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Medicines Legislation

The Human Medicines Regulations 2012

(SI 2012 /1916)
http://www.legislation.gov.uk/uksi/2012/1916/contents/madeLink to an external website
These Regulations, which came into force on 14 August 2012, consolidate the law of the United Kingdom concerning medicinal products for human use (“products”). They set out a comprehensive regime for the authorisation of products; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.  The regulations introduce a small number of limited policy changes to ensure that the legislation is fit for purpose.  These changes relate to statutory warnings for over the counter products, membership of review panels, health professionals’ exemptions, provisions for Patient Group Directions, pharmacist-instigated changes to prescriptions and repeal of section 10(7) of the Medicines Act 1968 which permitted pharmacy businesses to undertake limited wholesale dealing without a licence.  The Regulations implement EU Directive 2010/84/EU which introduces a strengthened, clarified and more proportionate regime for pharmacovigilance in the EU market.  Further information is available on the Medicines and Healthcare products Regulatory Agency (“MHRA”) website.  There are 349 regulations in 17 parts, followed by 35 schedules.
Part 1 (general) and Part 2 (administration) consolidate, with only minor and drafting amendments, the administration provisions in Part 1 of the Medicines Act 1968 (“the 1968 Act”), including the definition of the licensing authority as the body responsible for regulating products. Part 1 also provides for interpretation, and for special provisions concerning the applicability of the Regulations to a number of activities by pharmacists and others. The latter provisions consolidate, with only minor and drafting amendments, provisions in Part 2 of the 1968 Act, except for the repeal of section 10(7) of the Act, which concerns wholesale dealing by pharmacists.  (Please see a relevant feature on the MHRA website entitled “Supply of medicines by pharmacy to healthcare professionals”)
Part 3 (manufacturing and wholesale dealing) of the Regulations governs the manufacture and importation of, and wholesale dealing in, products. It consolidates, with only minor and drafting amendments, the provisions of Part 2 of the 1968 Act, and statutory instruments made under powers in that Part, on these topics. In doing so, the Regulations continue to implement the relevant obligations of the United Kingdom in respect of Directives of the European Parliament and of the Council.
Part 4 (requirement for authorisation) of the Regulations establishes that products must not be sold, supplied, or offered for sale or supply in the United Kingdom unless authorised, either by the United Kingdom licensing authority under the Regulations, or by the European Medicines Agency.
Parts 5 to 8 (marketing authorisations, certification of homoeopathic medicinal products, traditional herbal registrations and Article 126a authorisations) provide for the procedures for authorisation by the United Kingdom licensing authority of medicinal products in various categories. Part 5 (marketing authorisations) also provides for offences in the case of breach of the corresponding requirements in the procedures under certain European Regulations.
In respect of United Kingdom authorisation, Parts 4 to 8 of the Regulations consolidate, with only minor and drafting amendments, the following principal statutory instruments: the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, as amended, (“the marketing authorisations regulations”), the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, as amended,  (“the homoeopathic regulations”), except in respect of fees provisions that are not being revoked, and the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005, as amended, (“the traditional herbal regulations”). In doing so, the Regulations continue to implement relevant obligations under Directive 2001/83/EC. At the same time the Regulations repeal the parallel national scheme for the licensing of the sale and supply of products, found in Part 2 of the 1968 Act, but now almost entirely superseded by EU provision in this field.
