates: Details will be given within the Pre-Qualification Questionnaire.
IV.1.3)Reduction of the number of operators during the negotiation or dialogue
IV.2)Award criteria
IV.2.1)Award criteria

The most economically advantageous tender in terms of the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document
IV.2.2)Information about electronic auction

An electronic auction will be used: no
IV.3)Administrative information
IV.3.1)File reference number attributed by the contracting authority:

Not Applicable
IV.3.2)Previous publication(s) concerning the same contract
IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document

Payable documents: no
IV.3.4)Time limit for receipt of tenders or requests to participate

7.3.2012 – 12:00
IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates

19.3.2012
IV.3.6)Language(s) in which tenders or requests to participate may be drawn up

English.
IV.3.7)Minimum time frame during which the tenderer must maintain the tender
IV.3.8)Conditions for opening tenders

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: no
VI.2)Information about European Union funds

The contract is related to a project and/or programme financed by European Union funds: no
VI.3)Additional information

The Medicines and Healthcare products Regulatory Agency (MHRA) was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.
All licensed medicines available in the UK are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety, quality and efficacy. It is the responsibility of the MHRA and the expert advisory bodies set up by the Medicines Act to ensure that the sometimes difficult balance between safety and effectiveness is achieved. MHRA experts assess all applications for new medicines to ensure they meet the required standards. This is followed up by a system of inspection and testing which continues throughout the lifetime of the medicine.
The roles of the MHRA are to:
— provide a system of post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and medical devices,
— assess and, where appropriate evidence exists, authorise medical products for sale and supply in UK,
— oversee the Notified Bodies that audit medical device manufacturers,
— operate a quality surveillance system to sample and test medicines o to address quality defects o to monitor the safety and quality of unlicensed products o investigate internet sales and potential counterfeiting of medicines,
— regulate clinical trials of medicines and medical devices,
— monitor and ensure compliance with statutory obligations relating to medicines and medical devices,
— promote safe use of medicines and devices,
— manage the GPRD, British Pharmacopoeia and the Devices Evaluation Service.
The MHRA also hosts and supports a number of expert advisory bodies, including the Commission on Human Medicines (which replaced the Committee on the Safety of Medicines in 2005), and the British Pharmacopoeia Commission. In addition, as part of the European system of medicines approval, the MHRA or other national bodies may be the Rapporteur or Co-rapporteur for any given pharmaceutical application, taking on the bulk of the verification work on behalf of all members, while the documents are still sent to other members as and where requested.
Potential providers should note that, in accordance with the UK Government’s policies on transparency, the Contracting Authority intends to publish the invitation to tender and the text of the contract awarded, subject to possible redactions at the discretion of the Contracting Authority. Further information on transparency can be found at: http://www.gps.gov.uk/aboutus/transparency/.

All communications shall be in English. Tenders and all supporting documentation must be priced in Sterling and all payments under the contract will be in Sterling. Any contract or agreement resulting from the acceptance of a tender will be considered as a contract made in England according to English Law and subject to the exclusive jurisdiction of the English courts. The Contracting Authority does not bind itself to accept any tender and reserves the right to accept any part of the tender unless the potential provider expressly stipulates to the contrary.
Any Potential provider may be disqualified who meets any of the criteria outlined in 23 (4) of the Public Contracts Regulations 2006, as amended (implementing Title II, Chapter vii, Section 2 of Directive 2004/18/EC).
The Contracting Authority expressly reserves the right (i) not to award any contract as a result of the procurement process commenced by publication of this notice; and (ii) to make whatever changes it may see fit to the content and structure of the tendering competition; and in no circumstances will the Contracting Authority be liable for any costs incurred by the potential providers. Any expenditure, work or effort undertaken prior to contract award is accordingly a matter solely for the commercial judgement of potential providers.
The Contracting Authority will consider variant bids (if accompanied by a compliant bid) within the parameters outlined within the invitation to tender.
All participants must complete a Pre-Qualification Questionnaire (PQQ) which covers Economic and Financial capacity and Technical capacity. This procurement exercise will be conducted manually by the MHRA. Candidates wishing to be considered for this contract must register their Expression of Interest (Company name, contact name and position, telephone number and email address) with David Olszowka, Senior Regulatory Advisor, Inspection, Enforcement & Standards Division Tel: +44 2030806573 Email: david.olszowka@mhra.gsi.gov.uk – Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ. The PQQ will be issued and must be returned by the supplier no later than the 16.3.2012. The Invitation to Tender (ITT) will be issued by the MHRA upon evaluation of the PQQ and selection of the envisaged number of operators on the date given in section IV.3.5.

VI.4)Procedures for appeal
VI.4.1)Body responsible for appeal procedures
VI.4.2)Lodging of appeals

Precise information on deadline(s) for lodging appeals: The MHRA will incorporate a minimum 10 calendar days standstill period at the point that information on the award of the contract is communicated to tenderers. This period allows unsuccessful tenders to seek further debriefing from the contracting authority before the contract is entered into. Applicants have two working days from the award decision to request additional debriefing and that information has to be provided a minimum of three working days before the expiry of the standstill period. Such information should be requested from the contracting authority named in section 1.1. If an appeal regrading the awrad of a contract has not be successfully resolved the Public Contracts Regulations 2006(SI 2006 No. 5) provide for aggrieved parties who have been harmed or are at risk of harm by a breach of the rules to take action in the High Court (Englan, Wales and Northern Ireland). Any such action must be brought promptly (generally within three months). Where a contract has not been entered into, the Court may order the setting aside of the award decision or order the authority to amend any document and may award damages. If the contract has been entered into the Court may award damages.
VI.4.3)Service from which information about the lodging of appeals may be obtained

VI.5)Date of dispatch of this notice:30.1.2012