The Human Medicines Regulations 2012 Study Guide PDF

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The Human Medicines Regulations 2012

The Human Medicines Regulations 2012 Student study guide Facilitator David Gay

Required References This study pack Dale and Appelbe’s Pharmacy and Medicines Law 11th edition. (Available via Medicines Complete) The Human Medicines Regulations 2012 (http://www.legislation.gov.uk/uksi/2012/1916/contents/made) The Electronic medicines compendium

Contact Details [email protected]

Optional Medicines Ethics and Practice current Edition

Learning Outcomes This pack explores the Human Medicine Regulations (HMR) 2012 as amended. On completion of this pack you should: be able to explain the parts of the Regulations and what they cover; be able to explain the Principles of the regulations; understand the legal classification of human medicines and the restrictions these create; be aware of the legal requirements for a valid prescription for a Prescription Only Medicine, and; know the record keeping requirements for supplying a Prescription Only Medicine from a pharmacy.

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The Human Medicines Regulations 2012

Contents

Introduction......................................................................................................................................................3 What is a medicine?.........................................................................................................................................3 The regulations.................................................................................................................................................3 What is a Medicine?.........................................................................................................................................6 Marketing Authorisation (MA)..........................................................................................................................6 Traditional herbal medicines............................................................................................................................7 Homeopathic remedies....................................................................................................................................7 Unlicensed and ‘off-label’ medicines................................................................................................................8 Manufacturer’s license.....................................................................................................................................9 Wholesale Dealers’ Licenses.............................................................................................................................9 Pharmacy........................................................................................................................................................10 Legal classes of Medicines..............................................................................................................................11 General Sale...................................................................................................................................................12 Pharmacy Medicines......................................................................................................................................12 Prescription Only Medicines (POM)................................................................................................................12 Appropriate Practitioners...............................................................................................................................14 Prescriptions...................................................................................................................................................14 Legally valid prescriptions...............................................................................................................................15 Faxes...............................................................................................................................................................15 Repeatable prescriptions................................................................................................................................15 Repeat dispensing for NHS prescriptions........................................................................................................15 Electronic prescriptions..................................................................................................................................16 Combining electronic and repeatable prescriptions.......................................................................................17 Record keeping for supplies of POMs.............................................................................................................18 POM Exemptions............................................................................................................................................20

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The Human Medicines Regulations 2012

Introduction In your last study pack you learnt about the Medicines Act 1968, the forerunner to the Human Medicines Regulations 2012 (HMR) The Medicines Act has been in place for over 50 years. During that period it has been amended more than 380 times. That is over 380 separate statutory instruments, regulations and orders each changing some part or parts of the Act or modifying each other. It became very difficult to find the legislation on a particular subject because of the need to find all of the amendments. In 2009, the MHRA (look it up if you don’t know) began to codify medicines legislation; that is it pulled it all together in one document. It then conducted a review to assess any changes that might be needed. This eventually led to the enactment of the Human Medicines Regulations 2012 (HMR). The HMR replaces most of the Medicines Act 1968 together with most of the amendments to it. It means that almost all UK legislation about human medicines can now be found in one set of regulations. So much simpler than having to read the original Medicines Act, find amendments, find amendments to the amendments and finally work out what it all means. You lucky, lucky people.

What is a medicine? Before we consider the effects of the HMR, what is a medicine? Think about this and write your definition in the box below:

We will return to this on page 6.

The regulations Like the Medicines Act, the HMR provide a comprehensive system of controls for human medicines. They also implement several pieces of European legislation to bring UK law into line with European Directives. Every step of the supply chain is regulated; manufacture, import, distribution, sale and supply, labelling, advertising and pharmacovigilance. The regulations are written in 17 parts each of which has a title and deals with a different aspect of the law. The parts that are the most relevant to you at present are highlighted in green. Part Part 1 – General

Part 2 – Administration

Part 3 – Manufacturing and wholesale dealing

Description Contains important provisions that apply to much of the rest of the Regulations. These include a description of the role of Ministers and general definitions, including “medicinal product” and “advertisement”. There are further definitions in other Parts for terms that are only used in those Parts. Allows for the continuing functioning of a number of advisory bodies, including the Commission on Human Medicines and the British Pharmacopoeia Commission. It also provides rules for the appointment and role of expert advisory groups. With several associated schedules, sets out the rules for manufacturing, importing and wholesale dealing. It requires that these activities be the subject of a licence and establishes what the licensing authority must consider when assessing an application for a licence. It also provides rules around the suspension, revocation, and varying of licences and sets out requirements for Responsible Persons and Qualified Persons. It implements Titles 4 and 7 of Directive 2001/83/EC and includes provisions that were previously in Part 2 of the Medicines Act 1968 and the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789).