Part 9 (borderline products) of the Regulations consolidates, with only minor and drafting amendments, provision in the marketing authorisations regulations for the licensing authority to determine whether products that are supplied without authorisation are medicinal products and thus subject to the Regulations.
Part 10 (exceptions) consolidates, with only minor and drafting amendments, provisions in the marketing authorisations regulations, the homoeopathic regulations and the traditional herbal regulations concerning exemptions from the requirement for authorisation.
Part 11 (pharmacovigilance) consolidates provisions in the marketing authorisations regulations and the traditional herbal regulations concerning the monitoring of the safety of medicines in clinical use. This Part also implements the relevant amendments to Directive 2001/83/EC made by Directive 2010/84/EU. Part 11 also provides for offences in the case of a breach of the corresponding requirements under regulations of the European Parliament and of the Council.
Part 12 (dealings with medicinal products) governs the circumstances in which products may be sold, supplied and administered, and consolidates, with only minor and drafting amendments, the greater part of Part 3 of the 1968 Act, certain provisions of the latter which are outside the scope of Directive 2001/83/EC being left unrepealed.
Parts 1, 3, 5, 10 and 12 contain provisions consolidating the effect of the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882). In so doing, the Regulations continue to make provision necessary for the operation of regulations of the European Parliament and of the Council on advanced therapy medicinal products.
Part 13 (packaging and leaflets): Chapter 1 consolidates, with only minor and drafting amendments, provisions in the marketing authorisations regulations, the homoeopathic regulations and the traditional herbal registrations in respect of the information to be supplied with products, continuing to implement Directive 2001/83/EC. Chapter 2 consolidates certain United Kingdom provisions on child safety in the presentation of products. Part 5 of the 1968 Act, which made parallel provision, is repealed, and the instruments made under it revoked, except in respect of certain powers outside the scope of Directive 2001/83/EC.
Part 14 (advertising) consolidates, with only minor and drafting amendments, the Medicines (Advertising) Regulations 1994, as amended, and the Medicines (Monitoring of Advertising) Regulations 1994, as amended. In doing so, it continues to implement Directive 2001/83/EC. Part 6 of the 1968 Act, which made parallel provision, is repealed, and the instruments made under it revoked.
Part 15 (British Pharmacopoeia) consolidates, with only minor and drafting amendments, Part 7 of the 1968 Act.
Parts 16 (enforcement) and Part 17 (miscellaneous and general) consolidate, with only minor and drafting amendments, Part 8 (miscellaneous and supplementary provisions) of the 1968 Act as it concerns the topics in the Regulations. That Part remains in force, in amended form, in relation primarily to Part 4 (pharmacies) of the 1968 Act, which remains in force, and to certain other matters outside the scope of Directive 2001/83/EC.
Note on enforcement
Enforcement in Northern Ireland of the Regulations is the responsibility of the Department of Health Social Services and Public Safety and the function is conducted by officers of the Department’s Medicines Regulatory Group (“MRG”), in conjunction with, when appropriate, other organisations such as the Police Service, HM Revenue and Customs and the MHRA.
Note on Licences and Authorisations
All authorisations for medicinal products for human use and licences for manufacturers and wholesalers of such products across the UK are issued by the MHRA.  Through a Memorandum of Understanding, the Department has agreed with MHRA that while inspection and enforcement for these particular matters remains the Department’s responsibility, operationally the MHRA Inspectorate should be the lead authority for related inspection arrangements across the UK.  This includes inspection visits within Northern Ireland to ensure consistency of approach and provide assurance of a common standard.  MRG inspectors may take part in joint visits with MHRA inspectors.



