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Introduction to Pharmacy Practice

Dr Adrian Hunt

To identify the differences between primary and secondary legislation. To examine the scope of The Medicines Act 1968. To examine the licensing system for medicinal products.

This is the biggest piece of law that affects pharmacy. It is an example of CRIMINAL LAW.

Thalidomide tragedy. European Economic Community (EEC) Directives.

An Act or Parliament is referred to as PRIMARY legislation. Primary legislation provides a legal framework that sets an outline or overview of a subject. The areas covered by the Medicines Act include the following.

The major issues covered by the Act are: Licensing of medicines. Licensing the manufacture of medicines. Licensing for the wholesale supply of medicines. Control of the sale or supply of medicines. Control on the promotion of medicines.

Detailed rules are made under the Act and these are referred to as SECONDARY (delegated) LEGISLATION Since the Medicines Act was passed in 1968 a large number of REGULATIONS and ORDERS have been made. For example:
SI 1994 No 3144 Medicines (For Human Use) (Marketing Authorisations etc) Regulations 1994.

Secondary Legislation is legislation made under a Statute (Act) and so the different types of secondary legislation are referred to as STATUTORY INSTRUMENTS. (SI)

In August 2012 the Human Medicines Regulations (2012) was introduced which consolidated much of the existing secondary legislation passed under the Medicines Act into one set of Regulations.

Responsibility for the Medicines Act and legislation made under it rests with the Minister(s) of Health. Commission of Human Medicines advises Government.

Look at the website for the Commission for Human Medicines. nesadvisorybodies/CommissiononHumanMed icines/index.htm

Primary responsibility rests with the Minister of Health. Enforcement is delegated to: MHRA (Licensing matters). GPhC (Other matters) Both organisations have inspectors.

The law refers to relevant medicinal product rather than medicine. A relevant medicinal product is defined as.

(a) Any substance or combination of substances presented for treating or preventing disease in human beings. (b) Any substance or combination of substances which may be administered to human beings with a view to making a diagnosis or to restoring, correcting or modifying physiological functions in human beings.

All relevant medicinal products have to be granted a MARKETING AUTHORISATION. Without this they cannot be used for medicinal purposes. Products with a MARKETING AUTHORISATION are referred to as being licensed There are a small number of exceptions to this rule.

Marketing Authorisations are granted by one of two bodies: Medicines and Healthcare Regulatory Agency (MHRA). The European Medicines Agency (EMEA). (These are referred to as licensing authorities

Will only be issued if the licensing authority is satisfied about the following:
The product is safe. The product is of suitable quality. The product is efficacious. Submission must include a SUMMARY OF PRODUCT CHARACTERISTICS.

In order to ensure patient safety the manufacture and distribution of medicines are also subject to licensing regulations. Manufacturers Licences. Wholesale Dealers Licences.

Read and make notes on the document on the licensing system which is on Victory. Have a look at some Summaries of Product Characteristics on the following website: Look at the websites for the following organisations: Medicines and Healthcare Regulatory Agency (MHRA) The European Medicines Agency (EMEA)

If you would like to read up more about the scope of The Medicines Act 1968 and the licensing process, the following are a good starting point: Dale and Appelbes Pharmacy Law and Ethics (9th) Edition. Chapters 2 and 3. FASTtrack Law and Ethics in Pharmacy Practice. Chapter 2.

Test your understanding of the licensing system by completing the MCQ test which can be downloaded from Moodle.