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Part 4 – Requirement for authorisation

Part 5 – UK marketing authorisations

Part 6 – Certification of homeopathic medicinal products

Part 7 – Traditional herbal registrations

Part 8 – 126a authorisations

Part 9 – Borderline products

Part 10 – Exception to requirement for marketing authorisation

The Human Medicines Regulations 2012

The requirement that medicinal products be the subject of whichever is appropriate of a marketing authorisation, homeopathic certificate of registration, traditional herbal registration or Article 126a authorisation is a central feature of the legal framework and set out in this Part, along with provision for its enforcement. Contains detailed requirements regarding marketing authorisations. It sets out the material that needs to accompany applications for authorisations, and makes specific provision for generic medicinal products, biological medicinal products, products with well-established medicinal use, and new combinations of active substances. It also establishes the criteria that are considered in determining whether a product needs to be subject to prescription requirements. The Part imposes certain obligations on authorisation-holders, such as a requirement to take into account scientific and technical progress, and contains rules relating to revocation, variation, suspension, withdrawal of authorisations. Finally, it contains enforcement provision for medicinal products that are subject to the Paediatric Regulation. This Part implements Title 3, Chapter 1 of Directive 2001/83/EC and consolidates material found for the most part in the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (SI 1994/3144) Describes the homeopathic medicinal products to which it applies and sets out information that must be supplied with an application for a certificate of registration. As with marketing authorisations, it imposes certain obligations on registration holders and sets out rules regarding revocation, variation, withdrawals, and suspensions. Implements Chapter 2, Title 3 of Directive 2001/83/EC and consolidates the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (SI 1994/105). Describes the traditional herbal medicinal products to which it applies Part and sets out the information that must be supplied with an application for a traditional herbal registration. As with marketing authorisations and certificates of registration for homeopathic products, it imposes certain obligations on registration-holders and sets out rules regarding revocation, variation, withdrawals, and suspensions. Implements Chapter 2a, Title 3 of Directive 2001/83/EC and consolidates material currently found in the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (SI 2005/2750). Implements Article 126a of Directive 2001/83/EC. This article permits Member States, for justified public health reasons, to authorise the placing on the market of medicinal products authorised in another EEA state in the absence of a UK marketing authorisation. Establishes a process that may be followed when the licensing authority determines provisionally that an unlicensed product is a medicinal product and therefore subject to regulation as such. It permits persons supplying the product to make written and oral representations to the contrary, and for final determination. These provisions were previously found in the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (SI 1994/3144). Brings together exceptions from certain licensing requirements that are found in several different statutory instruments. These include the provision for “specials” that were previously in the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (SI 1994/3144) in accordance with the derogation found in Article 5(1) of Directive 2001/83/EC. These are unlicensed medicinal products that can be supplied providing that certain conditions are met. The Part also makes provision for parallel import licences, and provides an exemption from marketing authorisation requirements for advance therapy medicinal products and the supply of unlicensed medicines in response to the spread of toxic substances or nuclear radiation.

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Part 11 – Pharmacovigila nce

Part 12 – Dealings with medicinal products

Part 13 – Packaging and leaflets

Part 14 – Advertising

Part 15 – British Pharmacopoeia Part 16 – Enforcement Part 17 – Miscellaneous and general