Medicines Act 1968

(c.67)
(Partially repealed by the Human Medicines Regulations 2012)
http://www.legislation.gov.uk/ukpga/1968/67/contentsLink to an external website
When assessing the effect of medicines legislation it is important that all amending Statutory Instruments and Rules relating to the Act, Orders, or principal Regulations are identified and taken into account.  Some legislation, as presented on the web site www.legislation.gov.uk, has been revised to a point, but much is still only available as the original version.  Lists of amending regulations, where presented here under a piece of legislation, may not be complete.
Please note that the Human Medicines Regulations 2012 repealed aspects of the Medicines Act 1968 as follows:
Sections 2A to 9. Section 10(7). Sections 11 to 14. Section 15(1) and (2). Sections 16 to 57. Section 58(1A), (2) and (3). Sections 59 to 61. Sections 65 and 66. Section 67(3A), (5) and (6). Section 68. Sections 85 and 86. Section 89. Section 91(1). Sections 92 to 103. Section 108(3) to (5) and (7). Section 109(3). Section 110(3). Section 111(3). Section 112(7). Sections 115 and 116. Section 126(4). Section 130(2) to (8) and (10). Section 132(2), (3) and (5). Schedules 1A and 2. In Schedule 3, paragraphs 5 to 7.
The first comprehensive licensing system for medicines in the UK was the Medicines Act of 1968.  Following its introduction, much secondary legislation and many amendments were made.  The government consolidated medicines legislation, including much of the Medicines Act 1968, into one set of new regulations, the Human Medicines Regulations 2012, which came into operation on 14 August 2012 (see the section above).
The Ministers responsible for the administration of the Medicines Act are the Secretary of State concerned with Health in England and the Minister for Health Social Services and Public Safety in Northern Ireland.  The Act covers all of the United Kingdom and in many aspects Ministers act jointly.
Veterinary medicines were removed from the scope of the Medicines Act in 2005 with the introduction of the Veterinary Medicines Regulations.
The 1968 Act provided a system of licensing for manufacturing and dealing in medicines.  Some exemptions were included for certain persons, mainly to facilitate good healthcare in relation to medicines.
The Act classified medicines into three categories: a) Prescription Only Medicines which could only be supplied to the public on the prescription of an appropriate practitioner and could only be administered by, or in accordance with the directions of, an appropriate practitioner; b) medicines which could be sold to the public in a registered pharmacy by or under the supervision of a pharmacist; c) general sales list medicines which could be sold to the public in original, unopened manufacturers’ packs at any lockable premises.  Medicines which are controlled under Misuse of Drugs legislation are also subject to medicines legislation and continue to fall into the categories of Prescription Only Medicines or Pharmacy medicines as appropriate.
The Act described arrangements for pharmacy businesses, including the registration of pharmacy premises.  The use of titles such as “pharmacist” and descriptions such as “pharmacy” were restricted to use in accordance with the provisions of the Act.  These provisions remain in force in Northern Ireland.
Enforcement in Northern Ireland of such parts of the Medicines Act that remain in force is the responsibility of the Department of Health, Social Services and Public Safety and the function is conducted by officers of the Department’s MRG, in conjunction with, when appropriate, other organisations such as the Police Service, HM Revenue and Customs and the MHRA.



The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008

(SI 2008/2789)
http://www.legislation.gov.uk/uksi/2008/2789/contents/madeLink to an external website
These Regulations make provision about the duties of responsible pharmacists who are required, by virtue of section 72A of the Medicines Act 1968, to secure the safe and effective running of a pharmacy business at the premises from which it is carried on.
Amending Legislation
SI 2010/231 (The Pharmacy Order 2010 – GB effect).



The Prescription Only Medicines (Human Use) Order 1997

(SI 1997/1830)
The whole of the Order except articles 1(1) to (5), 5 and 10 and Schedules 1 and 2, was revoked and consolidated by the Human Medicine Regulations 2012 which came into force on 14 August 2012.
http://www.legislation.gov.uk/uksi/1997/1830/contents/madeLink to an external website
This Order, as amended, specified the descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, could be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which could be administered only by or in accordance with the directions of such a practitioner).  Many medicinal products were included in a class of such medicines by reason of their Marketing Authorisation, substances contained in them (see Schedule 1 of the Order) but others were included because of other criteria, such as their method of administration (see Article 3). In many cases the provisions of the Medicines Act 1968 applied subject to exemptions (See Articles 4 and 5 to 13 and Schedule 1).  Provisions for Prescribers, Prescriptions, Exemptions for emergency sale or supply, and Patient Group Directions were included.
Amending Legislation
Statutory Instruments: 1997/2044, 1998/108, 1998/1178, 1998/2082, 1999/1044, 1999/3463, 2000/1917, 2000/2899, 2000/3231, 2001/2777, 2001/2889, 2001/3942, 2002/549, 2003/696, 2003/2915, 2004/2, 2004/1189, 2004/2693, 2005/765, 2005/1507, 2005/2759, 2005/3324, 2006/915, 2006/2807, 2007/2178, 2008/464, 2008/1161, 2009/1165, 2009/3062, 2010/1136, 2010/2998, 2011/1327.



The Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008

(SI 2008/1692)
The whole of the Regulations was revoked and consolidated by the Human Medicine Regulations 2012 which came into force on 14 August 2012.
http://www.legislation.gov.uk/uksi/2008/1692/contents/madeLink to an external website
These Regulations, as amended, provided that, subject to the fulfilment of certain conditions in relation to the prescriptions which they gave, doctors and dentists in an EEA State other than the UK, or in Switzerland were appropriate practitioners within the meaning of section 58(2)(a) of the Medicines Act 1968 for medicinal products other than those which are controlled drugs in Schedules 1, 2 and 3 of the Misuse of Drugs Regulations (Northern Ireland) 2002. The effect of this was to enable the sale or supply of a medicinal product (other than a controlled drug in S1 to 3) in accordance with a prescription given by such a doctor or dentist, provided the conditions in relation to the prescription were complied with.  The “Exemptions for emergency sale or supply” as described in the Prescription Only Medicines (Human Use) Order 1997 also largely applied.
Amending Legislation
Statutory Instruments: 2010/1673, 2010/2785.



The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984

(SI 1984/769)
This instrument lapsed on 14 August 2012 as a consequence of repeals made to the Medicines Act 1968, and was consolidated by the Human Medicines Regulations 2012.
http://www.legislation.gov.uk/uksi/1984/769/madeLink to an external website
This Order specified classes of medicinal products which can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist.  Also classes of products were specified which with reasonable safety may be sold from automatic machines.  Products remained subject to the provisions of the Medicines Act in respect of licensing, labelling, packaging and promotion.
Amending Legislation
Statutory Instruments: 1985/1540, 1987/910, 1989/969, 1990/1129,1992/1535, 1994/2410, 1995,3216, 1997/2043, 1998/2170, 1999/852, 1999/2535, 2000/1092, 2000/2526, 2001/2068, 2001/4111, 2002/933, 2005/2750.



The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

(SI 1994/3144)
The whole of the Regulations was revoked and consolidated by the Human Medicine Regulations 2012 which came into force on 14 August 2012.
http://www.legislation.gov.uk/uksi/1994/3144/contents/madeLink to an external website
These Regulations implemented for the United Kingdom, European Council Directives concerned with the marketing of medicinal products.
These Regulations provided that no medicinal product for human use which is subject to the relevant Community provisions could be placed on the market in the United Kingdom or be dealt with by way of wholesale dealing unless there was in force in respect of it a marketing authorization granted either by the European Commission or by the UK licensing authority.
Regulations provided for the manner of making applications for a United Kingdom marketing authorization, the procedure for the consideration of such an application, the revocation and suspension of a marketing authorization and the suspension of the use or marketing of medicinal products and the obligations of applicants for and holders of marketing authorizations. Offences were created in connection with those obligations.
Schedule 1 made certain exceptions and exemptions from the requirement to hold a marketing authorization.  Schedule 5 contained provisions about the labelling of medicinal products.
Amending Legislation
Statutory Instruments: 1997/2884, 1998/3105, 2000/292, 2001,795, 2002/236, 2002/542, 2003/1618, 2003/2321, 2004/3224, 2005/768, 2005/1094, 2005/1710, 2005/2754, 2005/2759, 2006/914, 2006/1952, 2008/3097, 2009/1164, 2009/2820, 2009/3063, 2010/1882.



