Medicines Law 1

Medicines Act 1968

  • An enabling act, allowing for more detailed secondary legislation (Statutory Instruments)
  • Much of the Medicines Act and many of the Statutory Instruments have been repealed and replaced with...

1. Human Medicines Regulations 2012

  • brought together and simplified medicines legislation
  • 349 regulations in 17 parts, followed by 35 schedules
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Medicines Act 1968

2. Medical Devices Regulations 2002

  • covers with many non-medicinal product items that pharmacists deal with

3. Misuse of Drugs Act 1971 & Regulations 2001

  • controls the supply of medicines likely to be misused

4. Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008

  • introduced the role of the Responsible Pharmacist
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Regulation 2: Medicinal Products

In these Regulations 'medicinal product' means - 

a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

b) any substance or combination of substances that may be used by or administered to human beings with a view to - 

i. restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

ii. making a medical diagnosis.

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Marketing Authorisations

  • A medicinal product that is manufactured, sold, supplied, exported or imported as a medicinal product in Europe, must have a Marketing Authorisation (MA), also called a Product Licence (PL)
  • This is obtained from Medicines and Healthcare Products Regulatory Agency (MHRA)
  • The manufacturer submits an application to MHRA with detailes of the product, intended use, side effects, containers, labels, stability and safety studies, manufacturing process etc.
  • Medicines which meet the standards of safety, quality and efficacy are granted a Marketing Authorisation
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Considerations for Marketing Authorisations

Safety: Risk/benefit

Efficacy: Does it do what it should do?

Quality: Consistency is key

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'Off label' Medicines

If necessary, a product can be used outside the terms of its Marketing Authorisation. When the medicine is licensed byt its use is not, it is called 'off label' use, e.g.:

  • a product licensed for adults might be given to a child
  • higher (or lower) than licensed dose may be used
  • a different route of administration might be used (e.g. an injectable liquid might be given orally)
  • it might be given to treat a different condition
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Unlicensed Medicines

If the patient's needs still cannot be met, further options are:

  • import a medicine licensed in its home country (EU preferable to outside Europe)
  • an unlicensed medicine may be manufactured in the UK
  • an unlicensed medicine from outside the UK
  • a non-medicine (e.g. a chemical or supplement)

It is legal to do all these things but there is an increased responsibility on the prescriber and the pharmacist.

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Regulation 5: Classification of Medicinal Products

Medicines may only legally be supplied to the public from a pharmacy, unless the medicine could safely be used without the input of a pharmacist.

Three classifications of medicinal product are defined:

  • General Sales List Medicines (GSL)
  • Pharmacy Medicines (P)
  • Prescription Only Medicines (POM)

The longer a medication is used for and the more risks associated with its use, the stricter regulations will be.

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General Sales List Medicines (GSL)

  • Can be sold with reasonable safety without the supervision of a pharmacist.
  • Can be sold by retail from a premises which can be closed as to exclude the public.
  • Must have been made up in a container prepared elsewhere and no opened (original packs).
  • Cannot be sold from a vehicle or market stall.
  • Label is not required to have GSL in a box.
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General Sales List Medicines (GSL)

Certain medicines for human use cannot be classed as GSL:

  • eye ointments
  • products with high doses of vitamin A or D
  • anthelmintics (worming preparations, e.g. roundworms, threadworms)
  • parenteral products (injections)
  • enemas (large volume rectal products)
  • products for use wholly or mainly for irrigating wounds, bladder, vagina, rectum
  • aspirin for children
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Pharmacy Medicines (P)

 

  • Can be supplied from a registered pharmacy by or under the supervision of a pharmacist
  • Label must contain 'P' in a box with no other material
  • Must not be accessible to the public for self-selection
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Prescription Only Medicines (POM)

  • Only supplied on production of a prescription (usually)
  • Only supplied from a registered pharmacy by or under the supervision of a pharmacist
  • A medicinal product will be classified as a POM if it:

- needs medical supervision to reduce the possibility of harm 

- is widely and frequently misused

- is a new active substance

- is for parenteral administration (to be injected)

  • Label must contain POM in a box with no other material
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Prescription Only Medicines (POM)

There are many exemptions that allow supply of a POM without a prescription, e.g.:

  • in an emergency at request of prescriber/patient
  • Patient Group Directions (PGDs)
  • by other healthcare professionals in their practice (certain POMs only)
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