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Flashcards in Year 2 Semester 2 Deck (35):

Where is legislation for medicines set out?

In HMR 2012


What does legislation for medicines deal with?

Licensing affecting manufacture, sale, supply and importation of medicinal products.


What does Part 3 of HMR deal with?

Manufacturing and wholesale dealing


What does Part 4 of HMR deal with?

Requirement for authorisation


What does Part 5 of HMR deal with?

Marketing authorisations


What does Part 6 of HMR deal with?

Certification of homeopathic medicinal products


What does Part 7 of HMR deal with?

Traditional herbal registration


What does Part 9 of HMR deal with?

Borderline products


What does Part 10 of HMR deal with?

Exceptions to requirements for marketing authorisations etc


What are the main objectives of legislation?

- Ensure efficacy, safety and quality of the medicinal product
- withdrawal from use if any danger comes to light


Are authorised products and investigational products covered by legislation?



Define medicinal product

any substance or combination of substances which are:
1. presented as having properties that prevent or treat disease in humans
2. used by / administered to humans


Define authorised medicinal product

Product with marketing authorisation certificate of registration and traditional herbal registration


Define relevant medicinal product

A medicinal product that isn't a registrable homeopathic or traditional herbal medicinal product BUT has marketing authorisation


Define borderline substance

Shouldn't have any pharmacologically active substances or make medicinal claims.


Define medical device

Product covered by Medicinal Devices Regulation 2002 - includes sutures, dressings, contact lens care products.


What mark do medical devices have?

CE mark


What does legislation cover?

Involvement at any stages - licences and certificates are used


What are the licences and certificated available?

- Marketing authorisation
- Certificate of registration
- Traditional herbal registration
- Manufacturers licence
- Clinical trial authorisation


What do all relevant medicinal products require?

A marketing authorisation


In what circumstance was a 'product licence of right' granted?

Given to medicines that were on the market prior to Medicines Act 1968


Why is a MA required?

So that a product can be manufactured or assembles, imported or exported and sold or supplied. A medicinal product must be covered by a MA and held by the person responsible.


What must an application for a MA in the UK include?

1. Name and permanent address
2. Name of medicinal product
3. Detailed specification of product and constituents
4. Evaluation of potential environmental risks
5. Methods of manufacture and quality control
6. Data on - indications, compatibility and clinical studied
7. Pharmacovigilence
8. SPC, package and leaflet
9. Legal category


What are the types of application for a MA?

- New active substances
- Abridged substances
- Biological and biotechnological products


What must the licensing authority be satisfied with?

- product is safe and efficacious
- facilities for manufacture and quality control are adequate to ensure conformity with specification


How long are MAs initially granted for?

5 years - need to be renewed on expiry


What records should holders of MAs keep?

- adverse products
- sales / supplies
- sources of all materials


Are most medicinal products with a MA licence for used in children?

No - most have only been tested in adults and so use in children is unlicensed


What is the new category of MA for children?

Paediatric Use Marketing Authorisation (PUMP)


What age range was Bucculam licensed for?

3months - 18y/o
used to treat severe convulsions and epileptic seizures


When was Bucculam licensed for children?

7th September 2011


What are the labelling requirements for relevant medicinal products?

- Legible, comprehensible and indelible
- English or English + other languages
- Braille on outer packaging for blind or partially sighted people


What are the Schedule 24 outer & packaging information requirements?

1. Name of medicinal product
2. Strength and pharmaceutical form
3. Target audience
4. If it has up to 3 active substances, a common name for each active substance
5. Statement of active substances in product given as number and words per dosage unit or according to administration form for a given volume of weight
6. Pharmaceutical form & contents by weight, volume or doses of product
7. A list of all excipients or a list of excipients known to give effect
8. Method / ROA
9. Space for prescribe dose to be indicated
10. Warning that it should be kept out of children's reach
11. Special warning applicable to the product
12. Expiry date in clear terms
13. Any special storage precautions
14. Precautions relating to disposal
15. Name and address of holder of MA
16. Number of MA
17. Batch number
18. Instructions for use if not POM


What is required for labelling blister packs?

1. Name of product
2. Strength and form
3. Who product is for
4. Name of active substances
5. Name of MA holder
6. Expiry date
7. Batch number


What are the labelling requirements for paracetamol?

1. Products that contain paracetamol should say that they contain paracetamol
2. ' do not take more than the label says. If you don't better, go to GP'