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
Section I: Contracting authority
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, Victoria
For the attention of: David Olszowka
SW1W 9SZ London
Telephone: +44 2030806573
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)
Section II: Object of the contract
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).
— 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.
— 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.
Section III: Legal, economic, financial and technical information
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.
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
Section IV: Procedure
Objective criteria for choosing the limited number of candidates: Details will be given within the Pre-Qualification Questionnaire.
Section VI: Complementary information
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: firstname.lastname@example.org – 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.5)Date of dispatch of this notice:30.1.2012