Dealing with disputes over regulation of medicines
Disagreements over the regulation of medicines are dealt with according to a strict procedure which is set out in legislation and is part of the regulatory process. This ensures that applicants and licence holders have every opportunity to put forward their arguments. It also ensures that the licensing authority, advised by its experts, provides reasons for every decision it makes.
If, having complied with these procedures, an applicant or licence holder still disagrees with the licensing authority over a decision, it may apply to the Regulation of Medicines Review Panel for an independent review of the decision.
Regulation of Medicines Review Panel
The Regulation of Medicines Review Panel is a permanent panel of individuals who are independent of the pharmaceutical industry, the licensing authority or its advisors. The panel carries out independent reviews of licensing authority decisions, performing the function of the ‘person appointed’ in the Medicines Act 1968 and subordinate legislation.
Regulation of Medicines Review Panel Annual Report 2009/2010
(75Kb)
Panel members
The current chair of the panel is a legally qualified individual with previous experience of conducting tribunal and similar hearings. For details of permanent members of the Regulation of Medicines Review Panel see our Members section or Guidance Note on Independent Reviews (122Kb) (link).
Terms of reference
- Where an applicant for marketing authorisation, clinical trials authorisation, herbal registration, homeopathic certificate of registration or a licence for manufacturing or wholesale dealing disagrees with the decision or proposal of the licensing authority and is eligible in the relevant legislation to be heard by a ‘person appointed’, the Panel will, upon the applicant’s request, carry out a review of the decision or proposal and prepare a report.
- In the course of carrying out its independent review the panel will always:
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- conduct it in such away as it considers necessary to ensure fairness
- provide the applicant and licensing authority with an opportunity to give oral evidence at a hearing
- produce a report containing its findings based on any evidence or expert information presented to it and the results of any further enquiries it makes
- provide its report to the licensing authority and a copy of its report to the applicant.
- The licensing authority will always take into account the findings contained in the Independent Review Report when it makes its final licensing decision and may take into account any recommendations of the Panel.
- The chair will sit at each panel review with at least two other individuals from the panel who have appropriate medical and/or scientific expertise. Depending on the subject matter of the hearing, specialists in a particular field may be called upon by the Panel to advise them further in any way, including attendance with the Panel at any site visit which may be necessary, and advising the Panel at the hearing.
Procedure
In order to assist applicants and the licensing authority with the review process, the purpose of and procedures associated with an independent review are set out in the Regulation of Medicines Review Panel Guidance Note for Independent Reviews (122Kb) (link).
Fees
The fee for a review by the Regulation of Medicines Review Panel is £10,000. This fee is payable by the applicant when a request for a review is submitted.
Secretariat
Administrative support to the Regulation of Medicines Review Panel is provided by a Secretariat within the Policy Division of the MHRA. The Policy Division is separate from the Licensing Division of the MHRA. Members of the Secretariat are at no time involved with any of the processes or any decision making connected with the licensing of any medicine or medicinal product within the MHRA.
Other than as formally requested and received for the purpose of an independent review as outlined in the Regulation of Medicines Review Panel guidance, the Secretariat has no access to licensing authority papers, either generally or in the case of any individual independent review.
Contact details
Tracy Murray
020 3080 6329
tracy.murray@mhra.gsi.gov.uk
Karen Salawu
020 3080 6216
karen.salawu@mhra.gsi.gov.uk
Further information
Further information can be found in the attached Regulation of Medicines Review Panel Guidance Note (122Kb) (link) for appellants and the licensing authority.