The Medicines (Advertising) Regulations 1994

(SI 1994/1932)
The whole of the Regulations was revoked and consolidated by the Human Medicine Regulations 2012 which came into force on 14 August 2012.
http://www.legislation.gov.uk/uksi/1994/1932/contents/madeLink to an external website
These Regulations implemented parts of a European Council Directive (“the Advertising Directive”) concerning the advertising of medicinal products for human use and parts of another Directive (“the Homoeopathics Directive”) concerning homoeopathic medicinal products for human use.
Amending Legislation
Statutory Instruments: 1994/3144, 1996/1552, 1999/267, 2003/2321, 2004/1480, 2005/2787.



The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980

(SI 1980/1923)
This instrument lapsed on 14 August 2012 as a consequence of repeals made to the Medicines Act 1968, and was consolidated by the Human Medicines Regulations 2012
http://www.legislation.gov.uk/uksi/1980/1923/contents/madeLink to an external website
These Regulations consolidated, with amendments, some older provisions. The provisions consolidated related to the following matters among others: the location of automatic machines for the sale of medicinal products, the keeping of records by persons lawfully conducting a retail pharmacy business; restrictions as to the classes of persons to whom there may be sold prescription only medicines and pharmacy medicines, and exemptions from those restrictions.
Amending Legislation
Statutory Instruments: 1982/28, 1990/1124, 1992/2938, 1994/2411, 1994/3144, 1995/3215, 1997/1831, 1997/2045, 1998/1045, 1999/644, 1999/2510, 2000/1070, 2000/2494, 2000/1918, 2001/3849, 2003/698, 2005/764, 2005/1520, 2005/2745, 2006/914, 2007/2179, 2008/1162, 2009/3063.



The Medicines (Pharmacy and General Sale— Exemption) Order 1980

(SI 1980/1924)
This instrument lapsed on 14 August 2012 as a consequence of repeals made to the Medicines Act 1968, and was consolidated by the Human Medicines Regulations 2012
http://www.legislation.gov.uk/uksi/1980/1924/madeLink to an external website
This Order consolidated, with amendments, provisions granting exemption from the restrictions imposed by sections 52 and 53 of the Medicines Act 1968. (Section 52 provided that medicinal products not on a general sale list should be sold or supplied only on premises that are a registered pharmacy and by or under the supervision of a pharmacist. Section 53 provided that medicinal products on a general sale list could be sold elsewhere than at a registered pharmacy only if certain specified conditions are fulfilled.)
Amending Legislation
Statutory Instruments: 1982/27, 1989/1852, 1994/2409, 1994/3142,1994/3144, 1997/1350, 1998/107, 1998/2368, 2000/1919, 2003/697, 2003/1590, 2004/1, 2004/1190, 2004/1771, 2005/766, 2005/848, 2005/1507, 2005/2745, 2005/2750, 2005/2759, 2005/3324, 2006/915, 2006/2807, 2007/2178,  2008/1161, 2009/1165,  2009/3062, 2010/231, 2010/ 1136, 2011/1327.



The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

(SI2005/2789)
The whole of the Regulations was revoked and consolidated by the Human Medicine Regulations 2012 which came into force on 14 August 2012.
http://www.legislation.gov.uk/uksi/2005/2789/contents/madeLink to an external website
These Regulations implemented certain provisions of Directive 2004/27/EC of the European Parliament and of the Council (“the 2004 Directive”) amending Directive 2001/83/EC on the Community code for medicinal products for human use (“the 2001 Directive”), made changes to certain existing provisions which implemented Directive 2001/83/EC and made consequential amendments to various enactments.
The Regulations implemented the requirements of the 2004 Directive insofar as they related to the manufacture, assembly, importation and wholesale distribution of medicinal products to which those Directives apply (“relevant medicinal products”), and, as respects relevant medicinal products, replaced the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, which implemented the requirements of the 2001 Directive as respects those matters.
Regulation 9 imposed a requirement that wholesale dealers dealt only with specified persons.
Amending Legislation
Statutory Instruments: 2009/1164, 2010/1882.
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