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Licensing Guidelines and Regulations Posted 14/10/2011

The main characteristic of the British healthcare system is that nearly all healthcare services are offered by public authorities. The most important healthcare institution is the National Health Service (NHS), which was introduced in 1948 and covers all British residents. It is funded mainly through general taxation together with an element of national insurance contribution (an income based tax payable by employers and employees) and co-payments [1]

Primary care is provided by 302 Primary Care Trusts (PCTs), which receive budgets directly from the NHS and influence the way medicines are prescribed. PCTs are made up of groups of local physicians practices, community staff and representatives of the local community. The NHS operates as ‘gatekeeper’ system, whereby GPs determine access of patients to specialists. Most patients are exempt from co-payments [2].

Although some form of medicine regulation has existed in the UK since the time of King Henry VIII, it was not until 1971 that a comprehensive regulatory system was introduced [3].

The Medicines Act of 1968 (which became fully operational in 1971) provides the legal framework for the control of medicines in the UK [4].

This new medicines act brought most previous legislation on medicines together and also introduced a number of other legal provisions for the control of medicines. It was an enabling act providing for a system of licensing affecting manufacture, sale, supply and importation of medicinal products into the UK. It became unlawful to engage in these activities except in accordance with appropriate licenses, certificates or exemptions.

The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health (DoH), was created in 2003 and is the governmental body responsible for the licensing of medicines in the UK [5].

A licence, also referred to as a marketing authorisation, from the MHRA is required before any medicine can be used to treat people in the UK.

Licences for medicines are only granted by the MHRA when a product meets high standards of safety and quality and works for the purpose intended. The regulatory system also imposes rigorous standards on medicines manufacturers and wholesale dealers who trade in them.

The 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. Safety monitoring is also continuous and the MHRA also ensures that doctors and patients receive up-to-date and accurate information about their medicines. This is achieved by ensuring that product labels, leaflets, prescribing information and advertising meets the required standards laid down by the regulations.

Most new medicines are licensed by the EMA, to ensure that they are available to, and used in the same way, across all the member states of the EU [6].

The current relevant legislation is given in Directive 2001/83/EC relating to medicinal products for human use, amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC [7].

Proposals to change UK medicine legislation are subject to Ministerial decisions, which are taken on the advice of the MHRA. The DoH is responsible for any changes to NHS regulation for extended prescribing. The Home Office is responsible for the prescription of controlled drugs, under the terms of the Misuse of Drugs Act and Misuse of Drugs Regulations, and acts upon advice from the Advisory Council on the Misuse of Drugs (RCGP, 2006).

Regulations

The following regulations govern how primary care trusts (PCTs) administer National Health Service (NHS) pharmaceutical services:

  • SI 2005/641: The National Health Service (Pharmaceutical Services) Regulations 2005 [8]
  • SI 2006/552: The National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 [9]

These regulations include:

  • regulations for the control of entry procedures
  • fitness to practise procedures for pharmacists, appliance contractors and corporate bodies
  • terms of service for pharmacists, appliance contractors and dispensing doctors under the national pharmacy contractual framework.

Directions/Guidelines

The government has also issued guidelines to accompany these regulations [10]:

  • The National Health Service (Miscellaneous Amendments Relating to Prescribing, Pharmaceutical Services and Local Pharmaceutical Services etc.) (England) Directions 2006
  • The National Health Service (Pharmaceutical Services) Directions 2005
  • The Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2005 and determination
  • Directions to the Prescription Pricing Authority—Payments to chemists suspended by direction of the FHSAA
  • NHS Pharmaceutical Services (Fees for applications) Directions 2008
  • Implementing the Health Act 2006: NHS (Pharmaceutical Services) (Amendment) Regulations 2008—information for PCTs

References

1. Health Act 1999 chapter 8, as amended [monograph on the Internet] [cited 2011 May 13]. Available from: www.opsi.gov.uk/acts/acts1999/pdf/ukpga_19990008_en.pdf

2. Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. July 2006.

3. MHRA. How we regulate medicines. [monograph on the Internet] © 2010 Crown Copyright [cited 2011 May 13]. Available from: www.mhra.gov.uk/Howweregulate/Medicines/index.htm

4. MHRA Brochure. Medicines and Medical Devices Regulation: What you need to know. April 2008.

5. Royal College of General Practitioners (RCGP) Information Sheet: Prescribing in Primary Care. March 2006.

6. British Generic Manufacturers Association (BGMA). Performance of the MHRA [monograph on the Internet] London, UK, BGMA c2010 [cited 2011 May 13] Available from: www.britishgenerics.co.uk/key-issues/performance-of-the-mhra

7. European Commission, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to Medicinal products for Human use. Official Journal L – 311, 28/11/2004, p. 67-128

8. The National Health Service (Pharmaceutical Services) Regulations 2005 [monograph on the Internet]. Crown c2005 [cited 2011 May 13]. Available from: www.opsi.gov.uk/si/si2005/20050641.htm

9. The National Health Service (Pharmaceutical Services) Regulations 2006 [monograph on the Internet]. Crown c2006 [cited 2011 May 13]. Available from: www.opsi.gov.uk/si/si2006/20060552.htm

10. Department of Health (DoH) The National Archives. NHS (Pharmaceutical Services) Regulations. [monograph on the Internet]. Crown c2010 [cited 2011 May 13]. Available from: www.dh.gov.uk/en/Healthcare/Medicinespharmacyandindustry/Communitypharmacy/NHSpharmaceuticalregulations/DH_515

Useful information sources

EMA, Committee for Proprietary Medicinal Products (CPMP), Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) 24 July 2008 [monograph on the Internet] London, UK, EMA [cited 2011 May 13]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003011.pdf

EMA, Committee for Medicinal Products for Human Use (CHMP), EMA Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications (EMEA/CHMP/ 225411/2006) 2 July 2008 [monograph on the Internet] London, UK, EMA [cited 2011 May 13]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP), Note for guidance on modified release oral and trans-dermal dosage forms: Section II (pharmacokinetic and clinical evaluation) (CPMP/EWP/280/96) 1999 [monograph on the Internet] London, UK, EMA [cited 2011 May 13] Available from: www.ema.europa.eu/pdfs/human/ewp/028096en.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP), Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) 1995 [monograph on the Internet] London, UK, EMA [cited 2011 May 13] Available from: www.ema.europa.eu/pdfs/human/ewp/023995en.pdf

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