The Human Medicines Regulations 2012

Imposes obligations on authorisation holders and the licensing authority in relation to pharmacovigilance (the monitoring of the safety of medicines in clinical use and taking appropriate action to minimise risk). It implements for the first time in UK law Directive 2010/84/EU, which substantially amends the pharmacovigilance framework in Directive 2001/83/EC. Brings together many provisions currently previously in Part III of the Medicines Act 1968, the Medicines (Pharmacy and General Sale – Exemption) Order 1980 (SI 1980/1924), and the Prescription Only Medicines (Human Use) Order 1997 (SI 1997/1830), among others. Together, these provisions establish rules relating to the sale supply and administration of medicinal products related to their classification as general sale list, pharmacy, and prescription only. It also creates a number of exemptions from the basic rules for hospitals, certain professionals and supply under patient group directions (PGDs). Implements obligations found in Title 5 of Directive 2001/83/EC by consolidating provisions previously in Part V of the Medicines Act 1968, the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (SI 1994/3144), and the Medicines (Child Safety) Regulations 2003 (SI 2003/2317). It sets out the information that must appear on packaging and in leaflets, and contains specific rules for Braille, radionuclides, and homeopathic and herbal medicinal products. Implements Title 8 of Directive 2001/83/EC and consolidates the Medicines (Advertising) Regulations 1994 (SI 1994/1932) and the Medicines (Monitoring of Advertising) Regulations 1994 (SI 1994/1933). It contains a variety of prohibitions on advertising, including those relating to unlicensed medicines, prescription medicines, recommendations by scientists, and advertisements aimed at children. In addition, it sets out the information that needs to be included in advertisements and establishes rules for sampling, the promotion of medicinal products by medical sale representatives, and hospitality at meetings. It also contains a chapter called ‘Monitoring of Advertising’, which creates a process by which Ministers can determine whether an advertisement breaches these requirements, and in certain circumstances require that corrective action is taken. Finally, it requires Ministers to consider complaints about advertisements and permits Ministers to apply to a court for an injunction prohibiting a particular advertisement. A short part that provides for the publication of the British Pharmacopoeia and related documents. It consolidates several provisions previously in Part 7 of the Medicines Act 1968. Sets out how the draft consolidated regulations are to be enforced in England, Wales, Scotland, and Northern Ireland. It also provides inspectors with powers to enter, inspect, and search premises and seize medicinal products. Contains a variety of technical provisions, including those relating to prosecutions, defences, decisions made under the regulations, and liability. It also introduces Schedules that contain transitional provisions, consequential amendments, and repeals and revocations.

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The Human Medicines Regulations 2012

What is a Medicine? The term used in the HMR is not ‘medicine’ but a medicinal product. The definition appears in regulation 2 of part 1. Write the main points in the box below.

Note that the first part of the definition is by presentation (claims made for the product) and the second is by function (activity of the product on body systems).

Marketing Authorisation (MA) Before a medicinal product can be marketed, sold, supplied or imported (subject to some exemptions set out later) Regulation 46 of the HMR says that it must have a marketing authorisation (MA). This is one of the key parts of the regulations, it means that all conventional medicines and appliances marketed, sold, supplied or imported to the UK have to have been approved by a regulatory body which has seen evidence of their safety, quality and efficacy when used as specified within the MA. Homeopathic ‘treatments’ and herbal remedies are not classed as medicinal products and have different approval processes. The key difference being that a conventional medicine must be proven to be effective whilst this is not required for herbal or homeopathic products. Homeopathic products must have a certificate of registration and herbal remedies must have a traditional herbal registration or an article 126a authorisation. As of today (30th October 2019) there are two agencies that can issue Marketing Authorisations (MAs) valid in the UK; the Medicines and Healthcare Products Regulatory Agency ( MHRA) and the European Medicines Agency (EMA). If and when we leave the EU, only the MHRA will issue new MAs valid in the UK. MAs already issued by the EMA on existing medicines will continue to be valid for the time being. Any new medicines coming on to the market will be required to seek an MA from MHRA if they are to be marketed in the UK. MHRA and EMA are known as the licensing agencies. Authorisations granted by MHRA are only valid within the UK and those granted by EMA are valid across the EEA. An MA is normally granted for a period of 5 years or less, this being specified in the MA. The MA is initially granted to the developer of a new medicine after their application has satisfied the relevant agency that the medicine is safe, effective and of a suitable quality. The agency is not allowed to consider price; only safety, efficacy and quality. Note that, in this context safety doesn’t only mean the direct effects on the patient, it includes:  Any risks to the person administering the product or, if it is a machine, the person operating it.  Any danger to the health of the community  The extent to which the product may interfere with treatment, diagnosis or prevention of disease. Remember, there are no absolutely safe medicines. All medicines have some undesirable effects, interactions with other medicines or danger in overdose. This means that the agency has to consider the risks of the medicine and balance them against the benefits. This is known as a risk/benefit ratio.

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The Human Medicines Regulations 2012

Efficacy means that the medicine ‘does what it says on the tin’. That is it has the benefits claimed for it. An MA cannot be refused because there is already another product available with greater efficacy. Under quality, the agency must assess whether the medicine can be produced with sufficient quality assurance. Can the applicant guarantee the shelf life and consistent levels of active ingredient with low degradation? You can imagine that applying for a MA is a lengthy and costly process involving gathering and submitting a lot of evidence. The entire process is specified in detail in Part 5 of the regulations. The required evidence is produced during the drug development process which you will look at in depth within the Introduction to Drugs and Medicines strand. Tw...